NYIPLA The Report: 2024 Spring

In This Issue: “A Threat to the Public”? Non-Attorney Law Firm Ownership in Various Jurisdictions  By: Daniel Douglas, Weitzman Law Offices, LLC  Regents of the Univ. of Minnesota v. Gilead Sciences, Inc.: Indeterminacy in a Forest of Trees By: Andrea M. Wilkovich, Hoffmann & Baron, LLP  Effects of Xerox v. Bytemark and Nested Bean Inc. v. Big Beings Pty Ltd  By: Brandon R. Theiss, Volpe Koenig In This Issue: Spring 2024 Text In This Issue: Text Follow NYIPLA on social media! President's Corner “A Threat to the Public”? Non-Attorney Law Firm Ownership in Various Jurisdictions By: Daniel Douglas, Weitzman Law Offices, LLC Regents of the Univ. of Minnesota v. Gilead Sciences, Inc.: Indeterminacy in a Forest of Trees By: Andrea M. Wilkovich, Hoffmann & Baron, LLP Effects of Xerox v. Bytemark and Nested Bean Inc. v. Big Beings Pty Ltd  By: Brandon R. Theiss, Volpe Koenig Abitron Austria GmbH v. Hetronic Int'l, Inc. - Extraterritoriality of U.S. Trademark Protection: How Far Does it Go? By: Michelle P. Ciotola, Cantor Colburn LLP OpenSky Industries, LLC. V. VLSI Technology LLC– Fall-Out From Abusing The IPR Process By: Robert J. Rando and Alexis E. Marin, Greenspoon Marder, LLP Developments in the U.S. Copyright Office and U.S. Patent and Trademark Office Related to Artificial Intelligence  By: Robert E. Rudnick and James T. Corcoran, Gibbons P.C. The GDPR Meta Decision from the Irish Data Authority: Improper Transfers of Personal Data from Europe to the U.S. By: Simon P. Walsh, Cadwalader, Wickersham & Taft London In Re Monolithic Power Systems, Inc. – When Home for a Remote Worker can be a Residence By: Lynda L. Calderone, Calderone Bullock LLC The Continuing Saga of Section 101 Patent Eligibility: Patent Law After Tropp and Interactive Wearables Cert. Denials By: Keith McWha, Lerner David CHROMADEX, INC., Trustees of Dartmouth College v. ELYSIUM HEALTH, INC. By: Kathleen D. Rigaut, Howson & Howson, LLP Historian's Corner Board Minutes NYIPLA Events  Welcome New Members Upcoming Programs ROBERT RANDO Spring 2024 Dear NYIPLA Members, Thank you for entrusting me with the opportunity to lead our incredible Association during this past year. As my term in office as President has come to an end, I am reflecting on the wonderful and productive year we have had. Together, we achieved many of the goals I set out for us during the past year - culminating in the very successful 102nd Annual Dinner in Honor of the Federal Judiciary. None of which could have been accomplished without the hard work, diligent efforts, and dedication of my fellow Officers, Board members, Committee Chairs, other NYIPLA members, and Feikje and her staff. As I have stated before, my mission for the year, was to lay the foundation for building a bridge to the new generations of leaders, to grow our membership, and to encourage our members to continue to build on the egalitarian nature of intellectual property rights that cultivates and recognizes the richness of diversity and has historically empowered individuals from all walks of life to realize the promise of the American Dream. I am happy to report that all three of these goals were acted upon, were in large part achieved, and I trust, and hope, will continue well beyond my term in office. The NYIPLA is moving forward into the future with great momentum, significant membership growth, and many stellar future leaders. The several new Committees that we created, are and will be instrumental not only in bridging the past to the future but enable NYIPLA to remain at the forefront of nascent technologies as well as emerging legal issues across the entire spectrum of intellectual property. I encourage all of our members to investigate and join one or two of them. Three of the new Committees, the Arbitration, Mediation & Neutrals Committee, the Design Patents Committee, and the Membership Committee are specifically seeking additional members. I can now report that the video podcast series entitled “The Bridge to Future Leaders” in which I have conducted one on one interviews with a majority of our thirty-two past presidents is posted on our website. I will continue to use the platform to interview consequential and influential NYIPLA members and other leaders in the intellectual property space. One of which will soon be posted on the website, my interview with our beloved member, the Honorable Pauline Newman, Circuit Judge for the U.S. Federal Circuit. Speaking of the website, look for the new website that RRR Associations and I worked together on to update. It should be released in the near future. And, speaking of updates, the members of the ad hoc NYIPLA Bylaws project team were successful in conducting a diligent review and provided proposed amendments which were submitted to the Board and approved. There are also additional initiatives that are a work-in-progress and I intend to continue the effort to fulfill them. One program that a sub-committee of the Fashion Law Committee has been working on involves a novel program recruiting members of the judiciary to participate in a “fashion show” featuring redesigns of the traditional Judges’ black robes. Stay tuned for this great program to hopefully roll out in December. Another event that has been in the planning stage is the return of the NYIPLA annual Golf Outing as an Autism-related charitable event . Anyone interested in assisting with this event please reach out to the administration or to me. For a list and highlights of the various programs and events that occurred during the past year, bringing value to our members and reinforcing our commitment to the NYIPLA mission, I refer you to our last issue of the Report. Be sure to attend the next upcoming NYIPLA event: “ The NYIPLA Eighth Annual Second Circuit Summer Associate Moot Court CLE Program” on July 16, 2024, at 5:00 pm. Consult the website for registration information regarding this 1.5 CLE credit program (free for members). Some final thoughts and contemplations. While we live in turbulent times, the mission of our Association continues unabated to break through the cacophony of dissonant voices concerning intellectual property. Our collaboration and engagement with the three branches of the federal government enables us to assume a leadership role and to have our collective voices heard regarding the impact the decisions by the government have on the stability and quality of the acquisition, enforcement, and protection of IP rights. We may not always appreciate that as practitioners, and particularly as members of NYIPLA, what we do profoundly affects the lives of inventors, creators, and entrepreneurs, the broader community of humankind and the human condition. It is both humbling and exhilarating at the same time. As I stated in my speech at the Annual Judges Dinner: “How fortunate are we that, as members of NYIPLA, and as lawyers, we get to practice alongside and work with dreamers that have taken us to the outer reaches of our solar system, that have improved the human condition and cured diseases, the authors and writers that build on the ideas of the great novelists, playwrights, artists, poets and songwriters to create writings, plays, films and songs that touch the very essence of what it means to be human, and the entrepreneurs that toil in a garage and establish a brand that becomes the hallmark of a generation.” In closing I will say that it has been an honor and a privilege to lead this Association during the past year. I am also proud and thrilled that I leave us now in the very capable hands of our new President, Patrice Jean. Her energy, creativity, and outstanding leadership abilities are second to none. With Patrice at the helm, not only will NYIPLA membership grow and thrive, but we will also continue to realize the benefits and value that NYIPLA membership provides; and she will drive new and innovative initiatives and prospects for increasing it all in the future. Thank you. NYIPLA President's Corner Text NYIPLA Calendar “A Threat to the Public”? Non-Attorney Law Firm Ownership in Various Jurisdictions By: Daniel Douglas, Weitzman Law Offices, LLC I. A “THREAT TO THE PUBLIC” On August 7, 2023, the New Jersey State Bar Association released a position paper affirming its longstanding opposition to the possibility of nonlawyers owning a law firm or maintaining a business partnership with a lawyer. “The threat posed to the public and individual clients by non- lawyers practicing law and performing legal work outweighs the potential for good. Although the NJSBA remains mindful of the needs throughout New Jersey for affordable and low-cost legal services, inviting non-lawyers to practice law is not the solution…” The public has always been wary of lawyers’ profit motive, and misuse of client funds or accepting cases beyond a lawyer’s competency remain leading causes of bar sanctions or disbarment. The relative opacity of the legal profession can further increase the incentive for lawyers to conceal unethical conduct from their clients. As a result, it is reasonable to establish rules that mitigate the inherent risk that attorneys’ profit motive will interfere with their duties to their clients and as officers of the court. One such rule that has been widely accepted is ABA Model Rule 5.4(a), which generally prohibits business partnerships or fee sharing between lawyers and nonlawyers. The rule is largely motivated by a belief that nonlawyers will not feel the same scruples that lawyers might, and will not put the client first over the maximization of profits. At the very least, the rule ensures that those who will be making fraught ethical decisions will be answerable to the bar as licensed lawyers, rather than being nonlawyers who can walk away and form a new business after being accused of misconduct. Forty-eight states have adopted and continue to enforce the ABA Model Rule, while Arizona, Utah, and the District of Columbia have begun to experiment with departures from the traditional rule. Among the forty-eight, there has been both some discussion of experimentation and some backlash in response (including the NJSBA position paper mentioned above). II. THE ABA MODEL RULES OF PROFESSIONAL CONDUCT Rule 5.4(a) states that “A lawyer or law firm shall not share legal fees with a nonlawyer, except” for specific carve-outs, such as compensating a deceased attorney’s heirs, compensation packages for a lawyer’s employees, or compensation to non-profits, in narrow circumstances. Rule 5.4(b) continues, “A lawyer shall not form a partnership with a nonlawyer if any of the activities of the partnership consist of the practice of law,” and Rule 5.4(d) continues that “A lawyer shall not practice with or in the form of a professional corporation or association authorized to practice law for a profit, if” a nonlawyer owns any interest, serves as a director or officer, or directs and controls the professional judgment of lawyers. Despite movement in some states towards abrogation or wider exceptions to state implementations of Rule 5.4, the ABA remains in firm support of the rule. Resolution 115 was overwhelmingly approved by the ABA House of Delegates in February 2020. This joint resolution by the ABA Center for Innovation and four ABA standing committees urged all states to consider “regulatory innovations that have the potential to improve the accessibility, affordability, and quality of civil legal services,” but that “nothing in this Resolution should be construed as recommending any changes to any of the ABA Model Rules of Professional Conduct, including Rule 5.4, as they relate to nonlawyer ownership of law firms…” III. VARIATIONS IN THE DISTRICT OF COLUMBIA Washington, D.C. has had the longest experimentation with business structures permitting nonlawyer involvement in the legal practice. The District’s Rule 5.4(a) largely tracks with the Model Rule 5.4(a), but the District’s Rule 5.4(b) states that “A lawyer may practice law in a partnership or other form of organization in which a financial interest is held or managerial authority is exercised by an individual nonlawyer who performs professional services which assist the organization in providing legal services to clients…” and under the conditions that the organization exclusively provide legal services, that nonlawyers also agree to comply with the rules of professional conduct, that lawyers also take responsibility for ensuring nonlawyer compliance in writing.Rule 5.4(b) has departed from the Model Rule since 1991.  The intent of the rule has been a bit different from the typical idea of “nonlawyer owned firms,” with the stated intent of the DC Bar being that nonlawyers “economists work in a firm with antitrust or public utility practitioners,” “psychologists work with family law practitioners to assist in counseling clients,” “nonlawyer lobbyists work with lawyers who perform legislative services,” or “certified public accountants work in conjunction with tax lawyers,” so that the services provided by the firm to clients will be enhanced.Ownership of a law firm by a for-profit corporation, rather than a partnership, remains prohibited. Nevertheless, a firm with a nonlawyer ownership or partnership interest is permissible, and nonlawyers may even be listed in a firm name or on firm letterhead, so long as there is an appropriate disclosure avoiding the danger of misleading the public. See Ethics Opinion 244, issued November 23, 1993. IV. ABROGATION IN ARIZONA Arizona’s Supreme Court abrogated Rule 5.4 completely in August 2020, effective January 2021, and instead transitioned to a licensure system for “alternative business structures” (ABSs), nonlawyer-owned entities employing lawyers. Arizona has established a regulatory sandbox wherein ABSs apply for approval from the Arizona Supreme Court. Fifty-two such businesses are now operating in Arizona and providing legal services to the public. V. VARIATIONS IN UTAH Utah’s Supreme Court amended Rule 5.4 in 2020, opening the door relatively widely to nonlawyer-owned entities practicing law. Under the amended rule, a lawyer or law firm has a duty to prevent all interference with the lawyer’s “professional independence of judgment,” “duty of loyalty to a client”, and “protection of client confidences.” The lawyer or law firm must also ensure all clients have informed consent that a nonlawyer has an interest in the legal fees. Once these conditions have been satisfied, a nonlawyer-owned law firm can operate so long as it has requested licensing from the Utah Supreme Court’s Office of Legal Services Innovation, as required by Utah Supreme Court Standing Order No. 15. Forty-four such “authorized entities”—nonlawyer-owned firms or legal aid organizations—have been licensed to do so, as ofAugust 2023. VI. MOVEMENT IN NEW YORK In New York, Rule 5.4 is maintained and nonlawyer ownership of a New York law firm is prohibited. However, recent ethics opinions have opened up the possibility of some level of involvement and partnership. For example, in the 2022 Ethics Opinion 1246, the question was raised of partnership between a New York lawyer and a British lawyer who also happens to be part of an ABS in the U.K., owned by a non-lawyer. New York does not require that all lawyers be licensed in New York, so the partnership with the British lawyer is not in itself problematic, so long as there is no deception or misleading. If ABSs continue to become more common in other states, we may begin to see interstate partnerships between lawyers of thoseABSs and New York firms. VII. MOVEMENT IN CONNECTICUT The Connecticut Bar Association’s State of the Legal Profession Task Force was established in 2020, including a sub-committee for “Advancing the Legal Industry through Alternative Business Models.” The sub-committee has been tasked with exploring the evidence in favor of and against ABSs and recommending changes to the Connecticut Rules of Professional Conduct, if ultimately deemed advisable. It does not appear that the sub-committee has recommended or the state bar acted to make any such changes as of 2023. However, with the groundwork in place to recommend such changes, there may be experimentation in the coming years. VIII. PENNSYLVANIA AND NEWJERSEY As of the time of writing, it does not appear that Pennsylvania or New Jersey are seriously considering any substantive changes to Rule 5.4 or establishment of nonlawyer-owned firms or ABSs. IX .OTHER STATES’ RESPONSES Many states are experimenting with permitting strictly curtailed scopes of practice by nonlawyers within law firms, such as increased authority and independence of paralegals. However, few are actually considering modifications to their implementations of Model Rule 5.4. From 2015 to 2020, Washington allowed “limited license legal technicians,” nonlawyers with a limited scope license to perform lawyer-adjacent services, to be minority owners of a law firm. That policy experiment was ended without being renewed after 2020. California established a task force in 2020 to examine Rule 5.4 and recommend broadening, but like Connecticut, no substantive changes have been implemented. A similar committee in Florida actually made the recommendation in 2021 to follow Utah’s model and establish a regulatory sandbox to experiment with nonlawyer-owned firms. The Florida Bar Board of Governors rejected the recommendation, however, and in 2022 the Florida Supreme Court reaffirmed the retention of Rule 5.4 in its original form. The Chicago Bar Association has made recommendations that the Illinois Bar amend Rule 5.4, but likewise, no action has been taken. X. CONCLUSION The prohibition of nonlawyer ownership / partnership in law firms is underlay by a valid ethical concern. However, many argue that the competing concerns of providing legal services more efficiently to underserved communities and promoting competition are beginning to eclipse the fear of firms taking advantage of clients. Movement has been slow, but if Utah and Arizona continue to report positive results with their experiments, it is likely that there will continue to be experimentation in states with larger bars, and perhaps ultimately a refinement to Model Rule 5.4 to provide at least some flexibility with regard to nonlawyer ownership. I. INTRODUCTORY REMARKS This paper discusses the Opinion by Circuit Judge Lourie for the Court of Appeals for the Federal Circuit (“CAFC”) in the case of Regents of the Univ. of Minnesota v. Gilead Sciences, Inc., 61 F.4th 1350 (Fed. Cir. 2023) (“the Gilead case”). Circuit Judge Lourie, Circuit Judge Dyk, and Circuit Judge Stoll considered, inter alia, whether a finding by the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) that U.S. Patent No. 8,815,830 (“the ‘830 patent”) is not entitled to the filing dates of certain applications (referred to as “NP2-P1”) is supported by substantial evidence. Id. at 1353, 1356. II. BACKGROUND Sofosbuvir is “an FDA-approved drug marketed by” Gilead Sciences, Inc. (“Gilead”) “for treating chronic hepatitis C infections.” 61 F.4th at 1354 (citing J.A. at 142-43). With sofosbuvir “[f]alling within the genus of claim 1” of the ‘830 patent, Gilead petitioned for an Inter Partes Review (“IPR”) of claims 1-9, 11-21, and 23-28 of the ‘830 patent, which is owned by Regents of the University of Minnesota (“Minnesota”). 61 F.4th at 1354 (citing J.A. at 389-465); Gilead Scis., Inc. v. Regents of the Univ. of Minn., No. IPR2017-01712, 2021 Pat. App. LEXIS 4850, 2021 WL 2035126 (P.T.A.B. May 21, 2021) (“Decision”). A. The ‘830 Patent and its Priority Applications 1. The‘830Patent Claim 1 of the ‘830 Patent recites: A compound of formula I:   wherein: R1 is guanine, cytosine, thymine, 3-deazaadenine, or uracil, optionally substituted by …; R2 is halo; R6 and R7 are independently H or (C1-C6) alkyl; R3 is hydroxy; R4 is hydrogen, (C1-C6)alkyl, (C3-C6)cycloalkyl, aryl, aryl(C1-C6)alkyl, or 2-cyanoethyl; R5 is an amino acid; X is oxy, thio or methylene; …. (See claim 1 of the ‘830 patent). Claims 2-28 are dependent claims. (See claims 2-28 of the ‘830 patent). 2. The Priority Applications The application that issued as the ‘830 patent, i.e., U.S. Application No. 14/229,292, was filed on March 28, 2014, and claimed priority from four applications. 61 F.4th at 1354-1355. The applications from which priority was claimed are set forth in the below table. 3. P1 Claim 1 of P1 recites: A compound of formula I:   wherein: R1 is adenine, guanine, cytosine, thymine, 3-deazaadenine, or uracil, optionally substituted by …; R2 and R6 are each independently hydrogen, halo, hydroxy, (C1-C6)alkyl, (C3-C6)cycloalkyl, (C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl, (C1-C6)alkanoyloxy, trifluoromethyl, azido, cyano, -N(Rz)C(═O)N(Raa)(Rab), -N(Rz)C(═O)ORac, or NRadRae, provided that one of R2 and R6 is hydroxy halo, (C1-C6)alkoxy, (C3-C6)cycloalkyloxy, trifluoromethyl, cyano, or NRadRae…; R3 is hydrogen, halo, hydroxy, (C1-C6)alkyl, (C3-C6)cycloalkyl, (C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl, (C1-C6)alkanoyloxy, trifluoromethyl, azido, cyano, -N(Rz)C(═O)N(Raa)(Rab), -N(Rz)C(═O)ORac, or NRadRae; R4 is hydrogen, (C1-C6)alkyl, (C3-C6)cycloalkyl, aryl, aryl(C1-C6)alkyl, or 2-cyanoethyl; R5 is an amino acid, a peptide or NRaRb; R7 is hydrogen, halo, hydroxy, (C1-C6)alkyl, (C3-C6)cycloalkyl, (C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl, (C1-C6)alkanoyloxy, trifluoromethyl, azido, cyano, -N(Rz)C(═O)N(Raa)(Rab), -N(Rz)C(═O)ORac, or NRadRae; X is oxy, thio or methylene; …. (See claim 1 of P1).  Claim 2 lists five possibilities for R1 (one of which is uracil), with R1 being optionally substituted as specified in claim 2. Claim 13 depends from any one of claims 1-11 and recites that R2 is halo. Claim 21 depends from anyone of claims 1-20 and recites that R3 is hydroxy. Claim 33 depends from any one of claims 1- 32 and recites that R5 is an amino acid. Claim 45 depends from any one of claims 1-44 and recites that R6 is hydrogen or (C1-C6)alkyl. Claim 47 depends from any one of claims 1-46 and recites that R7 is hydrogen or (C1-C6)alkyl. (See claims 2,13, 21, 33, 45 and 47 of P1). B. IPR Gilead argued that claims 1-9, 11-21, and 23-28 of the ‘830 patent were not entitled to their claimed priority date and were, therefore, anticipated by U.S. Patent Application Publication 2010/0016251 to Sofia (“Sofia”), which had published on January 21, 2010. 61 F.4th at 1354 (citing J.A. at 389-465). Example 25 of Sofia discloses (S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro- 3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phosphorylamino}-propionic acid isopropyl ester, which has the following structure:  Sofia at 49, 58. According to Gilead, “in the nomenclature of the ‘830 patent,” Sofia contains oxy at X, uracil at R1, fluoro at R2, hydroxy at R3, phenyl at R4, the isopropyl ester of L-alanine, an amino acid, at R5, methyl at R6, and hydrogen at R7. Decision, 2021 Pat. App. LEXIS 4850, at*11 (P.T.A.B. May 21, 2021) (citing Pet. 18 (citing Ex. 1011 P 143)). It was “agreed that Sofia discloses every limitation of each challenged claim.” 61 F.4 that 1354 (citing Decision, 2021 Pat. App. LEXIS 4850, [WL] at *5). As noted by the CAFC, “[t]he result of the IPR thus hinged on Sofia’s prior art status and the critical date of the ‘830 patent.” 61 F.4th at 1354. The Board determined “that NP4 was filed after Sofia was published, and that NP3 contained the same disclosure as NP2.” Id. at 1355. The Board’s “priority analysis” thus focused “on the disclosures of NP2 and P1, each of which was filed before Sofia was published.” Id. (citing Decision, 2021 Pat. App. LEXIS 4850, [WL] at *5).  According to the Board, “NP2-P1 failed to provide written description sufficient to support the ‘830 patent’s priority claim” with there being “neither ipsis verbis support nor sufficient blaze marks to guide the skilled artisan to the claims of the ‘830 patent.” 61 F.4th at 1355. As claims 1-9, 11-21, and 23-28 “were not entitled to a priority date earlier than their own filing date of March 28, 2014,” the decision of the Board held that those claims are unpatentable as anticipated by Sofia. 61 F.4 that 1353, 1355 (citing Decision, 2021 Pat. App. LEXIS 4850, [WL] at *16-17). III. THE CAFC OPINION The CAFC considered an appeal by Minnesota of the decision of the Board. 61 F.4th at 1353. In particular, the CAFC reviewed “the Board’s decision regarding written description for substantial evidence.” 61 F.4th at 1356 (citing In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000)). A. The Legal Standard As noted by the CAFC, “[t]o receive ‘the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112.” 61 F.4th at 1356 (citing Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997)). As further noted by the CAFC, “[w]ritten description of ... a genus of chemical compounds … raises particular issues ….” 61 F.4th at 1356 (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350-52 (Fed. Cir. 2010) (en banc)). Significantly, “[a] broad outline of a genus’s perimeter is insufficient.” Id. Rather, as stated by the CAFC: …sufficiently describing a genus under Ariad requires a description of a claimed genus disclosing either (1) “a representative number of species falling within the scope of the genus,” … or (2) “structural features common to the members of the genus,” either of which must enable “one of skill in the art [to] ‘visualize or recognize’ the members of the genus.” 61 F.4 that 1358 (citing Decision, 2021 Pat. App. LEXIS 4850, [WL] at *4; quoting Ariad, 598 F.3d at 1350 (emphasis added)). With regard to genus claims, the CAFC has “looked for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” 61 F.4 that 1356 (citing In re Ruschig, 379 F.2d 990, 994-95, 54C.C.P.A. 1551 (CCPA1967); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326-27 (Fed. Cir. 2000)). According to Fujikawa, “just because a moiety is listed as one possible choice for one position does not mean there is ipsis verbis support for every species or sub-genus that chooses that moiety.” 61 F.4th at 1357 (quoting Fujikawa, 93 F.3d at 1571). As stated in Fujikawa, “[w]ere this the case, a ‘laundry list’ disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus.” Id. As further stated in Fujikawa, “[t]his cannot be because such a disclosure would not ‘reasonably lead’ those skilled in the art to any particular species.” Id. B. Minnesota’s Written Description Arguments on Appeal Minnesota contended “that the Board erred in holding that NP2-P1 do not show a written description of what is claimed in the ‘830 patent.” 61 F.4th at 1355. Minnesota’s argument was not “that it described a sufficient number of species to constitute a written description of the claimed subgenus.” Id. at 1356. Rather, Minnesota argued “that its earlier NP2-P1 applications literally described, or provided blaze marks to, the subgenus of the ‘830 claims in its broad outlines.” Id. Moreover, Minnesota argued “that the Board erred in failing to consider the holdings in Ariad.” Id. at 1358. C. The CAFC’s Analysis With the NP2-P1 disclosure “being broader than claim 1 of the ‘830 patent,” the CAFC noted that the NP2-P1 disclosure “has a relationship of genus to the narrower subgenus of the ‘830 patent claims.” Id. at 1356. NP2-P1 were determined to have “similar disclosures” in most “pertinent” respects. Id. at 1355. 1.No Ipsis Verbis Disclosure The CAFC disagreed with Minnesota’s argument “that P1 claim 47, combined with P1 claim 45 (… R6 substituents), P1 claim 33 (… R5 substituents), P1 claim 21 (… R3 substituent), P1 claim 13 (… R2 substituents), P1 claim 2 (… R1 substituents), and P1 claim 1 (…R4 substituents and … X)” constitutes “an ipsis verbis disclosure of the subgenus claimed in the ‘830 patent.” 61 F.4 that 1357. As stated by the CAFC, “[f]ollowing this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option.” Id. The CAFC noted that “all those optional choices do not define the intended result that is claim 1 of the ‘830 patent.” Id. The CAFC found Minnesota’s argument to be akin to an ipsis verbis argument rejected in Fujikawa. Id. (citing Fujikawa, 93 F.3d at 1571). As per the CAFC: “The claims of P1 recite a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group … it is quite unclear how many compounds actually fall within the described genera and subgenera.” 61 F.4th at 1357. The CAFC thus affirmed “the Board’s decision that there is no ipsis verbis written description disclosure provided by P1 claim 47 sufficient to support the ‘830 patent’s claims.” Id. 2. Insufficient Blaze Marks With Minnesota “failing to establish that P1 claim 47 constitutes an ipsis verbis disclosure,” P1 claim 47 was recast as a blaze mark. Id. at 1358. As per the CAFC, “… even if P1 claim 47 ‘blaze[s] a trail through the forest’ that runs close by the later-claimed tree, the priority applications ‘do[] not direct one to the proposed tree in particular, and do[] not teach the point at which one should leave the trail to find it.’” Id. (citing Fujikawa, 93 F.3d at 1571). The CAFC concluded “that the Board’s finding that NP2-P1 failed to provide sufficient blaze marks … was supported by substantial evidence.” 61 F.4th at 1358. 3. Ariad It was undisputed that “a representative number of species falling within the scope of the genus” was lacking. Id. (citing Decision, 2021 Pat. App. LEXIS 4850, [WL], at *4; quoting Ariad, 598 F.3d 1350). Thus, “the first requirement” of Ariad was “not at issue.” 61 F.4th at 1358. As regards “the second,” it was not error that “the Board addressed the question whether one of skill in the art would have been able to visualize or recognize the members of the claimed genus by ‘search[ing] for blaze marks that guide a skilled artisan to the claimed subgenera.’” Id. (citing Decision, 2021 Pat. App. LEXIS 4850, [WL], at *10). The CAFC noted that P1 claim 47, “through its multiple dependencies, encompasses a significantly larger genus than that claimed in the ‘830 patent….” 61 F.4th at 1358. With the structures being “so extensive and varied,” the CAFC conveyed that the P1 claim 47 structures “are not sufficiently common to that of claim 1 of the ‘830 patent to provide written description support.” Id. 4. NP3 and NP4 The CAFC noted that, as “NP3 provides the same disclosure as NP2, it too does not provide sufficient written description to support the ‘830 patent claims.” Id. The CAFC also noted that “[e]ven if NP4 did provide written description support for the ‘830 patent claims … Sofia would still be prior art.” Id. D. The CAFC’s Decision The CAFC affirmed the Board’s decision regarding insufficient written description and affirmed the Board’s decision holding claims 1-9, 11-21, and 23- 28 of the ‘830 patent unpatentable as anticipated by Sofia. Id. at 1353, 1360. IV. CONCLUDING REMARKS Yogi Berra reportedly said: “when one comes to a fork in the road, take it.” 61 F.4th at 1357. In the words of the CAFC, “[t]hat comment was notable because of its indeterminacy, its lack of direction.” Id. What is determinate, in the Gilead case, is that a multiple dependent claim in a priority application was insufficient to support a genus encompassed by the multiple dependent claim. Regents of the Univ. of Minnesota v. Gilead Sciences, Inc.: Indeterminacy in a Forest of Trees By: Andrea M. Wilkovich, Hoffmann & Baron, LLP Application Filing Date U.S. Provisional App. 60/634,677 (“P1”) December 9, 2004 International App. PCT/US2005/044442 (“NP2”) December 8, 2005 U.S. Patent App. 11/721,325 (“NP3”) June 8, 2007 U.S. Patent App. 13/753,252 (“NP4”) January 29, 2013 Effects of Xerox v. Bytemark and Nested Bean Inc. v. Big Beings Pty Ltd By: Brandon R. Theiss, Volpe Koenig I. Xerox Corp. v. Bytemark, Inc. In Xerox Corp12. v. Bytemark, Inc, (hereinafter “Xerox”) Director Vidal affirmed the Patent Trial and Appeals Board’s (hereinafter “Board”) decision denying the institution of Xerox’s Inter Partes Review (hereinafter “IPR”) petition IPR2022-00624 in the Director’s sua sponte Director Review. This precedential decision illustrates the importance of providing more than conclusory statements by an expert in support of an IPR Petition. At issue in Xerox is US 10,360,567 (’567 Patent), which relates to both a system and method for the distribution of electronic tickets. The ’567 Patent describes a process where a user can obtain and save an electronic ticket (“e-ticket”) on devices like mobile phones. Upon presenting the e-ticket, it can be verified by personnel through the observation of a visual element that does not require machine scanning. Furthermore, the ’567 Patent outlines a process for checking the authenticity of ticket data and the corresponding software on the user’s device to ensure no unauthorized changes have been made. Of particular importance, the invention detects a user’s fraudulent activity and stores the occurrence of such activity as a “data value” in the data record associated with the user’s account. Xerox filed an IPR petition challenging the validity of the claims of the ‘567 Patent, pointing to WO 2009/141614 A1 by Terrell (“Terell”) and several other secondary references. Xerox contended that Terrell described a system wherein, after identifying fraudulent activity, “the purchaser of the ticket could be blocked from further use of the system or pursued in respect of their potential fraud.” (Terrell, 14:15–17). Xerox further posited that an expert in the field would infer that such a restriction would necessitate documenting the restriction in the user’s account data record. Moreover, they argued that an expert would deem it logical to conclude that restricting the buyer’s access to the system would involve logging a data indicator of the fraudulent activity in the user account’s related data record. In support of these contentions, Xerox relied upon an expert’s declaration, which stated that a skilled artisan “would understand that [] blocking would require recording the blocking in a data record associated with that user’s account” and “would find it obvious that blocking the account of the purchaser from further use of the system would include storing a data value indicating the fraudulent activity in a data record associated with the user account.” (Decision, 2-3). In response, Bytemark contended that Terrell primarily suggests restricting a ticket buyer’s further access to the Terrell system due to suspected fraud. However, Terrell does not specifically mention that this would be executed by noting a data value indicating fraudulent behavior. Instead, other potential methods, like erasing the user’s account or reporting the user for fraudulent actions, might be implied. Bytemark further criticized Xerox’s contentions, asserting that a Person of Ordinary Skill in the Art (“POSITA”) would find the fraud limitation obvious, was conclusory at best and improperly attempts to use a POSITA’s common knowledge to supply a claim limitation that is wholly missing from the prior art without evidentiary support. The Board, in its Institution Decision, agreed with Bytemark and denied the institution of the IPR. The Board reasoned that the expert’s declaration merely repeated Xerox’s attorney’s argument verbatim without providing any additional evidence or technical reasoning. Accordingly, the Board afforded little weight to the expert’s declaration, and as a result, Xerox failed to meet its burden under 35 U.S.C. § 314 of “show[ing] that there is a reasonable likelihood that the Petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” (35 U.S.C. § 314). Xerox requested a rehearing and Precedential Opinion Panel (“POP”) review of the Board’s decision. However, Director Vidal interceded and initiated sua sponte Director Review. In the Director Review, Director Vidal agreed with the Board that the expert declaration “is conclusory and unsupported, adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” (Decision, 5). Director Vidal reasoned that instead of “setting forth facts and evidence in support of [Xerox’s] assertions,” the expert testimony merely “set[] forth [Xerox’s] conclusory assertions as though they [were] facts.” (Decision, 5). Accordingly, Director Vidal applied Federal Circuit precedent, including Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000), which holds that a “[l]ack of factual support for expert opinion to factual determinations, however, may render the testimony of little probative value.” Therefore, Director Vidal affirmed the denial of the institution of an IPR in IPR2022-00624. For Petitioners Director Vidal’s decision in Xerox is consistent with the Federal Circuit’s holding in Facebook, Inc. v. Windy City Innovation (hereinafter “Facebook”). In Facebook, the Court affirmed the Board’s holding that independent claim 1 was not unpatentable as obvious over the asserted prior art when “the Board considered Facebook’s expert’s testimony but determined that it did not add materially to Petitioner’s unpersuasive attorney argument” because it merely repeated Petitioner’s argument, nearly verbatim, without citation to the basis for his testimony.” (Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1340-41 (Fed. Cir. 2020)) (internal markup omitted). Accordingly, it is critical for Petitioners to include in their expert declarations a basis for their testimony and not merely base the testimony upon conclusory facts. For Patent Owners “Whether the prior art discloses a claim limitation, whether a skilled artisan would have been motivated to modify or combine teachings in the prior art, and whether she would have had a reasonable expectation of success in doing so are questions of fact.” (Univ. of Strathclyde v. Clear-Vu Lighting LLC, 17 F.4th155, 160 (Fed. Cir. 2021)) Director Vidal’s decision in Xerox highlights that conclusory expert statements that merely parrot attorney argument are not facts and, therefore, cannot satisfy a Petitioner’s burden for the institution of providing “[a] full statement of the reasons for relief requested, including a detailed explanation of the significance of the evidence including material facts.” (37 C.F.R. § 42.22(a)(2)) (emphasis added). This is critically important for a Petitioner in rebutting invalidity contentions and/or obviousness contentions that require a motivation to combine. In fact, the Federal Circuit expressly holds that “conclusory experttestimony and attorney argument cannot constitute substantial evidence of a motivation to combine.” (Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1375 (Fed. Cir. 2020)). Accordingly, Patent Owners are well-served to highlight how the expert’s alleged motivation to combine is merely a conclusory statement that is not supported by objective factual support and should therefore be afforded little weight. I. Nested Bean, Inc. v. Big Beings US Pty. Ltd In Nested Bean, Inc. v. Big Beings US Pty. Ltd. et al. IPR2020-01234, (hereinafter “Nested Bean”) the Director of the US Patent & Trademark Office (“PTO”), addressed the patentability of multiple dependent claims under pre-AIA 35 U.S.C. § 112, fifth paragraph3. The Director granted a rehearing and modified the Patent Trial & Appeal Board’s (“Board”) decision. The issue concerned whether the patentability of each version of a multiple dependent claim should be separately evaluated when it depends on multiple preceding claims. Specifically, at issue in Nested Bean is US Patent9,179,711 (“‘711Patent”) entitled “Swaddling Suit.” The '711 Patent pertains to a swaddling suit designed to limit the movement of a baby’s limbs, thereby reducing the startle reflex while permitting the arms to move to reach the mouth. The ‘711 Patent is a US National phase entry of a Patent Cooperative Treaty (“PCT”) Application that claims priority to an Australian Patent Application. The ‘711 Patent contains two independent claims, Claim 1 and Claim 2, and a complex set of dependent claims with multiple dependencies.4 Thecomplex set ofmultiple dependencies is shown in the following claim chart, which shows that purple claims depend on both independent Claim 1 (red) and Claim 2 (blue). Although multiple dependencies are common in other jurisdictions (e.g., Europe Patent Office) and permitted under 35 USC 112(5th),multiple dependencies are generally disfavored in the United States because “a separate fee is required in each application containing a proper multiple dependent”5 (MPEP 607 (III)) and “[f]or fee calculation purposes . . . a multiple dependent claim will be considered to be that number of claims to which direct reference is made therein. (37 C.F.R. § 1.75(c)). Accordingly, since it is more expensive to file a US patent application with multiple dependencies, granted patents with multiple dependencies are rare. In the case of the ‘711 Patent, the complex multiple dependencies are likely the result of the ‘711 originating from Australia, where multiple dependencies are common and not subject to an additional surcharge. Patent Owner, Big Beings, sued Nested Bean in the district court of Massachusetts (Big Beings USA PTY Ltd. v. Nested Bean, Inc., No. 1:20-cv-10101- IT (D. Mass.)) and alleged that Nested Bean’s “Zen One Classic Swaddle” infringed the ‘711 Patent. Nested Bean responded to the suit by filing an Inter Partes Review (“IPR”), IPR2020-01234, which challenged the validity of Claims 1-18 of the ‘711 Patent under six separate grounds. In its Final Written Decision, the Board found that Nested Bean had established that independent Claim 2 was unpatentable but had failed to prove by a preponderance of the evidence that Claim 1 was unpatentable. With regard to dependent claims 3-16, the Board found the claims to be unpatentable because “we consider claims 3–16 to be anticipated (or rendered obvious below) by the prior art if either version of these claims (the version depending from Claim 1 or the version depending Claim 2) is described by the prior art.” (Final Written Decision, Pg. 35 n7). Big Beings responded to the Final Written Decision by requesting a director review. In their request, Big Beings contended that the Board’s determination of the lack of patentability for Claims 3 to 16 was mistaken because these claims were dependent on both Claim 1 and Claim 2. Since the Board did not identify sufficient evidence to declare Claim 1 as unpatentable, Big Beings contended that the versions of Claims 3 to 16 that relied on Claim 1 should also not have been deemed unpatentable as derivatives thereto. The Director’s decision concluded that each version of a multiple dependent claim should be evaluated individually, similar to single dependent claims. In reaching this conclusion, Director Vidal recognized that “the Board’s consideration of multiple dependent claim patentability as to each of its alternatively referenced claims is an issue of first impression” due to the infrequency of challenged patents with multiple dependent claims. Accordingly, Director Vidal looked to the statutory language of 35 U.S.C. §112(5th), which states: A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. (Emphasis added). In addition, Director Vidal considered 35 U.S.C. §282 (a) in determining whether multiple dependent claims should be evaluated separately for each claim from which they depend. 35 U.S.C. §282 (a) states that: A patent shall be presumed valid. Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity. (Emphasis added). For further insights, Director Vidal relied upon the Manual of Patent Examining Procedure (MPEP). The MPEP 608.01(n) states that: a multiple dependent claim, as such, does not contain all the limitations of all the alternative claims to which it refers, but rather contains in any one embodiment only those limitations of the particular claim referred to for the embodiment under consideration. Hence, a multiple dependent claim must be considered in the same manner as a plurality of single dependent claims. (Emphasis added). Accordingly, Director Vidal concluded that “I interpret section 112, fifth paragraph, to require that the Board consider separately the limitations of each claim incorporated by reference into the multiple dependent claim.” (Decision, 18). Therefore, the Director concluded that “I agree with Patent Owner that “[t]aken together, the law is clear—multiple dependent claims must be treated as multiple claims, each comprising the dependent claim and one of the claims to which it refers, and the validity (and/or unpatentability) of each of the multiple claims must be considered separately.” (Decision, 11). As a result of the Director’s Decision, the Final Written decision was modified to reflect that only Claim 2 and the portions of dependent Claims 3-16 that were dependent on Claim 2 were unpatentable. Accordingly, the claims shown in aqua (left below) were held to be at least partially valid. This is a dramatic change from the original final written decision (right below), where the claims shown in orange were held to be invalid. Therefore, the Director’s decision aligned with the notion that a multiple dependent claim essentially functions as several single dependent claims and should be treated as such during patent evaluation. This distinction for clarity sets a precedent for the consideration of patentability for multiple dependent claims. Takeaways In the rare situation where the challenged claims in an IPR contain multiple dependencies, it is critical that the Petitioner separately present invalidity consideration for each branch of the multiple dependencies. Otherwise, the Patent Owner may be able to preserve the partial validity of the Patent by showing how the multiple dependent claim depends on at least one branch of the multiple dependency that has not been invalidated. 1 Other Petitioners in the IPR include ACS TRANSPORT SOLUTIONS, INC., XEROX TRANSPORT SOLUTIONS, INC., NEW JERSEY TRANSIT CORP., and CONDUENT INC. 2 NEW JERSEY TRANSIT CORP is a client of Volpe Koenig. However, the firm was not involved this matter. 3 Pre-AIA 35 USC §112(5th) and 35 USC §112 (e) contain identical language. 4 Multiple dependencies occur when a dependent claim relies on more than one preceding claim. In other words, the dependent claim incorporates limitations from multiple parent claims. This creates a hierarchical relationship where a dependent claim can be further narrowed down based on several previous claims. 5 The current USPTO multiple dependent claim fee is $860 for large entities. Abitron Austria GmbH v. Hetronic Int'l, Inc. - Extraterritoriality of U.S. Trademark Protection: How Far Does it Go? By: Michelle P. Ciotola, Cantor Colburn LLP I. INTRODUCTION In a 9-0 decision the Supreme Court of the United States vacated and remanded the decision of the United States Court of Appeals for the Tenth Circuit, holding that in applying the presumption against extraterritoriality, two provisions of the Lanham Act that prohibit trademark infringement are not extraterritorial and extend only to claims where the infringing use in commerce is domestic. Abitron Austria GmbH v. Hetronic Int'l, Inc., 600 U.S.__(2023). The issue on appeal was “[w]hether the court of appeals erred in applying the Lanham Act extraterritorially to petitioners’ foreign sales, including purely foreign sales that never reached the United States or confused U.S. consumers.” The Lanham Act is the federal trademark statute of the United States and provides a cause of action for trademark infringement. The Court specifically examined the foreign reach of 15 U.S.C. § 1114(1)(a) and § 1125(a)(1) of the Lanham Act, which provide as follows: 15 U.S.C. § 1114(1)(a) 1) Any person who shall, without the consent of the registrant— (a) use in commerce any reproduction, counterfeit, copy, or colorable imitation of a registered mark in connection with the sale, offering for sale, distribution, or advertising of any goods or services on or in connection with which such use is likely to cause confusion, or to cause mistake, or to deceive shall be liable in a civil action by the registrant for the remedies hereinafter provided. Under subsection (b) hereof, the registrant shall not be entitled to recover profits or damages unless the acts have been committed with knowledge that such imitation is intended to be used to cause confusion, or to cause mistake, or to deceive. And 15 U.S.C. § 1125(a)(1): (a) Civilaction (1)Any person who, on or in connection with any goods or services, or any container for goods, uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any false designation of origin, false or misleading description of fact, or false or misleading representation of fact, which— (A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or (B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damaged by such act. II. FACTS AND PROCEDURAL HISTORY Hetronic International, Inc. (“Hetronic”) manufactures radio remote controls for construction equipment and is based in the United States.Its products (and related services) are sold in more than 45 countries. The products bear “a distinctive black-and-yellow color scheme to distinguish them from those of its competitors.” Hetronic owns several U.S. trademark registrations, including U.S. Registration No. 6496386 for the following mark (which claims acquired distinctiveness under Section 2(f) of the Lanham Act)1. A representation of the mark follows:   At one time, Abitron Germany, GmbH, Abitron Austria GmbH, Hetronic Germany GmbH, Hydronic-Steuersysteme GmbH, ABI Holding GmbH, and an induvial (collectively “Abitron”) were licensed distributors of Hetronic. However, after concluding that it held rights to much of Hetronic’s intellectual property, including its trademarks, Abitron reversed engineered Hetronic’s products and began selling the same in Europe with the Hetronic brand, with some direct sales into the United States. Hetronic sued Abitron in the Western District of Oklahoma claiming trademark infringement under 15 U.S.C. § 1114(1)(a) and § 1125(a)(1) of the Lanham Act. Notably, Hetronic sought damages for Abitron’s infringing actions worldwide, not just those occurring in the United States. In response, Abitron argued that Hetronic sought an impermissible extraterritorial application of the Lanham Act. The District Court rejected Abitron’s arguments, and a jury awarded Hetronic approximately $96 million in damages. The award included not only Abitron’s direct sales into the United States but also its foreign sales of the allegedly infringing products worldwide. On appeal the Tenth Circuit affirmed the judgement, concluding that the Lanham Act extended to “all of [Abitron’s] foreign infringement conduct’ because the ‘impacts within the United States [were] of a sufficient character and magnitude as would give the United States a reasonable strong interest in litigation.” 10 F. 4th, at 1046. Cert was granted by the Supreme Court. The opinion of the Court was delivered by JusticeAlito, joined by Thomas, Gorsuch, and Kavanaugh, and Jackson, with a concurring opinion by Justice Jackson, and a concurring opinion by Justice Sotomayor, joined by Chief Justice Roberts, and Justices Kagan and Barrett. III. THE MAJORITY OPINION In addressing the question of whether § 1114(1)(a) and § 1125(a)(1) of the Lanham Act, the Court started with the presumption that “that legislation of Congress, unless a contrary intent appears, is meant to apply only within the territorial jurisdiction of the United States.” Morrison v. National Australia Bank Ltd., 561 U.S. 247, 255 (2010). The presumption “serves to avoid the international discord that can result when U.S. law is applied to conduct in foreign countries” and reflects the “commonsense notion that Congress generally legislates with domestic concerns in mind.” RJR Nabisco, Inc. v. European Community, 579 U.S.325, 335–336 (2016). A.Analysis In determining whether a statute is extraterritorial, the Court considered “a two-step framework”. Step one considers whether the provision in question is extraterritorial. This step requires a high bar and considers “whether ‘Congress has affirmatively and unmistakably instructed that’the provision at issue should ‘apply to foreign conduct.’” Id at 335, 337 (emphasis added). If the answer to this question is yes, then the claims may proceed. If the answer to this question is no, then consideration of the second step takes place. The second step considers whether the suit seeks a domestic application (permissible) or foreign application (impermissible) application of the statute. i. Step One of the Framework Under Step One of the framework, the question was whether the relevant provisions of the Lanham Act provide “a clear, affirmative indication” that they apply extraterritorially. Hetronic argued that the Lanham Act’s definition of “commerce” under § 1127, which is “all commerce which may be lawfully regulated by Congress” was sufficient to rebut the presumption against extraterritoriality. Hetronic’s reasoning was that the Congress can lawfully regulate foreign conduct under the Foreign Commerce Clause and that the Lanham Act’s definition of “commerce” is unique in the U.S. Code. The Court was not persuaded by these reasons, noting that “we have repeatedly held that even statutes … that expressly refer to foreign commerce’ when defining ‘commerce’ are not extraterritorial.” The Court determined that neither § 1114(1)(a) nor § 1125(a)(1) of the Lanham Act “provides an express statement of extraterritorial application.” The Court then turned their analysis to Step Two. ii. Step Two of the Framework In analyzing Step Two, the Court noted that to establish a “permissible domestic application” the “plaintiffs must establish that the ‘conduct relevant to the statute’s focus occurred in the United States” (emphasis added). Abitron argued that § 1114(1)(a )and § 1125(a)(1) focus on preventing infringing use of trademarks. Hetronic argues that the focus of these statutes is on protecting the goodwill of marks owners and preventing consumer confusion.2 The Court instead concluded that the conduct relevant to the focus of § 1114(1)(a) and § 1125(a)(1) was “use in commerce.” Violation of either provision requires “use in commerce.” The “location of the conduct” was the relevant consideration. The Court noted that “use in commerce” is the “dividing line” between foreign and domestic application of the Lanham Act. B. Holding The Court held “that § 1114(1)(a) and § 1125(a)(1) are not extraterritorial and that the infringing ‘use in commerce’ of a trademark provides the dividing line between foreign and domestic applications of these provisions.” IV. A BRIEF NOTE ON THE CONCURRING OPINIONS In Justice Sotomayor’s concurrence, she noted her disagreement with the determination that the focus should be “use in commerce.” Instead, she agreed with the position of the United States as amicus curiae that the correct focus of the relevant statutes is protection against consumer confusion. “The statute covers foreign infringement activities if there is a likelihood of consumer confusion in the United States and all other conditions for liability are established.” Justice Jackson’s concurring opinion elaborated on her understanding of the meaning of “use in commerce” in which she raised a hypothetical example of a German company making and selling “Coache” handbags, which are ultimately purchased in Germany and brought into the United States by students – for personal use. Justice Jackson reasoned that the mark affixed to the students’ bags is not “use in commerce” domestically and thus a claim of infringement would be extraterritorial and impermissible. This is compared to a scenario where the bags are purchased in Germany and sold in the United States. In the second scenario, she reasoned that there would be use in commerce domestically and the Lanham Act could then reach the German company. V. KEY TAKE AWAYS FOR BRAND OWNERS IN THE UNITED STATES 1. Reliance on U.S. trademark rights may not be enough in the event of third-party infringement. Depending on the nature of the infringing action, relying on trademark registrations and rights in the United States may not be enough to stop infringing activity by foreign entities. 2.Obtain and maintain trademark registrations in key jurisdictions outside the U.S. Consider important overseas markets and manufacturing locations as well as the possibility of future expansion. Obtain trademark protection in those key jurisdictions. In many countries, trademark rights are secured through registration and are based on a first to files ystem. Failure to file for trademark protection may not only impact a brand owner’s ability to enforce against infringement but would also impact the ability to operate in a given jurisdiction. 3.Carefully review all agreements and transactions with foreign entities Intellectual Property rights, including trademark rights can be impacted by agreements with third parties, including distribution agreements. It is important to have all transactional documents carefully reviewed to ensure no rights are inadvertently lost, assigned, or otherwise implicated. 1 The Registration covers, “wireless remote control apparatus for regulating operations of motorized machines, cranes, and lifting gears “in International Class 9.The registration includes the following mark description: “The mark consists of a three-dimensional configuration of the housing of the goods; the lower sides of the housing appear in yellow and the upper sides and top of the housing appear in black; the top of the housing features twin cylinders on either end of the housing, which are connected in the center by a rectangle, all in black; there is a rectangular upper-side panel in black that connects the twin cylinders and protrudes outward from the center of the housing; the knobs, joysticks, levers, and side paneling shown in the broken or dotted lines are not a part of the mark and serve only to show the position of the mark; white in the mark represents outlining, shading or transparent areas and is not part of the mark.” (See Trademark Status & Document Retrieval (uspto.gov)) 2 The United States as amicus curiae argued that the focus was only on consumer confusion. OpenSky Industries, LLC. V. VLSI Technology LLC– Fall-Out From Abusing The IPR Process By: Robert J. Rando and Alexis E. Marin, Greenspoon Marder, LLP I. INTRODUCTION In the current patent landscape, there are questions regarding the authority and conduct of the Director, and by extension the Patent Trial and Appeals Board (“PTAB’’ or “Board”), pursuant to the Leahy-Smith America Invents Act (“AIA”). Chief among them is the lack of clarity as to how the Director handles abuse of process of post-grant review proceedings, in particular inter partes review. Two main grounds are known: 35 U.S.C. 316 (“Conduct of Inter Partes Review”) provides in pertinent part: (a) (“Regulations”) the Director “shall prescribe regulations […] (6) prescribing sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or cause unnecessary delay or an unnecessary increase in the cost of the proceeding;” (b) (“Considerations”) the Director shall “consider the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to institute proceedings under this chapter.”1 37 C.F.R. 42.11 (“Duty of Candor; Signing Papers; Representations to the Board; Sanctions.“) provides in pertinent part: (d) (“Sanctions”) the Board is authorized to impose “an appropriate sanction on any attorney, registered practitioner, or party that violated ... or is responsible for the violation of” the certification requirements of 37 C.F.R. 11.18(b)(2) referenced in subsection (c) of Rule 42.11 in a trial or preliminary proceeding before the Board. Under subsection (d)(2)of Rule 42.11, an appropriate sanction can include an award of “reasonable expenses, including attorney’s fees incurred in a motion” for sanctions.2 Less clear, however, are: (1) what evidence supports a finding of violation of the duty of candor; (2) what factors dictate a finding of abuse of process; (3)the appropriate sanctions; and 4) how it translates procedurally. While the OpenSky Industries LLC (“OpenSky”) case does not definitively answer these questions, it sheds light on the Board’s approach to ethical violations.3 II. BACKGROUND A. VLSI Technology LLC v. Intel Corporation The dispute can be traced back to VLSI Technology LLC (“VLSI”) filing a complaint for infringement of Patent No. 7,725,759 B2 (“the ’759 Patent”) against Intel Corporation (“Intel”) in the Waco Division of the United States District Court for the Western District of Texas on April 22, 2019. In response, Intel filed two petitions for IPR.4 The Board applied the factors as set out in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“the Fintiv factors”), and given the “advanced stage” of the Western District of Texas litigation, denied institution of both proceedings.5 Significantly, the decision was issued priorto the June 21, 2022, Director’s Memorandum (“Memorandum”) which stated that “meritorious challenges will be allowed to proceed at the PTAB even where district court litigation is proceeding in parallel.”6 Intel’s requests for Precedential Opinion Panel (“POP”) review were similarly denied.7 The trial began on February 22, 2021, months after the initial scheduled date considered under the Fintiv factors.8 At trial, the jury found that Intel neither literally nor willfully infringed the ’759 Patent, but rather infringed a number of claims under the doctrine of equivalents. Additionally, the jury found that Intel did not prove by clear and convincing evidence that the claims were invalid, and awarded a total of $2.175 billion in damages across two patents to VLSI.9 B. OpenSky’s Petitions and Intel’s Joinder On June 7, 2021, OpenSky filed IPR petitions challenging several claims across both the ’759 Patent and the ’373 Patent.10 OpenSky copied extensively from Intel’s prior patents, and even refiled Intel’s expert supporting declaration without its knowledge. In the petition, OpenSky argued that the Board should not exercise discretion in denying institution under 35 U.S.C. §§ 314(a) or 325(d) because the district court decision did not reconsider the validity of the ’759 Patent, and the Fintiv factors analysis would support review for future patent disputes. VLSI filed a Patent Owner Preliminary Response on September 24, 2021, arguing that the petition should be denied, in light of: (1) OpenSky being formed right after the Intel verdict for the only apparent purpose of starting the IPR; (2) OpenSky’s petitions being stitched-together versions of Intel’s prior IPR petitions, sometimes “without even changing the cover pages”; and (3) the Board having already denied Intel’s IPR petitions.11 The Board initiated the IPR on December 23, 2021.12 More specifically, the Board argued that: (1) the Fintiv factors did not favor a denial because the jury trial decision did not resolve the unpatentability issue; (2) Intel’s petitions did not reach the merits; and (3) “road-mapping” concerns are minimized when previous petitions did not reach the merits.13 On January 6, 2022, VLSI challenged the institution decision with requests for rehearing and POP review, arguing that allowing OpenSky’s request did not advance public policy since it enabled them to extract “ransom payments” with no “infringement threat.”14 Less than a month after the Board initiated the petition, Intel filed for an IPR with a Motion for Joinder.15 The Board joined Intel on June 8, 2022, declining to discretionarily deny institution under 35 U.S.C. §§ 314(a) and 325(d) for similar considerations as those involved in OpenSky’s petition.16 Moreover, the Board allowed joinder as not subject to the one-year statute of limitations usually set forth in 35 U.S.C. § 315(b), and ultimately denied VLSI’s request for POP review.17 18 C. Director Review On June 7, 2022, Director Katherine Vidal ordered sua sponte Director review, and issued a Scheduling Order for said review.19 The Director identified two main issues of relevance, namely: What actions the Director, and by delegation the Board, should take when faced with evidence of an abuse of process or conduct that otherwise thwarts, as opposed to advances, the goals of the Office and/or the AIA; and How the Director, and by delegation the Board, should assess conduct to determine if it constitutes an abuse of process or if it thwarts, as opposed to advances, the goals of the Office and/or the AIA, and what conduct should be considered as such.20 Additionally, the Scheduling Order directed the parties to answer interrogatories and exchange certain types of information as part of Mandated Discovery. This included documents relating to “the formation and business of OpenSky;” “the filing, settlement, or potential termination of this proceeding, or experts in this proceeding, not already of record in the proceeding”; and “communications with any named party relating to the filing, settlement, or potential termination of this proceeding.”21 Notably, the Order stated that sanctions may be considered for misrepresentations or attempts to withhold evidence by adopting a narrow interpretation of the request.22 On July 15, 2022, OpenSky asked for an extension, which was granted on July 21, 2022.23 This was followed by an additional Order addressing the scope of the Mandated Discovery on July 29, 2022.24 The Order emphasized that a failure to comply would result in sanctions potentially including“[a]n order holding facts to have been established in the proceeding”, as perC.F.R. § 42.12.25 III. OPENSKY’S FAILURE TO COMPLY OpenSky filed a Notice of Objections on August 4, 2022, on the deadline for the exchange of documents across parties.26 Aside from some unsubstantiated objections, OpenSky argued that the Order exceeded the permissible scope of discovery under 35 U.S.C. § 316(a)(5) and 37 C.F.R. § 42.51, and that it was inconsistent with procedures governing non-routine discovery, since nothing “tend[ed] to show beyond speculation that in fact something useful will be uncovered.”27 In the October 4, 2022 Order, the Director found these arguments to be without merit.28 More specifically, under 35 U.S.C.§316(a)(5), discovery is permitted where “necessary in thei nterests of justice, and 37 C.F.R. § 42.51 is not relevant for Director-led discovery, since it only applies between parties.29 Rather, it is within the Director’s purview to“determine a proper course of conduct in a proceeding for any situation not specifically covered by [the other regulations] and to enter non-final orders to administer the proceeding.”30 As such, the Director was not bound to share the specific factors that would constitute its reasoning for discovery. In the Order OpenSky was found to have failed to comply with Mandatory Discovery by: 1) “refusing to provide confidential documents to the other parties in the proceeding, or instead, a privilege log listing privileged documents withheld for in camera review”; and 2) "failing to respond in good faith to the interrogatories, including withsupporting evidence.”31 In VLSI’s August 11, 2022 in camera review request, VLSI argued that OpenSky only provided about 170 public documents.32 OpenSky initially did not dispute its failure to produce documents in its initial brief, but argued later in its responsive brief that they provided a mix of public and confidential documents of “over 240 MB.”33 The Director deemed this insufficient, and per the Scheduling Order sanctionable conduct.34 OpenSky offered a version of facts that portrayed itself as a victim, even though it "fail[ed] to cite a single source of evidence to support its allegations of harassment.”35 Most responses to the interrogatories similarly failed to include evidence, and were found to be insufficient or unpersuasive.36 Importantly, OpenSky asserted that it had “not conditioned any action relating to this proceeding on payment or other consideration” by Patent Owner or anyone else, aside from paying its expert.37 This was unsupported by any evidence in contradiction to Intel and VLSI’s evidence.38 In light of such behavior, the Director assigned sanctions as per 5 U.S.C.§316(a) and 37 C.F.R. § 42.12(a), considering the harm caused.39 Given the core absence of evidence required for evaluating both abuse of the IPR process and OpenSky’s allegations of harassment, the Director deemed proper to “hold disputed factors as established against OpenSky.”40 IV. OPENSKY’S ABUSE OF PROCESS A. OpenSky’s Conduct On August 28, 2021, after OpenSky filed its Petition but before institution, OpenSky and VLSI entered into a “Confidential Discussion Agreement.”41 In light of the sanctions, the Director further inferred that negotiations were initiated by OpenSky.42 Afterwards, OpenSky contacted Intel, telling them that “VLSI has already reached out […] to discuss resolving the newly instituted IPR,” but “[w]hileOpenSky remains open to discussing this matter with VLSI, OpenSky would prefer to discuss the matter directly with Intel.”43 Given that OpenSky was seeking monetaryp ayment from Intel based on the IPR success, Intel refused partly to “avoid any potential risk of becoming a real-party-in-interest in OpenSky’s IPR.”44 In light of the rejection and of Intel’s Motion for Joinder, OpenSky reinitiated negotiation with VLSI, culminating in a scheme proposed by OpenSky on February 23, 2022.45 Notably, Patent Quality Assurance (“PQA”) LLC also submitted a Motion for Joinder.46 The proposed deal included terms such as: “Parties agree to work together to secure dismissal or defeat of petitioner”;“ OpenSky agrees not to negotiate with Intel or PQA”; “OpenSky refuses to pay expert for time at deposition so expert does not appear […]”; and “The day after VLSI files response, OpenSky and VLSI file motions to dismiss.”47 In the email, OpenSky also discussed how not producing its expert, on whom PQA relied, would be a“ potentially fatal evidentiary omission.”48 OpenSky set out a payment scheme without a specific amount, with a first payment due upon agreement, and the second due upon “denial of both joinder petitions.”49 VLSI reported the scheme to the Board, and no further negotiation occurred.50 OpenSky then continued its negotiations with Intel, particularly after its joinder. A pattern of behavior emerged, suggesting that OpenSky was not meaningfully intending to pursue the unpatentability, while also attempting to receive money from Intel. More specifically, OpenSky proposed to Intel that it would rest on its initial filing, not depose VLSI’s expert, and offer Intel the leading position in exchange for remuneration.51 OpenSky noticed VLSI’s expert for deposition only after Intel rejected the offer, and only four days before the reply brief was due.52 Then, OpenSky used Intel’s deposition outline but refused to seek an extension on the brief, offering “to let Intel write the reply on OpenSky’s behalf in exchange for remuneration and indemnity against any lawsuit brought by VLSI against OpenSky based on the IPR proceeding.”53 Again, Intel rejected, but provided OpenSky with a full brief, which it later filed.54 OpenSky did not request oral argument, not did it meaningfully participate at the oral hearing.55 B. Director’s General and Fact-Specific Considerations Generally, the Director found that OpenSky’s behavior in total amounted to abuse of process, since it involved “[i]nitiating a legal proceeding to deliberately sabotage for money, including offering to violate theduties of candor and good faithowed to the Board, [which] amounts to an abuse of process.”56 In addition, the Director specified how certain fact-specific elements were weighed: Petitioner’s Interest in the Proceeding: There is no standing requirement for IPRs, and nothing per se improper about someone who is not a patent infringement defendant filing an IPR decision. However, “where a petitioner has not been sued for infringement, and is a non-practicing entity, legitimate questions may exist regarding whether the petitioner filed the petition for an improper purpose.”57 Here, OpenSky did not perform an infringement analysis, and rather argued that because it used Intel products, it may be sued in the future, without providing any substantiation. In the alternative, OpenSky argued that it was in the public interest. By not providing evidence, the Director used adverse inferences to find that “the sole reason OpenSky filed the Petition was for the improper purpose of extracting money from either or both Intel and VLSI.”58 Recent Trial Verdict: Existence of trial verdict not per se improper, but “an entity filing an IPR on the heels of a large jury verdict may, when combined with other facts, raise legitimate questions regarding the motivation behind the Petition.”59 Here, similarly, OpenSky failed to provide evidence for any other purpose for its IPR request, and as such was viewed as for the purposes of extracting payment.60 ProximityofPetitioner’sFormation: “When the evidence demonstrates that an IPR petitioner was formed from whole cloth soon after a [significant] damages award, […] this suggests that the petitioner could be motivated to extract a financial windfall from the patent owner or the adjudicated infringer, rather than being motivated by any legitimate purpose.”61 Here, in light of no evidence to the contrary, OpenSky was deemed to be formed for the purpose of extracting payment.62 Seeking Compensation from Both Parties: While attempting to settle a dispute is acceptable, “double-dealing suggests that a petition was filed purely to extract rents, in either direction, rather than for legitimate purposes.”63 Here, OpenSky’s behavior was “both strong and concerning”, and where coupled with repeated statements that it lacked the resources to pursue the IPR, strongly showed that its purpose was to extract payment from either Intel or VLSI.64 Failure to Pursue the Merits: Where a party focuses on settlement or reimbursement, rather than pursuing the merits of the case, leads to view the party as seeking to extract improper payment from the IPR.65 Here, OpenSky failed to file briefs on time, participate meaningfully in hearings, while vigorously attempting payouts from both parties.66 Filing a Copycat Motion: Not per se improper since, for example, “a time-barred party may file a copycat petition when it is seeking joinder as provided by the AIA.”67 However, in some cases it may suggest an abuse of process, such as OpenSky’s failure to secure an expert witness which put the entire case injeopardy.68 C. Remedy The Director noted that the AIA granted the Office a broad range of remedies, and the Federal Circuit “allows theBoard to issue sanctions not explicitly provided in the regulation.”69 Consequently, the Director issued an order to show cause to OpenSky as to why it should not pay compensatory damages.70 Importantly, the Director did not terminate the proceeding, rejecting both VLSI’s argument that Intel was a time- barred party, and Intel’s argument that IPR proceedings terminate only where the petition is void ab initio because “the original petitioner was statutorily barred from bringing the petition in the first place.”71 Rather, the Director appealed to “first principles.”72 It stated that the IPR should continue insofar as it benefits the overall patent system, while not granting OpenSky any advantage. Consequently, (1) OpenSky was relegated to a silent understudy role without filing powers, (2) Intel was elevated to lead petitioner, and (3)the Board was ordered to show, based on the record at the time of the initial petition, whether there was a meritorious, compelling challenge.73 D. Subsequent Developments On October 14, 2022, the PTAB issued its Remand Decision, finding that even under a compelling merits standard, IPR should be instituted against VLSI.74 After three days, Director Vidal issued an order for sua sponte Director Review, andVLSI was authorized to file a Rehearing Request due to the Remand Decision.75 Consequently, on December 22, 2022, Director Vidal issued a decision finding no error with the PTAB determination, while also dismissing OpenSky from the proceeding.76 In parallel, the Director issued another decision dismissing PQA, finding that it misstated its exclusive reliance on OpenSky’s ‘borrowed’ expert from Intel’s original petition, and that PQA was similarly attempting to improperly extract payment from VLSI.77 On May 12, 2023, the Board ruled that the claims associated with the ’759 Patent were ultimately unpatentable.78 It remains to be seen how the clams regarding the other patents will be treated by the Board, and how the Federal Circuit will reconcile the findings with the pending appeal.79 V. CONCLUSION The OpenSky case emerges as a compelling case for the abuse of the IPR process. A few key lessons appear. First, the vast majority of factors considered here were not per se improper, with the exception of failing to pursue the merits of the case, and seeking compensation from both parties. However, OpenSky’s inability to comply with the interrogatory requests and Mandated Discovery directly led to a finding of breach of duty of candor and good faith, which then easily trickled into a finding of abuse of process. Strong compliance is required if one wants to avoid future violations. Second, as the October 4, 2022 and December 22, 2022 Orders make clear, one should strive for effective evidence-backed IPR requests. Future petitioners need to consider and anticipate the compelling merits standard when submitting their IPRrequest. Overall, the Director did not provide a clear standard for abuse of process. However, the OpenSky example sheds significant light into the factors that the Director and the Board may consider in the future, as part of a wider pattern of decisionsandguidelinesthattheDirectorhasimplemented.80 One wouldalsohaveto see how violations and malpractice during an IPR will affect practitioners in thefuture. Finally, potential Attorney Ethics violations could include Model Rules of Prof’l Conduct R.: 1.3 (“A lawyer shall act with reasonable diligence when representing a client”); 3.1 (“A lawyer shall not bring or defend a proceeding, or assert or controvert an issue therein, unless there is a basis in law and fact for doing so that is not frivolous.); 3.3 (“A lawyer shall not make false statements of fact or law, or offer evidence that they know is false”); 3.4 (“Duty of candor to the tribunal”); 4.1 (“A lawyer shall be truthful in statements to third parties’); and 8.4 (“A lawyer shall not violate the Rules of Professional Conduct, engage in conduct involving dishonesty or prejudicial to the administration of justice”). 1 Adapted from OpenSky Industries LLC v. VLSI Tech. LLC, IPR2021-01064, Paper 56, 4–5 (Assoc. of Amicus Counsel submission) (hereinafter all related papers and exhibits cited as “IPR2021-01064”). 2 Id. at 5. 3 For analogous violations of the Model Rules of Professional Conduct, see, infra, Conclusion. 4 IPR2020-00106, Paper 3; IPR2020-00498, Paper 4. 5 IPR2020-00106, Paper 17, 13. 6 Memorandum a t4–5. 7 IPR2020-00106, Papers 19 and 20; IPR2020-00498, Papers 19 and 20. 8 This was also considered under the Memorandum. 9 This figure refers to the award granted for both the ’759 Patent and Patent No. 7,523,’373 B2 (“the ’373 Patent”). See IPR2021-01064, Paper 102, 7. 10 IPR2021-01064, Paper 2; IPR2021-01056, Paper 2. 11 IPR2021-01064, Paper 9, 6. 12 Institution Decision 30. The IPR petition for the other patent, however, was denied based on the unavailability of an expert declarant on which OpenSky relied. IPR2021-01056, Paper 18, 10. 13 See Code200, UAB v. Bright Data Ltd., IPR2022-00861, Paper 18, 5 (PTAB Aug.23, 2022) (precedential). 14 IPR2021-01064, Paper 102, 11. 15 IPR2022-00366, Papers 3 and 4. 16 IPR2021-01064, Paper 43, 19–20. 17 See 35 U.S.C. § 315(b) (“The time limitation set forth in the preceding sentence shall not apply to a request for joinder under subsection (c).”). 18 SeeIPR 2021-01064, Paper 102, 12 19 IPR2021-01064, Papers 41 & 42; IPR2021-01064, Paper47. On the same day, the Director dismissed VLSI’s rehearing and POP review request regarding Intel’s joinder. 20 IPR2021-01064, Paper 47, 7–8. 21 IPR2021-01064, Paper 102, 13 (internal citations omitted); IPR2021-01064, Paper 47, 9–10. 22 Id. at 14. Cf. IPR2021-01064, Paper 47, 9–10. 23 Id. at 14. 24 IPR2021-01064, Paper 42. 25 Id. at 4. 26 IPR2021-01064, Paper 54; IPR2021-01064, Paper 51, 4. 27 IPR2021-01064, Paper 54, 2–3 (quoting Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012- 00001 (PTAB Mar. 5, 2013) (Paper 26) (precedential)). 28 Id. at 16–18. 29 Id. at 16–18. 30 Id. at 16 (citing 37 C.F.R. § 42.5(a)). 31 IPR2021-01064, Paper 54, 19. 32 IPR2021-01064, Paper 62. 33 IPR2021-01064, Paper 71; IPR2021-01064, Paper 91, 19. 34 IPR2021-01064, Paper 102, 20. 35 Id. at 21. 36 Id. at 21–25. 37 IPR2021-01064, Paper 71, 17. 38 IPR 2021-01064, Paper 102, 25. 39 Id. at 26. 40 Id. at 27 (referring to 37 C.F.R. § 42.12(b)(1)).Cf. IPR2021-01064 Paper 52, 4 (warning parties of the possibility of sanctions as wells explicitly mentioning this form of sanctioning). 41 IPR2021-01064, Paper 84,3. 42 IPR2021-01064, Paper 102, 20. 43 IPR2021-01064, Paper 66, 11–12. 44 Id. at 11–12. 45 Paper 84 ,4–5 46 IPR2022-00480. 47 IPR2021-01064, Paper102, 31. Additional provisions asked VLSI to take the full three months to oppose PQA’s motion, and to file its patent owner response. 48 IPR2021-01064, Paper102, 32. 49 Id. at 32. 50 Id. at 32. 51 Id. at 33. 52 IPR2021-01064, Ex. 1525. 53 IPR2021-01064, Ex. 1062; IPR2021-01064, Ex. 1525. 54 IPR2021-01064, Paper 42. 55 IPR2021-01064, Paper 61. 56 IPR2021-01064, Paper 102, 32 (emphasis added). See BTG Int’l Inc. v. Bioactive, 2016 WL 3519712 at *12 (“BTG has accordingly alleged sufficient facts to demonstrate that Defendants were using the IPR petition for an improper purpose—specifically,“as a threat and a club to extort and coercemillions of dollars . . . from BTG”). 57 IPR2021-01064, Paper 102, 35 58 Id. at 37. 59 Id. at 38. 60 IPR2021-01064, Paper 102, 38–39. 61 IPR2021-01064,Paper 102, 39. 62 Id. at 39. 63 Id. at 40. 64 Id. at 39–41. 65 IPR2021-01064, Paper 102, 41–42. 66 Id. at 41–42. 67 Id. at 42. See 35 U.S.C. § 315(c); 37 C.F.R. §§ 42.122(b), 42.101(b). 68 Id. at 42–43. 69 Apple Inc. v. Voip-Pal.com, Inc., 976 F.3d 1316, 1323 (Fed. Cir. 2020) 70 IPR2021-01064, Paper 102, 50–1. 71 IPR2021-01064, Paper 84, 24–25. 72 IPR2021-01064, Paper 102, 46. 73 Id. at 51. 74 IPR2021-01064, Paper 107. 75 IPR2021-01064, Paper 108. 76 IPR2021-01064, Paper 121. 77 Patent Quality Assurance LLC v. VLSCI Tech. LLC, IPR2021-01229, Paper 102 (PTAB Dec. 22, 2022) (precedential). 78 IPR2021-01064, Paper 135. 79 See VLSI Technology LLC v. Intel Corporation, No.22-1906 (Fed. Cir. June 15, 2022). 80 See, e.g., Commscope Technologies LLC v. Dali Wireless, Inc., IPR2022-01242, Paper 23 (Decision of Director) (February 27, 2023) (clarifying that, after OpenSky, the Board should always start analysis with the Fintiv factors for discretionary denials and if the result favors denial it should apply the compelling merits standard); see also Nicoletta Kennedy & Justin Kireger, PTAB Update: The USPTO Issues Revised Interim Guidelines for Director Review, JDSUPRA (July 25, 2023), https://www.jdsupra.com/legalnews/ptab-update-the-uspto-issues-revised-8604972/ (discussing recent developments to IPR such as the elimination of POP). Developments in the U.S. Copyright Office and U.S. Patent and Trademark Office Related to Artificial Intelligence By: Robert E. Rudnick and James T. Corcoran, Gibbons P.C. I. INTRODUCTION Artificial Intelligence (AI) is rapidly emerging as the new disruptive technology which should have large implications across many different aspects of society. Newer AI models such as OpenAI’s ChatGPT and Dall-E, Google’s Bard, and Microsoft’s Bing, to name a few, are all able to perform tasks in seconds which would take humans hours to complete. But what is AI? John McCarthy, one of the founders of the artificial intelligence field, defines AI as follows: It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable.1 AI is not new. It has been studied as early as the 1950s. AI started as rule based systems in the 1970s and 1980s and progressed into decision trees and training in the 1980s and 1990s. In the 2000s, modern AI was developed which included deep learning and larger datasets. The current AI technology is known as Artificial Narrow Intelligence (ANI). ANI is generally rule based and cannot solve unfamiliar problems. The best known examples of ANI are Siri, Alexa and IBM’s Watson. Artificial General Intelligence (AGI) is the next step of AI. It is a currently hypothetical AI in which the machine would be capable of machine intelligence and have human-like capabilities such as self-awareness, decision-making, consciousness and social skills. II. DEVELOPMENTS IN THE U.S. COPYRIGHT OFFICE A. U.S. Copyright Office March 2023 Guidance On March 16, 2023, the U.S. Copyright Office (“the Copyright Office”) issued guidance entitled “Copyright Registration Guidance: Works Containing Material Generated by Artificial Intelligence.”2 This Guidance is intended to provide a “statement of policy to clarify [the Copyright Office’s] practices for examining and registering works that contain material generated by the use of artificial intelligence technology. Specifically, that copyrights can only protect “material that is the product of human creativity” and that the term author “excludes non-humans.” The Guidance further states that “When an AI technology determines the expressive elements of its output, the generated material is not the product of human authorship. … As a result, that material is not protected by copyright and must be disclaimed in a registration application.” The Guidance provides the simple example that when an “AI technology solely receives a prompt from a human and produces complex written, visual, or musical works in response, the ‘traditional elements of authorship’ are determined and executed by the technology — not the human user.” However, the Guidance is clear that a work containing AI-generated material may contain sufficient human authorship to support a copyright claim. In this regard, the Guidance states that “what matters is the extent to which the human had creative control over the work's expression and ‘actually formed’ the traditional elements of authorship.” The Guidance provides two specific examples from its cases. The first is known as the “The Creativity Machine” case. In 2018, the Copyright Office denied an application for a visual work which was “autonomously created by a computer algorithm running on a machine.”3 The second case, known as the Zarya of the Dawn case was decided in February of 2023. In this case, the Copyright Office “concluded that a graphic novel comprised of human-authored text combined with images generated by [an AIservice] constituted a copyrightable work, but that the individual images themselves could not be protected by copyright.”4 Importantly, the Guidance states that “applicants have a duty to disclose the inclusion of AI-generated content in a work submitted for registration and to provide a brief explanation of the human author's contributions to the work.” In this regard, the Guidance stated that “AI-generated content that is more than de minimis should be explicitly excluded from the application.” The Guidance further states that applicants should take corrective action if they already submitted applications for works containing AI-generated material and failed to disclose the AI-generated content. B. U.S. Copyright Office Webinar On June 28, 2023, the Copyright Office presented a webinar addressing its March 16, 2023 Guidance.5 One big takeaway, which mirrored the Guidance, was applicant’s duty to disclose elements generated by AI which should be excluded from copyright protection. The Copyright Office provided guidance on what elements were protectable and which elements were not protectable based on illustrative examples of works and their creation. This Webinar also touched on an interesting point that the Copyright Office cannot independently verify whether the work is AI generated. However, we advise that it is important for authors to keep records detailing which protectable elements were contributed by human authors and which are not protectable because they were generated by AI. C. Conclusions In short, absent an act of Congress, or a court decision finding fault with the Copyright Office’s statutory interpretation, works generated solely AI are not protectable under copyright law. To the extent that part of the work is created under the creative control of a human author, that part, and only that part, is protectable under U.S. Copyright Law. One issue that will likely arise in the context of creation of works by a human using AI to assist is how much assistance by the AI will prevent the work from being copyrightable. In this regard, anyone using AI to create works should store and maintain input-output logs and any other information is helpful to demonstrate the human input into the creative work. III. DEVELOPMENTS IN THE UNITED STATES PATENT AND TRADEMARK OFFICE (USPTO) A. AIin the USPTO In 2019, the USPTO acknowledged the growth of artificial intelligence and importance of patentability issues in artificial intelligence by requesting comments on several issues including comments on the patentability of artificial intelligence inventions and issues surrounding AI generated inventions.6 On February 14, 2023, the USPTO again requested comments on the topic of artificial intelligence andinventorship.7 The USPTO defines aspects of artificial intelligence inventions, or “AI inventions” in different ways, i.e., (1) inventions that are developed by AI; or (2) inventions that utilize AI. The first aspect related to whether an AI program can be an inventor listed on a patent application. The second aspect is directed to patents and patent applications in which the invention therein are directed to, or involve the use of AI systems. A third aspect relates to the implications of using AI in assisting with the generation of inventions. This can include patents directed to inventions using AI as a tool, or inventions that involve other AI subject matters. We will discuss each in turn. B. Artificial Intelligence Systems Cannot Be Listed As Inventors on U.S. Patent Applications On August 5, 2022, the Federal Circuit held that the Patent Act requires an inventor to be a natural person in response to a patent applicant who alleged that an artificial intelligence system was the inventor of a patent application. Thaler v. Vidal, 43 F.4th 1207, 1209 (Fed. Cir. 2022), cert. denied, 143 S. Ct. 1783 (2023). In that case, the patent applicant, Stephen Thaler, asserted that he develops and runs artificial intelligence systems that generate patentable inventions. Mr. Thaler then sought patent protection through two patent applications and listed the artificial intelligence system as the inventor. After the U.S. Patent and Trademark Office (USPTO) denied the patent applications for failure to identify a valid inventor, Mr. Thaler and the USPTO adjudicated the matter in the U.S. District Court for the Eastern District of Virginia. The District Court found that the Patent Act requires an inventor to be a natural person.8 In affirming the District Court’s decision, the Federal Circuit first indicated that it need not perform an “abstract inquiry into the nature of invention or the rights, if any, of artificial intelligence systems.” Rather, the court began and ended on the “applicable text of the definition in the relevant statute.” The relevant statute, 35 U.S.C. § 100(f), states “[t]he term “inventor” means the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention. Thus, the court emphasized that there is no ambiguity that “the Patent Act requires that inventors must be natural persons; that is, human beings.”9 The Federal Circuit found that the Patent Act’s text clearly provides that inventors must be “individuals.”10 While the court noted that the Patent Act does not explicitly define “individual,” the court nevertheless found that this term is unambiguous based on a prior Supreme Court case, dictionaries, the Dictionary Act, and the text of the Patent Act itself.11 Notably the court found that all of these sources support the position that an individual must be a human being.12 The court also cited to its own precedents holding that corporations and sovereigns cannot be inventors under the Patent Act.13 C. Strategy for Inventions Generatedby AI or With the Use of AI In developing strategy for inventions generated by AI, practitioners must determine whether the AI or the human using the AI is the inventor. In the simplest example, if AI conceives of and reduces the invention to practice on its own, then absent an act of Congress, or an unlikely instance of the Court overturning its own precedent, the invention is not protectable under patent law. Thus, if AI generated the invention without sufficient human intervention, treating the invention as a trade secret should be considered as a possible strategy. This is especially true for AI-conceived inventions in certain technology fields, such as for example, computer hardware- or -software related inventions. A note of caution regarding this possible strategy is that a developer contemplating having a third party AI platform conceive an invention for it should be well aware of the applicable state and federal trade secret laws and the terms of service of the third party AI platform operator. Such awareness of the laws and terms of service will enable it to avoid having its proprietary data provided to the AI platform in a way that inadvertently precludes trade secret protection because the data was disclosed absent sufficient confidentiality terms, or is otherwise made part of the general or public data used to train and/or operate theAI platform for use by other third parties. On the other end of the spectrum, if a human conceived of the invention and only used the AI to speed up the reduction of practice of the invention, then the AI would not be an inventor and one can seek patent protection normally. For middle ground cases there is not much guidance or case law on point. The question may involve whether a human inventor was involved with conception of the invention. It is important to focus on the aspects of the claimed features of the invention which were created by the human inventor and not by the AI system. Thus, patent applications should rely upon human inventive acts where in the AI is used as a research tool, if possible. Some have argued that AI can be thought of as an extension of one’s mind.14 Others have stated that artificial general intelligence akin to human intelligence has not yet arrived because current AI cannot invent without human intervention.15 For example, one might argue that AI is a system that is trained by a human and its results are analyzed by a human and as such, it is just a tool used by a human inventor. Take an example provided by Novartis of using AI in identifying molecules with potential for having anti-malarial properties.16 An AI was trained by humans on a library of 21,000 molecules tested for anti-malarial properties and the AI generated 282 virtual molecules. Two of these molecules were tested further because they showed promising results. While AI was used in this invention, humans created the initial database, reviewed the AI generated results and selected candidates from the results and then further analyzed these results. It does not seem like the AI would be considered the inventor in this case. D. Inventions Directed to AI can be Patented Turning away from inventorship, the next major issue is whether inventions directed to, or related to, AI can be patented. On a basic level, AI systems or AI methods can be patented as long as they comply with the other requirements of the Patent Act. Obtaining a patent on training an AI system should also be possible. However, infringement of such patent may be difficult to detect, and would be somewhat limited on such an AI training patent because the commercial use would likely be the result produced by the trained AI system, and not the training an AI system itself. 1 McCarthy, John. (2004). What is Artificial Intelligence? Stanford University, CA. Retrieved on August 8, 2023, from http://cse.unl.edu/~choueiry/S09-476-876/Documents/whatisai.pdf. 2 88 FR 16190 (direct link: https://www.federalregister.gov/d/2023-05321) (“Guidance”). 3 U.S. Copyright Office Review Board, Decision Affirming Refusal of Registration of a Recent Entrance to Paradise at 2 (Feb. 14, 2022), https://www.copyright.gov/rulings-filings/review-board/docs/a-recent- entrance-to-paradise.pdf. 4 U.S. Copyright Office, Cancellation Decision re: Zarya of the Dawn (VAu001480196) at 2 (Feb. 21, 2023), https://www.copyright.gov/docs/zarya-of-the-dawn.pdf. 5 Presentation available at www.copyright.gov/events/ai-application-process/ 6 See 84 FR44889 available at www.federalregister.gov/d/2019-18443. 7 See 88 FR9492 available at www.federalregister.gov/d/2023-03066. 8 Thaler v. Iancu, et al., 1:20-cv-00903 D.I. 33 (E.D. Va. April 6, 2021). 9 Thaler, 43 F.4th at 1210. 10 Id. at 1211 11 Id. 12 Id. 13 Id. 14 Helliwell, Alice C. (2019). Can AI Mind Be Extended? Evental Aesthetics 8 (1):93-120. 15 Lim, Pheh Hoon and Li, Phoebe (2022). Artificial Intelligence and Inventorship: Patently Much Ado in the Computer Program. Journal of Intellectual Property Law & Practice, 17(4): 376–386. 16 Kearnes, Steven et al. (2022) Defining Levels of Automated Chemical Design. Journal of Medicinal Chemistry 65 (10), 7073-7087. The GDPR Meta Decision from the Irish Data Authority: Improper Transfers of Personal Data from Europe to the U.S. By: Simon P. Walsh, Cadwalader, Wickersham & Taft London I. EXECUTIVE SUMMARY In May of this year, Meta (formerly known as Facebook) was ordered to suspend its flows of data between the European Union (“EU”) and the U.S., and was issued with a record fine of Euro 1.2 billion (almost US$1.3 billion) by the Irish Data Protection Commission (“Irish DPC”) in respect of Meta transferring the data of individuals based in the EU to the United States in breach of EU privacy laws. II. WHY ARE EU TO US DATA FLOWS AN ISSUE? The EU has a strict regime of data protection laws, based around the EU’s General Data Protection Regulation (EU) 2016/679 (“GDPR”), and the Charter of Fundamental Rights (the “Charter”). The GDPR sets out a rigorous set of rights for data subjects in the EU, designed to guarantee the fundamental rights and freedoms set out in the Charter. A core principle of the GDPR is that data subjects’ rights should not be prejudiced by the transfer of data by those holding it to third countries where the protections of the GDPR are not also adequately met. Accordingly, Chapter V of the GDPR sets restrictions on transfers of personal data outside of the European Economic Area (“EEA”), designed “to ensure that the level of protection of natural persons guaranteed by this Regulation is not undermined” (Article 44 GDPR). The philosophy behind this is that personal data that benefits fromtheprotectionsundertheGDPRshouldcontinuetobenefitfromanequivalent standard of protection, even if it is transferred outside the EU (or UK under the UK’s equivalent legislation). To ensure that the required standard of protections is not undermined when data are transferred to a third country, Article 46 of the GDPR sets out a number of mechanisms that an exporter of data can use, being: (i) “adequacy decisions”; (ii) standard contractual clauses and other “appropriate safeguards”; (iii) binding corporate rules; and (iv) derogations for specific situations. A. Adequacy decisions The European Commission (“EC”) can pass “adequacy decisions”, declaring that the laws of a third country outside of the EEA provide an adequate level of protections for personal data. Data can be transferred to these third countries without the need for any of the additional safeguards (like standard contractual clauses, described below) being applied. The Commission has passed adequacy decisions in respect to Andorra, Argentina, Canada, the Faroe Islands, Guernsey, Israel, the Isle of Man, Japan, Jersey, New Zealand, Republic of Korea, Switzerland, and the UK. Where an adequacy decision is not in place, Article 46(1) of the GDPR provides or conditions for transfers of any data: “a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has provided appropriate safe guards, and on condition that enforceable data subject rights and effective legal remedies for data subjects are available.” Those “appropriate safeguards” include sets of standard contractual clauses that can be made between data exporters and importers, which guarantees standards of data protection for EU data (“SCCs”). B. Binding corporate rules Binding corporate rules (“BCRs”) can be used to govern international data transfers and are an alternative to using SCCs, but may only be used for transfers within the members of a group of companies. BCRs require a set of binding intra- group rules to be put in place, governing the transfers of data and require regulatory approval from an EU data protection authority for those arrangements. C. Derogations In the absence of an “adequacy decision”, SCCs or another appropriate safeguard, or BCRs, Article 49 of the GDPR includes several “derogations” where transfers can take place, in circumstances when: the data subject has given specific and informed consent to the transfer; the transfer is necessary for the performance of a contract between the data subject and the controller; or the transfer is necessary for the performance of a contract between the controller and another person which is made in the interests of the data subject (a ground that may only be relied upon occasionally). III. TRANSFERS FROM THE EU TO THE U.S.: A BUMPY ROAD For some time, the level of adequacy of the protections afforded to transfers of data from the EU to the U.S. has been controversial. The problem began in 2013, when whistleblower Edward Snowden revealed to the world the extent of the surveillance of data carried out by the U.S. Government. The sweeping powers granted to the U.S. authorities by the PRISM programme (and Executive Order 1233) prioritised national security over the fundamental rights which EU law grants to its citizens to protect the security and use of their personal data. The GDPR only allows such rights to be limited with regard to the necessity and proportionality of that interference. The EC and the U.S. have had many attempts at seeking to establish a level of comfort over the adequacy of protections afforded to EU data in the U.S. The first was the “Safe Harbor” mechanism: an agreement between the EC and the U.S. that would allow U.S. companies to meet the “adequate level of protection” required by the data legislation existing in Europe at that time.Under Safe Harbor, a U.S. company could self-certify annually to the Department of Commerce that it had complied with seven basic principles and related requirements that have been deemed to meet the data privacy adequacy standards of the EU. A. Safe Harbor struck down However, in 2013, Privacy activist, Max Schrems, challenged whether that “Safe Harbor” mechanism which was used by many tech organisations to transmit data between the EU and U.S. was adequate to provide EU data subjects with equivalent protections in the U.S. to those provided under EU law. In 2015, the Court of Justice of the European Union (“CJEU”) struck down the “Safe Harbor” mechanism, in the so-called “Schrems I” decision. In the context of the NSA PRISM program (as revealed to the public by Edward Snowden), the court concluded that U.S. companies would not be able to guarantee adequate personal dataprotection, because of the sweeping powers granted to the U.S. authorities to access data on individuals. According to Shrems I, the Safe Harbor principles should be limited to the extent necessary for national security, public interest, or law enforcement requirements. Therefore, it was ruled that under the European Directive on Data Protection in place at that time, it was not legal for any personal data transfers to occur between the EU and the U.S. This led to the invalidation of the Safe Harbor agreement entirely. B. EU-US Privacy Shield Following Schrems I, the EU and U.S. rushed to design a replacement and only a few months later, in July 2016, the EU-US Privacy Shield was implemented. The Privacy Shields ought to address the requirements set out by the CJEU ruling, which declared the old Safe Harbour framework invalid. The Privacy Shield imposed stronger obligations on companies in the U.S. to protect the personal data of individuals and stronger monitoring and enforcement by the U.S.Department of Commerce and Federal Trade Commission (“FTC”), including increased cooperation with the European data protection authorities. The Privacy Shield included commitments by the U.S. that any access to EU personal data by public authorities on national security grounds would be subject to clear limitations, conditions and oversight, preventing the generalised access which had been the concern of the CJEU in Schrems I. The Privacy Shield also created an “Ombudsperson” mechanism to handle and solve complaints or enquiries raised by EU individuals in this context. However, by 2020, the Privacy Shield was also gone. A second challenge by Max Schrems – the “Schrems II” decision – led to the invalidation of the scheme. The CJEU ruled that the laws of the U.S. did not satisfy requirements that are essentially equivalent to those required under EU law, finding that: (i) U.S. public authorities’ use and access of EU data were not restricted by the principle of proportionality (as EU law required); and (ii) the Ombudsperson mechanism in the Privacy Shield did not provide data subjects with any cause of action before a body that offered guarantees substantially equivalent to those required by EU law. It also ruled that whilst SCCs could be relied upon for transfers of data to third countries in respect of which no adequacy decision had been made, but only if any such transfers required a detailed data protection “transfer impact assessment” (“TIA”) of the laws of that third country to confirm that there was essentially equivalent protections in place for the data once exported and what supplementary measures could be put in place to ensure the protection of EU-based data. IV. THE META DECISION The invalidation of the Privacy Shield caused a significant issue for many businesses dealing with transatlantic data transfers. Many moved to the use of SCCs, as was the case for Meta. The Irish DPC’s decision found that Meta’s use of SCCs was incompatible with its obligations under the GDPR, finding that: (i) U.S. law, as a result of U.S. law surveillance powers, did not provide a level of data protection that is essentially equivalent to that provided under EU law; (ii) SCCs cannot compensate for the inadequate level of data protection provided by U.S. law; (iii) even SCCs paired with the additional safeguards that Meta deployed following the CJEU’s Schrems II decision could not meet the GDPR standard of essential equivalence; and (iv) it was not open toMeta to rely on the derogations provided in Article 49(1) GDPR (or any of them) when making the data transfers. The decision essentially closed the door on Meta relying on other GDPR transfer mechanisms to make its transfers to the U.S. legally. The decision to suspend Meta’s flows of data is a significant issue for all businesses but especially for Meta, given that its operations are very much centred in the U.S., despite its global reach into the EU. Last year, Meta warned its investors that approximately 10% of Meta’s global advertising revenue would be lost if the flow of data from the EU to the U.S. was suspended. The U.S. adtech giant’s business model hinges on access to user data, in order that it can track and profile web users to target them with behavioural adverts, so the tech giant was not in a position to apply extra safeguards (such as end-to-end encryption) which might otherwise be able to raise the level of protection on Europeans’ data exported to the U.S. Meta has said that it will appeal the decision and has sought to lay blame on the inherent conflict between the data protection regimes in the EU and the laws in the U.S., as opposed to a failing on Meta’s part in its privacy practices. The decision provides a transition period of around six months before Meta must suspend data flows, so the service will continue to work in the meanwhile. Meta has also said it will appeal and looks to be seeking to stay implementation while it takes its arguments back to court. In the meantime, however, the decision has also been somewhat overtaken by a further transatlantic development, as described below. V. THE EU-US DATA PRIVACY FRAMEWORK The EU and the U.S. have now tried, for a third time, to address the difficulties faced by EU to U.S. data transfers, and to sweep aside the concerns raised by the CJEU in the Schrems II case. Shortly after the Irish DPC issued its decision to fine Meta, the EC adopted its “adequacy decision” for the “EU-U.S. Data Privacy Framework” (“DPF”). On 10 July this year, days after the U.S. announced the completion of commitments under President Joe Biden’s executive order concerning the framework, the DPF was announced, and became operational on 17 July 2023. The DPF is essentially a modified version of the prior EU-US Privacy Shield, meaning that personal data can now be transferred from the EU to companies in the U.S. which self-certify under the DPF, without the need for any other data transfer mechanisms (like SCCs or BCRs) to be in place. The DPF has sought to address the two concerns that the CJEU raised in Shrems II: (i) that the blanket powers under section 702 FISA and Executive Order 12333 providing wide-ranging access to, and use of, the data of EU data subjects was not subject to any principle of proportionality, as required by the GDPR and the Charter; and (ii) that EU data subjects had no effective legal redress mechanismin the U.S. for any breaches of their data rights by U.S. surveillance practices, as required by Article 46(1) GDPR (and that the use of SCCs could not cure this, given that such clauses bound only the data importer and exporter, and not the U.S. authorities). As regards to (i),an essential element of the U.S. legal framework on which the adequacy decision is based concerns the Executive Order on “Enhancing Safeguards for United States Signals Intelligence Activities”, which was signed by President Biden on 7 October, and is accompanied by regulations adopted by the Attorney General. The Executive Order provides for safeguards that limit access to data gained from the EU by U.S. intelligence authorities to what is necessary and proportionate only to protect national security, as well as enhanced oversight by U.S. intelligence services to ensure compliance with limitations on surveillance activities. As regards to (ii), the U.S.Government has implemented a two-tier mechanism to address complaints from individuals in the EEA, in respect of access by U.S. intelligence agencies (where their data has been transferred to the U.S.). Individuals will have the power to submit complaints to their national data protection authority, which will then be passed to the U.S. via the European Data Protection Board (a body created under the EU GDPR to ensure a consistent application and enforcement of data protection law across the EEA). The initial investigation of complaints is performed by the U.S.intelligence’s Civil Liberties Protection Officer. If needed, individuals can then appeal a complaint to the newly established Data Protection Review Court (“DPRC”), an entity independent of the U.S.Government. The DPRC can issue binding decisions, including the ability to order the deletion of improperly collected data. The court can appoint a “special advocate” to represent the complainant’s interests and then once the investigation concludes, the complainant will be informed whether no violation of U.S. law was identified, or that a violation was found and remedied. A reasoned decision of the DPRC can be released later, if confidentiality requirements so allow. Data flow is therefore so significant that the U.S. authorities have altered their practices to put in place the EU-US Data Privacy Framework, with U.S. Department of Commerce DPF Director Alex Greenstein recently saying: “The reason this is all so important is that data flows and the transfers of personal data are a key enabler for basically all elements of the transatlantic economic relationship. It’s something so fundamental that it really underpins all elements of commerce and trade investment between the United States and Europe,” “That’s the biggest economic relationship in the world, and that’s why this has been such a priority for the Biden administration and for the EU.” The EC hopes that the efforts made by the U.S. government will be sufficient to fend off yet another challenge in the CJEU – in particular, the changes introduced by the U.S. intelligence community and the new redress mechanism are now seen as robust enough. However, risks will still remain because not all companies can take advantage of the new DPF. U.S. entities wishing to take advantage of the EU-US DPF need to register for self-certification (https://www.dataprivacyframework.gov/s/). Whether and how long the DPF will survive is a matter of conjecture at this stage: Max Shrems has already said that his not-for-profit data privacy organisation, NOYB, will be mounting a legal challenge. In particular, NOYB has raised concerns about the DPRC’s court process, which is shrouded in secrecy. Data subjects will not be able to be heard before the DPRC themselves – they will need to rely instead on the relevant data protection authority in the U.S. to commence the procedure and then for an appointed “special advocate” (with any reasoned decisions of the court only being available to data subjects if and when those decisions are declassified). And perhaps a political change of leadership in the U.S. will not feel the same way about making concessions to the EU on its data surveillance practices. If the latest DPF is challenged, tech giants (and regulators and governments) could find themselves back in the same place in another three years’ time. In Re Monolithic Power Systems, Inc. – When Home for a Remote Worker can be a Residence By: Lynda L. Calderone, Calderone Bullock LLC On September 30, 2022, the Court of Appeals for the Federal Circuit (CAFC) denied, in a split panel, a petition for writ of mandamus filed by Monolithic Power Systems, Inc. (the defendant in an infringement litigation) to dismiss or transfer the litigation from the U.S. District Court for the Western District of Texas (W.D. Texas) to the District Court for the Northern District of California (N.D. California) based on the presence of remote workers in W.D. Texas. The decision is interesting not only because of the basis for denying transfer of venue that is based essentially on four remote workers, but also because the panel of Justices Louri, Chen and Stark voted in favor or retaining venue and denied the petition for the writ, thus affirming the decision of Judge Albright of the W.D. Texas. I. The District Court The underlying case was a patent infringement action brought by Bel Power Solutions (Bel Power) against Monolithic Power Systems, Inc. (Monolithic) brought in the W.D. Texas for alleged direct and indirect infringement by Monolithic arising from the sale of power modules to original equipment manufacturers and other distributors and customers which use the min their own electronic devices. In Re Monolithic, 50 Fed.4th, 157, 158 (Fed. Cir. September 30, 2022). Monolithic moved to transfer the matter from W.D. Texas to N.D. California in by motion to dismiss under 12(b)(3) for improper venue and, alternatively to transfer under 28 U.S.C. §1406(a) on the basis that Monolithic was a Delaware corporation and did not “reside” in the district under the requirements of 28 U.S.C. §1400, the statute governing venue in patent litigations. Id. In the original motion, Bel Power asserted venue based on four employees who were alleged to conduct “systematic and continuous business” for Medtronic in Texas: Jason Bone, Robert Grullon, Sam Robinson and Victor Gallegher.” Bel Power Solutions, Inc. v. Monolithic Power Systems, Inc., Civil Action No. 6:21-CV-655,2022 BL166745, Part I (W.D. Texas May 4, 2022). The individuals were alleged to serve end users or make sales in Texas and Monolithic was alleged to have sought and hired them to support the geographic area in and around Austin, Texas. Monolithic counterargued that it is a Delaware Corporation with offices in San Jose, CA, Kirland, WA and Detroit, MI, but not in Texas. The District Court evaluated the facts citingIn Re Cray, 871 F.3d 1355, 1360 (Fed. Cir. 2017) as a basis for the controlling law based on TC Heartland LLC v. Kraft Foods Group Brands, LLC, 137 S. Ct. 1514 (2017). It noted that Cray held that to have a “regular and established place of business”, the defendant must have (1) a physical place of business in the district, (2) that place of business must be regular and established, and (3) it must be the defendant’s place of business under §1400(b), which was intended to be restrictive such that the plaintiff bears the burden of proof. Id. In assessing the place of business the district court stressed that the fixed presence need not be a fixed physical presence, and then cited various cases over the years finding worker’s presence to support venue, among which was the decision in RegenLab USA LLC v. Estar Techs. Ltd., 224 F. Supp. 3d 526, 552 (S.D.N.Y. 2018), wherein the court held home offices to be a place of the defendant noting that the employees had product in their homes and small centrifuges. See, Bel Power, at part II. After comparing the facts in the present matter to those of RegenLab, the W.D. Texas found that the facts weighed in favor of venue in Texas and against transfer. The court found persuasive that the employees were not required to live in Texas, customer suggestions, complaints and other feedback were alleged to be directed to the home office of Monolithic, and it also processed all sales. Monolithic also persuaded the court by noting that it did not promote the address or phone in Texas and it did not provide local secretarial or other support services. While there was evidence of an intent to hire in Texas, including specific solicitation, no hires were initially achieved, and those that were ultimately found did not have to work in Texas. Also considered were facts that favored staying in Texas including engineering samples for the employees, and use of those samples for internal testing and validation, and in some cases delivery of samples to customers. One employee maintained a “fair amount” of Monolithic equipment (oscilloscopes, power supplies, electric loads, a logic analyzer, a soldering iron and other items). Upon overall review the facts of RegenLab and Monolithic were viewed by the Court as “neutral”. As a result, the Court was not persuaded to transfer. Further, for transfer, the Court found that there were facts on either side, but that Monolithic did not persuade the Court through its witnesses that transfer to N.D. California (while a suitable venue) was better than leaving the case in Texas. One of the more persuasive points made was that the activities of the individuals in Texas were relevant to proving the indirect infringement claims. The Court found the private interest factors neutral with respect to access to proofs, however, was persuaded against transfer based on the availability to compel process and attendance of witnesses, including the four indivduals. Bel Power, Parts III and IV, with a final assessment that while the cost of attendance and convenience of willing witnesses favors transfer, the overall the other factors weighed against transfer. Regarding the public interest factor, it was assess as “slightly” weighing against transfer as the W.D. Texas was faster than the N.D. California for suchcases. II. The CAFC Panel Based on this ruling, Monolithic sought a writ to overturn the decision of the W.D. Texas at the CAFC and have a transfer ordered to N.D. California. The panel addressing the Court largely credited the factual analysis and explanation of the W.D. Texas District Court. The CAFC first assessed the denial of the writ. The writ process has been used in other cases to support patent venue transfers where the law was very unsettled and there was significant turmoil in the courts regarding the W.D. Texas, but in this case, the CAFC panel found at page 159- 160 of the opinion, that as venue transfer motions typically are not the proper relief for venue transfers, they are granted in situations where “immediate intervention is necessary to assure proper judicial administration” as in In re ZTE (USA) Inc., 890 F.3d 1008 (Fed. Cir. 2018), or when there is a “basic, unsettled, recurring legal issue” over which a “considerable amount of litigation producing disparate results” exist, citing In re Micron Tech., Inc. 875 F.3d 1091, 1095 (Fed.Cir. 2017) as well as In Re Cray, 817 F.3d at 1360. The CAFC reviewed fact-specific findings against current case law suchas that noted above and other cases, noting on the facts that the possession by one employee of a “fair amount” of the equipment as noted above, which was not normally found in a home and was used for his job, with the employees location also material to the employer, and concluded that the law was sufficiently consistent with the fact analysis to deny the need for the CAFC to step in by mandamus and found that Monolithic did not demonstrate “a clear and indisputable right to mandamus relief on its improper venue challenge”. It did not reach the merits of that challenge, but felt that the law was sufficiently consistently applied to not have to rely on a writ of mandamus. TheCAFC specifically noted that “our conclusion should necessarily not be interpreted as a disagreement with the dissent’s analysis of the ultimate merits of the venue issue.” In re Monolithic at160-161. With respect to the motion to transfer, the Court did not find an abuse of discretion. III. The Dissent by J. Lourie Judge Lourie’s dissent disagreed with the denial of writ because in his view, venue for Monolithic was improper in the W.D. Texas, since Monolithic did not reside in the district and the homes of its four employees there were not a “regular and established place of business” under §1400(b). He pointed to In re Cray, noted above and also Celgene Corp v. Mylan Pharms. Inc., 17 F.4th1111 (Fed. Cir. 2021) for the principle that merely showing that there is a physical location where employees carry on certain work is insufficient under §1400(b). J. Lourie further noted that Monolithic lacks a regular and established place of business. He felt to rule otherwise may erode the requirements by the details of what employees store in their home.Further, he felt that relying on a later overturning of an improper venue after trial is not an adequate remedy in the face of thepetition for mandamus as the case is then tried in an improper venue which is not efficient. In Re Monolithic, dissent at page 162. While he appreciated the panel’s concern over use of mandamus, he expressed that it would have been consistent with other similar uses of mandamus to ensure “proper judicial administration” which may cause confusion to the law relating to where a patent infringement suit may properly be brought based on the location of employee homes v. locating a “regular and established place of business.” Id. At 163. J. Lourie commented that “[g]iven the increased prevalence of remote work, I think immediate review by way of mandamus would be important to maintain uniformity of the court’s clear precedent.” Id. Another comment from J.Lourie was that it was not the CAFC’s intention in In re Cray in finding an employee’s home to be a regular place of business to create “a leaky sieve to accommodate avoidance of the basic requirements of the statute.” He also likened the facts of Monolithic more to those of Celgene, as there was no requirement to live in Texas and no restriction on the employees moving out of state and also no requirement of storage of equipment in their homes. Finally, he noted that the District Court erred by not considering the nature and activities in the N.D. Texas compared to those in other places of business of Monolithic in other venues. Id. at 162.  While the impact of this decision is not yet known, it does open a door to further attempts to forum shop patent venue in patent-friendly courts as well as to rely on and make the subject of discovery remote workers’ homes. The factual patterns in these cases do differ, and it is questionable whether such invasion of remote work locations would not be used as a basis for discovery overreach. It is possible to put it in a location where it lies on its own facts in terms of analysis, but also is a clear step away from the use of a writ of mandamus to avoid improper venue. This particular case is limited to the patent area, but it is also an interesting case in terms of its potential for application by analogy in other areas based on venue changes outside the patent context. The Continuing Saga of Section 101 Patent Eligibility: Patent Law After Tropp and Interactive Wearables Cert. Denials By: Keith McWha, Lerner David LLP Abstract: Discussions of patent eligibly continue as courts, and practitioners struggle to understand and uniformly apply the Alice two step test previously articulated by the U.S. Supreme Court. The U.S. Supreme Court’s decision not to grant cert in Tropp and Interactive Wearables to identify further guidelines to clarify the Alice test further the struggle as even the USPTO has admitted that such clarification would be welcome. With advancing technologies, the ever expanding umbrella of covering inventions under the abstract idea exception continues to be an issue in both patent prosecution and patent litigation. This paper summarizes the decisions in Tropp and Interactive Wearables, and explores Section 101. BACKGROUND Undeniably, Section 101 of the U.S. patent law has had more than its fair share of interpretation and for good reason. This section of the patent law continues to evade consistent interpretation and application among patent practitioners, courts, and even the U.S. Patent and Trademark Office (USPTO). The statue itself is rather simplistic but yet remains elusive to consistent application. Section 101 of the U.S. patent law was meant to provide a guidepost when inventions have subject matter that can receive patent protection. This provision providesfor patents having “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” As with any rule of law, there are certain exceptions. Courts have recognized that there are judicial exceptions, namely, laws of nature, physical phenomena, and abstract ideas lack the subject matter to become a patent. The abstract ideas exception has proven to be a formidable challenge yielding varied interpretations and subsequent confusion within the patent profession. The U.S. Supreme Court in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012 set forth a two- step framework for considering subject matter eligibility. Briefly, this two-step test involves (Step 1) first determining whether the claimed invention is in a statutory category. The defined four categories again are a process/method, machine, manufacture, and composition of matter. In MPEP 2106.03 Step 1 is discussed and provides examples of subject matter that does not fall within any category such as signals per se, software per se, and human organisms. Second, in the Step 2 of this test it is broken down into Step 2A and Step2B also known as the Alice/Mayo test. Step2A is further broken down into Step 2A prong on and Step 2A prong 2. Step 2A deals with the judicial exceptions, namely abstract idea, laws of nature and natural phenomena that includes products of nature. The first prong of Step 2A asks if the claim recites a judicial exception. If yes to the first prong of Step 2A then the second prong of Step2A asks if the claim recites additional elements that integrate the judicial exception into a practical application. If yes to the second prong of Step2A, Step2B asks an inventive concept inquiry whether the claim recites additional elements that amount to significantly more than the judicial exception. If yes to Step 2B then the claim has eligible subject matter under 35 USC 101. There has been significant disagreement among courts over the application of Section 101, especially from the application and interpretation of the “abstract idea” exception. Unfortunately, the U.S. Supreme Court guidance in this area lacks clear definition of the boundaries that constitutes an abstract idea. As a result diverse interpretations by several courts on the definition of an abstract idea has occurred. Indeed, the Federal Circuit has been divided at times over the application of the two-step Alice/Mayo framework that the Supreme Court has established to determine patent eligibility under Section 101. Furthermore, courts have been accused of introducing considerations from other requirements to patentability including enablement, novelty, and non-obviousness into the patent eligibility analysis. The USPTO has also admittedly struggled to apply consistently the two-step Alice/Mayo framework. Attempts to make the application more uniform such as providing the 2019 Revised Patent Subject Matter Eligibility Guidance the USPTO interpretation of an abstract idea in higher technologies is challenging for the USPTO examiners to consistently determine what subject matter is patent-eligible. The Supreme Court's decision to deny certiorari in Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electro Oy leaves several questions unanswered. These cases had been viewed as a possible vehicle to clarify the scope of the abstract idea exception. It was anticipated that the two-step framework for assessing patent eligibility would be further clarified as it relates to other patent doctrines such as novelty, obviousness, and enablement. A decision to hear these cases would have provided guideposts to (1) determining an appropriate level of generality at which to evaluate whether an invention falls within the realm of an abstract idea and (2) the propriety and degree of importing other patent-law doctrines into the analysis of abstract ideas. With the US Supreme Court's denial of cert these key questions remain for another day, leaving the patent practitioners today with uncertainty as to consistent application. Tropp v. Travel Sentry, Inc. Tropp v. Travel Sentry, Inc., No. 2021-1908 (Fed. Cir. Feb. 14, 2022), is directed at U.S. Patent Nos. 7,021,537 and 7,036,728 owned by Mr. David Tropp.These patents disclose a process of screening luggage without breaking luggage locks. Specifically the claims were directed to a method of improving airline luggage inspection by a luggage screening entity, and a method of improving carrier baggage inspection by a baggage screening entity, respectively.The patent’s solution was a dual-access lock that is opened by the owner or by a master key held by screening agents to ensure travel security without damaging passengers’ belongings. The patents were challenged by Travel Sentry that brought a declaratory judgment of non-infringement and invalidity based on Travel Sentry’s similar lock-and-master-key program. The District Court for the Eastern District of New York held Tropp’s patents to be patent-ineligible abstract subject matter under 35 U.S.C. § 101 noting “application of dual-access locks to airport luggage inspection,” was a long-standing practice. The court dismissed Tropp’s argument that his patents enabled an entirely new process. The court argued such process was merely a combination of existing practices. An appeal was filed to the Federal Circuit where Tropp argued an inventive concept transformed the claims into patent-eligible subject matter. The Federal Circuit affirmed the District Court’s decision holding that the patent claims were an abstract idea directed to a “longstanding fundamental economic practice and method of organizing human activity.” Although Tropp’s invention was physical in nature, namely the double lock system, it was assessed in the context of the abstract-idea exception that traditionally pertains to concepts such as mathematical formulas, economic practices, or methods of organizing human activities. The USPTO Solicitor General was invited to file a brief expressing the views of the United States in this case. As amicus curiae, the USPTO Solicitor however argued that Tropp was correctly decided. It was pointed out by the Solicitor that the claims in Tropp recited “a ‘process’ for coordinating one aspect of airport luggage inspection,” See, Brief amicus curiae of United States, Nos.21-1281, 22- 22 at 12 (U.S. Apr. 5, 2023) (“Solicitor’s Brief”) (quoting Bilski v. Kappos, 561 U.S. 593, 606-07 (2010)). The Solicitor further urged the U.S. Supreme Court to detach the eligibility inquiry from other statutory requirements, such as 35 U.S.C. 102, 35 U.S.C. 103, and 35 U.S.C. 112 that deals with novelty, obviousness, and written description, respectively. Id.at 16-18. The Solicitor in addition stated district court’s analysis in Tropp was flawed because these additional patentability issues conflated the issue of patent eligibility. Id. “[A]pplying modified versions of other doctrines in the guise of a Section 101 analysis unmoors those doctrines from the statutory text and diminishes their analytical rigor.” Id.18. The Solicitor concluded that Section 101 and the abstract-idea exception should be applied to “screen out the sorts of nontechnological innovations that do not warrant patent protection” regardless of novelty, non-obviousness, and adequacy of the written description.” Id. Interactive Wearables, LLC v. Polar Electro Oy Interactive Wearables, LLC v. Polar Electro Oy, No. 2021-1491 (Fed. Cir. Oct. 14,2021) is directed at U.S. Patent Nos. 9,668,016 and 10,264,311 that disclose a wearable content player with a remote-control device. The remote control is wirelessly connected to a content player and features a second user’s display for information associated with the content. The Eastern District of New York dismissed Interactive’s claims as directed tonan abstract idea of “providing information in conjunction with media content. Interactive Wearables, LLC v. Polar Electro Oy, 501 F. Supp. 3d 162, 179 (E.D.N.Y. 2020). The claims recited a wearable content player including a receiver, processor, memory, and display controlled by another remote control device to “provide to the user ... information associated with the content.” Id at 167. The district court found the claims also lacked inventive concept because the claims merely “invoke[d] conventional and generic components arranged in a conventional manner.” Id. at 179. On appeal, the Federal Circuit affirmed the district court’s dismissal. (citing Fed. Cir. R. 36). This decision raised several issues about the interpretation and application of Section 101. It demonstrated court’s decision to invalidate patents even if a process is not involved and giving a broad interpretation of what constitutes an abstract idea. The decision also raises issues for courts to bring in other patent-law doctrines such as novelty, obviousness, and enablement into the abstract-idea analysis. The Solicitor General again invited as amicus curiae stated while the claims in Interactive recited “a ‘machine’—a ‘tangible system’—in the form of a wearable content player and wireless remote-control device it should not fall under the umbrella of Section 101. According to the Solicitor, Interactive’s claims fall within patent law’s “traditional coverage of technological and industrial arts,” including “electronic hardware components that together compose a mechanical device.” Brief at 14. The Solicitor concluded that the EDNY’s articulation of the invention as an abstract idea was only a “function of the described machine.” Id. at 15 (“The district court’s characterization is akin to saying that a patent for a television is directed to the ‘abstract idea’ of displaying images and sounds.”) The Solicitor’s brief focused on the eligibility of hardware-based innovations, asserting that these are eligible “technological” advances. However, the Brief offered extraordinarily little guideposts on how to manage the “borderline cases” between the intersection of hardware and abstract ideas such as that found in combinations of hardware and software or firmware, which is software designed specifically for a piece of hardware. See id. at 14. There are many unanswered and difficult questions concerning how to deal with non-abstract advances in software and other high technologies. The Solicitor’s Brief eluded that an improved computer technology may receive apatent if other statutory conditions are satisfied even if the utility lies in the conduct of business, for example, which may be considered an abstract idea. CONCLUSION Intellectual property continues to play an important role in attracting private sector participation in developing and commercializing related applications. Advancement in technologies beyond earlier technologies when Section 101 was initially promulgated yearns at least a glimpse of further refinement in the interpretation of the abstract-idea exception in order to further protection of such high technological innovations. Such refinement with the denial of cert by the U.S. Supreme Court in Tropp and Interactive now remains in the possession with the Federal Circuit or Congress. Uncertainty will continue to exist with the application of Section 101 until defining limits of patent eligibility is further clarified. CHROMADEX, INC., Trustees of Dartmouth College v. ELYSIUM HEALTH, INC. By: Kathleen D. Rigaut, Howson & Howson, LLP I. Introduction 35 U.S.C. § 101 states: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement there of, may obtain a patent therefor, subject to the conditions and requirements of this title. I began prosecuting patents in the molecular biological arts in 1995. In my first 15 years of practice, it was rare to receive a §101 rejection alleging non- patentable subject matter. Our clients were obtaining patent protection forisolated nucleic acids of SEQ ID NO: X and natural allelic variants thereof, proteins encoded by such nucleic acids, monoclonal and polyclonal antibody preparations directed to a specified antigens without recitation of antibody sequences, along with diagnostic methods and kits using such molecules. While many of these patents have expired, none of those with remaining term would be enforceable today in view of the Supreme Court’s decision to significantly curtail what is considered patentable which occurred many years after these cases were filed. The present case is illustrative of the evolution of the Supreme Court’s interpretation of 35 USC §101 of the Patent Act over the last decade which tends to frustrate patent practitioners, and their clients, particularly those working in fields of recombinant molecular biology and software. See for example Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020), and Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014). Surprisingly, the patent eligibility hurdle under §101 has now been extended to the automobile arts as evidenced by the Supreme Court’s decision to deny the writ of certiorari in American Axle & Manufacturing Inc. v. Neapco Holdings LLC. Case No.1:15-cv-01168-LPS (D. Del.). In this case, the Supreme Court refused to consider whether the Federal Circuit erred when it found claims of U.S. Patent 7,774,911 to American Axle, directed to a method for manufacturing a shaft assembly of a driveline system, ineligible for patent protection under §101. After applying the two-step analysis, a split panel of the Federal Circuit held that 1) “as a whole, the claims are “directed to” one of the three categories of exceptions to patentable subject matter: abstract ideas, laws of nature, or natural phenomena”, in this case, Hook’s Law;and 2) the claims did not encompass a characteristic that added significantly more than the ineligible concept itself which would suffice to transform the invention into patentable subject matter. After the full Federal Circuit denied American Axle’s petition for a rehearing en banc in a 6-6 split decision, American Axle appealed to the Supreme Court who did not take up the case for review as mentioned above. The cited cases are illustrative of the greatly restricted view of patent eligible subject matter under §101. However, in each of these cases, amendmentof the claims to include a specific description of the surprisingly superior characteristic now required by the Court, while likely to overcome the §101 rejection, will often result in claims having significantly narrowed scope. II. Background A motion for summary judgment, filed by Elsyium Health, Inc., alleging that claims 1-3 of US Patent 8,197,807 were invalid under §101 of the patent statute for reading on a “naturally occurring” milk product, was granted by the District Ct. of Delaware. ChromaDex, Inc. v. Elysium Health, Inc., 561 F.Supp.3d 460 (D. Del. 2021). Chromadex Inc. appealed to the Federal Circuit contending that the dietary supplement encompassed by the claims contributed something “significantly more” due to the presence of elevated levels of nicotinamide riboside (NR), a form of vitamin B3, along with a number of other components. The Federal Circuit affirmed the district court’s decision, finding that the features Appellant’s relied upon as providing improved characteristics, were not recited in the claims, thereby rendering them broad enough to read on NR that is present in trace amounts in cow’s milk which is already known to increase NAD + biosynthesis upon oral administration. More particularly, the Court reminded Appellants that mere isolation and concentration of NR was no longer enough under Myriad. The holdings in Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204,65 L.Ed.2d 144 (1980) and Natural. Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1342 (Fed. Cir. 2019) were relied upon for the premise that unique characteristics, not already present in naturally occurring compositions, are also required to avoid a §101 rejection.  II.A. DeNovo review of Summary Judgment The Federal Circuit conducted a de novo review of the district court's grant of summary judgment applying the law of the 3rd regional circuit. See Junker v. Med. Components, Inc., 25 F.4th 1027, 1032 (Fed. Cir. 2022) (citing Gonzalez v. Secretary of Department of Homeland Security., 678 F.3d 254, 257 (3d Cir. 2012)). According to the Court, Summary judgment is appropriate when, drawing all reasonable inferences in the nonmoving party's favor, "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d202 (1986). Eligibility under § 101 may involve questions of fact but is, ultimately, a question of law that were view de novo. Nat. Alts. Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1342 (Fed. Cir. 2019); Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1342 (Fed. Cir. 2018). Historically, the granting of a summary judgment motion during patent litigation occurred infrequently, as issues raised in such cases are inherently too numerous, broad and complex. Other issues for consideration unique to patent cases include determination of claim construction and actual infringement relating to the practice of the claimed subject matter over the full scope of the granted claims. In the present case, the Federal Circuit held that the 3rd Circuit Regional Court appropriately granted summary judgment as there was no material fact in dispute. This holding is in keeping with the increasing trend of summary judgment adjudication of patent cases. II.B. The issued claims of the ‘807 patent encompass natural cow’s milk and are therefore patent ineligible under 35 U.S.C §101 In the opinion, the Federal Circuit Court provided a comparison of the composition claimed by the Appellant’s to cow’s milk, a naturally occurring, and therefore, patent ineligible composition. After applying the broadest interpretation of the claims over their full scope, the Court concluded that the only difference between the claimed composition and milk was that NR which is inherently present in milk, was present in Appellant’s composition at elevated levels. Claim 1 reads as follows: A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, ornicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer's solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increased NAD + biosynthesis upon oral administration. ChromaDex argued that the characteristics of isolated NR conferred new characteristics to the dietary supplement composition, such as improved stability, bioavailability, sufficient purity, and therapeutic efficacy. The Court rejected these arguments, noting that none of these features were recited in the claims. The Court further concluded that "the decision to create an oral formulation of NR after discovering that NR is orally bioavailable is simply applying a patent- ineligible law of nature." Id. at 467. Moreover, the ability to increase NAD + biosynthesis upon oral administration occurs when milk is consumed, albeit due to the present of tryptophan, rather than elevated NR. The Court noted that it could have ended the inquiry there based on the holding in Diamond v, Chakrabarty, supra, alone, as a distinguishing characteristic over thenaturally occurring composition was not present. However, the Court did provide analysis on step 2) of the inquiry and cited its holding in Natural Alternatives, supra, another case related to dietary supplement formulations. In that case, the supplements comprised beta-alanine, a naturally occurring molecule. Notably, because the claims recited specific treatment formulations comprising natural products in a dosage form, “between about 0.4 grams to 16 grams” which were effective to increase athletic performance, the Federal Circuit held markedly different characteristics from naturally occurring beta-alanine were present, thereby distinguishing the claimed supplements, rendering them patent eligible. Finally, the Court found that Appellant’s claims did not recite that the isolated NR was separated from lactalbumin thereby conferring increased bioavailability, did not include any specific level of NR that differed from that in milk, and encompassed a biological feature achieved when milk was consumed. In view of all the foregoing, the Federal Circuit Court held that summary judgment was appropriate.  III. Conclusion and Patent Drafting Tips In this case, it is likely that the claims of the ‘807 patent would have survived the motion for summary judgment if ChromaDex had included the features mentioned above, e.g., a dosage form comprising a specified level of NR as discussed in Natural Alternatives and/or requiring that the NR present be elevated, bioavailable and not in a complex with lactalbumin. Additionally, it is a good practice tip to counsel clients who have successfully licensed their technology to keep at least on continuation application pending. In ChromaDex, had a continuation application been pending, claims could have been presented to the USPTO that would avoid a §101 rejection. Using the Track One application filing strategy, and assuming no other complications, a valid patent would issue within a year or so. The language of §101 is clear. The invention to be patented must be a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. I submit that isolation and diagnosis of breast cancer based on the discovery of a deadly mutation in BRACA1 and BRACA2 genes is patentable subject matter. I still believe the holding in Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020). was a travesty and the Federal Circuit’s solution to find the method of diagnosis based on the presence and type of cffDNAin material blood objectionable under §101, while finding the method of preparation patentable was nothing more than a sleight of hand. The Federal Circuit remains bitterly divided on patent eligibility and appears to be waiting for the Supreme Court to step in and provide clarity. In view of the repeated denial of certiorari on several problematic cases, it seems that the Court is satisfied with the status quo. Thus, it will likely take an act of Congress to rectify the current unfortunate judicial interpretation of the metes and bounds of §101. Until then, attorneys and their clients would be well served to assess whether the invention disclosed can be construed to encompass naturally occurring compositions or natural law. If the answer is yes, claims to theinvention should be drafted to provide a clear and concise definition of the inventive application of the naturally occurring composition of matter orstructure, and ensure that something beneficial occurs, e.g., “increases athletic performance”, or in the software field, wherein performance of the program effects a desirable change in a measurable parameter. In view of the holding in Illumina, supra, patent holders would be well served to present both method of diagnosis claims, ideally comprising features that do not read on a natural law, along with method preparation claims whenever possible. If non-conventional process steps are included, this also will increase Applicant’s chances of satisfying the requirements of §101. Historians Corner BY: DALE CARLSON* Kudos to President Rob Rando for his podcast series hosting remembrances of past presidents on their time in office. The mission of our Association is all about building bridges with the bench and bar and with students having an interest in IP law. Our Association builds bridges with students with panel discussions at our regional law schools on "Diverse Careers in IP". It also provides cocktail gatherings for summer interns typically hosted by the Young Lawyers Committee. The NYIPLA also builds bridges with the judiciary by virtue of its annual Judges Dinner, now being held at the Hilton Midtown. In the beginning, however, these annual dinners were held at the Waldorf when the Waldorf and the Astoria were two separate hotels located on Fifth Avenue where the Empire State Building is now. The date of the first dinner was December 6th, 1922, during the height of Prohibition. Nonetheless, alcoholic beverages were served as shown by an empty cocktail glass on a menu in the form of a patent to inventors Cook & Chef distributed that evening. The menu is attached as Appendix A. Indeed, the menu observes, albeit tongue-in-cheek, that the contents of the cocktail glass may not have been made by a secret process "but certainly [were made] by a process in secret". Lots of things were special about that intimate first dinner, including the presence of Judge Giles S. Rich's dad, G. Willard Rich, as well as Archibald Cox, Jr's (of Watergate prosecution fame) dad, Archibald Sr., and both Judge Learned Hand and his brother Augustus. Only 258 judges and guests were present on that evening. A reissue version of the Cook & Chef patent describing the contents of the cocktail glass was featured at the 50th Judges Dinner in 1972, long after Prohibition was but a distant memory Decades later, during Chris Hughes' presidency in 2007, the NYIPLA hosted the Federal Circuit judges sitting in Manhattan at another dinner at the Waldorf=Astoria on Park Avenue on the occasion of that court's twenty-fifth anniversary since its creation in 1982. The dinner simulated the intimate feel of the first dinner in 1922 with about 250 judges and guests seated in the Starlight Room on the eighteenth floor of the hotel. A Commemorative Journal was distributed. The first portion of the journal is attached as Appendix B. The Waldorf has now been converted to luxury condos with the Starlight Room sporting and supporting a swimming pool for residents. In retrospect, 2007 was a high-water mark for the Court since the impact of the eBay and KSR decisions coming from SCOTUS had yet to be felt and the America Invents Acts had yet to be enacted. It appears to have marked the end of the so-called "golden age" of patent law running from 1982 until 2007. Perhaps the NYIPLA will host the Federal Circuit in Manhattan in 2032 for the Circuit's golden anniversary. Here's hoping a new golden age of patent law will materialize by then.   *Dale Carlson is NYIPLA past president and current historian. His email is dale.carlson@quinnipiac.edu. As Time Goes By - Building Bridges Historians Corner - Appendix A Historians Corner - Appendix A Historians Corner - Appendix A Historians Corner - Appendix A Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B Historians Corner - Appendix B In attendance were: Rob Rando, President, presiding Chris Loh Jeffrey Coleman David Goldberg (via phone) Linnea Cipriano (via phone) Eric Greenwald (via phone) Jenny Lee Patrice Jean Lauren Emerson (joined at 4:14 pm) Ashley Ross (joined around 4:15 pm) Heather Schneider (joined at 4:44 pm) Abby Struthers (joined at 5:26 pm) Feikje van Rein and Jack Caroddo attended from the Association’s executive office. Nick Forgione, Jennifer Denault, and Christine-Marie Lauture attended in-person from the Associate Advisory Council. Mark Schildkraut, Paul Bondor, and Khalil Nobles from the AAC were unable to attend. President Rob Rando called the meeting to order at 4:07 PM ET. The board waived reading of the minutes and approved the minutes for the December 2023 board meeting. Financial Report. Jeffrey Coleman reported that membership dues are up, Judge’s dinner revenue is up from last year, and total income and events revenue are up. However, total expenses are up (Hilton, Conrad, deposits), so net income is a bit less YTD. Feikje noted that the first checks from Judge’s Dinner cleared. New Members. Jeffrey Coleman reported that there are 3 new members. Motions to waive reading of the names and to admit the new members were passed. Membership Drive. Rob Rando discussed potential student ambassador program with board members, where perhaps there can be an NYIPLA representative from each school. Jenna presented proposal for membership drive with Moleskine and stickers. The board discussed the fact that student membership dues have not been increased since inception. Motion to increase student membership dues to $40 effective May 1st for renewals and February 1st for new members. Legislative Action Committee. Update to be provided next board meeting. 102nd Judges Dinner, March 22, 2024. Rob Rando reported that the keynote speaker search is ongoing. Feikje noted that guest invitations to go out this week (approx. 750). Presidents’ Forum. Rob Rando reported on the subcommittee call with Tony LoCicero and Chris Israel. Programs will be virtual and held in 3 segments – 1 on march-in rights, 1 on AI & copyright with Perlmutter opening remarks, and 1 on rule changes. The board discussed additional options for each panel, such as: Panel 1 AI as a creator – PTO official, academic; Panel 2 major decisions and impact, changes to march-in rights, FTC oversight, possibly Joe Allen of Bayh Dohl commission and Panel 3 PTAB discretion denial Board members also discussed an idea for separate panel or perhaps folded into existing forum idea covering Chevron deference since arguments on 2 Chevron defense cases will start next week, as well as panel structure and content (connect to PTO guidance, etc.). Board Meeting February 13th Rob Rando and Heather Schneider provided the below update: a. Past Presidents’ Dinner (location: somewhere near Willke) b. Podcast with past presidents has been going well c. Board meeting will be at Willkie Amicus Briefs Committee. Update to be provided next board meeting. Project Team Bylaws. Rob Rando noted that changes need to be approved by the March 2024 board meeting so that voting can be conducted at the annual meeting in May. March-in Rights. Comments due by Feb 6th. IOTY Support Letter. Rob Rando reported that last year’s IOTY winner is up for the Louisa Gross Horwitz Prize and has requested a letter of support for the award nomination. Motion to support request for letter of support for the Louisa Gross Horwitz Prize was passed. Previous / Upcoming Programs 12/19 PTAB ProgramDavid Goldberg 01/16 PTAB ProgramDavid Goldberg reported that Tony will discuss PREVAIL and IMPACT acts. Goal is to get a vote on it this quarter, 02/06 Zoom Out with NYIPLA! Eric Greenwald reported this is the 3rd annual virtual event serving as an informal look back over the year. Starts at 5pm ET. 02/07 Biosimilars Program Abigail Struthers reported that there are 3 speakers currently and looking into additional panelists. Location at Kramer office. 2024 IP Transactions Bootcamp Abigail Struthers and Feikje reported that there has only been 1 registration so far. The board agreed to push the event back to October 2024, subject to agreement from everyone on the planning committee. 03/22 DOD CLE Rob Rando reported that the Day of Dinner luncheon with CLE will be limited to honored guests only at the Conrad. Rob Isaacson is chairing the committee. The CLE will cover case management, recent updates in IP law, and litigation financing. Reached out to 4 judges so far, including Judge Swain and Judge Gilstrap. Invitations will be staggered, extending to broader honored guests. 2024 YLC/Entertainment Broadway Program Abigail Struthers reported that the Anti-counterfeiting CLE will be conducted by Heather McDonald from Baker Hostetler on April 17th. 2024 YLC/Women in IP Program Abigail Struthers reported that there are 2 speakers so far, with the goal of having female IP attorneys in leadership positions to showcase. Discussed moving the program date from March 18th because of Judge’s Dinner. 2024 FIT Program Rob Rando reported that the subcommittee is working on it. The program is built around redesigning judge’s robes and having judges model them. Current strategy is to expand potential pool of designers to include students of fashion law and new/emerging designers. He noted there is some difficulty in ironing out logistics. 2024 Golf Outing Rob Rando reported that a poll sent out to membership to gauge interest. Need to guarantee 72 golfers minimum to reserve May 6th. Event would include breakfast, lunch, and dinner, taking place at a desirable course on Long Island. 2024 Arbitration Program Abigail Struthers reported that there is no set program yet. Ideas being considered include: late spring/summer mediation of IP disputes; mock arbitration involving IP; considering updating treatise on arbitration of patent; discussed having a certification program. New Business. The board reviewed New York Law School’s request for sponsorship of their IP symposium and discussed the request for sponsorship. The Board approved $500 . Meeting adjourned at 5:57 pm ET MINUTES OF JANUARY 10, 2024 MEETING OF THE BOARD OF DIRECTORS OF THE  NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION  Union League Club New York, New York MINUTES OF FEBRUARY 15, 2024 MEETING OF THE BOARD OF DIRECTORS OF THE  NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION Union League Club New York, New York In attendance were: Rob Rando, President, presiding Abby Struthers Lauren Emersen (joined at 4:14 pm ET) Eric Greenwald (joined at 4:22 pm ET) Jenny Lee (joined at 4:30 pm ET) Heather Schneider (joined at 4:30 pm ET) David Goldberg (via Zoom) Cheryl Wang (via Zoom) Diana Santos (joined via Zoom from 4:30 pm to 5 pm ET) Feikje van Rein and Jack Caroddo attended from the Association’s executive office. From the Associate Advisory Council, Jennifer Denault joined in-person at 5:14 pm ET, and Christine-Marie Lauture attended via Zooml. Jeffrey Coleman, Mark Schildkraut, Paul Bondor, Chris Loh, and Khalil Nobles from the AAC were unable to attend. President Rob Rando called the meeting to order at 4:25 PM ET. The board waived reading of the minutes and approved the minutes for the January 2024 board meeting. Financial Report.Feikje noted that an accounting of Judge’s Dinner monies received is in progress. Some deposits have been made and more collections are expected. Payment of $100k to Hilton Hotel venue (as compared to $50k last year) has already been made. All expenses are on par with previous year. New Members.There are 11 new members including 4 students, 2 associates and 3 who have been active 3+ years. Motions to waive reading of the names and to admit the new members were passed. Membership Drive. Rob Rando reported that the membership drive promotion began and has been shared on social media and the NYIPLA weekly report. He noted that the drive needs board members to help push. The board explored ways to increase memberships, e.g., QR codes at the Judge’s Dinner. Legislative Action Committee.Paul Bondor will provide an update next month. Rob Rando reported that NYIPLA’s comments on march-in rights were provided to NIST. Due to time constraints, NYIPLA did not separately submit comments. Amicus Briefs Committee.David Goldberg reported that an email was sent last Friday requesting conflict checks for Liquidia v. United Therapeutics. For In Re Cellect, involving obviousness and patent term adjustment issues, a brief was put in at the Fed Cir., which denied en banc review, and there will be a petition for cert so a proposal will be circulated, which will take the same position at Fed Circuit. Brief is expected to be due late April / early May. 102ndJudges Dinner, March 22, 2024.Rob Rando reported that the keynote speaker contract is being negotiated. He noted that there are less tables than last year (about 10 tables) and less attendees at the Fed Cir. but more attendees from EDNY & 2ndCircuit. Presidents’ Forum. Rob Rando reported that Chris Israel, who is assisting with this project, has reached out to the Copyright Office with respect to the state of AI. Upcoming forum topics will include Regulatory Impacts on IP Law & Practice, AI (featuring a Chief Policy Officer from PTO), Potential Changes to March-In Rights and FTC Oversight on orange book patents (the committee is reaching out to the Bayh Dohl commission). The first forum is slated for the 1stweek of March. Project Team Bylaws. Feikje noted that changes must be submitted before the next board meeting for voting. Sponsorship.The board discussed 3 potential sponsorship opportunities, from PLI, ACI’s 22ndAdvanced Summit on Life Science Patents, and IAM Live (an automotive industry IP conference). The board determined that NYIPLA will not associate with or sponsor for-profit conferences such as ACI and IAM Live. IOTY Support Letter.Rob Rando reported that last year’s IOTY winner is up for the Louisa Gross Horwitz Prize and has requested a letter of support for the award nomination. Motion to support request for letter of support for the Louisa Gross Horwitz Prize was passed. Previous / Upcoming Programs -02/06 Zoom Out with NYIPLA! Eric Greenwald reported the event featured good conversation; no need for breakout rooms; 17 attendees; at least a few folks who are students and a practitioner that seems new to NYIPLA; Rob urged senior practitioners to attend next one. -02/07 Biosimilars Program Abigail Struthers reported the event was well-attended; 37 in-person attendees; featured individuals outside of NYIPLA to network with e.g., partners at other law firms -02/27 PTAB ProgramDavid Goldberg reported the event will provide CLE credit; this month someone from Patent office speaking on what people should consider when evaluating choice between request for continued examination vs appeal; did similar topic 2 years ago with updated information from PTO this time -03/08 YLC/Women in IP Meeting Abigail Struthers reported the event will take place from 1-2 pm via Zoom; women in leadership panel; so far Patrice Jean as speaker;no data on registrants yet -03/13 YLC Speed Networking SocialAbigail Struthers reported the event will take place at Stitch bar in midtown; 23 people registered as of Tuesday; may be more registrants; format is similar to speed dating but focused on career-related networking -03/22 DOD CLE Rob Rando reported that this program is being put together currently; the CLE topic is very targeted (case management in patent cases);16 judges have indicated will attend (travel is challenging) -04/24 YLC/AAC Deposition Training CLE Abigail Struthers reported that Heather will be one of the speakers; CLE will provide practical tips geared towards associates & young lawyers -07/2024 Second Circuit Moot Court Program Rob Rando reported that by next board meeting the firms to be invited will be determined; the board discussed prior & potential participants -2024 TM Half-Day CLE Abigail Struthers reported that the plan is to hold the event in June/July; Committee co-chairs Deidre and Lindsey are helping out -2024 YLC/Entertainment Broadway Program Abigail Struthers noted that there are no updates; Rob will reach out to Michael (previously at Greenspoon) -2024 IP Transactions Bootcamp Abigail Struthers reported the event is slated for October 2024 and dates are being considered; more substantive update in April/May; program is still in the works/early stages -2024 FIT Program Rob Rando reported that the subcommittee is making progress; not looking like April is likely; but still want to move forward; Will assess when it can be done; have call next week with subcommittee; currently not sure how far to move it back but might be pushed out to the fall due to students’ schedules -2024 Golf Outing Rob Rando reported that it is not looking like it will come together in May 2024 and may need to factor into scheduling the fact that the Fashion Law program likely pushed back to the fall; many positive requests from past presidents but not very involved in planning; -2024 Arbitration Program Abigail Struthers noted there are no real updates at this time. Committee Reports. Feikje noted there are upcoming deadlines for Connor Writing Competition, IOTY award and NYIPLEF scholarship. Meeting adjourned at 5:52 pm ET. MINUTES OF March 5, 2024 MEETING OF THE BOARD OF DIRECTORS OF THE  NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION By Zoom New York, New York In attendance were: Rob Rando, President, presiding Jeffrey Coleman Patrice Jean Linnea Cipriano Eric Greenwald Jenny Lee Heather Schneider Chris Loh Paul Bondor Ashley Ross NYIPLA Admin Cheryl Wang (joined at 4:31 pm) Diana Santos Abby Struthers Feikje van Rein and Jack Caroddo attended from the Association’s executive office. From the Associate Advisory Council, Nick Forgione and Christine-Marie Lauture jointed. Mark Schildkraut, and Khalil Nobles from the AAC were unable to attend. President Rob Rando called the meeting to order at 4:32 PM ET. The board waived reading of the minutes and approved the minutes for the January 2024 board meeting. Financial Report.Jeffrey Coleman reported that finances YTD are tracking in the right direction. Discussed whether there are accounts with better interest rates. Feikje confirmed that interest rates are higher YTD and that we are on top of the accounting. Chase andBofA in CDs both around 5% and one rolled out of CD last month. Checking account and Judge’s Dinner funds will not be put into CD as liquidity is necessary to pay expenses. New Members.Jeffrey Coleman reported that there are 6 new members since last month. Motions to waive reading of the names and to admit the new members were passed. There has been a significant increase in associate membership since last year and overall an increase in membership in all categories except student membership, which is still holding steady compared to last year. Close to reaching 1k members. Membership Drive. Rob Rando requested that membership drive be mentioned at all events and remains open to ideas to continue to drive increase in membership. Legislative Action Committee.Paul Bondor reported that there has not been much going on with Congress, which is currently preoccupied with many public policy debates in addition to it being an election year. The PREVAIL Act (involving PTAB practice – standing and claim construction requirements, serial petitions, etc.) has not moved around much. The PTAB Committee has put together slides about current activity in PTAB to track activity for presentations. WTO is looking at COVID waiver – some countries are requesting extended waiver for COVID treatments and tests in addition to vaccines. The US opposes WTO, which has put off the issues until a later time. Amicus Briefs Committee.David Goldberg reported that the In Re Cellect proposal was reviewed by the board with up to 4 members conflicted out. Discussed whether necessary to move forward with a quorum. The board passed a motion to approve the ABC moving forward with votes from board members not conflicted out. Nothing else imminent but ABC continues to monitor cases on the horizon. 102ndJudges Dinner, March 22, 2024.Rob Rando discussed attendance and registration in terms of tables and judges. Presidents’ Forum, March 14th. Rob Rando reported that US IP policy will be discussed and asked that members make the time to participate at the Forum. Inventor of the Year Award. Heather Schneider reported that she will follow up with the co-chairs. So far, 6 nominations received with the last nomination coming in over the last week so there has not been enough time to present at this board meeting. Will email to the board for review and vote so that winners can be contacted by the April board meeting. Project Team Bylaws. Subcommittee consisting of a group of board members including previous board members, met this week and reviewed entirety of bylaws. Jonathan Berschadsky worked on this as well. Markups and recommendations will be shared with the board for review by Friday. Bylaws require having a Membership Committee and potential candidates for chair / co-chair were discussed. Also discussed updating language and process for handling complaints. Key points explored include 1) quorum exceptions for Amicus Brief approvals with discussion of adding a provision so that non-conflicted minimum of 5 can vote (still under discussion and encourage board members to provide input as to whether unanimous is necessary) and 2) creation of a new membership category for administrative PLJs in addition to Associate/Government/Academic memberships – Patent Agents. It was noted that admin PLJs did not exist when membership and bylaws were written and this special category was created to align. Article III judges are honorary members but PLJs are not honorary members. The subcommittee also discussed potential clauses regarding attendance – not necessarily mandating but encouraging 70% attendance. Previous / Upcoming Programs -02/27 PTAB ProgramDavid Goldberg PREVAIL act is Jan PTAB meeting; PTAB would like NYIPLA to submit input on PREVAIL 3-4 PTAB judges discussing pros and cons for continuing examination or appealing; only made it halfway through discussion so will continue next meeting -03/05 Patent Litigation Program Christopher Loh reported that event was well-attended & well received today; 24 attendees; Michelle Ebert discussed litigation funding for patent cases; Discussed practical aspects and mechanics of litigation funding for funders and clients; Mostly funders are tech agnostic & mostly matters sufficient risk/reward ratio -03/08 YLC/Women in IP Meeting Abigail Struthers reported the event will be a virtual joint panel discussion with Ashley Ross,Leslie Spencer from Demarais and Patrice Jean from Hughes Hubbard; casual during regular lunch hour meeting time; celebrate women’s history month -03/13 YLC Speed Networking SocialAbigail Struthers reported the event will take place at Stitch bar; now have 35 registrants and at least 8 that have practice seniority; Discussed whether board members can have events put tentatively on calendars to raise awareness -03/19 PTAB ProgramDavid Goldberg reported the event will be the 2ndpart of discussion for RC vs appeal for continuation -03/22 DOD CLE Rob Rando reported the event will cover effects of recent IP law developments on case management; Magistrate Judge Burke from Delaware; Chief Judge Gilstrap from TX; Chief Judge Pallmeyer from Northern District of Illinois; former director Iancu for opening remarks; Encourage board members to attend the CLE; currently 20 judges; Judge Slomsky will bring law clerks -03/28 Careers in IP ProgramAbigail Struthers reported the event will be at Hofstra – President Rando will be speaking and Lynn Russo volunteered to join as a panelist -04/24 YLC/AAC Deposition Training CLE Abigail Struthers reported the event will take place at Willke – Heather, Rob and Allison will be speaking; Audrey as moderator; 6 pm ET; planning still in progress -05/08 Annual MeetingPatrice Jean reported that work on this event is in progress; Likely will do a CLE; asked Director Vidal to attend but unable to attend; Will ask Commissioner of Patents Vishali for talk by her about what’s going on at USPTO; will be at Union Club; Other question is honorees – once more selection is done then will be presented to board for approval -07/16 Second Circuit Moot Court Program Rob Rando reported that firms have not been invited yet but discussed fact pattern & firms to participate; Will research suitable fact pattern/case; 8 competitors; 4 teams; feedback from mock judges is very useful; judges appreciate and praise the program -2024 TM Half-Day CLE Abigail Struthers reported that event date is targeted for June 26 or June 27th; possible to host at Hughes Hubbard; In-house counsel confronting AI issues; possibly MOMA is interested; historically 50-60 attendees and held at King & Spalding -2024 YLC/Entertainment Broadway Program Abigail Struthers reported there are no updates yet; President Rando will reach out to Michael Patrick -2024 IP Transactions Bootcamp Abigail Struthers reported the event has been moved to October 2024; Taking place over Oct 8th, 15th, and 22nd; will reach out to contributors / participants starting in May -2024 FIT Program Rob Rando reported that this event has momentum; considering fall dates; will keep it going working out details of program itself; timeline too short to have program before fall -2024 Golf Outing Rob Rando reported the event has been pushed back; current idea is to recruit past president’s committee members – very interested; expect more work done by those with interest; need involvement for setting up program; timing TBD possibly late summer/fall; Potential charity event; discussed involving more local organizations; all options on the table -2024 Arbitration Program Abigail Struthers reported this event is time-sensitive – CLE at the annual meeting; will involve new arbitration rules; some courts mandate mediation like EDNY, Fed Cir Court of Appeals has mediation requirement for appeals; 2ndCir. has mediation requirement; beneficial to have Committee do a survey of where you have to mediate & where you don’t and giving 101 skills for mediation/arbitration; thought was to do mock program but will meet with Committee to discuss suitable format Meeting adjourned at 5:52 pm ET. PTAB Committee Meeting - RCE v. Appeal Considerations By: PTAB Committee On February 27, 2024, the New York Intellectual Property Law Association (NYIPLA) PTAB Committee had a discussion regarding the RCE v. Appeal Considerations. This interactive meeting was hosted by Co-Chairs Charley Macedo and Ken Adamo, of the NYIPLA PTAB Committee. After receiving a final rejection, applicants have a choice whether to appeal to the PTAB or file a request for continued examination (RCE). A panelist of PTO judges discussed how to navigate that choice. Additionally, they were joined by Clint Mehall, co-chair of NYIPLA's Patent Law & Practice Committee, who discussed an analytical view of different arguments mentioned in PTAB decisions and their correlation to outcome. Speakers: Hon. Jason J. Chung, Administrative Patent Judge, USPTO Hon. Michael T. Cygan, Administrative Patent Judge, USPTO Hon. Debra L. Dennett, Administrative Patent Judge, USPTO Clint Mehall, Partner, Davidson, Davidson & Kappel, LLC Patent Litigation Committee Meeting - Litigation Funding for IP Cases By: Patent litigation committee On Tuesday, March 5, 2024, the Patent Litigation Committee meeting featured a presentation on Litigation Funding for IP Cases from Michelle (Jacobson) Eber, Managing Director at West U Capital. Women in Leadership By: Young Lawyers and Women in IP Law Committees Attendees had an opportunity to celebrate Women’s History Month with the NYIPLA Young Lawyers and Women in IP Law Committees on Friday, March 8, 2024 between 1-2pm ET. We invited women in NYIPLA’s leadership to share insights into their leadership styles, early career lessons, and advice to those wanting to take on more leadership roles. Speakers: Patrice P. Jean, Partner, Hughes Hubbard & Reed LLP Ashley Ross, Partner, Kirkland & Ellis LLP Leslie M. Spencer, Partner, Desmarais LLP Co-Moderators: Jasmine De Cock, Associate, Fish & Richardson P.C. Lindsey Miller, Partner, Desmarais LLP Young Lawyers Committee Speed Networking By: young lawyers Committee On March 13, 2024, the NYIPLA Young Lawyers Committee had an evening of networking, food, and drinks! This speed networking social event was a fantastic opportunity to connect with fellow young lawyers and experienced attorneys. Whether you're a member or a non-member, all were welcome to participate. Attendees enjoyed two complimentary drinks and indulged in appetizers while engaging in one-on-one conversations with seasoned attorneys who provided valuable insights into their practices. This was a wonderful opportunity to expand your professional network and gain valuable knowledge in a relaxed and enjoyable atmosphere. NYIPLA Presidents' Forum: A Discussion with U.S. IP Policy Leaders By: fashion law Committee The Forum, which took place on March 14, 2024, was moderated by Past President and Co-Chair of the NYIPLA Legislative Action Committee, Anthony Lo Cicero, and included the following outstanding panel of U.S. IP Policy Leaders: • Sharon Israel, Chief Policy Officer and Director for International Affairs, USPTO • Stevan Mitchell, Director of the International Trade Administration's Office of Intellectual Property Rights (OIPR), U.S. Department of Commerce • Peter-Anthony Pappas, Professional Staff Member Detailee with the U.S. Senate Committee on the Judiciary, Senator Thom Tillis - Ranking Member of the Subcommittee on IP • Maria Strong, Associate Register of Copyrights and Director of Policy and International Affairs, U.S. Copyright Office PTAB Committee Meeting - Outcomes of Ex Parte PTAB Appeals By: PTAB Committee On March 19, 2024 the New York Intellectual Property Law Association (NYIPLA) PTAB Committee had a discussion regarding the Outcomes of Ex Parte PTAB Appeals. This interactive meeting was hosted by Co-Chairs Charley Macedo and Ken Adamo, of the NYIPLA PTAB Committee. Speakers: Kenneth R. Adamo, Principal, Law Office of KRAdamo Charles R. Macedo, Partner, Amster Rothstein & Ebenstein LLP Clint Mehall, Partner, Davidson, Davidson & Kappel, LLC The Effects of Recent and Pending IP Law Developments on Case Management By: Programs Committee NYIPLA hosted the "Day of Dinner" Luncheon CLE Program on March 22, 2024. The panel discussed the practical impact of changes and trends in the IP field on management of district court proceedings. The program started with opening remarks from Andrei Iancu, Former Undersecretary of Commerce for IP and USPTO Director, provided an overview of pending patent legislation. It was then be followed by the below panel of distinguished speakers: Honorable Christopher J. Burke, Magistrate Judge, U.S. District Court for the District of Delaware Honorable J. Rodney Gilstrap, Chief Judge, U.S. District Court for the Eastern District of Texas Honorable Rebecca R. Pallmeyer, Chief Judge, U.S. District Court for the Northern District of Illinois 102nd Annual DInner in Honor of the Federal Judiciary The NYIPLA hosted the 102nd Annual Dinner in Honor of the Federal Judiciary on Friday, March 22nd, 2024 at the New York Hilton Midtown Hotel. The Association presented the 22nd Annual Outstanding Public Service Award to Judge Joseph F. Bianco, Circuit Judge of the United States Court of Appeals for the Second Circuit. This award is given to a current or past member of the Judiciary that has provided an extraordinary level of Public Service. We were also joined by our Keynote Speaker, John Ondrasik, Singer and Songwriter, Five for Fighting. NYIPLA Diverse Careers in IP Program By: PTAB COmmittee Have you ever wondered what opportunities are available in today’s intellectual property marketplace? The panelists addressed these topics and more. On March 28, 2024 at Maurice A. Deane School of Law at Hofstra University, there was a panel discussing how you can navigate your career paths in a marketplace with diverse opportunities for intellectual property lawyers. Panelists: Peter Ausili, former Judicial Law Clerk for Hon. Leonard D. Wexler, former Assistant Dean for Career and Professional Development, Touro Law Center Maisha Imam, J.D. Candidate, Hofstra Law Robert J. Rando, Partner, Greenspoon Marder LLP Lynn M. Russo, Associate, Hughes Hubbard & Reed LLP Internship Insights: Making the Most of Your Summer Experience By: young lawyers committee On April 10, 2024, the NYIPLA Young Lawyers Committee had a virtual panel on Internship Insights: Making the Most of Your Summer Experience. Attendees heard from three accomplished panelists as they shared inside perspectives on their summer internships during law school. Whether you're navigating your first legal internship or aiming to maximize your experience as a summer associate, this event was a perfect opportunity to gain valuable insights from those who have been there. Attendees had the chance to get their pressing questions answered and gained valuable tips on how to excel this summer. Panelists: RJ McLaughlin, Associate, Pryor Cashman LLP Jonathan Presvelis, Associate, Greenberg Traurig LLP Audrey Trace, Associate, Leason Ellis LLP PTAB Committee Meeting: Ask the PTAB By: PTAB committee On April 16, 2024, the New York Intellectual Property Law Association (NYIPLA) PTAB Committee had a discussion regarding FAQs on Appeals, AIA Trials, and Hearings. This interactive meeting was hosted by Co-Chairs Charley Macedo and Ken Adamo, of the NYIPLA PTAB Committee.This panel featured frequently asked questions about appeals, AIA trials, and hearings. Speakers: Hon. Jeffrey W. Abraham, Lead Administrative Patent Judge, USPTO Hon. Ifti Ahmed, Lead Administrative Patent Judge, USPTO Patent Litigation Committee Meeting - Current Issues in Patent Damages Analysis By: patent Litigation committee On Tuesday, April 23, 2024, the Patent Litigation Committee meeting featured a panel discussion on Current Issues in Patent Damages Analysis from Dominic Persechini, Managing Director at Intensity, LLC; John Blair, Managing Director at Berkeley Research Group, LLC; and Na Dawson, Principal at Analysis Group, Inc. NYIPLA Events NYIPLA Events Last First Firm/Company/Law School State Membership Abdi Zehra Abdi Law PLLC New York Active 3+ Hon. Amundson Steven United States Patent and Trademark Office New Jersey Government/Academic Bowden Eva Davidson, Davidson & Kappel LLC New York Active 3- Briggs Rebecca Hinckley Allen & Snyder LLP Rhode Island Associate Butler Linda Kramer Levin Naftalis & Frankel LLP New York Active 3- Fellowes Alexandra Folio Law Group PLLC New York Active 3+ Goldhush Trevor New York Law School New York Student Gordon Jennifer New York Retired Keegan Timothy Goodwin Procter LLP New York Active 3+ Kim Jungsuh Brooklyn Law School New York Student Kritzer Michael Benjamin N. Cardozo School of Law New York Student Lee Heon Goo Baker Botts LLP New York Associate Pease Thomas Greenberg Traurig, LLP New York Active 3+ Vizzone Chloe Amster, Rothstein & Ebenstein New York Associate Westman Lea Schwegman Lundberg & Woessner New York Active 3+ Whitt Jacob Eagle Pharmaceuticals, Inc. New York Associate Yen Ping Fordham University School of Law New York Student   WELCOME NEW MEMBERS Events and Announcements www.nyipla.org Text NYIPLA Publications Committee Editorial Team Committee Co-Chairs  Giselle Ayala Mateus Richard Kurz Board Liaison Jenny Lee Committee Members Dale Carlson Robert Greenfeld Margaret Welsh   NYIPLA Executive Office 229 Seventh Street, Suite 202. Garden City, NY 11530 Tel: 1.201.461.6603 Email: admin@nyipla.org  Web: www.nyipla.org July 07/12/2024 YLC & WIIP Committee Summer Associate and Associate "How To" Roundtable 07/16/2024 8th Annual Summer Associate Moot Court Argument CLE Program 07/30/2024 PTAB Committee Meeting Text Text