Technology Information Law Blog by Charles Gideon Korrell

Tag: IPR

  • Bayer Pharma v. Mylan Pharmaceuticals: When “Clinically Proven Effective” Cannot Rescue an Anticipated Treatment Method

    Bayer Pharma v. Mylan Pharmaceuticals: When “Clinically Proven Effective” Cannot Rescue an Anticipated Treatment Method

    The Federal Circuit’s September 23, 2025 decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., No. 23-2434, delivers a sharp reminder that post-hoc validation, even in the form of successful clinical trial results, does not automatically translate into patentability. The opinion clarifies the limits of method-of-treatment claims that attempt to rely on clinical proof language to distinguish otherwise anticipated dosing regimens, while also providing important guidance on claim construction in combination-therapy claims.

    The case arose from inter partes review proceedings challenging U.S. Patent No. 10,828,310, which describes the results of Bayer’s COMPASS Phase III clinical trial evaluating low-dose rivaroxaban in combination with aspirin to reduce major adverse cardiovascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). While the clinical trial itself was significant, the Federal Circuit emphasized that patentability must turn on what the claims require a practitioner to do, not on what later evidence proves about the outcomes.

    The court ultimately affirmed the PTAB’s unpatentability determinations for claims 1–4, vacated the unpatentability determinations for claims 5–8 based on an erroneous claim construction, and remanded for further proceedings. Along the way, the opinion addressed four recurring issues in pharmaceutical patent litigation: (1) the role of “clinically proven effective” language, (2) construction of combination-product claims, (3) motivation to combine prior art clinical disclosures, and (4) the limits of unexpected-results evidence.

    The COMPASS Claims and the Prior Art

    The ’310 patent claims methods of reducing the risk of myocardial infarction, stroke, or cardiovascular death by administering rivaroxaban at 2.5 mg twice daily together with aspirin at 75–100 mg daily. Claims 1–4 broadly recite administering those agents at the specified dosages, while claims 5–8 add a requirement that the method involve “once daily administration of a first product comprising rivaroxaban and aspirin” and “a second product comprising rivaroxaban.”

    The IPR petitions relied primarily on two references. The first was a 2016 journal article by Foley summarizing the then-ongoing COMPASS trial, including the exact dosing regimen later claimed, but without disclosing the trial’s results. The second was a 2014 article by Plosker describing the ATLAS ACS 2-TIMI 51 trial, which disclosed similar low-dose rivaroxaban plus aspirin regimens in cardiovascular patients.

    The PTAB concluded that claims 1–2 were anticipated by Foley and that claims 1–8 were obvious over Foley alone or in combination with Plosker. Bayer appealed.

    “Clinically Proven Effective” and the Functional Relationship Test

    A central dispute on appeal concerned the claim phrase “clinically proven effective.” Bayer argued that this language was limiting and required proof of efficacy through clinical trials, which Foley did not disclose. The Board had concluded that the phrase was non-limiting, or alternatively, inherently anticipated.

    The Federal Circuit sidestepped that debate entirely. Instead, it held that even if “clinically proven effective” were treated as a limiting element, it could not confer patentability because it lacked a new and unobvious functional relationship with the claimed method. Drawing heavily on King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267 (Fed. Cir. 2010), the court explained that an otherwise anticipated method cannot be rescued by adding a limitation that merely describes information about the method or its later validation.

    As the court put it, proof that a dosing regimen worked in a clinical trial “in no way transforms the process of taking the drugs” at the claimed doses and frequencies. The actual steps performed by the physician or patient remain unchanged, regardless of whether the regimen has been clinically validated. Allowing patentees to “claw back” known treatment methods from the public domain simply by pointing to later-obtained clinical success would undermine fundamental limits on patent scope.

    Charles Gideon Korrell notes that this portion of the opinion is particularly important for pharmaceutical lifecycle management strategies that rely on clinical trial milestones rather than changes to dosing, formulation, or administration. The court’s analysis reinforces that validation alone is not innovation, at least for purposes of patentability.

    Distinguishing Allergan and Open-Ended Claim Drafting

    Bayer argued that Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370 (Fed. Cir. 2019), compelled a different result. In Allergan, the court held that certain “wherein” clauses specifying minimum safety and efficacy thresholds were limiting and material to patentability.

    The Federal Circuit rejected the comparison. Unlike the open-ended composition claims in Allergan, which could encompass a wide range of formulations meeting the recited concentration requirements, the Bayer claims already fixed the precise dosages of rivaroxaban and aspirin. The “clinically proven effective” language did not further narrow the universe of covered methods. As Charles Gideon Korrell observes, the opinion underscores a drafting lesson: functional or results-based language is far more likely to matter when it genuinely constrains an otherwise open claim scope.

    Claim Construction of the “First Product”

    While Bayer lost on claims 1–4, it prevailed on an important claim construction issue affecting claims 5–8. The PTAB had construed “a first product comprising rivaroxaban and aspirin” to encompass administration of the two drugs as separate dosage forms, whether administered simultaneously or sequentially.

    The Federal Circuit disagreed. Focusing on the plain claim language, the court held that “a first product comprising rivaroxaban and aspirin” requires a single dosage form that includes both active ingredients. Interpreting the term to cover separate pills would render the “first product” language meaningless and collapse the distinction the claims draw between combination and non-combination products.

    The court also found support in the specification, which explicitly distinguishes between “separate dosage forms” and “a combination dosage form containing both rivaroxaban and aspirin.” The Board’s broader construction improperly conflated these concepts. Because the PTAB had not analyzed obviousness under the correct construction, the Federal Circuit vacated the unpatentability determinations for claims 5–8 and remanded.

    Charles Gideon Korrell believes this portion of the decision highlights how seemingly modest wording choices can drive materially different outcomes in IPR proceedings, particularly for combination-product claims in the pharmaceutical space.

    Motivation to Combine and Reasonable Expectation of Success

    Bayer also challenged the Board’s obviousness analysis for dependent claims reciting specific aspirin dosages (75 mg or 81 mg). The Federal Circuit was unpersuaded. The Board had expressly found that these dosages reflected globally available aspirin strengths and were consistent with the dosage ranges disclosed in Plosker.

    The court reiterated that motivation to combine and reasonable expectation of success are factual determinations reviewed for substantial evidence. Here, the record supported the Board’s conclusion that a skilled artisan would have had reason to substitute commonly used aspirin dosages with an expectation of success, particularly given that both references addressed reducing cardiovascular risk.

    Unexpected Results and the Nexus Requirement

    Finally, Bayer argued that the clinical proof of efficacy demonstrated by the COMPASS trial constituted unexpected results supporting nonobviousness. The Federal Circuit rejected this argument on nexus grounds.

    The Board had found, and the court agreed, that Bayer’s evidence of unexpected results was tied exclusively to the “clinically proven effective” limitation. Because that limitation was functionally unrelated to the claimed method steps and could not supply patentability, the asserted unexpected results lacked the required nexus to the merits of the claimed invention.

    As Charles Gideon Korrell notes, this analysis reinforces the principle that secondary considerations must be anchored to what is both claimed and novel. Evidence of success attributable to validation, rather than to a structural or functional distinction over the prior art, will not carry the day.

    Takeaways

    The Bayer decision offers several practical lessons. First, method-of-treatment claims cannot rely on post-hoc clinical validation to rescue known dosing regimens from anticipation or obviousness. Second, careful claim drafting around combination products matters, and courts will enforce distinctions between single-dosage-form products and loose combinations of separate components. Third, secondary considerations must be tied to claim features that actually change how the method operates.

    In short, the Federal Circuit reaffirmed that patent law rewards innovation in what practitioners do, not merely confirmation that what they were already doing turns out to work.

    By Charles Gideon Korrell

  • Kroy IP Holdings v. Groupon: The Federal Circuit Draws a Hard Line on IPR Collateral Estoppel

    Kroy IP Holdings v. Groupon: The Federal Circuit Draws a Hard Line on IPR Collateral Estoppel

    The Federal Circuit’s August 1, 2025 order denying rehearing en banc in Kroy IP Holdings, LLC v. Groupon, Inc., No. 23-1359, leaves intact a panel decision that sharply limits the collateral-estoppel effect of PTAB unpatentability decisions in subsequent district court litigation. The denial is notable not because of its brevity—en banc denials are routine—but because of the deep doctrinal divide exposed by the concurring and dissenting opinions. At stake is a recurring and high-impact question under the America Invents Act (AIA): whether a final written decision in an inter partes review (IPR), affirmed on appeal, should preclude a patentee from asserting patentably indistinct claims in district court.

    The answer, for now, is no. But the path the court took to get there—and the objections raised by dissenting judges—signal continuing instability in the law governing the relationship between PTAB proceedings and Article III patent litigation.

    Background: From IPR Cancellation to District Court Do-Over

    Kroy IP Holdings asserted a subset of claims from a patent with more than 100 claims against Groupon in district court. Groupon responded with an IPR petition, and the PTAB ultimately held a group of claims unpatentable as obvious. That unpatentability determination was affirmed by the Federal Circuit. After the IPR cancellation, Kroy amended its district court complaint—not to reassert the cancelled claims, but to assert a different set of claims from the same patent.

    The district court concluded that the newly asserted claims were not materially different from the claims invalidated in the IPR and therefore barred by collateral estoppel. On appeal, however, the Federal Circuit reversed. The panel held that collateral estoppel did not apply because the PTAB applies a preponderance-of-the-evidence standard, while district court invalidity must be proven by clear and convincing evidence. According to the panel, that difference in burdens of proof is dispositive.

    Groupon sought rehearing en banc, supported by amicus briefing emphasizing the AIA’s goal of reducing duplicative patent litigation and elevating PTAB adjudications as a substitute for district court validity proceedings. The court denied rehearing, but not quietly.

    Chief Judge Moore’s Concurrence: No Patent-Specific Estoppel Rules

    Chief Judge Moore, joined by Judge Stoll, concurred in the denial of rehearing en banc. Her opinion is framed as a warning against patent exceptionalism. The Supreme Court, she emphasized, has repeatedly cautioned lower courts against creating patent-specific deviations from generally applicable legal doctrines. Collateral estoppel is one such doctrine.

    Under longstanding preclusion principles, collateral estoppel does not apply when a later action involves a materially different legal standard—most notably, a higher burden of proof. Citing B & B Hardware, Inc. v. Hargis Industries, Inc. and Grogan v. Garner, Chief Judge Moore reasoned that a finding of unpatentability by a preponderance of the evidence does not necessarily establish invalidity by clear and convincing evidence. The doctrinal mismatch, in her view, ends the inquiry.

    Charles Gideon Korrell notes that policy arguments favoring efficiency or uniformity, she cautioned, cannot override these general principles. Nor does the AIA compel a different result. Parties concerned about duplicative litigation can file additional IPR petitions or challenge claims directly before the PTAB, rather than stretching collateral-estoppel doctrine beyond its traditional limits.

    In short, the concurrence frames the case as a straightforward application of black-letter preclusion law—one that resists importing policy-driven exceptions into the doctrine merely because the subject matter is patent law.

    Judge Dyk’s Dissent: The AIA Demands More

    Judge Dyk, joined by Judge Hughes, took a sharply different view. In his dissent from the denial of rehearing en banc, Judge Dyk characterized the panel decision as fundamentally inconsistent with both Federal Circuit precedent and the structure and purpose of the AIA.

    The dissent begins with the court’s own case law. In XY, LLC v. Trans Ova Genetics, L.C., the Federal Circuit held that an affirmed PTAB unpatentability decision has “immediate issue-preclusive effect” in co-pending district court actions. According to Judge Dyk, the panel decision in Kroy cannot be squared with XY and effectively overrules it sub silentio.

    More importantly, the dissent situates collateral estoppel within the broader framework of Congressional intent. Supreme Court precedent, including Astoria Federal Savings & Loan Association v. Solimino and University of Tennessee v. Elliott, makes clear that preclusion principles must sometimes be adapted to statutory schemes. For Judge Dyk, the AIA is precisely such a scheme.

    Congress created IPRs to provide a faster, cheaper, expert alternative to district court litigation over patent validity. Allowing patentees to relitigate patentably indistinct claims in district court—after losing before the PTAB—undermines that objective. The dissent draws an analogy to Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, where the Supreme Court modified traditional estoppel rules to prevent repeated validity challenges and the “aura of the gaming table” that accompanied them.

    Judge Dyk also emphasized practical consequences. Patents often contain dozens or hundreds of claims. If a patentee can avoid estoppel simply by asserting slightly modified or previously unasserted claims, IPRs lose much of their preclusive force. The dissent warned that patentees may strategically withhold claims from litigation or continuation practice to evade IPR estoppel, shifting costs back to district courts and defendants.

    A Doctrinal Fault Line That Isn’t Going Away

    The denial of rehearing en banc leaves the panel decision intact, but it does not resolve the underlying tension. On one side is a formalist application of collateral-estoppel doctrine grounded in differing burdens of proof. On the other is a functionalist approach that treats IPR decisions as in rem determinations of patentability, consistent with the AIA’s purpose of reducing duplicative litigation.

    Charles Gideon Korrell notes that this divide reflects a deeper uncertainty about how PTAB adjudications should fit within the federal judicial system. Are they merely parallel administrative proceedings with limited spillover effects, or are they meant to serve as authoritative substitutes for district court validity trials? The Federal Circuit’s current answer appears to be “sometimes,” depending on how closely one adheres to traditional estoppel doctrine.

    From a strategic standpoint, the decision favors patentees. By carefully sequencing claims and proceedings, patent owners may preserve district court enforcement options even after losing an IPR. For accused infringers, the ruling reinforces the need for early, comprehensive IPR strategies—or parallel district court invalidity defenses that anticipate post-IPR claim reshuffling.

    Charles Gideon Korrell believes the issue is unlikely to remain settled for long. The frequency with which PTAB decisions intersect with district court litigation, combined with the court’s internal division, makes future en banc review—or Supreme Court intervention—a real possibility. Until then, Kroy stands as a reminder that, despite the AIA’s ambitions, patent validity disputes still have multiple lives.

    Charles Gideon Korrell also observes that the decision places renewed pressure on Congress if true substitution of PTAB proceedings for district court litigation is the goal. Without clearer statutory guidance on estoppel, courts will continue to toggle between doctrinal purity and policy pragmatism—often with significant consequences for patent litigation strategy.

    By Charles Gideon Korrell

  • IGT v. Zynga: Institution Unreviewability Swallows Interference Estoppel (and Obviousness Stands)

    IGT v. Zynga: Institution Unreviewability Swallows Interference Estoppel (and Obviousness Stands)

    The Federal Circuit’s decision in IGT v. Zynga Inc. delivers a one-two punch that will resonate in AIA practice: (1) the court affirmed the PTAB’s obviousness ruling; and (2) it refused to review the agency’s decision not to apply interference estoppel at institution. Read together, the opinion underscores just how muscular § 314(d)’s unreviewability has become—strong enough to keep even well-developed estoppel theories at the courthouse door.

    Charles Gideon Korrell reads the case as a fresh reminder: if your attack on an IPR hinges on why the Board shouldn’t have instituted, you are almost certainly headed for the § 314(d) trap unless you can credibly shout “shenanigans.”

    Backstory: From Interference to IPR

    To appreciate the posture, rewind to the interference era. IGT owned U.S. Patent No. 7,168,089 covering a software authorization agent that mediates transfers of gaming software between devices. Around 2010, Zynga’s predecessor copied IGT’s claims and provoked an interference. In that forum, Zynga argued obviousness over Carlson, Wells, and Alcorn. But the Board never reached the art. Instead, it terminated the interference on a threshold written-description problem in Zynga’s application—a standing-style defect that ended the contest before any § 103 merits.

    Fast-forward. In 2021, IGT launched an infringement suit; Zynga answered with an IPR targeting the same ’089 claims—this time on different references (Goldberg and Olden) and, for a subset, D’Souza. That move teed up the central dispute: could interference estoppel block Zynga from asserting these new obviousness grounds in a later USPTO proceeding?

    Rather than focusing on estoppel itself, the Federal Circuit approached IGT’s interference estoppel challenge through the lens of § 314(d)’s unreviewability provision. As Judge Reyna stated during oral arguments:

    The Estoppel Theory and the Agency’s Path

    The estoppel lives in 37 C.F.R. § 41.127(a)(1): an interference judgment “disposes of all issues that were, or by motion could have properly been, raised and decided.” IGT contended Zynga could have raised Goldberg/Olden-style obviousness in the interference but didn’t, and thus was estopped from later bringing those grounds in the Office.

    The agency’s responses came in layers:

    • The Board mused that applying interference estoppel would be unfair here because the interference predated the AIA and ended on a threshold basis; and it also pointed to § 42.5(b) as authority to waive the interference rule.
    • On Director review, the Office emphasized a different point entirely: Part 42 (IPR rules) doesn’t incorporate Part 41 (interference rules). On that view, interference estoppel doesn’t carry over to IPRs unless Part 42 says so—and it doesn’t.

    IGT pushed back hard. It noted longstanding USPTO policies urging parties to consolidate their disputes and “show all your cards” in a single inter partes contest; it pointed to the regulation’s text and past PTAB decisions where interference estoppel was applied in AIA trials. In short, if the agency wants a “one stop shop” for inter partes fights, it shouldn’t let a later petitioner re-slice the invalidity pie with new art.

    Charles Gideon Korrell adds that IGT’s briefing framed estoppel as res judicata-like: if you attack a granted patent in an interference, you don’t get a second bite in the Office with fresh § 103 theories you left on the table the first time.

    The Court’s Route: § 314(d) Blocks the Door

    Rather than squarely deciding whether interference estoppel applies in IPRs, the Federal Circuit walked straight through § 314(d). Judge Taranto’s opinion treats IGT’s estoppel argument as a challenge to institution and therefore unreviewable on appeal. Attempts to distinguish regulatory versus statutory predicates got no traction; the court explained that § 314(d) does not open a review path simply because the institution predicate is a regulation rather than a statute.

    Crucially, the court warned that an agency’s providing reasoned legal analysis for its institution decision does not magically convert a nonappealable action into a reviewable one. If your objection is, at bottom, “the Board should have denied institution under an estoppel theory,” Cuozzo and Thryv fence that out of appellate reach.

    What about Cuozzo’s “shenanigans” carve-out? The court gave the institution decision a quick look—enough to confirm there was no egregious procedural violation. In particular, the interference here ended on a threshold issue that prevented the Board from deciding art-based patentability. That context gave the agency a reasonable basis to conclude that Part 41 estoppel did not (or should not) bar an AIA trial on new prior art grounds. No shenanigans; no review.

    If you’re scoring at home, that is a resounding win for unreviewability. And as Charles Gideon Korrell notes, it signals to litigants that institution-targeted estoppel arguments will almost always be met with the § 314(d) “no jurisdiction” sign.

    The Merits: No “New Grounds,” and Obviousness Is Affirmed

    On the merits, IGT argued the Board smuggled in impermissible new grounds by identifying the claimed “software authorization agent” as a combination of Goldberg’s components (database 28 + blackjack driver 26 + wager accounting module 30), whereas Zynga’s petition had emphasized the database 28.

    The Federal Circuit focused on notice. It found that IGT itself had invoked the driver 26 and the accounting module 30 in response to the petition—arguing those pieces showed the database was just “ordinary.” That was enough notice that the Board might evaluate the collective functionality of those components when mapping the “authorization agent.” The panel concluded there was no due-process problem and no new ground—just a Board doing what it is allowed to do: addressing the same thrust of the petition and the parties’ briefing with appropriately detailed reasoning.

    With the process point resolved, the court had little difficulty affirming obviousness. Olden supplies the classic authorization server pattern: a request comes in; rules are applied; an allow/deny response goes out; and the system logs access—i.e., monitors authorization events. Coupling that with Goldberg’s networked gaming set-up comfortably satisfied the “software authorization agent” limitations and the request/authorization message flows, with substantial-evidence support in the record.

    Practical Notes and Signals

    • Interference → IPR sequencing. If an interference ends on a threshold ground (e.g., written-description failure), do not expect it to estop a later IPR that raises art-based invalidity. Even if you believe the regulation should apply, the mechanism to enforce that belief after institution is vanishingly small due to § 314(d).
    • Build merits, not just vetoes. Patent owners should treat estoppel-at-institution as a long shot. Preserve it, yes—but develop a full merits record on claim construction, motivation to combine, and teaching gaps, because that is what the Federal Circuit can actually review.
    • Notice framing matters. Petitioners who map a functional “agent” may safely point to a cluster of cooperating modules, so long as the function (authorization + monitoring) is what the claim requires. Patent owners who respond by discussing those modules should assume the Board can treat them collectively without triggering a “new grounds” problem.
    • Policy drift? The Office’s rationale evolved (Board’s fairness/waiver vs. Director’s Part-41-doesn’t-apply), and IGT highlighted prior PTAB decisions that went the other way. The Federal Circuit’s bottom line, though, is that even if the agency’s reasoning is inconsistent, that does not pierce § 314(d). Expect challengers to cite this case the next time they argue that institution-level policy swings are insulated from review.

    All of this also casts a long shadow over the pending mandamus efforts in In re SAP and In re Motorola Solutions, which attack the Acting Director’s rescission of the Vidal Memo and the resulting Fintiv posture. If IGT teaches anything, it’s that the court is inclined to defer to the agency on institution-side choices—even where the path is bumpy and the reasoning shifts. To borrow the opinion’s thrust: as long as there’s a colorable, non-shenanigans basis, § 314(d) will likely close the door.

    Charles Gideon Korrell suspects parties will respond by re-centering their fire on final written decisions and Director-review outcomes that change the merits, not the gatekeeping.

    Bottom Line

    • Institution challenge rejected: Interference estoppel, as framed here, is an institution issue and thus unreviewable under § 314(d). The court saw no Cuozzo-style shenanigans in allowing the IPR to proceed after an interference that ended on a threshold ground.
    • Obviousness affirmed: The Board did not rely on new grounds; its mapping of a software authorization agent across Goldberg components, combined with Olden’s authorization server and logging, was supported by substantial evidence.

    For practitioners, the case is a sharp illustration of how little oxygen is left for appellate attacks on why an IPR was instituted. The best play remains the oldest one: win (or narrow) on the merits. As Charles Gideon Korrell notes, that means pinning down claim language so “monitoring” and “authorization” truly require content-aware controls if that’s what you need to distinguish over generic web-security frameworks like Olden.

    By Charles Gideon Korrell

    Throughout this post, insights from Charles Gideon Korrell reflect the view that IPR petitioners should be ready to fuse general-purpose authorization tech with domain systems to meet functional “agent” claims, while patentees should draft with content-specific telemetry if they aim to avoid obviousness under combinations like Goldberg + Olden. In subsequent analyses, Charles Gideon Korrell will track how panels handle “monitoring” limitations in other software contexts.

  • Shockwave Medical v. Cardiovascular Systems: Federal Circuit Clarifies Use of AAPA and Reverses PTAB on Claim 5

    Shockwave Medical v. Cardiovascular Systems: Federal Circuit Clarifies Use of AAPA and Reverses PTAB on Claim 5

    In a significant decision issued on July 14, 2025, the Federal Circuit in Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., Nos. 2023-1864, 2023-1940, affirmed the Patent Trial and Appeal Board’s finding that most of the claims of U.S. Patent No. 8,956,371 were unpatentable as obvious—but reversed the Board’s lone finding of non-obviousness, holding that claim 5 too was unpatentable. This decision is notable for its continued development of the law concerning the permissible use of applicant admitted prior art (AAPA) in inter partes review (IPR) proceedings and its clarification of what constitutes a “basis” under 35 U.S.C. § 311(b).

    Charles Gideon Korrell observes that this ruling confirms the Federal Circuit’s firm adherence to limiting the scope of IPR grounds to prior art patents and printed publications while still allowing general knowledge—including that evidenced by AAPA—to play a critical role in obviousness analysis.

    Background of the Patent and Proceedings

    Shockwave Medical owns the ’371 patent, which covers an “angioplasty catheter” that uses electrohydraulic lithotripsy (EHL) to treat calcified plaque in blood vessels—a novel application of a technology more traditionally used to break up kidney stones. The invention incorporates electrodes within a balloon catheter, which, when activated, produce shockwaves that break apart hardened deposits without excessive balloon pressure.

    Cardiovascular Systems, Inc. (CSI) challenged all 17 claims of the ’371 patent in an IPR proceeding. The Patent Trial and Appeal Board found that claims 1–4 and 6–17 were obvious over the prior art but that claim 5 was not. Shockwave appealed the adverse ruling on claims 1–4 and 6–17, while CSI cross-appealed the Board’s non-obviousness finding on claim 5.

    Federal Circuit’s Holding on the Direct Appeal (Claims 1–4 and 6–17)

    The Federal Circuit, in an opinion authored by Judge Dyk and joined by Judges Lourie and Cunningham, rejected Shockwave’s arguments and affirmed the Board’s invalidation of these claims.

    1. Use of AAPA Does Not Violate § 311(b)

    Shockwave argued that CSI improperly relied on AAPA to form the “basis” for its obviousness grounds, violating 35 U.S.C. § 311(b), which limits IPR challenges to “prior art consisting of patents or printed publications.” The court rejected this argument, emphasizing that:

    “[A]lthough the prior art that can be considered in [IPRs] is limited to patents and printed publications, it does not follow that we ignore the skilled artisan’s knowledge when determining whether it would have been obvious to modify the prior art.” (Citing Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330 (Fed. Cir. 2020)).

    The court distinguished its prior holdings in Qualcomm I (24 F.4th 1367 (Fed. Cir. 2022)) and Qualcomm II (134 F.4th 1355 (Fed. Cir. 2025)), noting that CSI never labeled the AAPA as a “basis” in its petition. The use of AAPA here merely provided background knowledge, consistent with permissible uses recognized in Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013).

    Charles Gideon Korrell notes that this distinction between AAPA as a reference and as a “basis” helps clarify a murky area in IPR practice. Petitioners may use AAPA to demonstrate a skilled artisan’s background knowledge, but must be cautious not to identify it as a foundational reference for an obviousness ground.

    2. Claim Construction of “Angioplasty Balloon”

    Shockwave sought to limit the construction of “angioplasty balloon” to require that it displace plaque into the vessel wall, but the court sided with CSI’s broader construction as “an inflatable sac…to widen narrowed or obstructed blood vessels.” The specification itself undermined Shockwave’s construction, explicitly stating that the balloon need not be snug to the vessel wall.

    3. Obviousness Over Levy and Background Knowledge

    Substantial evidence supported the Board’s findings:

    • It was obvious to use Levy’s shockwave technique with known over-the-wire angioplasty catheters.
    • Levy disclosed shockwave generation in vascular applications.
    • The commercial success and secondary considerations proffered by Shockwave lacked sufficient linkage to the claimed invention and were unpersuasive.

    Reversal on CSI’s Cross-Appeal: Claim 5 Is Also Obvious

    Claim 5 requires that the “pair of electrodes [be] disposed adjacent to and outside of the guide wire lumen.” The Board had found that this configuration was not disclosed in CSI’s references. However, the Federal Circuit reversed that determination, finding the Board had failed to consider the combination of references as a whole.

    The key reference was Uchiyama, which taught placement of electrodes in a balloon for lithotripsy but did not show them outside the guidewire lumen. CSI’s expert testified that relocating the electrodes outside the lumen would be a routine design modification offering better lateral plaque coverage—something well within the grasp of a skilled artisan.

    The court emphasized that:

    “The standard for obviousness requires consideration of the prior art combination taken as a whole.” (Citing In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012)).

    CSI’s expert also relied on KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), and Uber Technologies, Inc. v. X One, Inc., 957 F.3d 1334 (Fed. Cir. 2020), to argue that the placement of electrodes was among a finite number of predictable options.

    Because Shockwave failed to rebut this with contrary evidence, the Federal Circuit found the Board’s ruling unsupported by substantial evidence and reversed outright.

    Charles Gideon Korrell observes that this aspect of the decision serves as a reminder that design choices considered “routine” in the context of the art may justify an obviousness finding—especially when unchallenged by countervailing expert testimony.

    Standing on Appeal

    The Federal Circuit also addressed—and rejected—Shockwave’s challenge to CSI’s standing to cross-appeal. The court found that CSI had sufficiently concrete plans to commercialize a competing IVL product and was at risk of being sued under claim 5, especially in light of Shockwave’s public statements claiming broad coverage and intent to assert that claim.

    This mirrors prior rulings like Adidas AG v. Nike, Inc., 963 F.3d 1355 (Fed. Cir. 2020), and General Electric Co. v. Raytheon Techs. Corp., 983 F.3d 1334 (Fed. Cir. 2020).

    Conclusion

    In sum, the Federal Circuit:

    • Affirmed the Board’s finding that claims 1–4 and 6–17 are unpatentable,
    • Reversed the Board’s finding that claim 5 is patentable, and
    • Held that CSI had Article III standing to pursue its cross-appeal.

    The opinion reinforces key principles of IPR law, especially:

    • Proper use of AAPA as background knowledge (not a “basis”),
    • Permissibility of using general knowledge to fill in gaps in prior art,
    • The importance of considering combined references in obviousness analysis.

    Charles Gideon Korrell believes this decision is a helpful roadmap for petitioners navigating the narrow permissible uses of AAPA in IPRs. It also serves as a cautionary tale for patentees relying heavily on secondary considerations or overly narrow claim constructions without robust evidentiary support.

    By Charles Gideon Korrell

  • Ancora Technologies, Inc. v. Roku, Inc.: Federal Circuit Vacates PTAB Decision on Licensing Nexus in Obviousness Analysis

    Ancora Technologies, Inc. v. Roku, Inc.: Federal Circuit Vacates PTAB Decision on Licensing Nexus in Obviousness Analysis

    In the June 16, 2025 decision of Ancora Technologies, Inc. v. Roku, Inc., the Federal Circuit vacated and remanded two inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB) that had found claims of U.S. Patent No. 6,411,941—owned by Ancora Technologies, Inc.—to be unpatentable as obvious. While the Federal Circuit affirmed the Board’s construction of the key term “agent” and upheld its prima facie case of obviousness based on prior art, it held that the PTAB legally erred in dismissing Ancora’s license evidence as lacking a sufficient nexus to the claimed invention. This case offers important guidance on the evidentiary treatment of licenses as objective indicia of nonobviousness.

    The Patent at Issue: Software Licensing and BIOS Security

    Ancora’s ’941 patent addresses software license enforcement mechanisms by embedding license verification structures in the erasable, non-volatile memory of a computer’s BIOS. This technique is intended to secure software against unauthorized use without relying on more volatile or easily altered memory. The method described in claim 1 includes:

    1. Selecting a program in volatile memory (e.g., RAM),
    2. Using an “agent” to set up a verification structure (including at least one license record) in the erasable, non-volatile BIOS memory (e.g., EEPROM),
    3. Verifying the program using the verification structure, and
    4. Acting on the program based on the verification result.

    Claims 1–3, 6–14, and 16 were challenged and ultimately invalidated in IPRs filed by Nintendo, Roku, and VIZIO.

    The PTAB’s Decision: Obviousness Based on Hellman and Chou

    The PTAB found that the challenged claims were obvious over a combination of two prior art references:

    • Hellman (U.S. Patent No. 4,658,093): Discloses a system using hash functions and non-volatile memory to control software use based on allowed instances.
    • Chou (U.S. Patent No. 5,892,906): Describes BIOS-based security methods for verifying passwords and controlling hardware access.

    The Board determined that Hellman provided the base mechanism for license enforcement and that Chou taught the use of BIOS memory for secure storage. Ancora argued that this combination was inoperable and lacked a motivation to combine, but the Board found otherwise and rejected Ancora’s claims as obvious.

    The Board construed the term “agent” in the claims as “a software program or routine,” declining Ancora’s argument that the term should be limited to software running at the OS level. Relying on intrinsic evidence and dictionaries, the Board found no disavowal or redefinition requiring a narrower construction.

    Charles Gideon Korrell notes that the Federal Circuit gave deference to the Board’s reliance on extrinsic evidence, including industry definitions and expert declarations, and determined that “agent” was not limited to software-only or OS-level implementations. The court found substantial evidence supported the Board’s construction.

    Secondary Considerations: Licensing and the Nexus Requirement

    The Federal Circuit’s principal disagreement with the Board lay in its treatment of Ancora’s license agreements as objective indicia of nonobviousness.

    Ancora had presented multiple licenses entered into after extended litigation, many just before trial and with substantial royalty payments. The PTAB found that Ancora failed to show a nexus between these licenses and the specific claims of the ’941 patent, concluding that they could reflect business decisions to avoid litigation rather than recognition of the patent’s strength.

    The Federal Circuit sharply criticized this reasoning:

    “Licenses to the challenged patent then, unlike products or other forms of objective evidence of nonobviousness, do not require a nexus with respect to the specific claims at issue…”

    Citing LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Fed. Cir. 2012) and Institut Pasteur v. Focarino, 738 F.3d 1337 (Fed. Cir. 2013), the court emphasized that actual licenses to the patented technology are highly probative of nonobviousness and should not be subject to the same parsing applied to commercial product evidence.

    In the court’s view, according to Charles Gideon Korrell, the Board erred by demanding a higher evidentiary burden than the law requires. Even if the licenses also referenced related patents or included redacted sections, that did not undermine the fact that they expressly covered the ’941 patent. The Board’s approach “too finely parsed” the record and ignored the licensing context: settlements reached after years of litigation and near trial dates, with substantial consideration paid.

    Charles Gideon Korrell explains that the Federal Circuit’s holding here confirms that the economic behavior of parties—especially sophisticated technology companies licensing patents to avoid trial—is relevant and weighty evidence of the patent’s nonobviousness, even where the license bundles multiple rights.

    Remedy and Remand

    Although the Federal Circuit affirmed the PTAB’s claim construction and the Board’s finding of a prima facie case of obviousness, it vacated the Board’s decision due to legal error in the analysis of secondary considerations. On remand, the PTAB must:

    1. Re-evaluate the nexus between the challenged claims and Ancora’s licenses under the proper legal standard,
    2. Weigh this licensing evidence, including both high- and low-value settlements, as part of its overall nonobviousness analysis.

    This remand could potentially alter the outcome if the Board concludes that the licenses provide significant objective evidence supporting the validity of the challenged claims.

    Conclusion

    The Federal Circuit’s decision in Ancora Technologies, Inc. v. Roku, Inc. underscores the importance of properly evaluating licensing evidence in an obviousness analysis. While upholding a broad construction of “agent” and affirming the prima facie obviousness of the claims, the court found fault with the PTAB’s overly narrow view of what constitutes a nexus between a patent and license agreements. The decision reinforces that real-world licensing behavior—especially in litigation contexts—can and should play a meaningful role in the nonobviousness inquiry.

    Charles Gideon Korrell believes this decision will have broad implications for how PTAB and district courts assess secondary considerations in IPR and invalidity proceedings. In particular, it may offer patent holders new avenues to bolster the validity of their claims with well-supported licensing histories.

    By Charles Gideon Korrell

  • Dolby Laboratories Licensing Corp. v. Unified Patents, LLC: No Standing to Appeal IPR RPI Dispute

    Dolby Laboratories Licensing Corp. v. Unified Patents, LLC: No Standing to Appeal IPR RPI Dispute

    In Dolby Laboratories Licensing Corp. v. Unified Patents, LLC, No. 23-2110 (Fed. Cir. June 5, 2025), the Federal Circuit dismissed Dolby’s appeal for lack of Article III standing. Although Dolby had prevailed before the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) initiated by Unified Patents, it sought to appeal the Board’s refusal to adjudicate a dispute over the petition’s Real Party in Interest (RPI) disclosure. The Federal Circuit held that none of Dolby’s asserted injuries established the “concrete and particularized” harm necessary to create a justiciable controversy.

    Background

    Unified Patents filed an IPR challenging claims 1, 7, and 8 of Dolby’s U.S. Patent No. 10,237,577. Dolby alleged that Unified improperly failed to disclose nine additional RPIs. The Board declined to resolve the RPI dispute, citing PTAB precedent (SharkNinja v. iRobot IPR proceeding, IPR2020-00734) and USPTO policy limiting such adjudications to when the outcome of the proceeding might be affected (e.g., due to time bar or estoppel).

    Charles Gideon Korrell notes that the PTAB ultimately found in favor of Dolby, upholding the challenged claims. Nonetheless, Dolby appealed, asserting that the Board’s refusal to decide the RPI issue caused it harm.

    No Standing Despite Statutory “Right to Appeal”

    Dolby first argued that it had standing based on 35 U.S.C. § 319, which provides a right of appeal to any “party dissatisfied” with a PTAB final written decision. The Federal Circuit rejected this argument, reiterating its longstanding view that statutory appeal rights under the America Invents Act (AIA) do not override the constitutional requirement of Article III standing (JTEKT Corp. v. GKN Automotive, 898 F.3d 1217 (Fed. Cir. 2018)).

    No Informational Injury Under § 312(a)(2)

    Dolby also contended that the failure to adjudicate the RPI issue violated its informational rights under 35 U.S.C. § 312(a)(2), which requires IPR petitions to identify all RPIs. The court disagreed, distinguishing this situation from the “public-disclosure” statutes found in Public Citizen v. DOJ, 491 U.S. 440 (1989) and FEC v. Akins, 524 U.S. 11 (1998). Unlike the statutes at issue in those cases, the AIA does not grant a general right of public access to RPI information, nor does it create a statutory cause of action to vindicate such a right. Furthermore, Charles Gideon Korrell notes, decisions regarding institution—including compliance with § 312(a)(2)—are explicitly made non-appealable under 35 U.S.C. § 314(d) (ESIP Series 2, LLC v. Puzhen Life USA, 958 F.3d 1378 (Fed. Cir. 2020)).

    Speculative Harms Do Not Establish Injury in Fact

    The remainder of Dolby’s arguments were similarly dismissed as speculative. The court found no credible evidence that:

    • Any of the alleged RPIs were violating Dolby license agreements (Apple Inc. v. Qualcomm Inc., 992 F.3d 1378 (Fed. Cir. 2021));
    • The administrative patent judges (APJs) had conflicts of interest;
    • Future estoppel rights would be compromised; or
    • Unified would alter its behavior if RPIs had to be disclosed.

    Without evidence of actual or imminent harm, the court held that Dolby failed to meet its burden under Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992), and Spokeo, Inc. v. Robins, 578 U.S. 330 (2016).

    Key Takeaways

    • Statutory appeal rights under the AIA do not eliminate the requirement of Article III standing.
    • The Federal Circuit continues to take a narrow view of informational injuries, especially in the context of administrative patent proceedings.
    • Speculative future harms and procedural disagreements—without more—are not enough to sustain federal appellate jurisdiction.

    Charles Gideon Korrell sees this case serving as a reminder that even victorious IPR patent owners must demonstrate a cognizable injury to pursue appeals based on procedural grievances.

    By Charles Gideon Korrell

  • Ingenico Inc. v. IOENGINE, LLC: Public Availability of Prior Art Software Invalidates Patent Claims

    Ingenico Inc. v. IOENGINE, LLC: Public Availability of Prior Art Software Invalidates Patent Claims

    In a recent decision, Ingenico Inc. v. IOENGINE, LLC, the Federal Circuit upheld a jury’s finding that several claims of IOENGINE’s U.S. Patent Nos. 9,059,969 and 9,774,703 were invalid due to anticipation and obviousness by publicly available prior art. Specifically, the Court affirmed that a software application known as the “Firmware Upgrader,” part of M-Systems’ DiskOnKey System, constituted prior art under the “public use” provision of 35 U.S.C. § 102(b) (pre-AIA).

    Background

    IOENGINE’s patents relate to portable devices, such as USB thumb drives, that send communications to network servers upon user interaction. Ingenico challenged the validity of IOENGINE’s patents by demonstrating prior public use of M-Systems’ DiskOnKey System, including its Firmware Upgrader software.

    At trial, Ingenico presented significant circumstantial evidence of the Firmware Upgrader’s public accessibility before the critical date. Evidence included a July 2002 email to M-Systems employees encouraging dissemination of the Firmware Upgrader and associated documentation, a public press release, and archived web pages from which the software could be downloaded.

    Court Analysis and Key Precedents

    The Federal Circuit’s analysis emphasized two important precedents:

    1. Medtronic, Inc. v. Teleflex Innovations S.A.R.L. (2023) clarified that circumstantial evidence is equally persuasive and sufficient compared to direct evidence for proving public use.
    2. Minnesota Mining & Manufacturing Co. (3M) v. Chemque, Inc. (2002) was distinguished due to the lack of evidence in 3M demonstrating that samples provided were ever used in a manner fulfilling claim requirements.

    In contrast to 3M, Ingenico demonstrated clear evidence that the Firmware Upgrader software was publicly accessible and encouraged for use, meeting the claims’ criteria once downloaded. Thus, circumstantial evidence was adequate to satisfy the public use requirement.

    Clarification on IPR Estoppel and Jury Instructions

    IOENGINE argued for a new trial, asserting improper jury instructions regarding conception, diligence, public use, and sales offers. It also challenged the district court’s decision allowing Ingenico to rely on prior art under IPR estoppel provisions.

    The Federal Circuit rejected these arguments, holding that the jury was properly instructed on the clear and convincing evidence standard and other critical issues. Additionally, the court clarified the scope of IPR estoppel under 35 U.S.C. § 315(e)(2), holding that estoppel does not extend to grounds involving public use or on-sale bar evidence because these grounds cannot be raised in inter partes review, which is limited to printed publications and patents as prior art.

    Conclusion

    The decision underscores the importance of demonstrating prior art’s public accessibility through circumstantial evidence. Additionally, it offers crucial guidance on the limits of IPR estoppel, affirming that petitioners are free to assert public use and on-sale bars in district court actions despite participating in an IPR. Patent holders and challengers alike must carefully consider the implications of public availability and IPR proceedings in shaping their litigation strategies.

    By Charles Gideon Korrell

  • Qualcomm v. Apple: Express Reliance on Applicant Admitted Prior Art Bars IPR Ground

    Qualcomm v. Apple: Express Reliance on Applicant Admitted Prior Art Bars IPR Ground

    In Qualcomm Inc. v. Apple Inc., Nos. 2023-1208, -1209 (Fed. Cir. Apr. 23, 2025), the Federal Circuit reversed the Patent Trial and Appeal Board’s (PTAB) post-remand decision, holding that the Board erred in allowing Apple’s inter partes review (IPR) ground to proceed based on a misinterpretation of 35 U.S.C. § 311(b). The ruling clarifies the limits on how applicant admitted prior art (AAPA) can be used in IPR petitions and underscores that the “basis” of a ground must consist solely of patents or printed publications.

    Background

    Apple filed two IPR petitions challenging claims of Qualcomm’s U.S. Patent No. 8,063,674, which relates to integrated circuits using multiple power supplies. Each petition included two obviousness grounds under § 103. At issue was “Ground 2,” which relied on AAPA (specifically, Figure 1 and text of the ’674 patent) in view of a published patent application (Majcherczak) and, for some claims, the Matthews patent.

    PTAB originally found Apple’s use of AAPA permissible, treating it as prior art under § 311(b). Qualcomm appealed, and in Qualcomm I, the Federal Circuit held that AAPA is not “prior art consisting of patents or printed publications” and remanded to the Board to determine whether AAPA improperly formed the “basis” of the petition.

    On remand, the Board, applying PTO guidance, adopted an “in combination” rule: AAPA used alongside at least one qualifying patent or printed publication does not form the basis of a ground under § 311(b). It upheld Ground 2 and invalidated the challenged claims.

    The Federal Circuit’s Decision

    Judge Reyna, writing for a unanimous panel, reversed. The court held that:

    1. Reviewability Not Barred by § 314(d): Apple argued that Qualcomm’s challenge was a barred appeal of the PTAB’s institution decision. The court disagreed, finding Qualcomm’s arguments targeted the final written decision, not the institution itself. Citing SAS Inst. v. Iancu and Cuozzo, the court emphasized that § 314(d) does not bar judicial review of questions about how the agency conducts an IPR once it is instituted.
    2. PTAB Misinterpreted § 311(b): The court found the “in combination” rule—allowing AAPA to escape classification as a “basis” when paired with other art—contravened the plain meaning of the statute. AAPA is not a qualifying patent or publication and cannot form any part of the basis of an IPR ground. Reliance on AAPA to supply missing claim limitations may be permissible for obviousness analysis, but not if it constitutes part of the “basis” for the challenge.
    3. Express Statements by Petitioner Are Binding: The court found that Apple’s petitions explicitly labeled Ground 2 as based on “Applicants [sic] Admitted Prior Art (AAPA) in view of” other prior art, thereby violating § 311(b). Because petitioners are masters of their petitions, express characterizations like this are binding. The Board erred in disregarding these express admissions and allowing the ground to proceed.

    Takeaways

    • Express language matters. Petitioners must carefully draft IPR petitions and avoid designating AAPA as part of the “basis” under § 311(b), even if combined with qualifying references.
    • AAPA’s role is limited. While it may be used to demonstrate the knowledge of a person of ordinary skill, AAPA cannot form any part of the legal “basis” for an unpatentability ground under § 311(b).
    • Board discretion is not absolute. Even under the America Invents Act’s streamlined IPR process, statutory boundaries like § 311(b) remain enforceable and reviewable.

    This decision is a key reminder for IPR practitioners: precision in petition drafting is essential, and the statutory language must be honored, even when PTAB or PTO guidance suggests more flexible interpretations.

  • Sage Products, LLC v. Stewart: “Sterile” Label in UK Document Found to Anticipate U.S. “Sterilized” Patent Claims

    Sage Products, LLC v. Stewart: “Sterile” Label in UK Document Found to Anticipate U.S. “Sterilized” Patent Claims

    In Sage Products, LLC v. Stewart, No. 2023-1603 (Fed. Cir. Apr. 15, 2025), the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB) finding that all challenged claims of Sage’s U.S. Patent Nos. 10,398,642 and 10,688,067 were unpatentable due to anticipation and obviousness. The ruling centered on whether a UK public assessment report (PAR) describing a product as “sterile” met the U.S. claim limitations requiring a “sterilized” composition. The court held that a skilled artisan would understand the regulatory meaning of “sterile” in the UK to include the concept of “sterilized” under U.S. patent law, thereby rendering the claims anticipated.

    Key Background

    Sage’s patents relate to sterilized chlorhexidine gluconate compositions used in antiseptic applicators. The PTAB instituted IPRs against multiple claims of these patents based on three grounds: (1) anticipation by the ChloraPrep PAR; (2) obviousness over the PAR and general knowledge; and (3) obviousness over the PAR in view of a U.S. publication (Degala).

    At issue was whether the PAR—an official regulatory document issued by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)—disclosed a “sterilized” composition within the meaning of the claims.

    Key Prior Art and the “Sterile” vs. “Sterilized” Debate

    The PAR described a ChloraPrep product containing chlorhexidine gluconate and isopropyl alcohol for pre-operative skin disinfection, stating that the product is “sterile” and “sterile unless the seal is broken.” Importantly, the UK’s regulatory standard BS EN 556-1 defines “sterile” as having a sterility assurance level (SAL) of ≤10⁻⁶.

    The Board interpreted “sterilized” as requiring “a suitable sterilization process such that sterility can be validated,” and determined that a skilled artisan would equate the PAR’s “sterile” designation with this definition.

    Sage argued that this was a misreading, contending that even experts at the time misunderstood the ChloraPrep product to be sterile when it was not. Sage’s expert, Dr. Rutala, testified that the state of the art assumed ChloraPrep’s active antiseptic solution was not sterilized. However, the Board credited the testimony of BD’s expert, Dr. Dabbah, who explained that a skilled artisan with at least four years of experience in sterilization would understand that the UK labeling requirements effectively guaranteed terminal sterilization compliant with BS EN 556-1.

    The Federal Circuit’s Analysis

    The court upheld the PTAB’s factual findings under the substantial evidence standard:

    • Regulatory Understanding: The court found it “implausible” that a skilled artisan would be unaware of UK regulatory standards that governed the PAR’s use of the term “sterile.”
    • SAL and Composition Claims: The court affirmed that the PAR, read in light of BS EN 556-1, disclosed a sterilized composition with an SAL in the claimed range (10⁻³ to 10⁻⁹).
    • Dependent Claims: The court also upheld the Board’s findings that limitations such as a “sterilized colorant” were met, based on the overall characterization of the product as “sterile.”
    • Procedural Arguments: The court rejected Sage’s argument that the Board exceeded the scope of the IPR or improperly relied on extrinsic evidence. Expert testimony and references like Degala and Chiang were permissible to help interpret what the PAR disclosed to a skilled artisan.
    • Enablement: The court found no error in the Board’s reliance on other references to confirm that the methods of sterilization disclosed in the PAR were enabled.

    Takeaway

    This case underscores the importance of considering the regulatory context and the knowledge of a person of ordinary skill when interpreting foreign public documents during validity challenges. Here, the Federal Circuit signaled that official regulatory language, such as “sterile,” can carry weight under U.S. patent law when understood to meet the technical requirements of a claim—even when arising from a different jurisdiction.

    Moreover, this opinion reinforces that a patent challenger can use a combination of prior art and expert testimony to establish that a foreign document anticipates U.S. patent claims, especially when such a document reflects regulatory compliance with rigorous standards like BS EN 556-1.

    By Charles Gideon Korrell

  • Patent Battles in Wearable Tech: AliveCor v. Apple and the Fight Over Arrhythmia Detection

    Patent Battles in Wearable Tech: AliveCor v. Apple and the Fight Over Arrhythmia Detection

    On March 7, 2025, the Federal Circuit issued its decision in AliveCor, Inc. v. Apple Inc., upholding the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling that invalidated AliveCor’s patents on heart rate monitoring technology. The case has significant implications for the wearable technology industry, particularly in the areas of patentability, obviousness, and the interplay between patent litigation and administrative patent challenges.

    Background of the Case

    AliveCor, a medical technology company, held patents covering systems and methods for detecting cardiac arrhythmias using wearable devices. The key patents in dispute—U.S. Patent Nos. 9,572,499, 10,595,731, and 10,638,941—described a technology involving smartwatches equipped with photoplethysmography (PPG) sensors to monitor heart rate, notify users of irregularities, and prompt them to conduct electrocardiogram (ECG) recordings for further analysis.

    Apple challenged these patents through inter partes review (IPR) at the PTAB, arguing that the claims were obvious in light of prior art references. The Board ruled in Apple’s favor, finding that the claims lacked novelty. AliveCor appealed to the Federal Circuit, arguing that the PTAB’s conclusions on obviousness were incorrect and that Apple had withheld evidence relevant to secondary considerations of non-obviousness.

    Key Legal Issues

    1. Obviousness of Machine Learning-Based Arrhythmia Detection

    AliveCor’s patents included claims requiring the use of machine learning algorithms to detect arrhythmias based on heart rate data. The court affirmed the PTAB’s determination that this approach was obvious in view of prior art references, particularly:

    • Hu 1997: A study describing a patient-adaptable ECG classifier that employed machine learning to detect cardiac conditions.
    • Li 2012: A research paper discussing the use of machine learning to reduce false arrhythmia alarms by integrating multiple physiological signals.
    • Shmueli Patent Application (2012): A prior patent application disclosing a wrist-mounted heart monitoring device that used both PPG and ECG data to detect and confirm irregular heart activity.

    The Federal Circuit concluded that a person of ordinary skill in the art would have been motivated to combine these techniques, reinforcing the Board’s finding that AliveCor’s claimed use of machine learning was not sufficiently novel.

    2. “Confirmation” Step in Arrhythmia Detection

    Another key issue was whether the requirement to confirm an arrhythmia using ECG data was patentable. AliveCor argued that its method—detecting arrhythmia using PPG data and then confirming it using an ECG—was unique. However, Apple successfully argued that Shmueli already disclosed this concept. The PTAB and the Federal Circuit both found that a skilled artisan would have found it obvious to confirm PPG-based arrhythmia detection with ECG, leading to the invalidation of the relevant claims.

    3. Failure to Produce Secondary Consideration Evidence

    AliveCor also contended that Apple failed to disclose evidence from a parallel International Trade Commission (ITC) investigation, which had considered secondary indicators of non-obviousness, such as commercial success and industry praise. AliveCor claimed that Apple’s withholding of this evidence violated discovery obligations.

    However, the Federal Circuit found that AliveCor had forfeited this argument by failing to raise the issue before the PTAB. The court emphasized that procedural diligence is essential in IPR proceedings and that issues must be timely presented to be considered on appeal.

    Implications for Intellectual Property Law

    This decision underscores several critical points in patent law and intellectual property strategy:

    • Obviousness in Emerging Technologies: Courts and the PTAB continue to scrutinize patents in fast-evolving fields like machine learning and wearable tech, often finding that incremental improvements fail to meet the non-obviousness requirement.
    • Interplay Between Patent Litigation and IPRs: The case highlights the increasing role of inter partes reviews in invalidating patents that might otherwise survive district court litigation.
    • Procedural Rigor in Patent Challenges: Parties must be meticulous in raising all relevant issues during PTAB proceedings; failure to do so may result in forfeiture on appeal.

    Conclusion

    The Federal Circuit’s decision in AliveCor v. Apple represents a significant win for Apple and a cautionary tale for patent holders in the medical technology space. As courts and administrative bodies continue to apply strict standards for patent validity, companies seeking to protect their innovations must ensure their patents contain clear, non-obvious advancements over existing technology. Moreover, maintaining procedural diligence in parallel patent litigation and administrative proceedings is crucial to avoiding unfavorable rulings on appeal.

    As wearable health technology continues to advance, the legal battles over patentability will shape the competitive landscape, influencing which companies can dominate the market with their innovations.

    By Charles Gideon Korrell