Key Takeaways

  • The Patent Trial and Appeal Board (PTAB) has reaffirmed its earlier priority determination in favor of the Broad Institute in the long-running interference dispute regarding the use of CRISPR-Cas9 in eukaryotic cells.
  • The decision remains significant because it was issued after remand from the U.S. Court of Appeals for the Federal Circuit, which had directed the PTAB to reassess its legal analysis under a clarified conception standard.
  • Despite this heightened scrutiny, the PTAB again found that the CVC group failed to establish prior conception of a working CRISPR-Cas9 system in eukaryotic cells. The ruling reinforces the principle that, because of the inherent unpredictability in biotechnology, how reduction to practice was accomplished takes on greater significance than in more predictable arts.
  • The decision has important implications for gene-editing technologies, biologics development, and the evolving relationship between platform patents and downstream therapeutic innovation.

Background

The CRISPR dispute concerns the invention of CRISPR-Cas9 for use in eukaryotic cells, including plant, animal, and human cells. The competing parties include the Broad Institute and the CVC group, which consists of the University of California, Berkeley, the University of Vienna, and key scientific figures such as Feng Zhang, Jennifer Doudna and Emmanuelle Charpentier.

While the CVC group was instrumental in developing CRISPR-Cas9 in bacterial systems, the legal dispute centers on whether they also conceived and reduced to practice its successful use in eukaryotic cells. This distinction is critical because eukaryotic applications are necessary for therapeutic and commercial use in humans.

Because the patents and applications at issue were either filed under or claim benefit to applications that were filed under the pre-America Invents Act framework, the case is governed by a first-to-invent interference proceeding. In the first stage of an interference, a determination is made as to which party filed the earlier application containing a conception and constructive reduction to practice of the invention. The second stage of an interference requires analysis of both conception and reduction to practice. Determining when conception has occurred in this second stage is always retrospective. The first decision is what constitutes either a constructive or actual reduction to practice. Only then can a determination be made as to when conception occurred. The first to reduce to practice prevails in an interference unless the second to reduce to practice can prove they had a prior conception and were diligent from prior to the conception of the first to reduce to practice until their own actual or constructive reduction to practice.

The following flowchart summarizes the key CRISPR interference proceedings and related patent disputes, illustrating how the Broad-CVC, ToolGen, and Sigma-Aldrich matters developed in parallel across PTAB proceedings, Federal Circuit review, and commercial implementation-related patent issues.

Our coverage of the first CRISPR interference decision was discussed in an earlier blog post: PTAB Sides with Broad in Patent Dispute over CRISPR Gene Editing of Eukaryotic Cells | RF EMerge

The PTAB’s March 2026 Decision

The PTAB found the evidence presented by CVC reflected ongoing research efforts rather than a completed inventive concept. In contrast, the Broad Institute provided evidence demonstrating successful reduction to practice of CRISPR-Cas9 in eukaryotic systems.

On March 26, 2026, the PTAB issued a judgment in the CRISPR-Cas9 Interference reaffirming priority in favor of the Broad Institute. The Board reached this conclusion after reconsidering the case on remand from the Federal Circuit. The appellate court had instructed the PTAB to apply a proper conception standard – specifically, whether the inventors had a “definite and permanent idea of the complete and operative invention” such that a person of ordinary skill could reduce it to practice without extensive experimentation. Applying that standard the Board again determined the CVC group did not establish a sufficiently definite and permanent idea of the invention in eukaryotic cells11. In the decision remanding to the Board, the Federal Circuit had affirmed the determination of the Board that CVC was not entitled to the benefit of its first two patent applications because they did not evidence conception of the invention and thus Broad had filed the earliest application with a conception of the invention. That meant that CVC had to provide evidence that it was the first to conceive the invention.

In determining CVC did not have a conception, the Board emphasized that adapting CRISPR-Cas9 from prokaryotic to eukaryotic cells was not a routine or predictable step. Instead, it involved significant technical uncertainty relating to cellular compatibility, guide RNA functionality, and nuclear delivery mechanisms.

As a result, the PTAB concluded that CVC did not have a conception prior to the actual reduction to practice by the Broad Institute and thus awarded priority to the Broad Institute.

Where Things Stand Next

The CVC- Broad CRISPR interference dispute will continue since CVC filed a Notice of Appeal at the Federal Circuit on May 26th. Future proceedings may continue to refine the legal standards governing conception and reduction to practice, particularly in unpredictable technological fields.

The parallel interference proceedings remain unresolved and warrant close monitoring as the ongoing legal disputes continue to develop, and their outcomes will be important in shaping the overall CRISPR-Cas9 patent landscape. In particular, the continuing involvement of ToolGen and Sigma-Aldrich highlights the broader reach of the interference framework beyond the central CVC-Broad dispute.

What the Decision Means for Biotech Innovation

This decision reinforces an important principle in patent law: in unpredictable scientific fields such as gene editing, an inventor must demonstrate more than a conceptual idea. The invention must be sufficiently developed to show that a person of ordinary skill could reduce it to practice without extensive experimentation or that it is actually operable in the relevant biological context.

The ruling also underscores the importance of experimental validation, particularly where the underlying science involves substantial uncertainty. Even where legal priority frameworks differ, the ability to demonstrate a functioning system remains central to how patentability is assessed in complex life sciences technologies. It is preferable to include actual experiments in the application because attempting to prove a person of ordinary skill could have reduced it to practice without extensive experimentation is always difficult.

More broadly, the decision arises within a large shift in biotechnology toward platform technologies. Because CRISPR-Cas9 functions not as a single product but a foundational tool, the patent determinations in this space will have cascading effects across the entire innovation ecosystem including downstream applications such as gene therapy, cell engineering, and advanced biologics development.

Further Considerations for Practitioners

The PTAB’s decision offers several important lessons for patent practitioners and life sciences companies.

  1. Patent applications in biotechnology should be supported by detailed experimental evidence that demonstrates operability in relevant systems. Conceptual disclosures alone may not be sufficient to establish description and enablement constituting conception of an invention.
  2. Under the America Invents Act (AIA), which took effect on March 16, 2013, the United States operates under a first-to-file system, which replaced the former first-to-invent framework. In practice, this means that the effective filing date of a patent application is usually determinative of priority, rather than the date of actual invention. Delays in filing can result in loss of rights even where conception occurred earlier.
  3. For platform technologies, early clarity on ownership and scope can significantly affect licensing leverage, freedom-to-operate, and downstream partnering opportunities.

Conclusion

The PTAB’s March 2026 decision reaffirming the Broad Institute’s priority in CRISPR-Cas9 is more than a procedural reaffirmation. It reflects a broader principle in patent law, namely that invention in unpredictable scientific fields requires demonstrated functionality rather than theoretical possibility. That evidentiary standard, when applied to foundational CRISPR-Cas9 technologies, contributes to prolonged and fragmented disputes over patent rights across the eukaryotic space. Organizations developing or commercializing CRISPR-based technologies should closely monitor these legal proceedings, as their outcomes may materially affect broader strategic planning in the genome-editing space including freedom-to-operate positions and licensing frameworks.

Looking Ahead

We will continue to monitor further developments at the PTAB and Federal Circuit regarding CRISPR-Cas9 and related patent proceedings, and provide insight and updates as they become available.

Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with us or your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.

R. Danny Huntington provided advice regarding interferences to the Broad Institute during proceedings prior to the remand.

  1. Regents of the University of California v. Broad Institute, Inc., Interference No. 106,115, Paper 2915 (PTAB March 26, 2026). ↩︎

Following up on our 2024 Trial Statistics Trends at the PTAB, this blog post expands on the statistics and trends at the PTAB for the Fiscal Year 2025 (“FY25”), which runs from October 1, 2024 through September 30, 2025.

Petitions Filed

In FY25, 1,433 petitions were filed, which was 145 petitions more than the petitions filed in FY24.[1] Out of the 1,433 petitions filed, 95% were for inter partes review (“IPR”) and 5% were for post grant review (“PGR”).[2] In comparison to FY24, the percentage of petitions filed in each technology remained consistent. Specifically, 67% of petitions were electrical/computer (compared to 69% in FY24), 20% mechanical or business methods (compared to 22% in FY24), 7% bio or pharma (compared to 6% in FY24), 6% chemical (compared to 3% in FY24), and less than 0.5% design (compared to less than 1% in FY24).[3] Accordingly, in terms of the number and technology fields for petitions filed, FY25 was consistent with prior fiscal years at the PTAB.[4]

Institution Rates

Unlike the consistency with the petitions filed, FY25 revealed significant differences in the institution rate trends. As a result of the changes described in the numerous memoranda issued by the PTAB over the past year, the PTAB split the disposition rates into Director Discretionary Considerations (“DSCO”) and Board Disposition Decisions.[5] For DSCO, the director denied institution for 304 petitions (60%) and referred 201 petitions (40%) to the Board.[6] Thus, out of 935 total petitions, the Board granted institution for 66% (620 petitions) and denied institution for 34% (315 petitions).[7] In combination, this resulted in an institution rate of 50% for FY25 based on the 620 petitions that were granted institution and the 619 petitions that were denied institution either by the Director or the Board.[8]

Outcomes

In FY25, 1,470 petitions reached an outcome at the PTAB between October 1, 2024 and September 30, 2025. Out of the total petitions, approximately 26% (387 petitions) reached final written decisions. Out of those that reached final written decisions, 17% (250 petitions) held all claims unpatentable, 4% (62 petitions) held all claims patentable, and 5% (75 petitions) held some claims patentable and some claims unpatentable. Additionally, 44% (644 petitions) were denied institution either by the Board or DSCO. For the remaining petitions, 25% (368 petitions) settled, 2% (36 petitions) requested adverse judgment, and 2% (35 petitions) were dismissed.[9]

Source: The data for this chart can be found at https://www.uspto.gov/patents/ptab/statistics

As shown by the chart above, the percentage of petitions denied institution in FY25 increased by at least 10% over the last five years, while the percentage of petitions to reach final written decisions decreased by at least 10%. Notably, the number of petitions to request adverse judgment, settle, or be dismissed remained relatively consistent, which indicates that this category of outcomes did not impact the institution rate.

Conclusion

The FY25 PTAB trends, specifically regarding the decrease in institution rates, reflect the changes that patent practitioners have monitored throughout the past year. As changes to the framework for discretionary denials continue, it is likely that institution rates will continue to decrease even more significantly than the 10% decrease reflected in FY25. Thus, it remains of important for PTAB practitioners to continue to monitor PTAB guidance and statistical trends to provide the best representation for their clients by considering alternative strategies and assessing risk.

 More information about the PTAB’s trial statistics for FY25 and previous years may be found at: https://www.uspto.gov/patents/ptab/statistics.

[1] See PTAB Trial Statistics FY25 End of Year Outcome Roundup IPR, PGR, USPTO, 3 https://www.uspto.gov/sites/default/files/documents/Trial_StatsFY25_Q4.pdf (last visited Dec. 20, 2024); see also PTAB Trial Statistics FY24 End of Year Outcome Roundup IPR, PGR, USPTO, 3 https://www.uspto.gov/sites/default/files/documents/ptab_aia_fy2024__roundup.pdf (last visited Dec. 20, 2024)

[2] See PTAB Trial Statistics FY25 at 3.

[3] See id.

[4] See https://www.ptablaw.com/2025/01/06/trial-statistics-trends-at-the-ptab-2024-edition/

[5] See PTAB Trial Statistics FY25 at 6.

[6] See id.

[7] See id.

[8] See id. at 7.

[9] See id. at 11.

The first half of 2025 has brought many changes at the United States Patent and Trademark Office (“USPTO”), including policy changes at the Patent Trial and Appeal Board (“PTAB”). At the end of March 2025, the issuance of the Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation memorandum (the “Interim Procedure”) and the Interim Processes for PTAB Workload Management memorandum (the “Workload Management”) initiated changes to discretionary denials for inter partes review (IPR) and post grant review (PGR) proceedings.[1] At the time, patent practitioners were unsure of the Workload Management’s exact impact. However, nearly six months later, we can now begin to analyze the resulting trends to understand the impact of the recent changes at the PTAB.

IPR & PGR Institution Rates

At this early stage, it appears that patent practitioners were accurate when they predicted that the number of discretionary denials would increase, resulting in a decrease in the number of institutions.

From FY22 to FY25 Q2, the institution rate for IPRs and PGRs increased from 66% to 68%.[2] Beginning in April 2025, after the issuance of the memoranda, the institution rate began to decrease. FY25 through April showed an institution rate by petition of 65%.[3] The institution rate decreased again according to the statistics for FY25 through May, which showed an institution rate of 63%.[4] Notably, the 63% institution rate by petition as of May 2025 is lower than the institution rate was in FY22, FY23, and FY24. Thus, in only a few months, the institution rate for IPRs and PGRs has decreased at a faster rate than by which it increased from FY22 to FY24.

Conclusion

Although it is too early to make conclusive predictions, the current institution rate trends show that the institution rate for IPRs and PGRs is decreasing at a rapid rate. The shift from a steadily increasing institution rate over the last few years to a sudden downward turn strongly suggests that the policy changes favor patent owners at the institution stage of proceedings. Based on the data through May 2025, the institution rate is likely to continue to decrease. In addition to the many procedural considerations at play, patent practitioners must now carefully consider the best big picture strategy for their clients. Adding some uncertainty to what is up ahead is the impending confirmation of John Squires as Director of the USPTO.  The current flurry of discretionary denial decisions is the work of Coke Morgan Stewart, the Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the USPTO.  We will need to wait and see, when Director Squires takes over, whether the policy direction that led to these discretionary denials and the decrease in institution rates will be maintained or taken in a different direction. As the landscape changes and as more data becomes available, it is vital that patent practitioners consider the practical impact of the statistical trends. 

[1] See  Memorandum from Chief Admin. Pat. Judge Scott R. Boalick to Members of the Pat. Trial and Appeal Bd. (Mar. 24, 2025); Memorandum from Acting Under Secretary of Commerce for Intell. Prop. and Acting Dir. of the U.S. Pat. and Trademark Office Coke Morgan Stewart to All PTAB Judges (Mar. 26, 2025); see also Waltersdorff, Stephanie, The USPTO Provides Further Guidance on Discretionary Denials Policy, Rothwell Figg PTAB Law Blog (June 2, 2025), https://www.ptablaw.com/2025/01/06/trial-statistics-trends-at-the-ptab-2024-edition/.

[2] See PTAB Trial Statistics FY24 End of Year Outcome Roundup IPR, PGR, USPTO, 6, https://www.uspto.gov/sites/default/files/documents/ptab_aia_fy2024__roundup.pdf (last visited Aug. 11, 2025). FY25 through Q1 was the period from October 1, 2024 to December 31, 2024. See PTAB Trial Statistics FY25 Q1 Outcome Roundup IPR, PGR, USPTO, https://www.uspto.gov/sites/default/files/documents/ptab_aia_fy2025_q1_roundup_.pdf (last visited Aug. 11, 2025). FY25 through Q2 was the period from October 1, 2024 to March 31, 2025. See PTAB Trial Statistics FY 25 Q2 Outcome Roundup  IPR, PGR, https://www.uspto.gov/sites/default/files/documents/ptab_aia_fy2025_q2_roundup.pdf (last visited Aug. 11, 2025).

[3] See PTAB Trial Statistics April 2025 IPR, PGR, https://www.uspto.gov/sites/default/files/documents/ptabaia20250430.pdf (last visited Aug. 11, 2025).

[4] See PTAB Trial Statistics May 2025, IPR, PGR, https://www.uspto.gov/sites/default/files/documents/ptabaia20250531.pdf (last visited Aug. 11, 2025).

Introduction

Acting Director of the USPTO, Coke Morgan Stewart, issued a memorandum last week that will change the way petitioners levy challenges to patents via inter partes review (IPR).[1]  The change will apply to any petition for IPR filed on or after September 1, 2025.

Overview of the 2025 Memorandum

The 2025 Memorandum curbs the use of applicant admitted prior art (AAPA), expert testimony, and general knowledge evidence to establish the basis of a challenge in an IPR petition.[2]  The USPTO institutes this change by rescinding its waiver of 37 C.F.R. § 42.104(b)(4), which holds that an IPR petition “must specify where each element of the claim is found in the prior art patents or printed publications relied upon.”[3]

Because AAPA, expert testimony, and evidence of general knowledge or ordinary skill do not constitute prior art patents or printed publications, petitioners can no longer use them to provide a claim element when setting forth the basis of their challenge.[4]  The USPTO states that the change will “provide a clear means for (i) identifying the petitioner’s legal and factual basis for satisfying the threshold for instituting IPR, and (ii) providing the patent owner with notice as to the basis for the challenge to the claims.”[5]

This guidance does provide clarity by establishing a bright-line rule that petitioners will follow when setting forth the basis of their challenge, but there remain unresolved issues in this area that patent practitioners and innovators should consider.

In prior memoranda, the USPTO permitted the use of AAPA and like-evidence, provided it did not make up the entirety of the basis for a challenge.[6]  The guidance then in effect (and now superseded) was that this evidence could only establish the basis of a challenge when asserted “in combination with reliance on at least one prior art patent or printed publication.”[7]  Basis language like, “Prior art reference X in view of AAPA” (or vice versa) was ostensibly proper under the USPTO’s so-called, “combination rule,” because AAPA and like-evidence “can supply legally relevant information, while not constituting the ‘basis’ of the obviousness ground raised under § 103.”[8]

However, in the case of Qualcomm Inc. v. Apple Inc., 134 F.4th 1355 (Fed. Cir. 2025), to which the Acting Director of the USPTO intervened, the Federal Circuit disagreed:

[T]he plain language of § 311(b) limits “the basis” to “prior art consisting of patents or printed publications.” The statute is clear. The Board exceeded this statutory limit by determining that the mere combination of AAPA with prior art patents or printed publications automatically excludes AAPA from the basis of a ground…. [T]he question is whether a petitioner has used AAPA as the basis, or part of the basis, of a ground—not whether the request relies on AAPA in combination with prior art patents or printed publications.[9]

Still, the Federal Circuit “recognize[d] that there are instances in which a petition may rely in part on AAPA, such as to indicate the general knowledge of a person of ordinary skill in the art.”[10]  And in the end, the Federal Circuit’s holding that the basis-at-issue was improperly founded on AAPA rested solely on the fact that Petitioner “did expressly state that AAPA is included in the basis of Ground 2.”[11]  The Court did “not consider whether, in substance, Ground 2 included AAPA in its basis” and “expect[s] that future cases may require the PTO and this court to consider the substance of a petition to determine compliance with § 311(b).”[12]

Key Takeaways

There are three major takeaways for PTAB practitioners from the 2025 Memorandum and the Federal Circuit’s holding in Qualcomm. 

  1. It is improper to explicitly state that the basis of a challenge to a claim includes AAPA, expert testimony, and/or evidence of general knowledge or ordinary skill. 
  2. Following the USPTO guidance and Circuit precedent, it appears that AAPA, expert testimony, and evidence of general knowledge or ordinary skill may still be used (1) to demonstrate the knowledge of the ordinarily-skilled artisan at the time of the invention and (2) to support a motivation to combine specific references. 
  3. The USPTO and Federal Circuit will likely continue to grapple with the issue of when AAPA, expert testimony, and evidence of general knowledge or ordinary skill constitutes part of a “basis” of a challenge as opposed to an allowable use, as there is still no substantive framework for determining whether AAPA and like-evidence have been improperly incorporated into the basis of a challenge.

[1] See generally USPTO Memorandum issued July 31, 2025 titled, “Enforcement and Non-Waiver of 37 C.F.R. § 42.104(b)(4) and Permissible Uses of General Knowledge in Inter Partes Reviews” (2025 Memorandum).

[2] Id. at 3.

[3] Id. at 1 (emphasis added).

[4] Id.

[5] Id. at 3.

[6] See USPTO Memorandum issued August 18, 2020 titled, “Treatment of Statements of the Applicant in the Challenged Patent in Inter Partes Reviews Under § 311” (2020 Memorandum) at 4; USPTO Memorandum issued June 9, 2022 titled, “Treatment of Statements of the Applicant in the Challenged Patent in Inter Partes Reviews Under § 311” (2022 Memorandum) at 2.

[7] 2020 Memorandum at 8-9; 2022 Memorandum at 4.

[8] 2020 Memorandum at 6; 2022 Memorandum at 4-5.

[9]  Qualcomm Inc. v. Apple Inc., 134 F.4th 1355, 1365 (Fed. Cir. 2025) (emphasis added).

[10] Id. (citing Koninklijke Philips v. Google, 948 F.3d 1330, 1339 (Fed. Cir. 2020)).

[11] Id. at 1366.

[12] Id. at 1368.

The USPTO’s recent guidance on discretionary denials has shifted patent practitioners back to the Fintiv and Sotera Wireless framework.

The Prior Framework: Fintiv & Sotera Wireless

In Apple Inc. v. Fintiv, Inc., No. IPR2020-00019 (PTAB Mar. 20, 2020), the Patent Trial and Appeal Board (the “Board”) implemented a holistic view of six factors (the Fintiv factors) for determining whether to exercise discretionary denial when there is a parallel, co-pending proceeding.[1] The six factors included:

  1. whether a stay exists or is likely to be granted if a proceeding is instituted;
  2. the proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision;
  3. the investment in the parallel proceeding by the court and parties;
  4. overlap between issues raised in the petition and in the parallel proceeding;
  5. whether the petitioner and the defendant in the parallel proceeding are the same party; and
  6. other circumstances that impact the Board’s exercise of discretion, including the merits.[2]

On December 1, 2020, the Board also issued a decision in Sotera Wireless, Inc. v. Masimo Corp., No. IPR2020-01015 (PTAB Dec. 1, 2020), which set forth the Sotera stipulation.[3] A Sotera stipulation is a stipulation by the petitioner that “if IPR is instituted, they will not pursue in the District Court Litigation any groundraised or that could have been reasonably raised in an IPR.”[4] Where this stipulation is made, the fourth Fintiv factor strongly favors not exercising discretion to deny institution.[5]

The Interim Procedures Memorandum

In response to this framework, the USPTO issued a memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (the “Interim Procedures Memorandum”) on June 22, 2022.[6] Under this memorandum, the Board would not exercise its authority to deny institution in light of a parallel proceeding when the parallel proceeding was an ITC proceeding, there was a Sotera stipulation, or compelling evidence of unpatentability was presented.[7] Median time-to-trial statistics in the district of the co-pending litigation would be considered by the Board.

USPTO’s Rescission of Interim Procedure Memorandum

On February 28, 2025, the USPTO rescinded the Interim Procedure Memorandum.[8]

Subsequent Guidance: March 24th and 26th Memoranda

As a follow up to the Interim Procedure Memorandum rescission, the Chief Administrative Patent Judge issued a memorandum on March 24, 2025 entitled “Guidance on USPTO’s rescission of ‘Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation’” (the “Guidance Memorandum”).[9] The Guidance Memorandum explained that the Interim Procedures Memorandum was only intended to provide guidance while the USPTO explored potential rulemaking. Accordingly, when no final rules were proposed, the USPTO rescinded the Interim Procedures Memorandum. The Guidance Memorandum included five key points regarding the discretionary denials policy:[10]  

  1. The rescission is applicable if (1) the Board has not issued an institution decision or (2) a request for rehearing or Director Review of an institution decision was filed and is pending.
  2. The Fintiv factors apply when there is a parallel proceeding at the ITC.
  3. Timely-filed Sotera stipulations are highly relevant and considered as part of the holistic analysis under Fintiv, but they are not dispositive on their own.
  4. The Board can consider evidence relating to the proximity of the district court’s trial date, such as median time-to-trial statistics.
  5. The Fintiv factors are to be considered as part of a balanced assessment, including the strength of the merits, but compelling merits are not dispositive on their own.

Two days later, on March 26, 2025, the Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the USPTO issued a memorandum entitled “Interim Processes for PTAB Workload Management” (the “Workload Management Memorandum”).[11]

The Workload Management Memorandum primarily addressed the procedures for IPR and PGR institution decisions.[12] Under this guidance, the institution decisions are bifurcated between (i) discretionary considerations and (ii) merits and other non-discretionary statutory considerations. First, the Director and at least three PTAB judges determine whether discretionary denial is appropriate. If it is appropriate, the Director issues a decision denying institution. If it is not appropriate, the petition is referred to a three-member panel of the Board to handle the case in the normal course.

As part of the separate discretionary denial briefing, the patent owner may file a brief explaining applicable bases for discretionary denial within 2 months of the date on which the PTAB enters a Notice of Filing Date Accorded. Subsequently, the petitioner may file an opposition brief no later than one month after the filing date of the patent owner’s brief.[13]

Moreover, the Workload Management Memorandum sets forth specific considerations that the parties are permitted to address, including, but not limited to:

  • Whether the PTAB or another forum has already adjudicated the validity or patentability of the challenged patent claims;
  • Whether there have been changes in the law or new judicial precedent issued since issuance of the claims that may affect patentability;
  • The strength of the unpatentability challenge;
  • The extent of the petition’s reliance on expert testimony;
  • Settled expectations of the parties, such as the length of time the claims have been in force;
  • Compelling economic, public health, or national security interests; and
  • Any other considerations bearing on the Director’s discretion.[14]

Conclusion

As the updated discretionary denial policy is implemented, it is likely that there will be an increase in the number of discretionary denials. Although the recent memoranda have indicated that the processes are temporary, it is unknown how long they will remain in place and what may replace them. Accordingly, practitioners before the Board should continue to monitor the Board’s discretionary denial decisions.

 More information about the USPTO’s discretionary denial policy can be found at: https://www.uspto.gov/patents/ptab/faqs/interim-processes-workload-management. 

[1] See Apple Inc. v. Fintiv, Inc., No. IPR2020-00019 (PTAB Mar. 20, 2020).

[2] See id. at 5-6.

[3] Sotera Wireless, Inc. v. Masimo Corp., No. IPR2020-01015 (PTAB Dec. 1, 2020).

[4] See id. at 18.

[5] See id. at 19.

[6] See Memorandum from Under Secretary of Commerce for Intell. Prop. and Dir. of the U.S. Pat. and Trademark Office Kathy Vidal to Members of the Pat. Trial and Appeal Bd. (June 21, 2022).

[7] See id.

[8] See USPTO rescinds memorandum addressing discretionary denial procedures, USPTO, https://www.uspto.gov/about-us/news-updates/uspto-rescinds-memorandum-addressing-discretionary-denial-procedures (last visited May 26, 2025).

[9] See Memorandum from Chief Admin. Pat. Judge Scott R. Boalick to Members of the Pat. Trial and Appeal Bd. (Mar. 24, 2025).

[10] See id.

[11] See Memorandum from Acting Under Secretary of Commerce for Intell. Prop. and Acting Dir. of the U.S. Pat. and Trademark Office Coke Morgan Stewart to All PTAB Judges (Mar. 26, 2025).

[12] See id.

[13] Discretionary denial briefing has a limit of 14,000 words and a reply brief has a limit of 5,600 words. See id. at 2.

[14] See id.

The Patent Trial and Appeal Board (PTAB) recently designated its decision in Cambridge v. Sfara (IPR2024-00952) as an informative decision.[1] This designation addresses an important issue in inter partes review (IPR) proceedings: inconsistent claim construction arguments between district court litigation and PTAB petitions.

Claim Construction Inconsistency

The PTAB’s holding centered on Petitioner’s proposed construction of the term “component.” The term “component” appeared repeatedly within the independent claims related to vehicle crash detection. For example, “a first detecting component operable [to] detect a first parameter and to generate a first detector signal based on the first detected parameter.”

In the corresponding district court litigation, Petitioner’s position was that “’component’ terms in the challenged claims should be means-plus-function terms governed by §112(f) and that such terms are indefinite for failure to identify corresponding structure to perform the recited functions.”[2] Petitioner also emphasized that whether means-plus-function applies to the term “component” “will be most significant to the resolution of the case and/or will be case or claim dispositive or substantially conducive to promoting settlement.”[3]

Petitioner’s IPR petition took a very different approach. Instead of arguing that the “component” terms were governed by §112(f), Petitioner instead argued that these terms should be given their plain and ordinary meanings. Moreover, Petitioner’s IPR petition only mentioned their district court means-plus-function argument in a footnote. Failing to address its means-plus-function argument was fatal for Petitioner’s IPR petition.

The Board held 37 C.F.R. § 42.104(b)(3) mandated that the “Petition should have explained why the plain and ordinary meaning of the ‘component’ terms should apply in this proceeding (why the inconsistent positions are warranted) or set forth an alternative means-plus-function claim.”[4] In denying the petition, the Board highlighted Petitioner’s deterministic language from its district court filing (e.g., “will be most significant” and “will be case . . . dispositive”) as an important factor in its decision.[5]

Key Takeaways for Practitioners

The PTAB’s designation of this case as informative serves as a cautionary example for practitioners whose cases are being litigated simultaneously in district courts and IPR proceedings. To the extent practitioners take differing claim construction approaches in the two proceedings, they should offer a clear and justified explanation for why they are doing so.

[1] Found at Precedential and informative decisions | USPTO

[2] Cambridge Mobile Telematics, Inc. v. Sfara, Inc. (majority opinion), IPR2024-00952, Paper 12 (December 13, 2024), at p. 6.

[3] Id. at 7.

[4] Id. at 8.

[5] The deterministic language was from the Joint Claim Construction and Prehearing Statement. Specifically, the Board highlighted the following passage, “construction of the listed “component” terms—specifically, whether those terms are means-plus-function limitations governed by 35 U.S.C. § 112(f), and if so, whether the specification properly discloses corresponding structure for the recited function in those limitations—will be most significant to the resolution of the case and/or will be case or claim dispositive or substantially conducive to promoting settlement.” Id. at 7.

The Federal Circuit’s holding in United Servs. Auto. Ass’n v. PNC Bank N.A., No. 2023-2171, 2025 WL 339662 (Fed. Cir. Jan. 30, 2025) reversed a Patent Trial and Appeal Board (“PTAB”) decision finding no motivation to combine.  The opinion is nonprecedential, but the Federal Circuit’s analysis of the facts in light of recent precedent is instructive for patent practitioners. 

On May 11, 2022, the PTAB granted PNC Bank N.A.’s (“PNC”) petition for inter partes review (“IPR”) of claims 1-20 of U.S. Patent No. 10,769,598 (“the ’598 patent”).  The ’598 patent is directed to remote check deposit technology and owned by the United Services Automobile Association (“USAA”).  In its final written decision, the PTAB found claims 1 and 8-20 obvious over a combination of three prior art references but declined to find dependent claims 2-7 obvious over the same combination.

Dependent claims 2-7 of the ’598 patent require an error processing step to verify that the image of a to-be-deposited check meets certain criteria, i.e., the check is legible, appropriately sized, correctly oriented, etc.  Crucially, claims 2-7 require that an error processing step occurs on the client’s mobile device, before the image is relayed to the bank’s server.

In the IPR, PNC pointed to a client-side error processing step disclosed in one of the three prior art references it successfully asserted in combination against claim 1, arguing that one of ordinary skill in the art would have been motivated to include in the combination “a thin client” that “‘detect[s] whether the check is endorsed’ and ‘check[s] for an imprint image, a scanned serial number, and the like, to indicate that the check had been properly scanned’ before uploading the check image to the payee bank.”  See PNC Bank N.A. v. United Servs. Auto. Ass’n, No. IPR2022-00076, at 58 (P.T.A.B. May 10, 2023) (citing the prior art).  As the PTAB wrote, “Petitioner contends that an ordinary artisan would have been motivated to include Byrne’s error checking in the mobile device of the Garcia-Byrne-Singfield combination.”  Id.

The PTAB disagreed with PNC: “Even if an ordinary artisan could have made the proposed combination, we are not persuaded that Petitioner has sufficiently shown that he would have been motivated to do so.”  Id. at 59 (emphasis original).  The PTAB gave significant weight to USAA’s argument that “there would be substantial reason not to [use client-side error processing].”  Id. at 58.  PNC presented known advantages of incorporating client-side error processing, but the PTAB found that PNC’s expert testimony undercut its argument when they admitted “[t]here are tradeoffs associated with doing the verification processing on either the client or the server.”  Id. at 61 (internal cite omitted).  The PTAB ruled that it could not find a motivation to combine under a preponderance of the evidence.  PNC cross-appealed the ruling on claims 2-7.  USAA appealed the ruling on claims 1 and 8-20.

On appeal, the Federal Circuit affirmed the PTAB’s obviousness ruling on claims 1 and 8-20.  For claims 2-7, the Federal Circuit held that “the Board erred in rejecting PNC’s motivation to combine solely because this alternative arrangement also had claimed benefits.”  United Servs. Auto. Ass’n v. PNC Bank N.A., No. 2023-2171, 2025 WL 339662, at 9 (Fed. Cir. Jan. 30, 2025).  “The Board’s preoccupation with the benefits associated with server-side error processing led it to ignore the undisputed benefits of [client-side error processing].”  Id. at 10.

The Federal Circuit considered recent precedent in articulating a standard for motivation to combine.  “The combination does not need to be the best or preferred approach but need only be ‘desirable in light of the prior art.’”  Id. at 9-10 (quoting Honeywell Int’l Inc. v. 3G Licensing, S.A., 124 F.4th 1345, 1356 (Fed. Cir 2025) (emphasis added).  “[T]he relevant inquiry is simply whether skilled artisan would have been motivated to modify the prior art as claimed.”  Id. at 9 (citing Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021) and Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)) (emphasis added).

When applying the law to the facts, the Federal Circuit stated that this is “the precise situation where a person of ordinary skill in the art is ‘left with two design choices,’ in which case we have explained that ‘[e]ach of these two design choices is an obvious combination of prior art elements.’”  Id. (quoting ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1367 (Fed. Cir. 2016)).

Considering the PTAB’s overwhelmingly positive record of affirms on appeal, patent practitioners should pay close attention to the Federal Circuit when it decides to step in.  Here, in reversing the PTAB’s determination, the Federal Circuit provides several articulations of the standard for motivation to combine.  PTAB practitioners should craft their arguments around the Federal Circuit’s preferred language to optimize their chances on appeals and best protect their clients’ interests.

SOURCES

PNC Bank N.A. v. United Servs. Auto. Ass’n, No. IPR2022-00076 (P.T.A.B. May 10, 2023)

United Servs. Auto. Ass’n v. PNC Bank N.A., No. 2023-2171, 2025 WL 339662 (Fed. Cir. Jan. 30, 2025)

On March 4, 2025, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) decision in Restem, LLC v. Jadi Cell, LLC, No. 23-2054, 2025 WL 679195, at *1 (Fed. Cir. Mar. 4, 2025), finding that the patent challenger failed to prove that the claims were unpatenable and offering two key takeaways.

The Parties and the Patent

Jadi Cell, the patent owner, owned U.S. Patent No. 9,803,176 (“the ’176 patent”). The ’176 patent is directed to “stem cells with specific cell markers…obtained from the subepithelial layer (SL) of mammalian umbilical cord tissue through a two-step process[.]” See id. (citing U.S. Patent No. 9,803,176 (filed Dec. 31, 2012)). Claim 1 of the ’176 patent recites:

1. An isolated cell prepared by a process comprising:

placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate; and

culturing the subepithelial layer such that the isolated cell from the subepithelial layer is capable of self-renewal and culture expansion,

wherein the isolated cell expresses at least three cell markers selected from the group consisting of CD29, CD73, CD90, CD166, SSEA4, CD9, CD44, CD146, or CD105, and

wherein the isolated cell does not express NANOG and at least five cell markers selected from the group consisting of CD45, CD34, CD14, CD79, CD106, CD86, CD80, CD19, CD117, Stro-1, or HLA-DR.

’176 Patent.

Restem, the patent challenger, challenged claims 1-15 of the ’176 patent based on inherent anticipation or, alternatively, obviousness. See Restem, LLC, 2025 WL 679195 at *1.[1]

Claim Construction

Before addressing the inherent anticipation argument, the Federal Circuit first addressed the claim construction of two terms: (1) “placing” step and (2) “isolated cell.” See id. at *1-3.

Regarding the first term, the PTAB did not import additional steps from the specification “because the specification [did] not uniformly require those steps in all disclosed embodiments.” See id. at *1 (citing Joint Appendix). The PTAB consequently determined that the prior art references disclosed the claimed two-step process, but did “not disclose the [specific cell markers] because the prior art processes do not necessarily produce cells with the claimed cell marker expression profile[.]” See id. at *1 (internal citations omitted). Restem argued against this claim construction because it implicitly “require[d] steps beyond the claimed two-step process.” See id. at *2 (citing Appellant’s Brief). However, the Federal Circuit did not agree. See id. Thus, the Federal Circuit found no error in the PTAB’s construction of “placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate” as “to intentionally place umbilical cord tissue comprising the subepithelial layer so that it touches a growth substrate to permit cell culture.” See id. at *1 (citing Joint Appendix).  

Regarding the second term, the PTAB “declined to construe ‘isolated cell,’ but construed ‘expresses/does not express’ to mean ‘the marker is confirmed present/absent relative to a control sample,’ which is ‘consistent with [the PTAB’s] interpretation of ‘isolated cell’ as indicating a cell population[.]’” See id. at *2 (internal citations omitted). Finding the intrinsic evidence unclear, the PTAB used extrinsic evidence and found agreement among the experts. See id. Restem argued that the PTAB should not have construed the second term contrary to its express definition. See id. Although the Federal Circuit agreed with Restem that the PTAB “implicitly construed ‘isolated cell’ as ‘a cell population,’” it determined that this construction was supported by the claim language and prosecution history. See id. at *2-3.

Restem’s Inherent Anticipation Challenge

Relying on precedent, the Federal Circuit clearly stated the law regarding inherent anticipation and product-by-process claims. “Inherent anticipation requires ‘the disclosure of the prior art [be] sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.’” Id. at *3 (quoting SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44 (Fed. Cir. 2005) (cleaned up)). A product-by-process claim is defined as “one where the product is defined, at least in part, in terms of the process by which it is made.” Id. (citing SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006)). For product-by-process claims, the focus is different in determining invalidity versus infringement. For invalidity, the focus is on the product, not the process. See id. (citing Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369-70 (Fed. Cir. 2009)) (emphasis added). For infringement, the focus is on the process and the product. See id. (citing Amgen Inc., 580 F.3d at 1370) (emphasis added).

Restem’s inherent anticipation argument was that “inherency is automatic for product-by-process claims” because “once the process steps are met, the product is necessarily present.” See id. (citing Appellant’s Brief). However, the Federal Circuit disagreed, explaining that “Restem’s argument conflates the anticipation and infringement analyses for product-by-process claims by improperly shifting the analysis from whether the prior art discloses the claimed product to whether the prior art discloses the claimed process.” Id. (emphasis original).

The PTAB found that the cells claimed in the ’176 patent were distinguished from other stem cells based on the cell marker expression profile. See id. In its review, the Federal Circuit determined this finding was supported by substantial evidence. See id. at *4. Specifically, the Federal Circuit stated that “Restem did not provide any testing evidence to show cells produced by [the prior art’s] process would inevitably, as inherency requires, have the claimed cell marker expression profile.” See id. (citing Joint Appendix and In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012)). Thus, the Federal Circuit affirmed the PTAB’s decision that Restem failed to show the claims were unpatentable. See id.

Conclusion

The takeaways from this case are twofold.

First, the analysis for invalidity of product-by-process claims is distinct from the analysis for infringement of product-by-process claims. For invalidity of product-by-process claims, it matters whether the prior art discloses the claimed product, not the claimed process.

Second, this case serves as a helpful reminder to patent practitioners that the prosecution history of a patent can have a significant impact during litigation. Thus, practitioners prosecuting a patent should carefully consider the future impact of arguments set forth during prosecution. Similarly, patent litigators should consider utilizing a patent’s prosecution history to their client’s advantage during litigation.

[1] The PTAB found that claim 9 was not obvious for two reasons, but Restem only challenged the PTAB’s alternative basis. See id. at *4. For this reason, the Federal Circuit held that it “need not reach the [PTAB]’s alternative basis to affirm.” See id.

On Friday, February 28, 2025, the United States Patent and Trademark Office (USPTO) announced the withdrawal of the June 2022 memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which had been issued by former USPTO Director Kathi Vidal.

The 2022 Memorandum was intended to clarify the Patent Trial and Appeal Board’s (“PTAB”) application of the 2020 decision in Apple Inc. v. Fintiv (“Fintiv”). The rescinded memorandum outlined three scenarios in which the PTAB would not deny institution of an inter partes review (“IPR”) petition based on Fintiv:

  1. The PTAB will not deny institution when a request for denial under Fintiv is based on a parallel International Trade Commission (ITC) proceeding.
  2. The PTAB will not deny institution under Fintiv if the petitioner stipulates not to pursue the same grounds in a parallel district court proceeding or any grounds that could have reasonably been raised in the petition (known as a Soltera stipulation).
  3. The PTAB will not deny institution under Fintiv if a petition presents compelling evidence of unpatentability.

With the rescission of this guidance, the PTAB’s approach to discretionary denials is likely to change in several ways:

  • The PTAB will now consider whether a petition related to an ongoing ITC proceeding is subject to discretionary denial.
  • The PTAB will no longer consider Soltera stipulations as definitive in determining whether to exercise discretion to deny institution.
  • The Board will evaluate the petition based on the Fintiv factors rather than the “compelling merits” analysis outlined in the 2022 Memorandum.

Going forward, practitioners and patent owners are instructed to refer to the PTAB’s precedential decisions for guidance, including Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A). Additionally, practitioners should also be aware that any portion of a PTAB or Director Review decision relying on the 2022 Memorandum will not be considered binding on the PTAB.

On January 27, 2025, the Federal Circuit held that the Patent Trial and Appeal Board (“PTAB”) “has jurisdiction over IPRs concerning expired patents.” See Apple Inc. v. Gesture Tech. Partners, LLC, 2025 WL 299939, *2 (Fed. Cir. Jan. 27, 2025).

Background and Procedural History

Apple, the inter partes review (“IPR”) petitioner, filed an IPR petition in June 2021. See id. at *1. The patent at issue was U.S. Patent No. 8,878,949 (“the ’949 patent”), related to image capture technology and owned by Gesture. See id. Apple asserted that all claims of the ’949 patent were obvious over the prior art. See id. The PTAB held that several claims of the ’949 patent were unpatentable and that others were not shown to be unpatentable. See id. Both parties appealed the PTAB’s decision to the Federal Circuit. On appeal, the Federal Circuit addressed arguments directed towards both jurisdiction and obviousness. This blog discusses only the jurisdictional portion of the court’s analysis.

Patent Owner Argues PTAB Lacks Jurisdiction over Expired Patents

At the Federal Circuit, Gesture argued “that the [PTAB] could not exercise jurisdiction over this IPR because the ’949 patent expired in May 2020, before Apple filed its petition in June 2021.” See id. at *2. Gesture relied on Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 584 U.S. 325 (2018), stating that “jurisdiction over the expired patent becomes limited to the Article III courts” because patent owners lose their exclusionary rights when a patent expires. See id. Rather, the patent owner’s rights “become[ ] limited to collecting damages that formerly existed through an infringement action in an Article III court[.]” See id. Therefore, Gesture reasoned that the PTAB did not have jurisdiction over the ’949 patent.

Federal Circuit’s Holding

Acknowledging that the Federal Circuit has not “squarely addressed whether the [PTAB] may institute IPRs for patents after they have expired[,]” the court stated affirmatively that “the [PTAB] has jurisdiction over IPRs concerning expired patents.” See id. To support its holding, the Federal Circuit relied on Oil States and the public-rights doctrine. See id. at *3. The Federal Circuit also noted that this is not the first case it has reviewed involving expired patents in an IPR decision, which implicitly shows that the PTAB has jurisdiction over expired patents. See id.

Despite its reliance on the same case, the Federal Circuit rejected Gesture’s argument. The Court summarized the Oil States holding, stating that “IPRs fall within the public-rights doctrine and do not violate Article III.” See id. (citing Oil States Energy Services, 584 U.S. at 337). The Court further emphasized the fact that although an expired patent limits a patent owner’s rights, it does not eliminate their rights. See id. For example, a patent owner of an expired patent can sue for past damages. See id. (citing Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011). In that light, the Federal Circuit reasoned that “Gesture fail[ed] to explain why an IPR, which ‘would have a consequence on any infringement that occurred during the life,’ of the patent, falls outside the scope of the public-rights doctrine solely because the patentee’s prospective right to exclude others has terminated.” See id. (internal citations omitted) (citing Sony Corp. v. Iancu, 924 F.3d 1235, 1238 n.1 (Fed. Cir. 2019).

Conclusion & Takeaway

With the Federal Circuit’s confirmation that the PTAB has jurisdiction to conduct IPR proceedings over expired patents, PTAB practitioners can now proceed with confidence when challenging an expired patent. Apple, Inc. v. Gesture Tech. Partners makes it clear that the PTAB has jurisdiction over IPR proceedings involving expired patents.