• By Kevin E. Noonan

    The evolution of subject matter eligibility after the Supreme Court's decisions in Prometheus v. Mayo, Alice v. CLS Bank, and Association for Molecular Pathology v. Myriad Genetics has resulted in a regime of predictable unpredictability and certain uncertainty (a recent cogent treatment of the phenomenon in computer science technology patenting can be found in "The Narrow Pathway to Patent Eligibility in the Federal Circuit").  The situation is reminiscent of the state of obviousness in mid-Twentieth century prior to enactment of § 103 of the patent statute, when whether a patented invention was protected was a matter of judicial subjectivity.  As a consequence and as recognized by Justice Jackson, "the only patent which is valid is one which this court has not been able to get its hands on," Jungerson v. Ostby, 335 U.S. 560, 571 (1949).

    A brief survey of seminal obviousness cases illustrated this similarity:

    • Hotchkiss v. Greenwood (1850) standard:  an inventor's invention must have "more" than what an "ordinary or skillful mechanic" would provide.

    • Cuno Engineering Corp. v. Automatic Devices Corp. (1941):  the inventive act had to come into the mind of an inventor in a "flash of genius" and not as a result of tinkering.  "The new device, however useful it may be, must reveal the flash of creative genius, not merely the skill of the calling."

    • Graham v. John Deere (1966):  interprets the statute to conform to the Court's requirements that a patentable invention must be distinguished over the relevant prior art.

    • Sakraida v. Ag Pro, Inc. (1976):  necessary to show some "synergy" between those known elements and denied patentability because the invention "simply arrange[d] old elements with each performing the same function it had been known to perform."

    • Sakraida expressly disregarded by Federal Circuit in Stratoflex, Inc. v. Aeroquip Corp. (Fed. Cir. 1983):  "[a] requirement for 'synergism' or a 'synergistic effect' is nowhere found in the statute . . . virtually all patents are 'combination patents,' if by that label one intends to describe patents having claims to inventions formed of a combination of elements."

    • "Teaching, Suggestion, or Motivation" (TSM) test developed by Federal Circuit, set aside by Supreme Court in KSR v. Teleflex but based on Graham and tied to the statute and prior art.

    Even the semantics of subject matter eligibility (SME) determinations and their analysis conjures the subjectivity and uncertainties of obviousness; how more defined or reliable is the existence of an "inventive concept" and the "flash of genius," "synergy," or something "more" that the endeavors of an "ordinary mechanic"?  The history of how the Patent Office, Patent Trial and Appeal Board, numerous district courts, and the Federal Circuit have implemented the two-part Mayo/Alice test shows that subjectivity and unreliability.  It isn't far-fetched to consider that these consequences are not definitive for the same reasons obviousness without reliance on prior art was subject to subjective considerations (hindsight in obviousness); it is often more productive to recognize a "know it when you see it" approach ala Justice Potter Stewart (on entirely different circumstances and subject matter).  Indeed, one of the organizing principles (to the extent they can be understood) of subject matter ineligibility is often based on overbroad claiming (as in Morse v. O'Reilly, a case cited in support of SME deficiencies that had been better recognized for over a century as having failed to satisfy the disclosure requirements under Section 112).

    The history of Federal Circuit jurisprudence (that has led some members of that Court to bemoan the outcome of these cases; see Judge Moore's dissent in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC ) are set forth below:

    Table 1
    Table 2

    There are some certainties in these cases, nevertheless.  For example, diagnostic methods are almost per se ineligible.  There has been some eligibility traction in formulating claims based on natural laws in the context of a novel assay employing the natural law in certain situations; however, the consequences can be relying on new assays for each circumstance and avoiding "routine, well-understood, and conventional" assays.  More frequently claims are drafted in the context of a method of treatment informed by the results of diagnostic assay (see "Natural Alternatives International, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019)" and "Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019)").  Such claims are susceptible to two well-recognized caveats:  inherent prior art anticipation (when individuals identified as treatment recipients received drug prior to development of the diagnostic assay; novel pharmaceuticals can avoid this outcome), and the "divided infringement" problem, when infringement is effectuated by separate practitioners of the recited limitations of the treatment method (wherein, for example, who administers the test is different from who administered the treatment and either actor cannot be characterized as being under the "direction and control" of the other).  The most coherent calculus for method claims to pass SME muster was enunciated by Judge Lourie in his Vanda decision, illustrating the advantages of claiming specifically and thereby avoiding overbreadth:

    At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.  They are different from Mayo.  They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation.  Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation.  Accordingly, the claims are patent eligible [emphasis added].

    Similarly, natural products are per se generally ineligible, although Cellzdirect and Illumina decisions suggest isolated natural product having specific utility not possessed by product in nature may be eligible when properly/adequately claimed.  Generally, formulations and combinations not arising in nature can be eligible and while databases of biological information are often per se ineligible, their use may be (as in XY).

    An Illustration of when formulations have failed to be eligible is Chromadex v. Elysium Health (Fed. Cir. 2023) (which is explained at least in part as being granted in 2005, prior to the imposition of current standards of SME).  The claims of U.S. Patent No. 8,197,807 are directed to dietary supplements comprising nicotinamide ribonucleotide, converted in vivo to NAD+, a co-enzyme involved in redox reactions:

    Image 1Claimed were compositions formulated with other components as set forth in the table (reproduced in the opinion), which had in common many similarities to milk except for the limitation that the nicotinamide ribonucleotide ([NR]) was isolated.  The Federal Circuit's analysis resembled in many respects an obviousness assessment and characterized the claims as "reading on" milk with the exception that [NR] is "isolated."  But under Myriad being "isolated" is not enough (in contrast to the state of SME when these claims were prosecuted under, inter alia, In re Bergy).  The opinion also noted that the claims were "very broad," consistent with overbreadth being a hallmark of claims failing to recite eligible subject matter, and with the distinctions with Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, where the Court recognized that claims to a natural product (beta-alanine) were patent-eligible for reciting "specific treatment formulations that incorporate[d] natural products" and that those formulations "ha[d] different characteristics and c[ould] be used in a manner that beta-alanine as it appears in nature cannot."

    Image 2To the extent a claiming strategy can be elucidated from these cases it might be to assiduously avoid overbroad claiming, based on current application of Section 112 criteria (Judge Lourie's Vanda specificity example).  A useful analogy might be to adopt a "pointillist approach" that avoids overbreadth and preemption by reciting a plurality of narrow claims directed to specific embodiments, as illustrated by Georges Seurat's "A Sunday Afternoon on the Island of La Grande Jatte" (also analogous to Twentieth Century television transmission; see "The Last Lone Inventor" for further descriptions).

    Image 3
    There is another way to look at the issue of SME and the 'judicial exceptions" contained in Shahshahani, "Against the abstract ideas exclusion," 40 Berkeley Technology Law Journal (forthcoming 2025).  In this paper the rationales for SME are applied to conventional abstract ideas and natural laws and found wanting.  Rather than accepting the conventional wisdom for the need to protect inventions that are "building blocks" due to perceived risks of inhibiting future innovation (by preemption), Professor Shahshahani argues that such building block inventions are important to incentivize by patents because their recognition and the application of natural laws and abstract ideas provides the capacity for development of future inventions employing them.  One illustration of this analysis is that while natural law often predates human discovery of it and could fall under the eligibility limitations in Parker v. Flook, human knowledge of the law provides the opportunity and ability to apply such natural laws and thus the applications thereof should not be precluded from eligibility.  The deficiencies of the conventional rationale for the judicial exceptions are further developed by recognizing that evidence supporting the conventional wisdom regarding preemption is not always correct, citing evidence that patents on genes did not inhibit genetic research, as shown by Bhaven Sampat & Heidi Williams, How Do Patents Affect Follow-On Innovation? Evidence from the Human Genome, 109 AMER. ECON. REV. 203, 217-19, 232 (2019) (existence of "gene patents" did not inhibit genetic research ) and Janet Freilich & Sepehr Shahshahani, Measuring Follow-On Innovation, 52 RES. POL'Y 104854 (2023) (finding that gene patents close to expiration caused an increase in follow-on research but those that were far from expiration had no effect).  This scholarship suggests that a reevaluation of the premises upon which the exceptions (natural laws, natural phenomena, abstract ideas) are based ("tying up" and thereby inhibiting fundamental building blocks necessary for future innovation) should be reconsidered for not being valid and not having the deleterious effects ascribed to them.  While perhaps not being (at the present time) a strategy for successfully arguing patent eligibility before the PTO or a district court in the absence of the Supreme Court addressing SME concerns (having denied certiorari to do so in almost 100 cases), further empirical evidence on the continued viability of SME restrictions may someday spur a necessary and beneficial reassessment.

    * Taken from a presentation at the American Conference Institute's 23rd Annual Advanced Summit on Life Sciences Patents, presented on May 19th, 2025 in New York City.

  • By Michael Borella

    2025-06-09 ImageIn June 2014, the U.S. Supreme Court handed down Alice Corp. v. CLS Bank Int'l, establishing a now-infamous two-step, judicially-imposed test for patent subject-matter eligibility that narrowed the broad statutory eligibility principles set forth in 35 U.S.C. § 101.  Under Alice, one must first determine whether a patent claim is directed to an ineligible concept such as an abstract idea, a law of nature, or a natural phenomenon.  If so, the second step requires further determination of whether the claim as an ordered combination amounts to significantly more than just the ineligible concept.  In theory, this framework was meant to prevent the sweeping preemption of fields of technology that ostensibly should remain in the public domain.  In practice, however, the Alice test has proven exceedingly difficult to apply consistently, especially for software inventions.  Despite software having a concrete manifestation on physical media and being used to change the state of tangible devices, it often gets lumped into the abstract idea category even when claimed so narrowly that it can only preempt a specific use case.

    The disarray is such that even older precedents that were once shining examples of eligibility have been thrown into doubt.  The Supreme Court's own 1981 Diamond v. Diehr decision, which upheld the eligibility of a patent on a computer-implemented rubber curing process, was reaffirmed as good law in Alice.  Yet, the Alice test as currently applied could easily be used to argue that Diehr's claims are actually ineligible.[1]  This uncertainty has real-world consequences, raising the risk and cost for small and mid-sized companies seeking to protect their innovations.

    If Alice set the stage, the U.S. Court of Appeals for the Federal Circuit — the court that hears all patent appeals from district courts and the United States Patent and Trademark Office (USPTO) — has written the chapters that followed.  The last decade has seen the Federal Circuit dramatically narrow the scope of patent-eligible software, decision by decision.  First, many business methods were declared ineligible, then more and more software inventions implemented on a general-purpose computer, then even software on any platform, and eventually some non-software innovations got swept up as well.

    This tightening chokehold is reflected in the Federal Circuit's own track record.  In 2024, for example, the Federal Circuit decided 22 patent cases on substantive grounds of § 101 and found the claims eligible in only one.[2]  In other words, a staggering 95.5% effective invalidity rate of patents on appeal.  For patent owners, the Federal Circuit has become an abattoir for software patents, with only the rarest of claims surviving.

    On the front lines of patent eligibility, the USPTO has tried to bring some stability to the chaos.  The USPTO periodically issues guidance to help examiners (and applicants) navigate the morass of § 101 case law.  A notable effort was the January 2019 Revised Patent Subject Matter Eligibility Guidance, which categorized abstract ideas into three buckets (mathematical concepts, methods of organizing human activity, and mental processes) and instructed examiners to consider a claim to recite an abstract idea only if it falls into one of those recognized categories.  The 2019 guidance also introduced the notion of considering whether a claim involving an abstract idea integrates it into a practical application.  If the claimed invention is applied in a specific manner that improves technology or another field, it might be deemed patent-eligible at step one despite involving an abstract idea.  This gave applicants new arguments to overcome rejections by pointing to technological benefits in their inventions.

    By many accounts, the 2019 guidance somewhat reined in the wild inconsistency of examiner decisions and led to a modest increase in software patent allowances . . . for a while.[3]  However, unpredictability still rules the USPTO's application of Alice, especially across different examiner art units.  Some examiners (particularly in business-method oriented units) continue to issue near-automatic § 101 rejections, while others in computer hardware, software, and communications art units might be more receptive if the applicant articulates a clear technical improvement.  Appeals to the Patent Trial and Appeal Board (PTAB) are often an uphill battle — recent statistics show the PTAB affirms examiners' § 101 rejections about 90% of the time.[4]  In effect, unless you can fit your claim into the mold of a past case found eligible or an example from USPTO guidance, the safer bet is that the PTAB will say "no patent for you."

    The subjective nature of Alice leaves room for reasonable minds to differ.  And they do.  The experience of practicing before the USPTO can feel like trying to shoot at a moving target.  Even after the 2019 guidance, applicants faced divergent outcomes on similar inventions.  Examiners have significant discretion in characterizing what a claim is "directed to" at step one and what counts as "conventional" at step two.  Thus, a savvy applicant must preemptively stack the deck in their favor through careful drafting (more on that below).

    In late 2023 and 2024, the USPTO began grappling with how emerging technologies like artificial intelligence (AI) fit into the eligibility framework.  Under a mandate from former President Biden's 2023 Executive Order on AI, the USPTO issued an Updated Subject Matter Eligibility Guidance in July 2024 focusing on AI-related inventions.  Many had hoped this update — the first in almost five years — would address some of the widely voiced concerns about the unpredictability of examining AI and software inventions. Unfortunately, the 2024 Guidance dashed those hopes.[5]

    The update largely restated generic eligibility principles and added only a few AI-specific examples.  Even worse, the guidance arguably doubles down on a hardline approach suggesting that advances in AI and uses of AI are likely ineligible unless they are implemented in specific hardware circuitry or cause a significant change to the state of an ancillary system.  In other words, merely improving an AI algorithm in software might not satisfy the USPTO's idea of a practical application unless you tie it to a particular machine or a real-world effect, even if that improvement saves massive amounts of compute and storage capacity on the algorithm's host computer.

    The Supreme Court, for its part, has repeatedly declined to hear new patent eligibility cases that might clarify the doctrine.  This includes denying certiorari in 2022's American Axle case, which many hoped would address the Federal Circuit's overly aggressive application of the law of nature exception and maybe soften Alice's impact.  In Congress, a bipartisan group of legislators has been pushing for reform.  Senators Thom Tillis and Chris Coons, among others, recently re-introduced the Patent Eligibility Restoration Act (PERA) to rewrite § 101 and roll back some of the Alice-era exclusions.  But this is not the first time that a version of PERA has been introduced, and the patent community is waiting for the bill to get much closer to being a law before giving it their full attention.

    Thus, 2025 can be characterized as largely status quo in terms of patent eligibility.  Stakeholders are still watching the Supreme Court and Capitol Hill for rays of hope, perhaps a sense that someone, somewhere is going to pull the eligibility doctrine back to solid constitutional ground.  But there is no reason to believe that meaningful change will take place this year.

    Given this challenging landscape, what can attorneys, applicants, and patentees do to improve their odds of surviving a § 101 challenge?  While no strategy is foolproof (indeed, even the most meticulous drafting cannot guarantee eligibility under an uncertain test), there are techniques that can tip the scales at least a modest amount.  Patent practitioners over the last decade have essentially reverse-engineered the patterns of decisions to develop a playbook for software patents.  Below are some best practices as a mix of drafting tips and prosecution strategies to help prevent or overcome a § 101 challenge.

    1.  Focus on a specific technical improvement: Frame the invention as a solution to a technical problem, not a business.  Put differently, the claimed invention should improve the operation or performance of machines rather than that of businesses or people.  In the specification, clearly articulate the technological improvement or advantage the software provides.  For example, does it make a computer run faster, use memory more efficiently, use less network capacity, or operate under reduced power requirements?  Does it improve features fundamental and specific to computer technology, such as network security, data compression, parallel processing, or overall availability?  The Federal Circuit has emphasized that software claims directed to an improvement in computer functionality are not abstract.  Make sure the claims explicitly recite the features that form this improvement, and that the specification describes how those features solve a specific technical challenge.  In short, tell a story of innovation in real-world technology rather than casting the invention of an automation of a business process or human task.  In fact, try to avoid emphasizing or even mentioning any business process or human task at all.

    2.  Avoid outcome-driven claim language: Draft concrete, step-by-step claims that explain how the invention achieves its results.  Purely functional or result-oriented claims (e.g., "determining a classification for the data using machine learning") are red flags.  Instead, include the specific mechanisms or steps that carry out the improvement.  If your invention uses an algorithm, spell out key steps of that algorithm rather than claiming just the end result.  If it processes data, indicate how the data is processed in a new way.  Broad and generic claims are especially vulnerable under § 101, so consider adding technical limitations.  For instance, instead of "generating a network map," you might claim a specific step like "iteratively constructing a network map based on real-time telemetry data received from network nodes."  This helps tie the idea to concrete procedures or components.

    3.  Recite hardware or real-world effects (when possible): One way to show a claim is not abstract is to root it in a physical context or device.  If the software interacts with new or specialized hardware, include those details.  Even if it's running on a generic computer, mention any sensors, controllers, or other devices that are part of the system and used by the invention. Similarly, if the software produces a tangible real-world result (e.g., controlling an industrial process, adjusting a camera's settings, or providing a specific type of medical treatment), emphasize that.  Simply saying "by a computer" or "on the internet" is unlikely to help. But describing, for example, how a specific AI algorithm embedded in a medical imaging device yields clearer images for diagnosis will make the invention more concrete.

    4.  Highlight any non-conventional techniques: Under Alice step two (the inventive concept analysis), claims that merely use routine or well-known computer functions won't cut it.  If your invention uses an algorithm or data processing technique that is not conventional, or combines steps in a unique way, call that out in the specification.  The goal is to create a factual basis that, if someone later alleges that the claimed invention involves just standard computing, you can rebut that by pointing to your disclosure.  After the Federal Circuit's 2018 Berkheimer decision and ensuing USPTO memos, examiners are supposed to provide evidence when they claim something is well-understood, routine, or conventional.  While this policy is not always followed strictly, it arms you with an argument:  if you have described why your solution is innovative at a technical level, you can insist that an examiner (or court) acknowledge those concrete details rather than ignoring them.

    5.  Include a statement of technical improvement in the specification: In the unpredictable world of software patents, the specification is your lifeline.  Use it to explicitly teach why the invention is technologically significant.  Don't assume the benefit is obvious.  Include an explanation of the technical problem (e.g., "existing media distribution systems could not handle real-time network changes without significant adaptation delay, which led to failures in live streaming or broadcasting") and how your invention overcomes it ("the claimed embodiments provide a solution by incorporating an iterative machine learning model that dynamically updates a representation of the network in real-time, something not achievable with prior manual or static methods").  The statement of technical benefit can take various forms, but it should include descriptions of at least:  (i) the technical deficiencies in previous systems, (ii) the how the claimed invention overcomes these technical deficiencies, (iii) as many of the claimed invention's technical advantages as you can come up with (e.g., "by reducing the number of database accesses by an order of magnitude, these embodiments use less computational, network, and power capacity than conventional techniques.").  Finally, leave the door open for other technical improvements potentially flowing from the claimed invention as well as the possibility that this invention could be used to solve other technical problems not explicitly discussed in the specification.

    6.  Reinforce the technical improvement at every opportunity in the specification: Even a general statement of technical improvement might not be enough.  As you describe and specify the invention, consider enhancing each and every feature with a sentence or two describing its technical improvement.  The goal is to repeatedly hit the reader over the head with technical improvements, as well as to give you a number of locations in the specification to point to during prosecution or litigation that support the patent eligibility of the claims.  One example might be, "The system pre-allocates memory blocks in a deterministic schedule based on static task profiling, avoiding dynamic memory access during execution.  This eliminates runtime memory fragmentation and latency spikes in real-time systems, improving timing predictability and reliability and thus providing a concrete enhancement in computer memory management."  Another example might be, "The scheduler dynamically assigns processor cores and their clock rates based on predicted energy consumption models for application tasks derived from historical sensor and usage data.  Doing so reduces power consumption without user-perceivable performance degradation, directly improving hardware resource management in mobile computing."

    7.  Include performance results or data demonstrating an improvement: Benchmarking data, latency reductions, improved throughput, or lower resource usage can help substantiate that the invention provides a technical benefit.  However, applicants must exercise caution — if your claims recite an abstract idea, examiners and courts may construe performance gains as improvements to abstract idea itself rather than to the underlying computing technology.  To mitigate this risk, the specification should clearly tie the performance benefits to specific technical features — such as arrangements of software modules, hardware interactions, or architectural changes, rather than to general functional outcomes.

    8.  Add narrower embodiments that include more hardware or specific steps: In case the broad version of the claims hits an eligibility roadblock, these more focused embodiments might survive.  For example, reciting specific hardware components such as a sensor, display controller, or network interface can help anchor the claim in concrete technology rather than abstract functionality.  Similarly, adding detailed steps, like preprocessing data in a defined format, performing a particular type of signal transformation, or using a designated memory allocation strategy, can demonstrate that the invention is not merely a result-oriented abstraction.  These narrower embodiments provide fallback positions during prosecution or litigation and can help show that the claimed invention improves the operation of a particular machine or system.  In some cases, it may be beneficial to include at least one very narrow claim directed to the precise implementation over which protection is sought.  This forces the examiner to engage with a concrete technical contribution of the invention rather than dismissing all possible implementations as highly general abstract ideas.  Even if such a claim has limited commercial value on its own, it can serve as a foothold for establishing eligibility and opening dialogue during prosecution.

    9.  Be aware of USPTO examples and precedents: It can be helpful to draft claims that are comparable to ones that have been deemed eligible in the past.  The USPTO's examples (from 2019 and the 2024 update) provide model claims that the USPTO purports to be eligible.  If the invention is technologically similar to one of these examples, consider using language from the example in your specification.  Nonetheless, some examiners are skeptical of this USPTO guidance, as it does not have the authority of Federal Circuit case law.

    10.  Don't over-rely on Enfish and McRo: While these Federal Circuit cases are still good law and provide useful guidance for arguing that software-based claims can be eligible when they improve the functioning of a computer itself, they represent relatively rare wins in a legal landscape that has grown more skeptical of software patents.  Subsequent decisions have narrowed their reach, often distinguishing them on factual grounds or finding that later claims failed to recite comparable specificity.  Courts now expect a more rigorous showing that the invention solves a technological problem in a non-generic way, preferably with supporting disclosures in the specification that demonstrate how the claimed advance is achieved and why it matters from a technical perspective.  When drafting claims and a specification, do not assume that any similarities to the claims of Enfish or McRo will be given much weight by an examiner.

    11.  Always interview the examiner when you are dealing with a § 101 rejection during prosecution: Examiner interpretation of subject matter eligibility varies widely, and what one examiner considers a clearly abstract idea, another might view as a technological improvement.  These differences are often shaped by the examiner's background, personal approach to the Alice framework, and the prevailing norms of their art unit.  Different examiners and art units can have dramatically different § 101 rejection rates even within the same technical center.  An interview gives you the opportunity to understand how the examiner is construing the claims, what part of the specification they find compelling (if any), and whether they are open to particular claim amendments or additional details that could overcome the rejection.

    It bears repeating that even following all these best practices is not a guarantee.  The legal standard for patent eligibility remains, to put it mildly, a work in progress.  By heeding these lessons, however, particularly the careful tailoring of claims and the emphasis on detailed technical improvements in the specification, practitioners can significantly improve their chances of securing and defending software patents in this hostile environment.

    [1] https://www.patentdocs.org/2021/04/could-alice-be-used-to-invalidate-diehr-of-course-it-could.html.

    [2] https://www.patentdocs.org/2025/05/the-narrow-pathway-to-patent-eligibility-in-the-federal-circuit.html.

    [3] Numerous attorneys report anecdotally that the rate of § 101 rejections in 2025 has increased over that of previous years.

    [4] https://www.patentdocs.org/2024/08/91-that-is-the-rate-at-which-the-ptab-affirms-examiner-section-101-rejections.html.

    [5] https://www.patentdocs.org/2024/07/uspto-publishes-updated-subject-matter-eligibility-guidance-focusing-on-ai.html.

  • By Kevin E. Noonan

    United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of pulmonary hypertension and their dispute is not yet over, both parties filing suits asserting patents against one another.

    Image 1Treprostinil

    In their extensive litigation, UTC has asserted claims in U.S. Patent No. 9,593,066 as well as U.S. Patent No. 10,716,793.  The District Court held that the asserted claims of the '066 patent were invalid for anticipation or were not infringed, a decision affirmed in all respects by the Federal Circuit, and that the asserted claims in the '793 patent were infringed and were not invalid (see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)".  In an inter partes review proceeding, the Patent Trial and Appeal Board held that the challenged claims of the '793 patent (which the District Court held were infringed) were invalid for obviousness, a decision also affirmed by the Federal Circuit (see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2024)).

    In the more recent cases, UTC asserted (in the Middle District of North Carolina, 1:25CV368, before Judge Thomas Schroeder, complaint filed on May 9, 2025) claims of U.S. Patent No. 11,357,782 (issued June 14, 2022, which expires May 14, 2027) for methods of treating pulmonary hypertension using dry powder formulations; claim 1 is representative:

    1.  A method of treating pulmonary hypertension comprising:
        providing an inhalation device for treating pulmonary hypertension in a human suffering from pulmonary hypertension comprising a powder formulation of treprostinil or a pharmaceutically acceptable salt thereof and a dry powder inhaler configured to administer single event dose of the powder formulation comprising treprostinil or a pharmaceutically acceptable salt thereof,
        wherein the single event dose comprises at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths,
        wherein the dry powder inhaler is configured to administer the entire single event dose in less than 5 minutes with at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof being inhaled per breath through coordinated actuation of the dry powder inhaler with each breath, and
        administering to a human suffering from pulmonary hypertension with the dry powder inhaler the single event dose comprising at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths,
        wherein the human administers the entire single event dose with the dry powder inhaler in less than 5 minutes by inhaling at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath, and
        wherein administration of an additional single event dose in the same manner occurs at least 3 hours later.

    An important distinction is that UTC's product, encompassed by the limitations of the '782 patent is a new formulation of UTC's Tyvaso® product called Tyvaso DPI®, which obtained FDA approval in 2022 and (according to UTC's complaint) "is the first marketed dry powder formulation of treprostinil in the United States."  Liquidia's accused product, Yutrepiaä, is also a dry powder formulation of treprostinil approved by FDA on August 19, 2024.  However, this approval came with the caveat that Liquidia's product would not get final approval until UTC's 3-year regulatory exclusivity expired on May 23, 2025, which approval was granted when that deadline recently passed (although Liquidia has not yet put its Yutrepiaä product on the market).

    UTC alleges that practicing Yutrepia's label will literally infringe claim 1 of the '782 patent, as well as claims 2, 3, 8.  UTC's complaint, filed May 9, 2025 asks for a declaratory judgment of inducing infringement under 35 U.S.C. § 271(b) and contributory infringement under 35 U.S.C. § 271(c) based on Liquidia's current failure to launch their product.  UTC's allegations are based on "Liquidia's unauthorized development, manufacturing, commercial marketing, distribution, offers for sale, sales and/or use of Yutrepia™ (treprostinil) inhalation powder for the treatment of pulmonary hypertension ("PH")," based on "tentative approval" of Liquidia's Yutrepiaä product.  UTC's allegations are illustrated by this cartoon included in the complaint:

    Image 2
    Liquidia asserts non-infringement based on UTC's claims requiring coordination between actuation of the dry powder in the inhaler and inhalation by the patient, which is not required by the Yutrepia's device/method.  Liquidia further asserts invalidity based on the PTAB's invalidation of the '793 patent based on timing (the Final Written Decision of the IPR in the '793 patent was issued "only weeks after" allowance of the '782 patent), and that a related UTC application (US 2022-0323459 A1) was rejected for obviousness based on the reasoning in the FWD in the '793 IPR.

    In a separate litigation, UTC filed suit under the Hatch-Waxman Act in the District of Delaware against Liquidia's earlier Yutrepiaä product when Liquidia amended its NDA (NDA No. 213005, filed under § 505(b)(2)) for this drug to include a new indication, pulmonary hypertension associated with interstitial lung disease ("PH-ILD").  Initially UTC asserted the '793 patent (later invalidated by the PTAB in inter partes review; see above) and U.S. Patent No. 11,826,327, claim 1 being representative:

    1.  A method of improving exercise capacity in a patient having pulmonary hypertension associated with interstitial lung disease [i.e., PH-ILD], comprising administering by inhalation to the patient having pulmonary hypertension associated with interstitial lung disease an effective amount of at least 15 micrograms up to a maximum tolerated dose of treprostinil or a pharmaceutically acceptable salt thereof in a single administration event that comprises at least 6 micrograms per breath.

    Relevant to proceedings in the Middle District of North Carolina case (see below), UTC's motion for preliminary injunction to prevent Liquidia from marketing its Yutrepiaä product was denied in that case.  This case is set for trial this month.

    In another dispute in inter partes review, the PTAB invalidated UTC's challenged claims in U.S. Patent No. 9,604,901, with claim 1 being a representative claim:

    A pharmaceutical batch consisting of treprostinil or a salt thereof and impurities resulting from (a) alkylating a benzindene triol, (b) hydrolyzing the product of step (a) to form a solution comprising treprostinil, (c) contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil, (d) isolating the salt of treprostinil, and (e) optionally reacting the salt of treprostinil with an acid to form treprostinil, and wherein the pharmaceutical batch contains at least 2.9 g of treprostinil or its salt.

    This decision was affirmed by the Federal Circuit (see "United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)").

    For its part Liquidia sued UTC for infringement of its U.S. Patent No. 10,898,494, which patent issued January 26, 2021 and expires May 5, 2037 and recites representative claim 1:

    1.  A method for treating a patient, comprising:
        administration of a dry powder composition comprising
        from about 100 micrograms to about 300 micrograms treprostinil or a pharmaceutically acceptable salt thereof to a patient
        by inhalation using a dry powder inhaler over one to four breaths to treat pulmonary hypertension.

    Liquidia's complaint mirrors UTC's complaint but is limited to inducement and/or contributory infringement (the patient being the literal infringer by using the inhaler as prescribed).  Liquidia interprets UTC's treatment regimen containing on its label to direct patients to administer 112 micrograms (mcg) or 128 mcg at each treatment session for 4 sessions per day, which falls within the scope of UTC's asserted claims.

    The most recent activity in these litigations was the District Court's denial in its North Carolina action of UTC's motions for a temporary restraining order and preliminary injunction.  In denying these motions, the District Court held that UTC failed to satisfy the requirement for a showing of a likelihood of success on the merits and that Liquidia's Yutrepiaä product market entry would cause irreparable harm.  The basis for UTC's failure to satisfy the "likelihood of success" requirement focused on whether the asserted claims were invalid for obviousness.  As explained in the opinion, in the preliminary injunction context the burden on the accused infringer is to raise the invalidity issue "that [the patentee] cannot show 'lacks substantial merit,'" citing BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391, 1399 (Fed. Cir. 2022).  But, the District Court cautioned, "[t]he burden of presenting a substantial question of invalidity at this stage is lower than what is required to prove invalidity at trial," under Entegris, Inc. v. Pall Corp., 490 F.3d 1340, 1351 (Fed. Cir. 2007), and other authority.  Here, Liquidia's basis for asserting invalidity was the PTAB's IPR decision that the '793 patent was invalid for obviousness (a decision that issued after the Examiner allowed the application leading to the '782 patent).  Liquidia's position is that the disparate decisions create a contradiction, insofar as the '793 invalidation was based on the same prior art as the '782 allowance (a representative claim from each patent shown side-by-side below):

    Table 1
    The Examiner for the application that resulted in the '782 patent reasoned that "a person of ordinary skill in the art would be unable to 'predict the dose, the number of breaths, and the timing of taking the drug' based on the relevant prior art," a conclusion not reached by the PTAB Board in invalidating the '793 patent (specifically the dose range, 15-90 micrograms, and delivery in "one to three" breaths).  Liquidia's invalidity argument was supported, they contended, by rejection of claims in UTC's U.S. Patent Application No. 17/745,333 for obviousness made after the PTAB's decision invalidating the '793 patent became available.  UTC's attempts to distinguish the limitations recited in these claims and the disclosure in the specification were unavailing in attempting to convince the District Court that Liquidia's obviousness arguments were unsupported by the evidence; the District Court supported its decision regarding such arguments by UTC's failure to convince the Examiner during prosecution of the '333 application using similar arguments, the comparison of the three sets of claims shown in this table:

    Table 2(It being clear that claim 1 of the '782 patent is recited with significantly more specificity (i.e., limitations) than the claims of either the '793 patent or the '333 application; nevertheless these distinctions were not persuasive before the District Court.)  And in the denial of UTC's preliminary injunction motion, Judge Schroeder rejected arguments based on any differences in effect regarding the '793 and '782 claims being method of treatment claims and the '333 application claims being directed to pharmaceutical compositions, saying that "[i]f it is not the case that what constitutes an obvious inference from the prior art with respect to a pharmaceutical product is obvious as to a method of treatment, UTC has not persuasively made that case."

    Turning to the "irreparable harm" prong of the requirements for a preliminary amendment, the District Court also found a lack of persuasiveness from UTC.  Rather, the Court was persuaded in part by UTC's delay in bringing suit on the '782 patent (from June 2022 until May 9, 2025, for purportedly strategic reasons, as well as a six-month delay from the date when FDA established Liquidia's Yutrepiaä product label — the Court characterized this situation as involving "last-minute filing").  Also relevant was Liquidia's assertion that it was sufficiently "financially viable" to compensate UTC for any monetary losses it might incur after a Yutrepiaä product launch.  The Court further expressed doubts about the risk of price erosion argued by UTC, and UTC's cause was not aided by statements by UTC executives minimizing the risk of a Yutrepiaä product launch, in some instances to be less than 5% of their current revenues.

    In view of UTC's failures in establishing the first two prongs of the requirements for being granted a preliminary injunction, the District Court's relatively perfunctory analysis of the other two prongs (balance of the hardships and the public interest) did nothing to change the outcome, and the Court denied the injunction of these grounds.

    As a consequence of the District Court's decision, within days Liquidia announced that it was preparing for a full commercial launch of its Yutrepiaä product.  And UTC's third quarter 2024 projected annual revenues of $3 billion provided important incentives for further litigation over this market.

  • By Michael Borella

    Background:  The oral argument of Bob v. Algorithm Savings & Loan (2014), p. 6:

    JUSTICE HÄAGEN-DAZS:  Imagine King Tut lounging outside his pyramid, surrounded by gold and bad financial instincts.  He's handing out chits left and right, "Good for one unit of gold, redeemable later."  He's got an abacus guy furiously moving beads to keep up.  Eventually, the abacus guy says, "Uh, dude, you've promised more gold than you actually have."  So Tut yells, "Stop!"  Crisis averted.  Or take my mother—she didn't need a computer.  Just one glance at my checkbook and she'd declare, "Hey, you've overdrawn. Stop!"  So now I ask you what, exactly, is less abstract about a computer saying "stop" instead of my mom or a Bronze Age accountant with a bead toy?

    Scene:  A quiet conference room at a law and technology symposium.  An experienced patent attorney with a degree in computer engineering sits across from retired U.S. Supreme Court Justice Häagen-Dazs.  They are discussing technology in the context of patent law.

    Justice Häagen-Dazs:  I've always been skeptical about software patents.  I recall, in Bob, we noted that using a computer to perform an abstract idea isn't enough.  After all, isn't a computer just a very fast abacus?

    Patent Attorney:  With respect, Justice Häagen-Dazs, I would argue that's a profound oversimplification.  An abacus is a passive mechanical tool.  It requires a human operator to interpret, manipulate, and extract meaning.  It doesn't process anything on its own.  A microprocessor, on the other hand, is an active, autonomous computing engine capable of executing millions of logic operations per second according to programmed instructions.  It doesn't just assist a person's calculation, it performs the calculation.

    Justice Häagen-Dazs:  But aren't both merely performing arithmetic?

    Patent Attorney:  The distinction lies in functional capacity and architecture.  A microprocessor implements a general-purpose model of computation, like a Turing machine.  It can simulate any algorithmic process, given enough time and memory.  In practice, an abacus has no such versatility.  It can't run an operating system, control a spacecraft, or manage a distributed database on its own or even with the assistance of a human.  It doesn't have conditional logic, memory registers, or instruction sets.  When patent law considers eligibility, this matters because we're not just talking about number crunching.  Computers are dynamic, programmable systems that change state and manage complex workflows.

    Justice Häagen-Dazs:  You mean my King Tut hypothetical from Bob was wrong?

    Patent Attorney:  Your analogies conflate what is being done with how it is being done.  Yes, the goal of preventing overspending is the same.  But the mechanism for achieving that goal in a computer is entirely different from a human using common sense or manually tallying numbers.  As a more tangible example, if the only known method of binding two pieces of wood together is a nail, then that should not prevent the inventor of the screw from obtaining a patent.

    Justice Häagen-Dazs:  But couldn't a human operating an abacus do anything a microprocessor could do?  Isn't it just a generic tool like a pen and paper or a handheld calculator?

    Patent Attorney:  No one has ever used an abacus to stream a video or encrypt HTTPS traffic, much less train a large language model — for good reason.  The analogy breaks down because an abacus can only be used to perform simple mathematical operations to solve small scale problems.  It would be absurd to contend that you could replace a modern graphical processor with even thousands of humans armed with abacuses.  The problems being solved and the solutions are fundamentally different.

    Justice Häagen-Dazs:  But the concern I had — and still have — is that merely implementing a longstanding human practice on a computer shouldn't suffice for patent eligibility.  Otherwise, we'd be monopolizing abstract ideas with trivial technological dressings.

    Patent Attorney:  The key question is whether the computer implementation is trivial.  If it merely automates a human practice using generic computing steps, such as storing, retrieving, and displaying, then forget about § 101 — it's not patentable as obvious.  But in many cases, the implementation is non-trivial in that the inventors aren't just using the computer as a faster pencil.  They are solving technical problems that arise only in the context of computer implementation.  Take for example a method of organizing human activity, say, a known manual accounting method.  If someone's claim is so broad that it covers that method, it's clearly unpatentable.  But if the same concept is implemented in a way that changes how the problem is solved because of the unique constraints or capabilities of the computing environment, and further the claim reflects this difference, then the computer is inseparable from this solution.  The notion of the abstract idea from Bob fails to reflect this fundamental fact.  Going back to a pre-Bob regime of patentability would not result in thousands of low-quality patents, especially if the USPTO properly applies the principles of obviousness, functional claiming, and definiteness from the patent statute.

    Justice Häagen-Dazs:  So in your view, the difference is not merely one of speed or convenience but of computational capability?

    Patent Attorney:  Precisely.  A microprocessor embodies a flexible, programmable platform capable of executing a vast range of machine-readable instructions.  It's not just an electronic abacus.  It is a fundamentally different class of tool.  Comparing it to an abacus is like comparing a steam engine to a horse.

    Justice Häagen-Dazs:  I see.  Perhaps I underestimated how much abstraction and logic can be embedded in hardware.  But I've been told over and over that there's something special happening under the hood in software patents, yet I can't see what's happening.  I'd rather err on the side of caution than risk giving twenty-year monopolies to ideas that should remain in the public domain.

    Patent Attorney:  Um, there's this thing called "discovery" where parties can produce evidence, such as source code, system architectures, and technical declarations from programmers, to show exactly what's happening "under the hood."  The courts don't have to guess.

    Justice Häagen-Dazs:  Yes, yes, I'm aware of discovery.  But even then, I see lines of code, flowcharts, declarations by experts with PhDs in computer science . . . and I still don't see a machine.  I see words.  Diagrams.  Assertions that something is "faster" or "more efficient."  To me, it's all just squiggly nonsense in a box labeled "processing unit."  It might as well be alchemy.

    Patent Attorney (getting visibly annoyed):  Justice Häagen-Dazs . . . Steve . . . a microprocessor is neither alchemy nor it is an abacus.  As my Gen Z kids like to tell me, this is what happens when you let old people make the important decisions . . . .

    Justice Häagen-Dazs (looking at a sundial strapped to his wrist):  Oh dear, is that the time?  I'm late for pickleball.  Toodles!

    Justice Häagen-Dazs stands up and hurries toward the exit, only to collide with an attendee entering the room.  The attendee's mobile phone (which happens to be running an investment app) slips from their hand and lands squarely on Justice Häagen-Dazs' foot.  He winces and curses the "abstract idea" that just fractured his toe and cost him six weeks of pickleball.

    End Scene

  • By Kevin E. Noonan

    "Plus ça change, plus c'est la même chose," Jean-Baptiste Alphonse Karr (1849)

    Federal Trade Commission (FTC) SealIn the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging the propriety of those listings and demanding that the companies delist these patents (see "FTC Announces Efforts to Police Pharmaceutical Companies' Patent Behavior" and "FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy").  The changes during the past 100+ days of the Trump Presidency could hardly be more dramatic:  Chairwoman Lina Khan and two Commissioners appointed by Democratic Presidents are gone (voluntarily or by disputed Presidential fiat) and almost any Biden initiative has been challenged or reversed; indeed, with apologies to Justice Jackson it can fairly be said that "the only [Biden initiative] which is valid is one which this [President] has not been able to get [his] hands on."

    The FTC's crusade against Orange Book-listed device patents is the exception to this trend (proving that the perception that "drugs cost too much" and that patents are to blame is bipartisan, as is the seeming misunderstandings regarding the purported linkage between them).  The latest FTC action has been another spate of warning letters sent to Novartis, Mylan, Teva, Amphastar, and Covis (indicating that at least some of the previously threatened companies had earlier complied).

    One difference in this latest foray is the existence of the Federal Circuit affirmance of a district court order to delist, in Teva Pharms. Inc. v. Amneal Pharms. LLC, following the doctrinal grounds relied upon by the FTC in its former incarnation.  This should come as no surprise, because the FTC filed amicus briefs before both courts, and the district court opinion was unabashed in incorporating the arguments in the FTC's brief in support of its ruling and the legal reasoning supporting it.

    While the changes in philosophy between the two Administrations (and the composition of the FTC could not be more partisan), in practice the rhetoric in the letters are almost identical.  Each letter asserts that the recipient has an "ongoing obligation to ensure the propriety of its patent listings in the FDA's [Orange Book]," citing the earlier letters, all the letters expressly referenced the Federal Circuit decision in Teva v. Amneal, and in Teva's case not limiting the delisting demand to the patents at issue in that case.  The earlier public pronouncements are relegated to a footnote in these letters but were cited as a reminder nonetheless.  And all these letters were signed by Kelse Moen, Deputy Director, Bureau of Competition; Mr. Moen was appointed by FTC Chair Andrew Ferguson on February 18, 2025.

    The FTC has been enunciating these threats for almost two years, and while being conventionally active in pursuing judicial remedies as in Teva v. Amneal (and previously in the series of cases resulting in FTC v. Actavis) has not followed through on its demands.

    The patents challenged by the FTC for each pharmaceutical company are as follows:
    Table

  • By Michael Borella

    Love it or hate it, artificial intelligence (AI) has ushered the world to an inflection point.  The power of large language models (LLMs) is changing the structure of labor markets, education, informational gatekeeping, and governance.  It is still unclear whether these changes will lead to a utopian scenario in which all human needs are taken care of by machines or a neo-feudal hellscape in which a few ultra-wealthy technocrats cyber-rule over billions of platform-dependent serfs.  Or maybe we land somewhere in between.  Regardless of where it is ultimately headed, AI is the current big thing and on track to continue expanding.

    Given this, it is important (and even mildly entertaining until you get to the end of this article) to consider the weirdness of some AI-adjacent subcultures.  While the vast majority of individuals working in the AI space do not adhere to these philosophies and beliefs, a handful of notable and highly-influential technologists are either true believers or have been known to rely on these fringe philosophies.

    The rationalists are a loosely affiliated intellectual community focused on human reasoning, understanding cognitive biases, and anticipating long-term risks from advanced technologies such as AI.[1]  Many believe that artificial general intelligence (AGI) poses an existential risk unless it is aligned with human values.  This sounds fine, but some rationalists have taken this to an extreme degree, overlapping intellectually with longtermers, another esoteric niche that places the needs of future humans at or above the level of those of current humans.[2]

    This has led to some strange positions, often based on self-centered, post-hoc justifications.  Longtermers place an equal moral weight on the well-being of future humans and that of current humans.  Thus, they posit that there will be many more human beings in the future than there are now, and so a utilitarian and "rational" conclusion is to optimize for the needs of those of the future even if this causes some degree of suffering in those of the present.  Sometimes these lines of thinking are referred to as "effective altruism."

    Probably the most famous effective altruist is Sam Bankman-Fried, who justified enriching himself by making risky investments with other peoples' money as a way to improve the overall welfare of the world.[3]  Bankman-Fried was to eventually give it all away in massive acts of philanthropy.  In practice, this alleged mission did not work out so well, and Bankman-Fried was sentenced last year to 25 years in prison for fraud and conspiracy related to his operation of the FTX cryptocurrency exchange.

    Other well-known individuals in various rationalist circles subscribe to or are influenced by similar ideas, and have not (yet) been convicted of a crime.  Venture capitalist Marc Andreessen views rationalism and longtermism through a libertarian-accelerationist lens, viewing failure to adopt AI a greater danger than any of its existential risks.  In fact, Andreessen has provided a non-individualized list of "enemies" who purportedly stand in the way of AI growth.[4]  Andreessen's The Techno-Optimist Manifesto, a very long blog post espousing his beliefs, has a strangely messianic glow.  But no matter how you frame it, Andreessen is preaching for a low-regulation environment that would be good for Andreessen, allowing him to add multiples to the billions he already enjoys.

    BasiliscoBut Andreessen is not the only rationalist to flirt with religion.  An online community of rationalists had a major kerfuffle over the thought experiment called Roko's Basilisk.[5]  In short, it asks us to consider that a future super-intelligent AI might punish anyone who knew about it but didn't help bring it into existence.  In particular, the Basilisk would perform simulations of these people, the simulated copies subjected to extreme suffering, possibly for very long periods of time.[6]

    Of course, this is just a sophisticated variation of Pascal's Wager, a much older thought experiment about the existence of God.[7]  Nonetheless, online panic ensued, leading to moderators banning discussion of the Basilisk on their forum.  And it does not end there.  According to some reports, tech CEO and armchair efficiency expert Elon Musk met the singer Grimes (mother of 3 of his at least 14 children) due to Twitter discussions of the Basilisk.[8]

    And that is just the short list.  Arguments could be made that others have promoted controversial, ethically questionable, or arguably sociopathic ideas in the furtherance of AI (and often themselves at the same time).  These include OpenAI CEO Sam Altman (deemphasizing AI safety while using fear tactics to gain influence and power), investor Peter Theil (pushing for AI use in authoritarian contexts), and former Coinbase CEO Balaji Srinivasan (advocating for cloud-based governance and rule by techno-elites, with AI as a central tool).

    Some AI evangelists on the more careful side of things will attempt to rationalize their arguments by stating that AGI is an engine of abundance and the distribution of the excess wealth is a political rather than technological problem.[9]  Yet, it is rare in human history for a political system to distribute wealth equally or equitably, and we have many counter-examples of the exact opposite occurring.

    But let's end on an even darker note.  The Zizians are a small cult-like group that grew out of the rationalist movement.  They are currently believed to be involved in the deaths of six individuals in 2022 and 2025.[10]  To be clear, the Zizians are not mainstream rationalists.

    I personally know dozens of people working in the AI space and I have to admit that they are all pretty chill.  It would not be accurate or fair to lump the majority of AI users, developers, and advocates under the "weird" moniker.

    But the statements of a number of very powerful individuals, many of whom currently lead the AI community, have been more than just weird.  They are also troubling because they reveal a willingness to dismiss oversight, minimize risks, and speak in abstract, hyper-rational terms that often ignore real-world human suffering.  On the other hand, these are some of the same people who brought us aggressive online ads, social media, meme coins, and surveillance capitalism.  So their vision of the future, however well-funded and covered in altruistic gloss, deserves critical scrutiny rather than blind trust.

    [1] https://en.wikipedia.org/wiki/Rationalist_community.

    [2] https://en.wikipedia.org/wiki/Longtermism.

    [3] https://www.newyorker.com/news/annals-of-inquiry/sam-bankman-fried-effective-altruism-and-the-question-of-complicity.

    [4] Someone powerful making lists of enemies has never gone wrong.  Nope.  Not once.

    [5] https://en.wikipedia.org/wiki/Roko%27s_basilisk.

    [6] Ironically, the rationalists, many of whom claim to be atheists, appear to have recreated a version of the Christian hell.

    [7] https://en.wikipedia.org/wiki/Pascal%27s_wager.

    [8] https://www.vice.com/en/article/what-is-rokos-basilisk-elon-musk-grimes/.

    [9] See, e.g., https://www.aei.org/articles/the-age-of-agi-the-upsides-and-challenges-of-superintelligence/.

    [10] https://en.wikipedia.org/wiki/Zizians.

    Image of Basilisco, desenho de Rodrigo Ferrarezi by Rodrigo Ferrarezi, from the Wikimedia Commons under the Creative Commons Attribution 3.0 Unported license.

  • By Michael Borella

    Federal Circuit SealThe last 11 years have taught us much about the Federal Circuit; namely, that a majority of the judges simply do not seem to appreciate software.  Given the statements that several have made in opinions, one might be able to go as far as saying that some of these judges appear to fundamentally misunderstand how software is developed and works in practice.

    Like creeping autocracy, those of us subject to their rule have watched the gradual erosion of what types of inventions are eligible for patenting under 35 U.S.C. § 101.  Initially, business methods were found largely ineligible, then software executable on a general purpose computer, then software executable on any platform, and then non-software inventions as well.  The consequences of the subjectivity the Court has engendered include a highly unpredictable examination process at the U.S. Patent and Trademark Office and that the validity of any invention under § 101 can be challenged with a straight face.

    The vast majority of those in the patent legal community are aware of this slow-moving coup, and their reactions vary from disapproving frowns to recoiling in shock.  The few voices in favor of the status quo include non-practitioners from academia and those who financially benefit from things remaining the way they are.  The piecemeal nature of this death by 1000 cuts results in absurd rulings occurring before the legal community is generally aware that the velociraptors were testing the fences.  And by then, mechanisms for reversing course are compromised.

    To put some numbers to the situation, we considered all substantive § 101 decisions that came down from the Federal Circuit in 2024.

    Table
    We considered 23 cases, of which only 2 involve claims that were found eligible.  Thus, the Federal Circuit determined that claims were not eligible an astounding 91.3% of the time.  To be fair, one of the cases in which claims remained eligible — EcoFactor, Inc. v. Google LLC — was decided on procedural grounds.  Thus its inclusion in this list is for purposes of completeness.  Recalculating with this case removed results in a 95.5% invalidity rate.

    The fact that the Federal Circuit is a brutal venue for patentees with § 101 challenges should come as no surprise.  The Court has been willing to view the exceptions of Alice v. CLS Bank Int'l expansively for years.  Despite the Supreme Court's warning to "tread carefully in construing this exclusionary principle lest it swallow all of patent law," said law is now curled up like the mythical ouroborous worm.

    Put in context, between 2021 and 2023, the USPTO's Patent Trial and Appeal Board (PTAB) affirmed examiner's § 101 decisions about 90% of the time.  Thus, the appeals process for § 101 offers scant hope that patents survive.

    But it is instructive to take a deeper dive into the one case where the Federal Circuit substantively reviewed the claims and found them eligible.  Claim 11 of Contour IP Holding LLC v. GoPro, Inc. recites:

    11.  A portable, point of view digital video camera, comprising:
        a lens;
        an image sensor configured to capture light propagating through the lens and representing a scene, and produce real time video image data of the scene;
        a wireless connection protocol device configured to send real time image content by wireless transmission directly to and receive control signals or data signals by wireless transmission directly from a personal portable computing device executing     an application; and
        a camera processor configured to:
            receive the video image data directly or indirectly from the image sensor, generate from the video image data a first image data stream and a second image data stream, wherein the second image data stream is a higher quality than the first image data stream,
            cause the wireless connection protocol device to send the first image data stream directly to the personal portable computing device for display on a display of the personal portable computing device, wherein the personal portable computing device generates the control signals for the video camera, and wherein the control signals comprise at least one of         a frame alignment, multi-camera synchronization, remote file access, and a resolution setting, and at least one of a lighting setting, a color setting, and an audio setting,
            receive the control signals from the personal portable computing device, and
            adjust one or more settings of the video camera based at least in part on at least a portion of the control signals received from the personal portable computing device.

    Here, the Court found that "when read as a whole, claim 11 is directed to a specific means that improves the relevant technology . . . an improved POV camera through its combination of claim limitations and requirement that the claimed POV camera processor be configured to record low- and high-quality data streams in parallel, followed by the low-quality data stream's wireless transfer to a remote device."  According to the Court, "[t]he claims thus require specific, technological means—parallel data stream recording with the low-quality recording wirelessly transferred to a remote device—that in turn provide a technological improvement to the real time viewing capabilities of a POV camera's recordings on a remote device."

    Notably, the District Court construed the claim term "generate" to require parallel recording of video streams.  Apparently, this led the Federal Circuit to find that the claim language was sufficiently specific.  The Court also looked to the specification to find that it "discloses improving POV camera technology through specific means of generating high- and low-quality video streams in parallel and transferring a low-quality video stream to a remote device, and the claims reflect this improvement."

    Accordingly, the claim is not directed to an abstract idea, and the Court did not need to opine on whether it included an inventive concept.

    Ultimately, this decision remains frustrating, as it does not clearly delineate what level of detail is required for a software-based claim to be patent eligible.  The claim certainly had a few factors going for it, including that it was reasonably narrow, directed to a physical device, benefited from a claim construction that invoked a technical improvement, and that the claim’s technical improvement was described as such in the specification.  A sampling of the other cases in the above table finds that the majority involve claims that are directed to business methods operating on general purpose computers, include eligibility arguments not supported by the claim language, omit describing the alleged technical improvement in the specification, and/or exhibit claim language that is outcome oriented.

    These distinctions reinforce what has become the norm in modern patent drafting — submit claims that are not overly broad or vague, explicitly recite a technical improvement not believed to be in the prior art, and describe how the technical improvement solves a technical problem.  Even by doing all of this, a determination of patent eligibility is not guaranteed in the presence of such an uncertain test, but it may push the odds in the applicant's favor.

  • By Kevin E. Noonan

    Federal Circuit SealOnly a few days after the one-year anniversary of hearing oral argument, the Federal Circuit handed down its decision in Regents of the University of California v. Broad Institute, Inc. on Monday.  The opinion reviewed the Patent Trial and Appeal Board's decision in Interference No. 106,115 between Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively "CVC" before the PTAB, here, "Regents") over CRISPR (clustered regularly interspaced short palindromic repeats) technology for gene editing.

    To briefly recap, the '115 interference was the second interference between these parties after Interference No. 106,048 was dismissed for there being no interference-in-fact; see "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning" and affirmed by the Federal Circuit in Regents of the Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286 (Fed. Cir. 2018).  The '115 interference was provoked by Regents to overcome the basis for the decision in the '048 Interference; specifically Regents filed additional continuation applications reciting eukaryotic embodiments of CRISPR technology, reading directly on eukaryotic CRISPR claims in Broad's granted patents.  The PTAB awarded priority to Broad in this interference based, inter alia, on Broad convincing the Board that putative failures by Regents in reducing to practice their conception indicated that Regents' conception was incomplete or defective and Broad's conception thus occurred before Regents'.  The specifics of this reasoning is set forth in the Board's decision (see "PTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115") and the parties arguments and grounds for appeal set forth in their briefs (see "CVC Files Appeal Brief in Interference No. 106,115"; "CVC Files Response and Reply Brief in Interference No. 106,115 Appeal"; "Broad Files Reply Brief in Interference No. 106,115 Cross-Appeal").

    The Federal Circuit's opinion recites much of the factual and procedural background contained in these briefs and the history of the '115 interference (including the Board's decisions on the parties' Preliminary Motions; see "PTAB Decides Parties' Motions in CRISPR Interference"), but the opinion is significant for its decision that the Board erred as a matter of law on the priority question.  It is interesting to note that the panel is careful to describe in their explication what each party claims to be the case regarding their conception and reduction to practice of the claimed eukaryotic CRISPR embodiments.

    The opinion, by Judge Reyna joined by Judges Hughes and Cunningham, affirmed in part, vacated in part, and remanded, in consideration of these grounds of appeal.  Regents based its appeal on the Board's priority determination and that its earliest provisional applications (P1, filed May 2012 and P2, filed October 2012) failed to satisfy the written description requirement and thus Broad was designated Senior Party.  For Broad, its appeal was based on the Board's claim construction regarding the scope of the term "guide RNA" as being limited to single guide RNA species wherein the crRNA and tracerRNA components of the CRISPR-Cas9 complex were covalently linked, usually by a short spacer nucleic acid (a species of which, termed Chimera A, was the basis for Regents' earliest date of conception).

    The opinion begins with Regents' disputed date of conception and the completeness thereof.  The panel held that the basis for the Board's determination that Regents' conception was defective was legal error, because it "require[ed] Regents' scientists to know that their invention would work."  This amounted to a conflation of the "distinct legal standards for conception and reduction to practice."  Reciting established law, the opinion asserts "[t]here are three stages to the inventive process: (1) conception, (2) reasonable diligence, and (3) reduction to practice," citing Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996).  Under Burroughs Wellcome Co. v. Barr Lab'ys, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994), the panel states that "an inventor need not know that his invention will work for conception to be complete" because, inter alia, "[k]nowledge that the invention will work, 'necessarily, can rest only on an actual reduction to practice,'" citing Applegate v. Scherer, 332 F.2d 571, 573 (CCPA 1964), and Univ. of Pittsburgh of Commonwealth Sys. of Higher Educ. v. Hedrick, 573 F.3d 1290, 1299 (Fed. Cir. 2009).  Based on this precedent, the Board having denied Regents the benefit of its earliest conception date based on uncertainty on its operability was error according to the Federal Circuit.  The panel further noted that the evidentiary basis for the Board's decision was "almost exclusively . . . Regents' scientists' statements expressing uncertainty about whether the experiments had succeeded and suggesting modifications to their CRISPR-Cas9 system" and thus to conclude that they did not have a "definite and permanent idea" on this basis was error.  The Board improperly applied the Burroughs standard, which defined "[f]actual uncertainty [which] is when '[the subsequent course of experimentation, especially experimental failures, reveal uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.'"  The Board's error was in depending on the Regents' scientists statements rather than determining whether those statements were accompanied by "modifications in their experiments that substantively changed their original idea."

    Another basis for Board error was the failure to determine whether Regents' conception (i.e., the "plan" for performing CRISPR gene editing in eukaryotic cells) was used successfully by Regents scientists themselves or any other groups, using only routine skill and routine techniques.  Put another way, the opinion asserts that the proper analysis is to determine "whether [Regents' scientists] had formed the idea of [the invention's] use for [its intended] purpose in sufficiently final form that only the exercise of ordinary skill remained to reduce it to practice" "without extensive research or experimentation" under Burroughs.  The experiences of third parties is relevant both for their failures (citing Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1207 (Fed. Cir. 1991)) and successes (citing Brand v. Thomas, 96 F.2d 301, 303 (CCPA 1938)).  Also relevant, according to the opinion was the course of conduct of the "alleged inventor" with regard to whether she "contemplated the use of routine skill or methods at an asserted conception date, or used such routine skill or methods during subsequent, successful experimentation conducted by [her]."  The Board's failure to consider routine methods or skill in reducing the invention to practice, and instead "focusing almost entirely on Regents' scientists' statements about perceived experimental difficulties and doubts about success" was another source of Board error.  This error was illustrated by the Board deciding that it was not enough that the Regents' inventors had "conceived of the mechanics" of the invention but instead must have had an "operative invention" to have conceived.  In doing so, the panel found that the Board had misapplied the Court's Hitzeman v. Rutter precedent, which concerned an instance where there was a "bare hope" for a result that had "never before [been] achieved," 243 F.3d 1345, 1358–59 (Fed. Cir. 2001).  The proper distinction in this case was that the claim limitations were not directed to a result but rather to whether CRISPR functions in a eukaryotic cell, according to the opinion.  Failing (refusing, according to the panel) to consider "whether a person of ordinary skill could have achieved the function of editing eukaryotic DNA" was error by the Board.  The proper standard is there being "more than a 'general hope,' but less than knowing with certainty that the invention would work" according to the opinion.

    The Court also held that the Board erred by failing to consider Regents' evidence of the success of others in using their conception to successfully reduce eukaryotic CRISPR to practice.  By focusing on the purported difficulties encountered by Regents' scientists in reducing the invention to practice the Board legally erred in not considering whether Regents' scientists "described routine methods or skill at the asserted conception dates and used those methods or that skill to achieve purported successes during subsequent experimentation."  The Board erred by assuming that the purported difficulties in reduction to practice indicated that the invention required undue experimentation to be carried out, according to the opinion.

    The opinion sets out its conclusions as to the scope and extent of the Board's error in its priority determination:

    In sum, the Board erred by failing to consider routine methods or skill, focusing almost entirely on Regents' scientists' perceived experimental difficulties and related statements of doubt.  We thus vacate the Board's decision on conception and remand for the Board to decide on conception under the proper application of the legal framework.  On remand, the later party to reduce to practice will have the opportunity to show, under a conception date established by the correct standard, either (1) it was "the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice," Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998), or (2) it had "prior conception of the claimed subject matter and communication of the conception to the adverse claimant."  Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993).

    The opinion then turned to Regents' appeal of the Board's decision in Preliminary Motions that Regents' earlier priority documents did not satisfy the written description requirement for determination of which party was entitled to be designated as the Senior Party.  The panel determined that the Board properly applied the rubrics regarding whether the P1 or P2 disclosures satisfied the requirement based on the complexity and unpredictability of the invention as understood by one having ordinary skill in the art. While acknowledging that working examples or description of an actual reduction to practice are not required under Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the panel also asserted that the determination depends on how the ordinarily skilled worker would understand what was described within "the four corners of the specification."  The Board here "properly tailored its analysis to the specific facts of this case, rather than applying a one-size-fits-all approach."  The Federal Circuit also rejected Regents' argument that the Board's decision violated the provisions of the Administrative Procedures Act for failing to consider disclosure that would have supported possession of the invention.  The Court saw no indication that the Board had improperly relied upon or only considered evidence of one route of practicing the invention (using expression vectors) and not others (microinjection) and thus upheld the Board's written description determination.

    Turning to Broad's appeal on claim construction grounds regarding the term "guide RNA," the panel held that the appeal is moot, because the Board made its determinations in denying Broad's Preliminary Motions on "independently sufficient grounds . . . unrelated to claim construction."  Under these circumstances, "the relief sought would not have an impact on the legal interests of the parties" and thus the appeal is moot.

    The decision was entirely in Regents' favor with regard to priority and amounts to almost a mandate in Regents' favor on remand.  The opinion criticized, found legal error, and vacated every basis upon which the PTAB panel awarded priority to Broad.  Of course, as a consequence the question of what group of inventors were the first to invent and thus are entitled to patents on eukaryotic versions of CRISPR remains undecided, with all the investment and licensing uncertainty that these circumstances create.  And it is unlikely that investors, licensees, or the public will have a definitive answer on this issue any earlier than one or two years from now.

    Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2025)
    Panel: Circuit Judges Reyna, Hughes, and Cunningham
    Opinion By Circuit Judge Reyna

  • By Andrew Velzen

    PocketPairI have previously written extensively on the ongoing legal battle between Nintendo / The Pokémon Company (referred to herein collectively as simply "Nintendo") and PocketPair over PocketPair's popular video game Palworld.[1]  This past week, PocketPair published a blog post addressing some of the recent and upcoming in-game changes.[2]  The PocketPair blog post is worth analyzing vis-a-vis Nintendo's recently filed U.S. patent applications.

    Before jumping into the meat of PocketPair's blog post, though, let's check in with the status of Nintendo's developing U.S. patent portfolio related to this case.  As I discussed in one of my previous posts, Nintendo has filed three patent applications that, on their face, are seemingly meant to target Palworld.[3]  To remain consistent with the nomenclature I have used previously, I will continue to refer to these three U.S. patent applications as:  U.S. App. No. 18/652,874 ("US-App-3"), U.S. App. No. 18/652,883 ("US-App-4"), and U.S. Pat. App. No. 18/776,729 ("US-App-5").  As I previously noted, two of these applications (US-App-3 and US-App-5) have both issued as U.S. patents (US-App-3 issued in December 2024 and US-App-5 issued in February 2025).

    There has also been additional activity in US-App-4 since my last post.  On December 4, 2024, a final Office Action issued in US-App-4 in which the Examiner rejected the pending claims as obvious under 35 U.S.C. § 103, but indicated one of the dependent claims (claim 22) as allowable.  On March 4, 2025, Nintendo filed a response with the U.S. Patent and Trademark Office (USPTO).  In the response, rather than accepting the allowable subject matter of claim 22, Nintendo responded by:  (i) submitting a further amendment that slightly narrowed the independent claims and (ii) arguing that the prior art did not render the claims obvious.  The patent examiner at the USPTO was persuaded by this response and issued a Notice of Allowance for US-App-4 on April 4, 2025.  Nintendo now has until July 7, 2025 to pay the issue fee, which would result in an issued U.S. Patent.[4]  To summarize, Nintendo now has two patents and will likely soon have a third, as well.

    Turning to PocketPair's blog post, PocketPair communicated three important things:  (1) that PocketPair "continue[s] to dispute these [patent infringement] claims and assert the invalidity of the patents in question"; (2) that PocketPair's v0.3.11 patch to Palworld (which "removed the ability to summon Pals by throwing Pal Spheres and instead changed it to a static summon next to the player" and implemented several changes to "other game mechanics") was "indeed a result of the ongoing litigation"; and (3) that PocketPair's upcoming v0.5.5 patch to Palworld (which will change "gliding" such that it is "performed using a glider rather than with Pals") represents "yet another compromise" in order to "prevent further disruptions to the development of Palworld."

    While the only currently pending litigation is in Japan (i.e., there is no counterpart patent infringement litigation currently pending in the U.S.), the U.S. patent applications described above are sister applications to the presently asserted Japanese patents and cover similar game mechanics.  Further, to my knowledge, the version of Palworld presently playable in Japan is identical to the version of Palworld playable in the U.S.  Hence, any changes made to Palworld to avoid Japanese patent infringement may also assist with (e.g., be done with the purpose of) avoiding U.S. patent infringement.

    On their face, the changes described in item (2) and (3) above from PocketPair's blog post do seem to relate directly to the claims issued (or allowed) in US-App-3, US-App-4, and US-App-5.  For example, the claims of the issued patents corresponding to US-App-3 and US-App-5, respectively, cover (i) "catching a field character" with a "catching item" and then later the "field character" fighting a "fighting character" and (ii) "catching a first virtual character" with a "virtual object" and then later launching the "virtual object" and displaying the "first virtual character" fighting a "second virtual character."[5]  Thus, the changes to Palworld in patch v0.3.11 could certainly assist in avoiding infringement of US-App-3 and US-App-5.  Likewise, the changes to Palworld in patch v0.5.5 could assist in avoiding infringement of US-App-4 (assuming US-App-4 ultimately issue as a patent), since the claims of US-App-4 relate to "causing [a] player character to board an air boarding object."[6]

    It is important to note, however, that PocketPair's modification of game mechanics is not an admission of infringement of the U.S. patents.  This is especially true when coupled with PocketPair's statement from the blog post that PocketPair "continue[s] to dispute" the patent infringement claims.  Further, while modification of game mechanics is not an admission of infringement, neither does it insulate PocketPair from liability for any previously committed acts of patent infringement.  Instead, PocketPair may simply be taking steps to mitigate risk moving forward.

    For example, should it ultimately be determined that PocketPair committed patent infringement in the U.S., multiple remedies could be applied.[7]

    A first type of remedy could include assessing damages against PocketPair in the form of a reasonable royalty.  A reasonable royalty depends on both a "royalty rate" (e.g., the monetary value per unit of infringing product sold that is attributable to the infringing feature) and a "royalty base" (e.g., the number of units of infringing product sold).  The shorter the amount of time that an infringing product is for sale, the less the so-called "royalty base."  For example, any copies of Palworld sold after any infringing feature has been removed from the game could not be included in the "royalty base" (since those copies were not infringing).  Hence, PocketPair could be amending the features to protect against a higher monetary judgment should it ultimately lose a patent infringement case.

    A second type of remedy could include an injunction.  PocketPair may be enjoined (i.e., judicially forbidden) from selling products in the future that include infringing features.  Thus, to prevent future software development / game design time being committed to removing infringing features, PocketPair may simply be proactively removing allegedly infringing features now.  Likewise, removal of such features upfront may both:  (i) preemptively adjust player expectations regarding those features and related features being included in-game; and (ii) prevent additional game features that rely on the underlying infringing features from being developed in the interim (i.e., between now and any infringement judgment).

    Appropriately thirdly, PocketPair may avoid treble damages in the U.S. by removing the features in question now (i.e., upon becoming aware of the U.S. patents in question).  According to 35 U.S.C. § 284, when there is a finding of patent infringement, "the court may increase the damages up to three times the amount found or assessed."  Treble damages are traditionally rendered as a result of the defendant's willful infringement (e.g., the defendant performing one or more actions that the defendant knows would be covered by a claim of a valid patent of which the defendant was aware).  Due to the presently ongoing legal battles (both in Japan and in the U.S.), PocketPair has almost assuredly been made aware of the two issued U.S. Patents (and allowed US-App-4).  For example, PocketPair may have received one or more threatening letters from Nintendo indicating that Nintendo believes PocketPair to be infringing Nintendo's U.S. patents (e.g., along with copies of the U.S. Patents in question).  This puts PocketPair on notice and, if PocketPair continues to infringe Nintendo's patents thereafter (without any other protections in place, such as a non-infringement opinion), should Nintendo ultimately prevail in a U.S. lawsuit, PocketPair could be on the hook for three times the amount for any infringing acts committed after being put on notice.

    As a result, it is very plausible that PocketPair maintains its innocence in terms of patent infringement liability, but for at least the three remedy-related reasons above, has decided to remove the features in question anyway.  This is speculation, but in addition to mitigating risk for the reasons above, PocketPair may also be changing in-game elements based directly on ongoing negotiations with Nintendo.  It is likely that settlement negotiations have at least been floated between the two parties (if not actively ongoing).  Further, part of those settlement negotiations would likely include PocketPair's agreement to remove certain game features from Palworld.  Thus, by removing the features from the game currently (and by issuing a public blog post about it), PocketPair may be negotiating in good faith with Nintendo.

    What happens from here on out will likely be based on PocketPair's appetite for a legal battle.  Nintendo is arguably in a relatively strong negotiating position at the moment, as it has already filed suit in Japan and has obtained two (likely soon-to-be three) related patents in the U.S.  Additionally, PocketPair has had immense success over the last year with Palworld.  It may be more of a risk than PocketPair is comfortable with to stake some of that success in a multinational litigation against Nintendo.  In other words, depending on the terms of a negotiated agreement, it may be safer for PocketPair to simply capitulate to Nintendo's requests (e.g., remove certain features from Palworld and pay Nintendo some amount of money), rather than fight the charges of infringement.[8]

    Should PocketPair desire to take this fight further, though, there are certainly avenues in the U.S. that could be pursued.  For example, PocketPair could haul Nintendo's U.S. patents back into the USPTO in an Inter Partes Review (IPR) proceeding or a Post Grant Review (PGR) proceeding in an attempt to invalidate the patents, as described in my previous pieces.

    Since its outset, this has been an interesting case to follow, with aspects touching on many different areas of intellectual property law.  Given the size of the parties involved (and the relative success of their respective games), I think the entire gaming industry is watching to see how it plays out.  Regardless of the outcome, this legal battle clearly highlights that patents remain an effective tool in the gaming space, even if their use has fallen out of vogue somewhat post-Alice.[9]

    [1] See https://www.patentdocs.org/2024/04/palworld-friend-or-foe.html; https://www.gamesindustry.biz/nintendos-patents-were-designed-to-take-on-palworld; https://www.mbhb.com/intelligence/snippets/what-the-pokemon-companys-patent-applications-are-evolving/.

    [2] https://www.pocketpair.jp/news/20250508.

    [3] https://www.gamesindustry.biz/nintendos-patents-were-designed-to-take-on-palworld; https://www.mbhb.com/intelligence/snippets/what-the-pokemon-companys-patent-applications-are-evolving/.

    [4] It is somewhat of an interesting side note that Nintendo has yet to pay the issue fee in US-App-4 (as of May 10, 2025).  Whereas in both US-App-3 and US-App-5, Nintendo paid the issue fee a week or two after getting a Notice of Allowance, in US-App-4, it has been over a month since the Notice of Allowance was issued and Nintendo has yet to pay the fee.

    [5] U.S. Pat. Nos. 11,179,111 and 12,220,638.

    [6] U.S. Pat. App. Pub. No. 2024/0286040.

    [7] See, e.g., 35 U.S.C. § 284.

    [8] Worth noting, should PocketPair and Nintendo come to terms on a settlement regarding the Japanese patent infringement suit, such a settlement agreement would most likely be written to avoid any patent litigation in the U.S., as well.  Said differently, if PocketPair agrees to a settlement with Nintendo, PocketPair would presumably be globally insulated against future litigation over related patents.

    [9] Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014).

  • By Kevin E. Noonan

    Federal Circuit SealOnly a few days after the one-year anniversary of hearing oral argument, the Federal Circuit handed down its decision in Regents of the University of California v. Broad Institute, Inc.  In short — and to be explicated more fully in a coming post — the decision was completely in the Regents' favor (except for the panel affirming the Patent Trial and Appeal Board's decision on Preliminary Motion denying Regents the benefit of the priority date of two earlier-filed provisional applications on written description grounds).  The opinion, by Judge Reyna joined by Judges Hughes and Cunningham, criticized, found legal error, and vacated every basis upon which the PTAB panel awarded priority to Broad.  The Federal Circuit also found moot Broad's cross-appeal seeking to have the language of the Count regarding "guide RNA" to encompass both single- and dual-guide embodiments.  The case was remanded to the PTAB, instructing the Board "to reconsider the issue of conception in a manner consistent with this opinion."

    Of course, as a consequence the question of what group of inventors were the first to invent and thus are entitled to patents on eukaryotic versions of CRISPR remains undecided, with all the investment and licensing uncertainty that these circumstances create.  And it is unlikely that investors, licensees, or the public will have a definitive answer on this issue any earlier than one or two years from now.