By Joshua Rich and Mike Borella –

On February 13, 2024, then-USPTO Director Vidal issued inventorship guidance for AI-assisted inventions;[1] on November 28, 2025, new USPTO Director Squires revoked and replaced it. But both the earlier guidance and current Revised Inventorship Guidance are based on previously decided Federal Circuit precedent. That is, the change in guidance is not based on a change in law, but rather a change of administrations. As a result, as Director Squires has emphasized on other fronts, examiners are being counseled to be more flexible and more pro-patent grant in approaching their interpretation of the same case law. That is, in sports parlance, the modification is really a “point of emphasis” – the rules haven’t changed, but officials are to focus differently on how they are to be enforced.

Both the earlier guidance and Revised Inventorship Guidance are based on 35 U.S.C. § 115 and the Federal Circuit’s decision in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022), which establish that only natural persons (that is, humans) can be named inventors on patent applications or issued patents. AI systems therefore cannot be named as inventors. The question, as always, is who “conceived” of an invention, an issue that preceded the development of AI systems and continues to be a fact-intensive, challenging quandary today. In both the earlier and current guidance, examiners were directed to Burroughs Wellcome Co. v. Barr Labs., Inc., 40F.3d 1223 (Fed. Cir. 1994) for the test to answer that question.

Based on that legal background, the four major points of both guidance are the same. First, the USPTO generally presumes that the human inventors named on the application data sheet and oath and declaration are the true inventors of the invention claimed in a patent application. Second, no AI system (or other non-human person or thing) can be named as an inventor for a patent application or issued patent. Third, when multiple humans are involved in the inventive process, traditional inventorship principles (including the factors set forth in Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998)) apply. Fourth, the same analysis applies for utility patents, plant patents, and design patents.

Where the Revised Inventorship Guidance and prior guidance differ is more subtle. First, the prior guidance was published concurrently with a discussion of examples “to provide assistance to the public and examiners on the application of this guidance in specific situations.” Presumably, those examples are no longer useful in discussions with examiners.[2] Second, the Revised Inventorship Guidance rejects any reliance in the Pannu factors in determining inventorship between a human inventor and AI.[3] The prior guidance did rely on the Pannu in requiring that a human meet the test when determining inventorship on a claim-by-claim basis. And the first Pannu factor is that “a person must “contribute in some significant manner to the conception or reduction to practice of the invention,” which is always a requirement for inventorship.[4] So to the extent that there is daylight between the two sets of guidance, it is based on applying the traditional test for conception, rather than the Pannu factors, when there is only a single human inventor.

All in all, the tone of the Revised Inventorship Guidance may be more important than the changes from the previous guidance. It is far shorter and less legalistic, more in line with Director Squires’s “open for business” approach. It wasn’t published for notice and comment rulemaking, like the prior guidance, so it can more easily be revoked. Given that it relies on Federal Circuit precedent, however, that is unlikely in the absence of a change in the law. So perhaps the most important advice it provides lies in a sentence in the legal standards section: “There is no separate or modified standard for AI-assisted inventions.”

Nonetheless, a dose of caution is warranted, both for applicants and for practitioners. Just because the USPTO is unlikely to consider the inventorship during prosecution or post-grant review proceedings, this does not mean that you should not investigate carefully to ensure the proper inventors are named when the application is filed and when the patent issues. During the research process, the best practice is to keep a clean record of which features were human conceptions when AI is used in the ideation process. Challengers in court will likely scrutinize whether the human inventor(s) possessed a “definite and permanent idea” of the complete invention or merely had a “general goal or research plan” that the AI solved. If AI was used, the human inventor(s) may need to demonstrate (preferably with contemporaneously recorded evidence) that they conceived of each and every claim element themselves. Otherwise, the patent could be invalidated for incorrect inventorship or rendered unenforceable for inequitable conduct for intentional misrepresentation of inventorship.

One way for applicants to mitigate such risk is to document their specific vision of the invention, such as through sketches or written descriptions, before using an AI tool. Further, applicants should also retain records of any changes they made to designs after being generated by AI that relate to the claimed invention. Additionally, applicants should retain histories of their interactions with AI (e.g., prompt / response logs), as these records can serve as evidence that a human exercised control over the AI’s output and used the AI strictly for assistance.

Finally, the Revised Inventorship Guidance reiterates that a U.S. patent application claiming priority to a foreign patent filing must share at least one human inventor with that earlier application to be valid. When a foreign application has named an AI inventor, applicants can strip the AI from the inventorship list when entering the U.S. But the USPTO has made it clear that it will flatly reject any priority claim to a foreign application that names an AI system as the sole inventor, meaning applicants will effectively lose their earlier filing date if no human was originally named.

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[1] For a fulsome discussion of the February 13, 2024 guidance, see https://patentdocs.org/2024/02/12/uspto-issues-guidance-about-inventorship-of-ai-assisted-inventions/.

[2] The examples were published at http://www.uspto.gov/​initiatives/​artificial-intelligence/​artificial-intelligence-resources. They are no longer available there.

[3] Indeed, the Revised Inventorship Guidance states that “Pannu is inapplicable when only one natural person is involved in developing an invention with AI assistance because AI systems are not persons and therefore cannot be ‘joint inventors’ so there is no joint inventorship question to analyze.”

[4] The other Pannu factors require a joint inventor to “(2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.”

By Michael S. Borella –

Once upon a time, patent eligibility was not controversial or difficult to understand. Then along came Alice Corp. v. CLS Bank, and with it the Supreme Court’s bright idea to replace statutory clarity with metaphysical hand-waving about so-called abstract ideas. The result has been a decade of improvisation, where examiners and judges try to divine the essence of a claimed invention by sniffing for abstraction like sommeliers. One of the most unintuitive outcomes is that an independent claim can be patent-eligible while a dependent claim that narrows it with more detail can be found ineligible.

To make the issue concrete, let’s consider two claims about routing data packets in a network.

1.          A computer-implemented method for dynamically routing data packets in a packet-switched network, the method comprising:

receiving, by a network interface of a router, a data packet comprising a header and a payload;

parsing, by a packet-processing module executed by a processor of the router, the header to extract a destination network address and a priority value;

analyzing, by the packet-processing module, a packet-type indicator contained in the payload to identify a packet type;

selecting, from among a plurality of output ports, an output port based on the destination network address, the priority value, and the identified packet type, in combination with current link-utilization metrics of the output ports stored in a routing table maintained in memory;

updating the routing table to record packet-transmission statistics associated with the data packet; and

transmitting the data packet via the output port.

This claim is about as technical as it gets. It involves a processor, a routing table, memory, and measurable performance metrics. The improvement is concrete; namely, dynamic routing based on link utilization and packet type to improve throughput. Under U.S. case law and patent office procedure, this claim should be a textbook example of non-abstractness. It is the kind of claim that can sneak through the Alice gauntlet.

Now, let’s add a dependent claim.

2.         The computer-implemented method of claim 1, wherein the packet type corresponds to a banking transaction, the payload comprising encrypted banking transaction data formatted according to a predefined financial messaging protocol, and wherein selecting the output port further comprises prioritizing the data packet for transmission over a low-utilization output port.

Here, the claimed invention still processes packets and it still selects output ports based on a combination of factors. The only change is that the payload now contains encrypted banking transaction data, and the routing algorithm prioritizes the packets for transmission on a low-utilization output port. Not only does this balance load but it allows these types of packets to be processed faster due to the relationship between network link utilization and latency.

And yet, under Alice, that dependent claim is probably ineligible. Why? Because the payload includes banking transaction data. Suddenly, one can argue that the invention is directed to the abstract idea of intermediating financial transactions. Never mind that the machine is still transmitting the same bits through network interfaces. The difference in the semantic content of the bits is determinative.

To be fair, the patentee still has an opportunity to argue that claim 2 in its full context (which includes all limitations of claim 1) recites an inventive concept that overcomes its allegedly abstract nature. However, the Alice test provides a number of pathways for contending that claim 2 fails to provide such an inventive concept. For example, courts may conclude that the type of narrowing of claim 2 is a field-of-use restriction rather than an inventive concept, or that speeding up financial transactions addresses a fundamental business need rather than a technical improvement. They may also view the limitations of claim 1 as well-understood, routine, and conventional, whereas this avenue would not be available when claim 1 is considered in isolation.

These two claims illustrate how the Alice framework can turn a concrete, machine-based process into an abstract idea merely by referencing the data to which the process is applied. Under this logic, there are cases in which the more specifically you describe a computer-implemented method, the greater the risk of ineligibility. A broad, generic claim about “routing data packets” may be safe. But narrow it down to “routing banking packets with latency reduction,” and it magically transforms into an abstract business concept. This inversion of logic punishes claim language precision, the very thing patent law is supposed to reward.

It is difficult to overstate how irrational these results can be. Routing packets? Not abstract. Routing packets containing medical data? Abstract. Encrypting chat messages? Not abstract. Encrypting stock trades? Abstract. In these cases, the technology has not changed. Instead, the message encoded in the bits determines whether the machine performing the task is concrete or abstract. It is like deciding that a hammer is a physical tool when driving nails to construct a table but an abstract idea when used to make a treasure chest.

This doctrinal absurdity doesn’t just distort legal reasoning. It also warps applicant behavior. Under Alice, applicants have a perverse incentive to claim their inventions more broadly than they otherwise would. Normally, a careful drafter writes claims to highlight concrete technical features such as precise hardware interactions, data structures, and control logic. But thanks to Alice, there are situations where the more you explain about what your system actually does, the easier it is for an examiner or judge to find in it an abstract idea. So applicants may hedge their bets by de-emphasizing the actual invention they wish to protect and keeping claims focused on the broader technical features. In some cases, this involves omitting any discussion of the actual intended use of the technology from the patent application completely. In other words, Alice can reward exactly the kind of overbroad claiming that its advocates continue to complain about.

By Manav Das –

We added some tariffs with pride,
Hoping that’ll keep rivals outside.
But inventors soon found
There was less cash around
And our own breakthroughs quietly died.

With all the talk about tariffs, and the recent Oral Hearing at the Supreme Court, I started wondering as to how this impacts intellectual property (IP). Tariffs are defined as taxes levied against imported goods, calculated as ad valorem tariffs, a percentage of the declared customs value. Since 2018, the United States government has significantly escalated the use of these tools, most notably through Section 301[1] of the Trade Act of 1974 and Section 232[2] tariffs. The current administration has used tariffs as a leverage in foreign policy. These tariffs are primarily intended to compel U.S. companies to diversify and move their manufacturing supply chains out of foreign countries and reinforce domestic industry. The long-term goal is to use this punitive tax as a negotiating tool, a revenue source, and a protective mechanism for favored domestic sectors.

Tariffs and IP:

So how do tariffs impact IP? The imposition of elevated tariffs creates immediate operational and financial stress, which flows directly into IP management decisions. The tariffs represent a substantial tax burden paid by US businesses[3]. This cost immediately drains capital resources that companies would otherwise allocate toward research and development, equipment investment, and job creation. Also, tariffs often go unnoticed in their interaction with intellectual property payments. Off-invoice payments, such as royalties and license fees associated with imported merchandise, carry the potential to significantly increase the dutiable customs value. 

The core adverse impact of tariffs on IP is the mandatory diversion of capital. By requiring companies to allocate billions of dollars in scarce resources toward tariff payments, the policy directly impedes investment in future innovation. Tariffs impact semiconductors[4], life sciences[5], quantum computing[6], and artificial intelligence[7], to name a few industries.

The negative financial impact of tariffs can be strategically offset to some extent by utilizing domestic policy incentives. The Credit for Increasing Research Activities[8] (R&D credit) is recognized by economists as a vital policy alternative or offset to protectionist trade measures. While tariffs increase the cost of doing business, the R&D credit functions as a subsidy to innovation by reducing tax liability.

Tariffs impact individuals as well, at least through inflation and disruptions to the supply chain. While companies may be able to offset some of their tariff-related costs, there are no corresponding “R&D credits” for individuals. Other than setting up companies and going through a demanding set of criteria, individual innovators have little to no tax benefits for innovative activities, including filing patents and related filing and attorney fees.

Tariffs and the Supreme Court:

The Supreme Court recently heard a consolidated case, Trump v. V.O.S. Selections[9] and Learning Resources v. Trump[10], that directly challenges the legality of wide-ranging tariffs imposed under the International Emergency Economic Powers Act[11] (IEEPA). This body of tariffs includes the “Reciprocal tariffs” and “Fentanyl tariffs”, which have raised the applied U.S. tariff rate and generated billions of dollars in revenue[12], paid by U.S. importers. The core legal question is whether Congress lawfully delegated sufficient authority to the President under the IEEPA to impose such sweeping taxes on imported goods. Notably IEEPA does not include the words “tariff” or “duty.” Challengers argue that the administration’s actions amount to an unconstitutional delegation, as Article I of the Constitution grants Congress the power to regulate commerce and set tariffs.

Lower courts, including the Court of International Trade and the Federal Circuit, have generally ruled against the broad IEEPA-based tariffs. Initial reporting of the Oral Hearings seems to indicate that the Supreme Court may be leaning toward agreeing with the lower courts. Should the Supreme Court decide that the IEEPA-based tariffs are unlawful and must end, then companies will experience a major reduction in import costs, freeing up capital for reinvestment in R&D, innovation, and equipment. On the other hand, should the Supreme Court uphold the IEEPA-based tariffs, businesses must treat high import taxes as a permanent, systemic risk. This reinforces the long-term strategic necessity of maximizing the R&D tax credit as an innovation offset and relocating supply chains to avoid persistent tariff exposure.

Tariffs and Taxes:

While the core purpose of the tariffs is ostensibly to bring manufacturing home and spur innovation, the adverse impact on R&D investment may certainly impede any such gains, and result in long-term loss of US competitiveness in global innovation leadership. I am not an economist, much less a political economist. Although to me, politics is the art of couching economic reality in the context of life, liberty, and the pursuit of happiness (consider themes from elections past: “read my lips, no new taxes,” “it’s the economy, stupid!” or the most recent buzzword: “affordability”). Whenever companies are faced with budget cuts, a knee-jerk reaction is to cut IP budgets, trim down IP portfolios and R&D teams, resort to trade secret protection, and so forth.  

I am not a tax specialist either. However, as a layman ruminating from the outside, it seems reasonable that there must be some instrument to protect R&D from the ravages of the political economy, or even the economy in general. The R&D tax credit appears to be one such instrument. There may be benefits in raising the tax credit for companies as a percentage of gross revenue. There may also be benefits in a graded scheme that allows for a higher percentage credit to companies with lower gross revenues.

However, this does not help individuals. A real benefit would be from giving a tax credit or a deduction to individuals for innovative activities. Such activities can be tailored to spur innovation. For example, experimental activities, software and equipment purchases, etc. where the credit or deduction is realized in the calendar year when there is a measurable end benefit, such as a designed product, a proof of concept, a launch of a startup, patenting activities, etc. I leave it to the experts to determine the precise points in the innovation lifecycle where such tax benefits may be most effective.

In the meantime…

Regardless of the Supreme Court’s outcome, IP and finance teams must implement strategies to manage tariff risks. Some options are:

Maximize the R&D Credit: The R&D credit remains an important tool, especially if tariffs are upheld, acting as a capital reclamation mechanism. The credit provides a 10% average return on investment (ROI) on qualified spending, offsetting the direct cost of tariffs on innovation capital.

Customs Compliance Audit: Cross-border licensing agreements must be rigorously audited to minimize the dutiable value risk. Royalty and IP-related fees can be structured carefully to prevent U.S. Customs and Border Protection (CBP) from deeming them dutiable, which would exacerbate the overall tariff liability.

Supply Chain Resilience: Investing in US-based R&D and domestic manufacturing serves as the ultimate long-term hedge against tariff uncertainty, reducing import cost exposure while strengthening IP protection under U.S. law.

In conclusion, the U.S. IP landscape is currently defined by profound economic uncertainty. Should the Supreme Court uphold the tariffs, this would codify the current elevated risk environment, transforming IP and R&D strategy from a compliance exercise into a necessity for corporate survival against sustained high import costs. If tariffs must serve as a protective mechanism for favored domestic sectors, there need to be offsetting credits for businesses and individuals to protect and increase R&D investment.

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[1] Section 301 of the Trade Act of 1974, available at: https://www.congress.gov/crs-product/IF11346 (last accessed November 9, 2025).

[2] Section 232 of the Trade Expansion Act of 1962, available at https://www.congress.gov/crs-product/IF13006 (last accessed, November 9, 2025).

[3] The Economic Impact of Tariffs, Knowledge at Wharton, Penn Wharton Budget Model (PWBM) analysis, available at: https://knowledge.wharton.upenn.edu/article/the-economic-impact-of-tariffs/, April 2025 (last accessed on November 6, 2025).

[4] Short‑Circuited: How Semiconductor Tariffs Would Harm the U.S. Economy and Digital Industry Leadership, Information Technology and Innovation Foundation Report, available at: https://itif.org/publications/2025/05/21/short-circuited-how-semiconductor-tariffs-would-harm-the-us-economy/, May 2025 (last accessed on November 6, 2025).

[5] Impact of Proposed Tariffs on the Life Sciences Industry, KPMG, available at: https://kpmg.com/us/en/articles/2025/impact-of-proposed-tariffs-on-the-life-sciences-industry.html, 2025 (last accessed on November 6, 2025).

[6] Trade Deals May be a Hopeful Sign, But Tariffs Still Threaten U.S. Quantum Leadership, Quantum Insider, available at: https://thequantuminsider.com/2025/07/28/trade-deals-may-be-a-hopeful-sign-but-tariffs-still-threaten-u-s-quantum-leadership/, July 2025 (last accessed on November 6, 2025).

[7] How Trump’s Tariffs Could Make AI Development More Expensive, Time Magazine, available at: https://time.com/7275771/trump-tariffs-ai-development-china/, April 2025 (last accessed on November 6, 2025).

[8] 26 U.S.C. § 41, available at: https://www.law.cornell.edu/uscode/text/26/41 (last accessed November 9, 2025).

[9] V.O.S. Selections, Inc. v. Trump, No. 24-1287 (U.S. Nov. 5, 2025).

[10] Learning Resources, Inc. v. Trump, No. 24-1287 (U.S. Nov. 5, 2025).

[11] International Emergency Economic Powers Act, available at: https://www.congress.gov/crs-product/R45618 (last accessed November 9, 2025).

[12] Erica York, Alex Durante, Trump Tariffs: Tracking the Economic Impact of the Trump Trade War, Tax Foundation, October 31, 2025, available at: https://taxfoundation.org/research/all/federal/trump-tariffs-trade-war/ (last accessed November 9, 2025).

By Kevin E. Noonan –

The new Director of the Patent and Trademark Office, Undersecretary of Commerce for Intellectual Property John A. Squires has spent the last few weeks making serious policy changes in the Office (see “New Director Overturns PTAB Procedural Precedents: Part I“; “USPTO Proposed New Rules Limiting the Availability of Inter Partes Review, But Are They Legal?“).  Towards the end of last month, the Assistant Commissioner for Patents Brian E. Hanlon made his contribution, issuing a Memorandum to the Patent Examining Corps entitled “Advance notice of change to the MPEP with respect to false assertions or certifications of entity status.”

The Memorandum references an Official Gazette Notice on June 12, 2025 on “Statutory Penalties for False Assertions or Certifications of Small and Micro Entity Status,” later published at 1536 OG 204 (July 8, 2025).  Substantively that Notice informed the public that the Office could “institute a review of pending patent applications or patents to determine whether there is a false entity status claim that resulted in the payment of at least one fee in an unentitled reduced amount”; in a footnote the Assistant Commissioner was careful to reassure that this Notice does not suggest any lack of previous authority to review small entity status or had “previously refrained from doing so.”

The most recent Notice identified the changes to the M.P.E.P. that will effectuate the desired effects of the Memorandum, in particular M.P.E.P. § 410 (ante- and penultimate paragraphs), giving “employees reporting to the Assistant Commissioner for Patents that oversees the Office of Petitions” the authority to review a claim for small entity status entitlement “as well as [assessing] the reasonableness of their conduct” in doing so.  This portion of the Memorandum cites 37 C.F.R. § 11.18(b) for determining violation of an applicant’s or practitioner’s duties of disclosure and 37 C.F.R. § 11.18(c) for sanctions to be imposed in the event such violations are determined.

Further changes in M.P.E.P. § 509.03(b) are set forth with regard to “any attempt to fraudulently establish status as a small entity or pay fees as a small entity,” which will be considered to be fraud on the Office, and that an applicant cannot rely on any verbal advice “inadvertently” given regarding entitlement to small entity status.  The same “employees reporting to the Assistant Commissioner for Patents that oversees the Office of Petitions” referenced above are given the authority (“may review”) whether the applicant or patent owner is entitled to small entity status.  Similar provisions apply under M.P.E.P. § 509.04 for micro entity status under 37 C.F.R. § 1.29(j).

Finally, the Memorandum discloses provisions under M.P.E.P. § 1001.02(b) for reconsideration requests under circumstances that a claim for small entity status was determined to be “falsely made and not in good faith.”

These changes came into effect upon issuance of the Memorandum on October 24, 2025.

What the Memorandum does not do is provide any rationale or basis for or any evidence that claims to small or micro entity status are being improperly made.

By Kevin E. Noonan –

In a seemingly otherwise run-of-the-mill, albeit precedential, decision, the Federal Circuit affirmed a stipulated judgment of non-infringement in Aortic Innovations LLC v. Edwards Lifesciences Corp.

The case arose in litigation over the claims of Aortic’s U.S. Patent Nos. 10,881,538, 10,966,846, 10,987,236, and 11,129,735 directed towards devices for transcatheter aortic valve replacement; two alternatives of such devices are illustrated in the opinion as comprising a “balloon-expandable frame” and a “self-expanding frame”:

Claim 1 of the ‘735 patent is set forth in the opinion as representative:

1. An endovascular transcatheter valve assembly comprising:
an outer frame,
wherein the outer frame is formed from a metallic material and defines an open cell configuration
wherein the outer frame includes an inflow end at a proximal portion thereof and an outflow end at a distal portion thereof,
wherein the outer frame is formed by a plurality of struts that adjoin each other at the inflow end to form apices:
an inner frame that engages a prosthetic heart valve having prosthetic leaflets, wherein the inner frame includes a cylindrically extending inner graft covering extending at least partially radially outwardly of the prosthetic heart valve and radially inwardly of the outer frame for providing sealing to the prosthetic heart valve,
wherein the outer frame is secured to the inner graft covering by stitching a proximal portion of the outer frame;
an outer seal for preventing paravalvular leaks that at least partially extends over at least two most proximal rows of cells formed in the outer frame,
wherein the outer seal is formed of outwardly extending fibers positioned externally to the outer frame,
wherein the valve assembly has a radially com-pressed orientation and a radially expanded orientation,
wherein the valve assembly is configured to press some of the fibers against native leaflets of the aorta of the patient
wherein an end of the apices of the outer frame that are most proximal are covered by the outer seal and the graft covering,
wherein the end of the most proximal apices of the outer frame extends more proximally than a proximal end of the outer seal.

(wherein outer frame is italicized for being the claim element at issue in the case).

The District Court construed the term “outer frame” to be consistent with disclosure in the specification, particularly structure 416 identified in a dual-frame transcatheter valve illustrated by this Figure 20:

and structure 216 identified in a dual-frame endo-graft device illustrated by this Figure 9:

In this construction the District Court held that the term “outer frame” be interpreted as being interchangeable with “a self-expanding frame” as asserted by Edwards (rather than by its plain and ordinary meaning as Aortic argued) because Aortic had acted as its own lexicographer by using the terms “outer frame,” “self-expanding frame,” and “self-expanding outer frame” interchangeably.  The parties stipulated that under this construction Edwards’ accused SAPIEN 3 Ultra valve, a single, balloon-expandable frame did not infringe the asserted claims.

In the meantime, and relevant to this appeal, Edwards filed inter partes review petitions against the asserted patents and instituted IPRs for all but the ‘735 patent.  The District Court entered judgment based on the stipulation of non-infringement and this appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Reyna and joined by Judges Prost and Chen.  (The Court dismissed the appeal for lack of jurisdiction regarding the ‘538 patent, in which the Patent Trial and Appeal Board held in a Final Written Decision that all claims were invalid, relying on Fresenius USA, Inc. v. Baxter Int’l, Inc., 721 F.3d 1330, 1340 (Fed. Cir. 2013)).  Turning to the merits, the panel agreed with the District Court’s construction that the term “outer frame” comprised embodiments that were also “self-expanding” and that the terms are interchangeable, and affirmed the District Court’s claim construction accordingly.  The basis for the Court’s conclusion on this construction was that a patentee is permitted to be its own lexicographer, provided that a definition of a claim term “other than its plain and ordinary meaning” must be set forth clearly and when this written description is satisfied the term should be construed in that way, citing Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1367 (Fed. Cir. 2012).  This definition does not need to be disclosed as an explicit redefinition of a term otherwise having a plain and ordinary meaning, however, but may define terms by implication, under Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001).  This burden is greater than “[s]imply referring to two terms as alternatives or disclosing embodiments that all use the term[s] the same way[, which] is not sufficient to redefine a claim term” according to the opinion.  But should the patent disclose a “consistent and clear interchangeable use of two terms [this] can result in a definition equating the two terms” according to the Court, citing Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1329 (Fed. Cir. 2009); Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1282 n.6 (Fed. Cir. 2017); Bid for Position, LLC v. AOL, LLC, 601 F.3d 1311, 1317–18 (Fed. Cir. 2010); Tate Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 968 (Fed. Cir. 2000); and Bell Atl., 262 F.3d at 1274–75 (and setting forth the bases in this precedent for the Court to arrive at a determination of redefinition).

The panel agreed with the District Court that “[h]ere, a skilled artisan would understand that the claimed term ‘outer frame’ is a ‘self-expanding frame,’” citing the portions of the specification relied upon by the District Court (structure 416 in Figure 20 and structure 216 in Figure 9).  According to the opinion, “this disclosure clearly indicates that structures 216 and 416 are outer frames that must self-expand.”  In addition, the panel cited the consistent disclosure in the specification that “claim 1’s ‘outer frame’ is a ‘self-expanding frame,’” citing multiple examples of such disclosure in the summary section.  Citing GPNE Corp. v. Apple Inc., 830 F.3d 1365, 1370 (Fed. Cir. 2016), for the rubric that “when a patent repeatedly and consistently characterizes a claim term in a particular way, it is proper to construe the claim term in accordance with that characterization,” the opinion asserts that “the specification clearly and consistently conveys that the self-expanding nature of structures 216 and 416 is present in all embodiments of those devices.”  In view of this understanding, the Court held that the District Court was correct that the skilled artisan would understand the disclosure to be consistent with this construction.

The opinion also somewhat summarily rejected Aortic’s additional argument that the Court should judicially estop Edwards from arguing that the term “outer frame” should be construed as anything other than its plain and ordinary meaning due to putative inconsistencies between their argument before the District Court and before the Patent Trial and Appeal Board during inter partes review proceedings, finding that Aortic had forfeited this argument by not raising it before the District Court.

Aortic Innovations LLC v. Edwards Lifesciences Corp. (Fed. Cir. 2025)
Panel: Circuit Judges Prost, Reyna, and Chen
Opinion by Circuit Judge Reyna

By Michael S. Borella –

From a technical standpoint, everything a computer does involves reading, manipulating, and storing information through microcode instructions that move around 0’s and 1’s. Each operation performed by a processor, such as addition, comparison, and data transfer, can be manually simulated as a series of these instructions. Undergraduate students in computer architecture courses routinely perform such exercises with a pencil and paper to understand how a processor works. In principle, one could simulate any software algorithm this way (albeit with the parallel portions serialized). But completing even modest tasks might take years.

U.S. patent law fails to appreciate these facts, and the consequences are absurd.

The law deems certain categories of inventions as ineligible for patenting, among them those drawn to so-called abstract ideas. Mental processes are a sub-category of abstract ideas. The reasoning behind this exclusion seems straightforward and even reasonable at first blush – if something can be performed purely in the human mind, like adding two small numbers or making a basic decision, it should not be patentable. However, the doctrine has expanded far beyond that.

Under decisions such as CyberSource Corp. v. Retail Decisions, Inc., courts have ruled that a mental process also includes tasks that could be performed by a human using pen and paper. The U.S. Patent and Trademark Office (USPTO) adopted the same stance in its Manual of Patent Examining Procedure (M.P.E.P.) § 2106, asserting that there is no distinction between processes performed entirely in the mind and those that require physical aids. Courts have gone even further, declaring that claims performed by a computer can still be considered mental processes. Cases like Mortgage Grader v. First Choice Loan Services and Intellectual Ventures I v. Symantec treat computer-implemented methods as mental acts simply because they can be theoretically replicated by the human mind.[1]

This principle is a legal fiction. A process that requires a machine executing billions of instructions per second is treated as if it were a mere mental exercise even though it is not and never could be. No amount of coffee will help a person think their way through these complex calculations, much less at a rate that would provide a useful result in a reasonable period of time. And the consequences can be dire for patentees, with claims to legitimately innovative technical inventions being rejected by the USPTO or invalidated by courts because their steps could be simplified to appear analogous to human thoughts.

In In re Killian, the Federal Circuit wrote a small treatise defending this nonsense.  The USPTO’s Patent Trial and Appeal Board (PTAB) continues to wield the mental steps doctrine like a sledgehammer against software applicants, affirming examiners’ patent eligibility rejections at a very high rate.

The USPTO’s own guidance attempts to draw a line between processes that “can practically be performed in the human mind” and those that cannot. Examples deemed mental include generic data analysis and DNA sequence comparison, while examples deemed non-mental include GPS position calculations, network packet inspection, and certain encryption methods. Yet the logic behind these distinctions is paper-thin.

For example, comparing BRCA1 and BRCA2 gene sequences – which the USPTO believes to be mental tasks – involves analyzing tens of thousands of DNA base pairs, an undertaking as unsuited for human performance as inspecting hundreds of network packets, which the USPTO classifies as non-mental. The supposed boundary between these categories has no technical coherence.

The doctrine collapses because it confuses what is theoretically imaginable with what is physically possible. While a human could, given enough time and paper, emulate any computer program, that does not make machine-based computation a mental act. Software execution is a physical process of manipulating electrical states in silicon, not a series of thoughts.

By treating computer-implemented algorithms as abstract mental activities, courts ignore the physical nature of software execution and the integral relationship between code and hardware. Software causes a machine to change states and behaviors when its instructions are performed. Separating the idea of the algorithm from the computer that carries it out distorts both technology and law. This is like confusing a mere recipe with the act of cooking using kitchen utensils and appliances.

This confusion has especially damaging effects on emerging fields like machine learning. Despite the USPTO’s own examples showing that certain machine learning claims are not drawn to mental processes, examiners frequently reject similar claims as ineligible. The reasoning is circular: because a neural network follows mathematical logic, it can be performed mentally, even though no human could realistically simulate millions of weighted matrix operations by hand.

The current application of the mental steps doctrine, coupled with the Supreme Court’s overly-broad abstract idea exclusion, has made software patent eligibility unpredictable and irrational. Courts invoke metaphysical distinctions between “thinking” and “computing” while ignoring the physical, technical character of modern digital systems. As a result, patent examiners are left to apply vague rules that depend more on inconsistent precedent and personal interpretation than on consistent reasoning.

A rational approach would confine the doctrine to its original intent – excluding only those inventions truly meant to be performed mentally by humans. A claim to a method that requires a computer should not be treated as a mental process simply because it can be described in terms of steps that have an attenuated relationship to human thought.

If anyone still insists that computers and human minds are analogous for patent eligibility purposes, I invite them to prove it. Go ahead and train a large language model in your head. Memorize billions of parameters, calculate trillions of matrix multiplications, backpropagate the gradients, and fine-tune it across terabytes of text. You have to do it all mentally, of course, or maybe with a handy pen and paper if you need a physical aid. But you can’t do it because no human can. If you disagree, then go ahead and try and show me the results. I’ll wait but probably not long enough, because by the time you finish the sun will have boiled the oceans and swallowed the Earth.

* This article has been adapted from the author’s earlier article, “The Mental Process Exception to Patent Eligibility is Remarkably Brainless,” Patent Docs, Jan. 9, 2023.

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[1] To be fair, a claim deemed abstract can still be eligible if it also recites an “inventive concept.” But in practice, this can be quite difficult because once a claim is characterized as directed to an abstract idea, courts often view most or all of its features as part of that abstraction. Further, generic hardware or using routine functions cannot provide an inventive concept. The courts have set a high bar for a claim surviving once it has been damned to the Hell of abstraction.

By Michael S. Borella –

It has been over a decade since the Supreme Court blessed us with the two-step framework for patent eligibility under 35 U.S.C. § 101 in Alice Corp. v. CLS Bank. First, one must determine whether the claim at issue is “directed to” a judicial exception, and if so, one must then decide whether the claim adds “significantly more” than the alleged exception itself.

The ambiguities of this test are legion. But beyond its shortcomings, the Federal Circuit and the U.S. Patent and Trademark Office (USPTO) have both modified it in substantive fashions. So now we have three “Alice tests” that share a name but can be applied differently in practice.

At surface level, the original Alice decision was about abstract ideas implemented in software, and whether reciting generic computer hardware in a claim made the overall claims any less abstract. But the Court’s language in the opinion made it clear that their actual concern was one of preemption.

We have described the concern that drives this exclusionary principle as one of pre-emption. Laws of nature, natural phenomena, and abstract ideas are the basic tools of scientific and technological work. Monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it, thereby thwarting the primary object of the patent laws. We have repeatedly emphasized this concern that patent law not inhibit further discovery by improperly tying up the future use of these building blocks of human ingenuity.

The Court’s stated rationale was straightforward – to not allow monopolization of the “building blocks of human ingenuity.”[1] In this light, the Alice test was supposed to ask whether a claim effectively preempted use of such a building block in the form of an abstract idea (whatever that means this month), law of nature, or natural phenomenon.

Further, this preemption-centric logic at least ties § 101 to a policy rationale. If a claim does not preempt others from using the “basic tools of scientific and technological work” it is eligible. Unfortunately, the Court left out the small matter of how one is supposed to measure preemption. Is it claim breadth? Use of functional language? Market impact? Who knows. How much and what does one need to add to an abstract idea in order to make it “significantly more?” Again, who knows? The Court shrugged and walked away, leaving the Federal Circuit to fill in the blanks. This was a mistake.

The Federal Circuit looked at Alice, nodded politely, and proceeded to ignore its core premise. Instead, the appellate court has stripped preemption from the test. In Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit wrote:

The Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability. For this reason, questions on preemption are inherent in and resolved by the § 101 analysis . . . . While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility . . . . Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the [Alice] framework, as they are in this case, preemption concerns are fully addressed and made moot.

In the span of three sentences, the Federal Circuit both acknowledged that preemption is the basis of the Alice test and then declared that preemption is irrelevant when one applies the Alice test. This is the jurisprudential equivalent of agreeing that a solid foundation is essential, then building a house on sand anyway. The Supreme Court’s § 101 decisions do not treat preemption as an incidental consequence of the analysis; they treat it as the reason the analysis exists. By declaring that preemption concerns are “moot” once the claim fails the Alice test, the Federal Circuit inverted the structure of the doctrine. Ariosa instead treats the test as self-justifying, in that preemption begins and ends with whatever conclusion the court reaches. Through this doctrinal sleight of hand, the Alice test as applied by the Federal Circuit does not ask whether a patent blocks others from using one of the basic tools of scientific and technological work.

This has resulted in many remarkably narrow claims that recite far more than basic building blocks to be ruled too abstract for patenting in a highly conclusory manner. This shift also means that § 101 is doing the job of § 102, § 103, and § 112 all at once, but without the pesky constraints of evidence or claim construction.

So, preemption has gone from the cornerstone of the analysis to an irrelevant footnote. Which brings us to the third version of the test – the USPTO’s bureaucratic remix.

Never one to miss a chance to turn doctrine into paperwork, the USPTO took Alice and did what federal agencies do best: they added complexity. The 2019 Revised Patent Subject Matter Eligibility Guidance broke the first step of the Federal Circuit test into two parts, each with its own long list of relevant considerations.

Particularly, the two substeps of the judicial exception inquiry are: does the claim recite a judicial exception,[2] and if so does it integrate that exception into a practical application? Examiners must then run through a list of factors, such as improvements to technology, meaningful limitations, specific machine use, etc., each of which can support eligibility. Only then do we reach Step 2B, where the “inventive concept” analysis lives, chained to the unhelpful “well-understood, routine, and conventional” mantra.

The USPTO’s 2019 guidance was supposed to improve consistency, but it mainly made § 101 rejections and rebuttals longer and more convoluted. Worse, none of this is binding on the courts, so an applicant who finally navigates the Office’s Alice labyrinth may find their patent declared ineligible on the pleadings by a district court judge.

The USPTO’s Alice test is thus a triumph of administrative structure over substance. It replaces two vague steps with three vague steps, aimed at creating the illusion of objectivity. Kafka would be proud.

So we have three distinct versions of the same test. The Supreme Court’s Alice test is fundamentally based on preemption, the Federal Circuit’s Alice test ignores preemption, and the USPTO is too busy drawing flowcharts to care either way. Each of these tests speaks its own language, none of which is intelligible. A claim that passes the USPTO may fail in court. A claim that would survive under the Supreme Court’s stated rationale might never make it past an examiner or the Federal Circuit. The only common thread is uncertainty.

If Congress or the Supreme Court ever decides to clean this up, here is a two-step process they could use that is actually workable in practice. Step one: admit the obvious – the Alice test is an incomprehensible mess. Step two: go back to a pre-Alice regime and focus on § 102, § 103, and § 112.

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[1] Some would argue that, ironically, Alice has strengthened the monopoly power of large companies by weakening patent law so that these companies can “efficiently infringe” competitors’ patents given that invalidating such patents was made dramatically easier.

[2] The USPTO goes to pains when trying to explain the difference between the language “directed to” and “recites.” One of the more bizarre outcomes of the USPTO’s version of the test is that an eligible independent claim that does not recite a judicial exception can have an ineligible dependent claim that does.

By Kevin E. Noonan –

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies contained thereinunder, and the Food and Drug Administration exhibited this tendency in a recent Draft Guidance regarding the requirements for a biosimilar-producing applicant to obtain approval for an abbreviated Biologic License Application (aBLA).

Here the outcome is lower drug prices, as expressly stated by Secretary Kennedy in a press release. Characterizing the change as an illustration of “bold action,” the press release attributes the lower number of approved biosimilar drugs (76) compared to conventional small molecule generic drugs (over 30,000) as the result of “a burdensome approval process” (ignoring the difference between the over forty years that have elapsed since passage of the Hatch-Waxman Act and fifteen years since the BPCIA was passed as part of the Affordable Care Act, as well as the recognized differences in technology and costs/efforts for bringing a biosimilar drug to market (see “No One Seems Happy with Follow-on Biologics According to the FTC” and “Emerging Health Care Issues: Follow-on Biologic Drug Competition“). FDA Commissioner Marty Makary M.D., M.P.H. echoes his boss’s theme, stating that “[b]y streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans” (Dr. Makary’s philosophy can be found in his book, Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health). Now-former Director, FDA Center for Drug Evaluation and Research, George Tidmarsh, M.D., Ph.D. in more measured tones characterized the changes as being due to the FDA’s commitment “to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness,” a worthy aspiration but perhaps being less than expected or hoped-for. The economic and political impetus is also set forth in the press release, which notes that “[e]xpensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%.” There is little to no recognition that perhaps the reason approved biosimilar drugs are “as safe and effective as the branded drugs” is because of the “burdensome approval process” (a blind spot shared by many; see “Interchangeable Biosimilars: In a Battle of Safety vs. Cost, Where Does Sen. Lee Stand?“).

The press release states simply the point of the new Guidance: based on “the agency’s accrued data and experience since the first biosimilar was approved in 2015” (the same evidence excoriated as being “unduly burdensome” earlier in the press release), “comparative efficacy studies generally have low sensitivity compared to many other analytical assessments,” and touts that the new Guidance “reduces this unnecessary resource-intensive requirement for developers to conduct comparative human clinical studies” in favor of such analytical studies. Also denigrated are testing requirements for interchangeability, which has been the subject of earlier Guidance changes.

The Guidance is remarkably brief in view of the purported sea change it is promised to produce in biosimilar approval requirements. The Guidance itself reiterates some of these policy-based (as opposed to science-based) rationales for the changes set forth therein. The Introduction section of the Guidance sets forth an earlier Guidance (Scientific Considerations in 37 Demonstrating Biosimilarity to a Reference Product) from 2015 providing information related to satisfaction of the statutory requirements under Section 351 of the PHS Act for biosimilarity and FDA’s interpretation thereof (including “comparative analytical studies, an assessment of toxicity, comparative human PK and PD studies (if there is a relevant PD measure(s)), and a clinical immunogenicity assessment.” The devil being in the details, the Guidance announces that the substantive changes are a consequence of the “significant experience in evaluating analytical differences between proposed biosimilar products and their reference products and understanding the impact of those analytical differences on clinical performance.” According to the Guidance, “currently available analytical technologies can structurally characterize highly purified therapeutic proteins and model in vivo functional effects with a high degree of specificity and sensitivity using in vitro biological and biochemical assays” and “comparative analytical assessment (CAA) is generally more sensitive than a [comparative efficacy study,] CES to detect differences between two products” relevant to biosimilarity.  Under circumstances where a CAA indicates biosimilarity as defined in the statute, “FDA recommends that sponsors consider a streamlined approach where a CES may not be necessary to support a demonstration of biosimilarity,” which may include “an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity.” In a specific recommendation the Guidance provides that:

A streamlined approach should be considered when:

• The reference product and proposed biosimilar product are manufactured from clonal cell lines, are highly purified, and can be well-characterized analytically;

• The relationship between quality attributes and clinical efficacy is generally understood for the reference product, and these attributes can be evaluated by assays included in the CAA; and

• A human pharmacokinetic similarity study is feasible and clinically relevant.

The Guidance also recognizes “there may remain” instances and circumstances where a CES may be appropriate, and sponsors are “encouraged” to discuss such instances and circumstances with the Agency.

As with all draft Guidances, this one sets forth immediately before the Introduction the caveat that:

Whether the requirements in this Guidance improvidently expose the public to inadequately tested/screened/examined biosimilar drugs will depend on how the Guidance is implemented and (with even more uncertainly) the particular biologic drug for which the biosimilar is approved. And it remains questionable whether any such changes will significantly impact the number, time to market, or cost savings of new biosimilar drugs.

By Joshua R. Rich –

Usually, when an issue is actually considered and resolved after a full and fair opportunity to litigate, the doctrine of issue preclusion can bar the losing party from relitigating the issue in another case.  That is, judicial economy is best served by not allowing a losing party a second bite at the apple on questions it had every reason to fight over, but failed.  But as Inland Diamond Products shows, there can be an exception:  in certain circumstances when the earlier decision was made based on a lower standard of proof, courts will not honor that earlier decision by applying issue preclusion and will make later parties prove their case from whole cloth.

The Inland Diamond Products case was the second round of fighting over the two patents-in-suit (U.S. Patent Nos. 8,636,360 and 9,405,130).  In 2017, Inland brought a patent infringement lawsuit against Hoya Optical Labs of America in the U.S. District Court for the Eastern District of Texas alleging infringement of claims of the two patents.  Hoya responded by filing petitions for inter partes review against the two patents in late 2017 and early 2018.  The district court litigation and IPRs continued in parallel until August 2018, when the parties settled the litigation.  Importantly, however, the settlement expressly did not moot the IPRs.  Instead, they carried forward to resolution, with some of the claims (including the independent claims) being found invalid for obviousness in mid-2019.  But some of the claims survived.

With those surviving claims in hand, Inland sued Cherry Optical for patent infringement in the U.S. District Court for the Eastern District of Wisconsin.  After almost three years of hard-fought litigation, Cherry Optical moved for summary judgment of invalidity due to obviousness.  It based its motion in part on the earlier IPR decisions, reasoning that Inland should be bound to the earlier finding that the independent claims of the asserted patents were obvious and Inland should only be permitted to argue that the additional elements of the dependent claims rendered them nonobvious.  The District Court agreed, applying issue preclusion to narrow Inland’s possible arguments to only those additional elements.  But those differences were not enough to overcome the prior art references and arguments that Cherry Optical asserted and the District Court granted summary judgment of invalidity.

While the appeal from the District Court’s decision in the Inland Diamond Products case was pending, the Federal Circuit decided two cases that dictated its decision here.  In ParkerVision, Inc. v. Qualcomm Inc., 116 F.4th 1345 (Fed. Cir. 2024), the PTAB found apparatus claims invalid in an IPR; the patentee then asserted the method claims of the same patent in district court litigation.  The accused infringer cited the same invalidating art in the litigation and the District Court barred the patentee from providing expert witness testimony on the same factual issues that were resolved in the IPR.  Because the PTAB’s decision was made under the preponderance of the evidence standard, not clear and convincing evidence (the standard for invalidation in litigation), the Federal Circuit ruled that estoppel could not apply.  Similarly, in Kray IP Holdings, LLC v. Groupon, Inc., 127 F.4th 1376 (Fed. Cir. 2025), the Board held claims of the relevant patent invalid in an IPR.  When Kray sought to assert immaterially different claims in litigation, the District Court dismissed its complaint due to issue preclusion.  Again, the Federal Circuit refused to apply issue preclusion and reversed the dismissal based on the different burdens of proof on invalidity in the Patent Office and district court.

Given the precedent of the ParkerVision and Kray decisions, the Federal Circuit’s reversal of summary judgment in the Inland Diamond Products case was preordained.  But as the court noted, the earlier cases had to distinguish the decision in XY, LLC v. Trans Ova Genetics, L.C., 890 F.3d 1282 (Fed. Cir. 2018).  In that case, the Federal Circuit applied issue preclusion to bar relitigation of the validity of a claim that had been invalidated in an IPR when the appellate court concurrently decided the two appeals.  It held the appellate decision means “the claim no longer exists and cannot be asserted as a basis for infringement.”  But given the later precedent of ParkerVision and Kray, it seems to be a thin reed to distinguish between the two situations:  only if the Federal Circuit decides the two appeals on the same day (or invalidates the patent claims earlier) does the reasoning even apply?[1]

The Federal Circuit did provide some guidance for the District Court – and future litigants – after reaching its conclusion.  First, in a footnote, it indicated that there would be another reason to ignore issue preclusion in early IPRs.  Specifically, it said claim constructions rendered based on the “broadest reasonable interpretation” cannot preclude relitigation because the claim construction standards are different.  In this case, that would be another reason that applying issue preclusion was erroneous, beyond the distinction in standard of proof of invalidity and the asserted claims themselves not having been invalidated.  Furthermore, even if the same prior art was asserted as invalidating closely related claims, the District Court could not rely on the PTAB’s decision to shorten its analysis; the patent challenger would carry the burden of proof and the patentee must be allowed to mount a full challenge to the invalidity arguments.

The Inland Diamond Products case limits the value of a successful IPR.  Coming at almost exactly the same time as proposed rules that limit the availability of IPRs[2] and the Director’s decision to resolve all institution issues himself,[3] it is another blow to IPRs as an option for resolving validity issues.  The intent in creating IPRs was to avoid the need for fulsome litigation of validity issues if the Patent Office could resolve them more quickly and inexpensively.  The Inland Diamond Products case eliminates all of those efficiencies.

Inland Diamond Products v. Cherry Optical (Fed. Cir. 2025)
Panel: Circuit Judges Prost, Reyna, and Chen
Opinion by Circuit Judge Prost

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[1] Given the reasoning of these cases, it isn’t clear if the Federal Circuit would apply issue preclusion to allow a PTAB finding of invalidity to prevent assertion of infringement of the same claim in a district court or if the IPR appeal were still pending when an infringement appeal were decided.

[2] https://patentdocs.org/2025/10/19/uspto-proposed-new-rules-limiting-the-availability-of-inter-partes-review-but-are-they-legal/

[3] https://patentdocs.org/2025/10/19/new-director-overturns-ptab-procedural-precedents-part-i/

By Michael S. Borella –

The U.S. Patent and Trademark Office (USPTO) is trapped in a perpetual battle on two fronts.  First, there is their application backlog, which can extend patent pendency by months or years.  Second is the systemic challenge of patent quality.  These two problems are not independent of one another. Low-quality examination is characterized by incomplete searches and rushed analysis, which can lead to rounds of Requests for Continued Examination (RCEs), appeals, and even costly post-grant litigation.  Conversely, under pressure to reduce pendency, examiners may conduct less-thorough examinations, thereby harming quality.

For decades, the solutions have been incremental, bureaucratic, or both.  Examiner interviews, accelerated examination programs, and various pilot programs have nibbled at the edges of the problem.  The most recent, the “Streamlined Claim Set Pilot Program,” continues this tradition by offering a simple, but flawed bargain: trade your claims for a spot at the front of the examination queue.

These solutions misdiagnose the illness.  The problem is not the number of claims; instead, it is the profound inefficiency of the first substantive interaction between the applicant and the examiner.  A first non-final office action is often the output of many examiner hours being spent on cold-start prior art searches. In many cases, this office action contains prior art rejections that could have been avoided.  If the applicant had known of the closest prior art, they likely would have narrowed their claims to focus examination on more protectable aspects of the invention.

With the rise of generative artificial intelligence (AI), there are new options on the table.  One that we’d like to propose for discussion is what we call AI-First Triage (AIFT).  This change would fundamentally restructure the examination front-end to accelerate prosecution, improve patent quality, and create a more collaborative, efficient process for applicants and examiners alike.  Particularly, AIFT is designed to front-load information sharing between the USPTO and the applicant and incentivize early, substantive amendments where appropriate.  The process would be simple, universal, and mandatory, updating the current examination procedure.  Further, it would be provided at no charge for all new applications.

The main principles of AIFT would be as follows.

• AI Search (The “Zeroeth” Office Action): Upon filing and completion of formalities, every new patent application would be processed by an in-house, private generative AI search engine. This tool would analyze the specification, drawings, and, most critically, the as-filed claims.
• The AI Advisory Action: Within a few weeks of filing, the applicant would receive an initial AI advisory action.  This office action would not contain statutory rejections.  Instead, it would be an AI-generated search report.  The report would contain the results of the AI search, mapping the most relevant prior art references found by the AI search to specific claim elements.  For example, the report might include a claim chart mapping each claim element to a specific location in a prior art document where the AI search engine contends that it found disclosure of the element.  Notably, the AI search would only identify prior art and would not provide any legal reasoning.  In other words, the AI search would not provide a § 101 or § 112 analysis, nor would it provide a motivation to combine should it use multiple references against a claim.
• The Applicant’s Choice: The applicant would then have a two-month, non-extendable window to respond to this AI advisory action.  There would be two simple options.  The first would be to file a preliminary amendment that makes a substantive narrowing amendment to at least one independent claim in view of the AI search.  The applicant would have the option of including remarks explaining why the narrowing amendment results in claims that the cited art does on read on.  The second would be to take no action and not file a response. In the latter case, the applicant can still file a preliminary amendment at any time before the first action on the merits.
• The Examination Queue: If the applicant chooses the first option, the application is placed into a prioritized queue for examination by a human patent examiner.  If the applicant chooses the second option, the application is placed in the standard (slower) examination queue.
• The Non-Final Action: Regardless of which option the applicant chooses, the next office action is issued by a human examiner and is a non-final office action.  The examiner is free to use or discard the AI search results, conduct their own search, and formulate their own rejections.  This preserves the applicant’s established right to respond to a complete, human-led examination on the merits.

AIFT addresses a bottleneck in the examination process by speeding up the prior art search.  This creates a virtuous incentive for applicants to engage with prior art and improve patent quality from the start.  This up-front sharing of information and incentive for early amendment is likely to more quickly to disposal of an application (i.e., allowance or abandonment) by identifying prior art before the examiner lifts a finger.  Additionally, we expect that such a procedure would reduce the rate of RCEs, which are one of the greatest contributors to pendency, making the entire examination process more efficient.

AIFT can also improve patent quality.  First, it would augment examiners by providing an AI search across extensive databases.  Examiners could then spend less time looking for needles in haystacks and more time conducting an analysis of the prior art.  Second, by presenting applicants with relevant prior art early, applicants are encouraged to amend broad or vague claims early in the process.  Third, the initial AI advisory action could act as a filter, prompting applicants to abandon clearly anticipated or clearly obvious inventions early, freeing up examiner resources for other applications.

Despite AIFT having advantages, there are several concerns that may hinder its deployment.  Applicants would face a significant dilemma if presented with low-quality or irrelevant AI-cited prior art, forcing them to either make an unnecessary amendment to gain docket priority or be penalized with a longer wait time for challenging the AI’s findings.  Thus, the quality of the AI search would be key and some degree of human oversight may be needed.  Further, filing a preliminary amendment in response to an AI advisory action would create prosecution history estoppel before the applicant ever interacts with a human examiner.  This may incentivize some applicants to ignore the AI search results.  Moreover, some applicants might strategically file overly broad initial claims specifically so they can concede a narrowing amendment in response to the AI search.  This gaming of the system would result in a faster examination without having to file a focused claim set up front, effectively turning the collaborative step into a mere procedural hurdle to be cleared for a docketing advantage.

While potentially problematic, each of these issues could be mitigated.  AI is a learning technology and the USPTO’s AI search model could be updated with examples of when a human examiner successfully used the AI-cited prior art to motivate an applicant to amend their claims, as well as when the human examiner overrode the AI-cited prior art and used different art to reject the claims.  Applicants could mitigate the estopped issue by filing a response with minimal or no substantive remarks, relying on the claim amendments to speak for themselves.  Also, Applicants could make it clear on the record that the amendments were made without prejudice and merely to expedite prosecution.  Finally, if necessary, applicants can be disincentivized from gaming the system by modifying the procedure as follows.  The first human-produced office action can be final when the applicant does not amend the claims in response to the AI advisory action and the human examiner’s prior art rejections are based entirely and solely on the prior art references that were previously cited in the AI advisory action (if the human examiner adds any new prior art to the rejections, their action must be non-final).  It is recommended that the human examiner would need the head of their technical center to approve such a first-action final.

The USPTO cannot solve its dual pendency and quality crisis by merely repackaging old ideas or coming up with another pay-to-play docket manipulation approach that fails to improve search quality, claim clarity, or examiner decision making.  The proposed AIFT, in contrast, is a re-imagining of the examination process that places a powerful information technology tool at the very beginning, creating a collaborative triage step to help applicants produce better claims for human examination, and to help examiners conduct better searches. USPTO should stop tinkering with the queue and instead innovate at the core of the examination process itself.