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Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

by | Apr 3, 2025 | ,

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America Invents Act (AIA) 35 U.S.C. § 102(e) as of the provisional filing date, explaining that all portions of the published patent application that are relied upon by the US Patent & Trademark Office (PTO) to reject the claims must be sufficiently supported in the provisional application. In re Riggs, Case No. 22-1945 (Fed. Cir. Mar. 24, 2025) (Moore, Stoll, Cunningham, JJ.)

Several inventors who work for Odyssey Logistics filed a patent application directed to logistics systems and methods for the transportation of goods from various shippers by various carriers across different modes of transport (e.g., by rail, truck, ship, or air). PTO rejected the application under § 102(e) in view of Lettich, which claimed the benefit of a provisional application (Lettich provisional), and as obvious in view of Lettich in combination with the Rojek reference.

The inventors appealed the Lettich rejections to the Patent Trial & Appeal Board, arguing that Lettich did not qualify as prior art under § 102(e). The Board initially agreed with the inventors, but the Examiner assigned to the application requested a rehearing, asserting that the Board applied the incorrect standard for § 102(e) prior art. The Board ultimately issued its decision on the Request for Rehearing, stating that it had jurisdiction over the Examiner’s request and that the Examiner’s arguments regarding Lettich’s status as prior art under § 102(e) “[we]re well taken.” The Board amended its original decision “to determine that Lettich is proper prior art against the instant claims.” The Board then reviewed and affirmed the Examiner’s anticipation and obviousness rejections. The inventors appealed.

The Federal Circuit vacated and remanded the Board’s decision. With respect to whether Lettich qualified as § 102(e) prior art, the Court found that the Board’s analysis was incomplete. The Court concluded that the Board correctly applied the test set forth in the Federal Circuit’s 2015 decision in Dynamic Drinkware v. National Graphics by determining that the Lettich provisional supported at least one of Lettich’s as-published claims. However, the Court found that this test was insufficient because all portions of the disclosure that are relied upon by the PTO to reject the claims must also be sufficiently supported in the priority document. Although the PTO asserted that the Board had conducted this additional analysis, the Federal Circuit disagreed and vacated and remanded for the Board to determine whether the Lettich provisional supported the entirety of the Lettich disclosure that the Examiner relied on in rejecting the claims.



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The Clear and Unmistakable Standard for Applying Prosecution Disclaimer

by | Apr 3, 2025 |

The US Court of Appeals for the Federal Circuit found that a district court misconstrued claim terms based on a misapplication of the clear and unequivocal disavowal standard and vacated its noninfringement decision. Maquet Cardiovascular LLC v. Abiomed Inc., Abiomed R&D, Inc., Abiomed Europe GMBH, Case No. 23-2045 (Fed. Cir. Mar. 21, 2025) (Reyna, Taranto, Cunningham, JJ.)

Maquet owns a patent related to a system that provides greater precision in deploying a blood pump to a patient’s circulatory system. The district court construed three patent terms. The district court construed the term “guide mechanism comprising a lumen” to include a negative limitation that the guidewire lumen “is not distal to the cannula.” The court justified this limitation by citing to the prosecution history of a related patent where Maquet disclaimed the broader claim by merely accepting the examiner’s proposed revisions. The district court also construed both guide wire terms in two other claims to include another negative limitation: “the guide wire does not extend through the free space in between the rotor blades.” The district court similarly justified this negative limitation by citing to the parent patent’s prosecution history, finding that Maquet had given up a broader version of the claim. The district court’s construction effectively limited the scope of Maquet’s claims to exclude the accused products, and the parties stipulated to the entry of a final appealable judgment of noninfringement. Maquet appealed.

Maquet argued that the district court erred in its construction of the three terms by misapplying the law of prosecution disclaimer. The Federal Circuit agreed, finding that the district court incorrectly relied on Maquet’s prosecution history to reach its conclusions on claim construction. The district court cited to an amendment made in a different (but related) patent prosecution and a different claim. The Federal Circuit explained that although the prosecution history of a related patent may be relevant, the claim limitations in the two applications must be similar in order for the prosecution disclaimer doctrine to apply. Here, the Court found that the amendment in the related patent was not sufficiently similar to the limitation at issue to constitute a disclaimer for the claim at issue. The related case claim did not claim a guide mechanism, nor did it require the lumen be in a specific position. The Federal Circuit found that the district court erred in its construction by improperly applying prosecution disclaimer.

The Federal Circuit also determined that the district court erred in its construction of the guide wire claim terms by applying prosecution disclaimer and interpreting a restriction on their scope. The Court found that while the prosecution history of the parent patent’s claims was sufficiently similar and thus relevant, Maquet did not disavow either claim’s scope during the relevant prosecution. The Court noted that mere silence in response to a notice of allowance typically does not rise to clear and unmistakable claim disavowal. The Court also observed that statements made during an inter partes review (IPR) proceeding may be used to support a [...]

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What’s the (Re)issue? Patent Term Extensions for Reissue Patents

by | Mar 27, 2025 |

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)

Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.

The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.

Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.

Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).

The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of [...]

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When “It’s Obvious” Just Isn’t Enough: Challenger’s Burden to Prove Obviousness

by | Mar 27, 2025 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision that a patent was not obvious because the petitioner failed to show sufficient support of obviousness based on prior art. AMP Plus, Inc. v. DMF, Inc., Case No. 23-1997 (Fed. Cir. Mar. 19, 2025) (Lourie, Bryson, Reyna, JJ.)

DMF owns a patent directed to a compact recessed lighting system designed for installation in a standard electrical junction box. In 2019, AMP, doing business as ELCO, petitioned for inter partes review of several claims of the patent on three grounds of unpatentability:

  • Anticipation by a prior reference
  • Obviousness based on a combination of two references
  • Further obviousness based on an additional source.

The Board found that one claim was anticipated but ruled that ELCO failed to prove unpatentability of the other claims, including the claim at issue on appeal. The claim at issue describes a system with wires connected to a driver and a first connector, coupled to a second connector that in turn is connected to the building’s electrical system. This specific connection was referred to as “Limitation M.” ELCO appealed. In that earlier appeal (2022), the Federal Circuit affirmed the Board’s ruling on all claims except the claim at issue and remanded the case back to the Board for further analysis.

On remand, the Board concluded that ELCO failed to demonstrate the unpatentability of the claim at issue because ELCO’s petition lacked a substantive analysis of Limitation M. The Board found ELCO’s argument that a prior art marine lighting system could be adapted for the claimed building use unsupported by evidence and ruled that the claim at issue was not obvious. Again, ELCO appealed.

ELCO raised two main arguments. First, it argued that the Board erred in not determining that the claim at issue was anticipated by a prior reference, as the Board had previously found another claim to be anticipated by the same reference. The Federal Circuit rejected this argument because ELCO had only challenged the claim at issue on the basis of obviousness in its original petition, not anticipation. Since the issue of anticipation was not raised in the petition, the Court determined that ELCO could not introduce this new ground of unpatentability on appeal.

Second, ELCO argued that its petition had sufficiently demonstrated the obviousness of Limitation M based on the prior references. The Federal Circuit disagreed, finding that ELCO’s petition did not adequately address the specific requirement for coupling the system to a building’s electrical infrastructure. The petition failed to discuss how the recessed lighting system would be installed in a building, and the references cited did not provide adequate support for the argument of obviousness for this particular limitation.

The Federal Circuit emphasized that it was not the Board’s responsibility to supplement the petitioner’s arguments or search for evidence to support an inadequately supported claim challenge. The Court reiterated that an obviousness analysis does not require the Board to fill gaps in the petitioner’s original [...]

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Even Jepson Preambles Require Written Description Support

by | Mar 27, 2025 |

The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well known in the prior art. In re Xencor, Inc., Case No. 24-1870 (Fed. Cir. Mar. 13, 2025) (Hughes, Stark, Schroeder, JJ.)

Xencor filed a patent application claiming a modified anti-C5 antibody treatment with certain amino acid substitutions that provide for longer serum half-lives and reduce the need for more frequent treatment. The application included:

  • A Jepson claim reciting, “[i]n a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising” certain amino acid substitutions, wherein the modified antibody has “increased in vivo half-life.”
  • A non-Jepson claim directed to “a method of treating a patient by administering an anti-C5 antibody comprising” certain amino acid substitutions, wherein the modified antibody “has increased in vivo half-life.”

The specification provided one example of an anti-C5 antibody, 5G1.1, and three high-level examples of potential uses for anti-C5 antibodies. The examiner rejected the claims for lack of written description. Xencor unsuccessfully appealed the rejection to the Patent Trial & Appeal Board. Xencor then unsuccessfully petitioned the Board for reconsideration. Xencor appealed to the Federal Circuit, which resulted in a remand to the Board’s Appeals Review Panel (ARP).

The ARP concluded that Jepson claim preambles require written description support and that the preamble language of “treating a patient” was limiting – even without the Jepson claim format – because it gave life and meaning to the claim recitations “increased in vivo half-life” and “administering.” Because the specification did not provide a representative number of species to support the broad genus of anti-C5 antibodies, a description of conditions that can successfully be treated with an anti-C5 antibody, or even a single working example describing treatment with an anti-C5 antibody with the claimed modifications, the ARP found that the claims lacked written description and that Xencor had not shown that anti-C5 antibodies were well known. Xencor again appealed, arguing that “treating a patient” was not limiting and that Jepson preambles do not require written description support.

With respect to the preamble of the method claim, the Federal Circuit noted that Xencor agreed that the “administering” portion was limiting but nonetheless argued that “treating a patient” was not. Although a preamble can be split into limiting and non-limiting parts, the Court reasoned that the preamble here could not be neatly packaged into separate portions because the phrase “treating a patient” was directly connected through the word “by” to the phrase “administering an anti-C5 antibody,” and each phrase gave meaning to the other. The Court further explained that the entire preamble provided the raison d’être of the claimed method: When a patient is treated with the modified anti-C5 antibody, the treatment lasts longer, reducing the frequency of treatments. Accordingly, the Court agreed with the ARP that the recitation “treating a patient” was limiting.

The Federal Circuit [...]

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No APA Review of Commission Refusal to Issue Sua Sponte Show Cause Order

by | Mar 27, 2025 |

The US Court of Appeals for the Federal Circuit dismissed an appeal challenging a US International Trade Commission decision that upheld an administrative law judge’s (ALJ) order, ruling that such an order was within the Commission’s discretion and unreviewable. Realtek Semiconductor Corp. v. International Trade Commission, Case No. 23-1095 (Fed. Cir. Mar. 18, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)

DivX filed a complaint at the Commission against Realtek alleging a violation of § 1337 of the Tarriff Act. DivX later withdrew the complaint. Realtek subsequently filed a motion for sanctions against DivX, alleging certain misconduct. The ALJ denied the motion on procedural grounds. Realtek subsequently petitioned for Commission review, asking the Commission to exercise its authority to issue a sua sponte order requiring DivX to show cause explaining why it had not engaged in sanctionable conduct. The Commission decided not to review and adopted the ALJ’s order without comment.

Realtek appealed, contending that the Commission violated the Administrative Procedure Act (APA) by not issuing a sua sponte show cause order. The Commission argued that Realtek’s appeal should be dismissed, contending that the issue raised was unreviewable.

The Federal Circuit agreed with the Commission, stating that under § 701(a)(2) of the APA, decisions made by an agency are unreviewable by the Court when they are entrusted to the agency’s discretion by law. The Court explained that the sua sponte issuance of a show cause order is a decision that “may be, not must be,” entered by the ALJ or on the Commission’s initiative. Therefore, the decision not to act sua sponte is a decision that remains wholly within the agency’s discretion.

The Federal Circuit rejected Realtek’s argument that the Commission’s refusal to act was reviewable because the Commission failed to provide reasoning, and that Commission review would have allowed the Court to determine if there were “illegal shenanigans” in exercising discretion. However, the case cited by Realtek involved the review of “shenanigans” that fell within the Court’s reviewable categories, not one related to the Commission’s refusal to issue a show cause order sua sponte. The Court found no support for Realtek’s claim that discretionary agency actions under § 701(a)(2) become reviewable under the APA simply because the agency fails to provide its reasoning.



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Power Play: Pull the Plug on Parallel District Court Litigation, ITC Investigation

by | Mar 20, 2025 |

The US Court of Appeals for the First Circuit vacated a preliminary injunction, explaining that the district court should have immediately issued a statutory stay of the proceeding under 28 U.S.C. § 1659(a) because a co-pending case at the International Trade Commission involved the same issues and parties. Vicor Corp. v. FII USA Inc., Case No. 24-1620 (1st Cir. Mar. 6, 2025) (Gelpí, Thompson, Rikelman, JJ.)

Vicor filed a § 337 complaint with the Commission against Foxconn asserting power converter module patents while simultaneously suing Foxconn for patent infringement in a Texas district court. Under § 1659, at the request of the party charged in the § 337 complaint, a federal district court must stay proceedings in a civil action between the same parties “with respect to any claim that involves the same issues [as those] involved” in the Commission action. Foxconn successfully secured a stay of the Texas litigation under § 1659.

Foxconn then initiated arbitration in China before the China International Economic and Trade Arbitration Commission (CIETAC), claiming that Vicor had agreed to such arbitration under the terms of their purchase order. The Commission’s administrative law judge denied Foxconn’s request to terminate the § 337 case, finding that Foxconn had waived that defense by failing to timely raise an arbitration defense.

Vicor then sued Foxconn in a Massachusetts district court, disputing any arbitration agreement. The district court issued a temporary restraining order (TRO) and later a preliminary injunction, blocking the CIETAC arbitration. In the Massachusetts litigation, Foxconn sought a § 1659 stay and sought to vacate the TRO. Although the district court agreed that a stay would be permitted, the court rejected the motion to vacate the TRO. The court referenced the All Writs Act, which provides that federal courts “may issue all writs necessary or appropriate in aid of their respective jurisdictions,” as justifying injunctive relief. Foxconn appealed.

The First Circuit agreed that § 1659 applied in the Massachusetts litigation and found that the statute’s plain text required an immediate stay upon Foxconn’s request without granting Vicor a preliminary injunction. The primary issue before the First Circuit was whether Vicor’s claims against Foxconn at the Commission involved the same issues as those in the Massachusetts litigation.

Reviewing the text of § 1659, the First Circuit determined that Vicor’s district court claims in the Massachusetts litigation encompassed the same issues as those raised in the § 337 proceeding. In its Massachusetts litigation, Vicor sought relief under the Federal Arbitration Act to enjoin the CIETAC arbitration and relief under the Declaratory Judgment Act for a ruling that Vicor was not bound by the arbitration terms of the purchase order agreements with Foxconn. Central to both proceedings was Vicor’s argument that it had not agreed to the purchase order terms. Because this issue was common to both the § 337 proceedings and the Massachusetts litigation, the First Circuit determined that the district court needed to issue an immediate stay to Foxconn under § 1659.

Vicor argued that for § 1659 [...]

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Get a Grip: Not All Cords Have Handles

by | Mar 20, 2025 |

The US Court of Appeals for the Federal Circuit vacated a district court’s grant of summary judgment of noninfringement because the district court improperly narrowed a claim term during its construction. IQRIS Technologies LLC v. Point Blank Enterprises, Inc. et al., Case No. 2023-2062 (Fed. Cir. Mar. 7, 2025) (Lourie, Linn, Stoll, JJ.)

IQRIS sued Point Black and National Molding for infringing its patents related to “quick release systems on tactical vests.” The patent claim vests include a “pull cord.” When pulled, the pull cord causes releasable hooks to disengage, detaching the front and rear portions of the vest. The defendants moved for summary judgment of noninfringement, arguing that the claimed “pull cord” is “a cord on the exterior of the ballistic garment grasped by a user that is capable of disengaging the releasable fastener or releasable hook when a user pulls on the pull cord.” IQRIS argued that the term should be construed as “a component which, when put into tension, can result in activating the releasable fastener.”

The district court construed “pull cord” as a “cord that can be directly pulled by a user to disengage a releasable fastener or releasable hook,” a construction that excluded cords with a handle. The district court found that one of the accused products featured a “trigger manifold” that enabled the user to apply “indirect force to [an] internal wire by applying a direct force to the trigger.” As a result, the district court determined that no reasonable jury could find infringement for that product. For another product, the district court found summary judgment to be appropriate because to rule otherwise, the accused vest would improperly encompass prior art criticized in the “background of the invention” portion of the patent specification. The specification criticized prior art having “cutaway vests with ‘handle’ release systems.”

IQRIS appealed. The Federal Circuit considered whether the district court correctly restricted “pull cord” to cords that are “directly pulled by a user.” The Court found that the claim language, which made no reference to “who or what pulls,” did not distinguish between direct and indirect pulling. Citing the patent specification, the Federal Circuit disagreed with the lower court’s interpretation, noting that the specification referred to a directly pulled element as a “pull cord” but an indirectly pulled element as just a “cord.” The Court noted that even though all disclosed embodiments depicted a directly pulled pull cord, “our precedent counsels against reading this requirement into the claims when the claims do not expressly require as much.”

The Federal Circuit next considered whether the proper construction of the term “pull cord” excluded cords with handles. The Court found that “nothing in the claim language, specification, or prosecution history supports this construction.” The claim language was “silent about the structure of the pull cord,” and the specification “suggest[ed] otherwise because each of the figures depicts a circular ball at the end of the pull cord[], suggesting that the inventors contemplated pull cords with handles.” While the specification criticized the cutaway [...]

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Palette of Evidence: PTAB Must Consider Entire Record to Determine Prior Art Status

by | Mar 20, 2025 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board patentability determination, finding that the Board failed to consider the entire record regarding the prior art status of a sample and did not explain why it did not do so. CQV Co., Ltd. v. Merck Patent GmbH., Case No. 23-1027 (Fed. Cir. Mar. 10, 2025) (Chen, Mayer, Cunningham, JJ.)

Merck owns a patent that covers alpha-alumina flakes included in paints, industrial coatings, automotive coatings, printing, inks, and cosmetic formulations to impart a pearlescent luster. CQV petitioned the Board for post-grant review (PGR) of the patent, arguing that the challenged claims were obvious in view of prior art samples of Xirallic®, a trademarked product produced by Merck. In its final written decision, the Board found that CQV had not adequately supported its contention that the alleged Xirallic® lot qualified as prior art and therefore had not shown by a preponderance of the evidence that the challenged claims were unpatentable. CQV appealed.

The Federal Circuit reviewed the Board’s finding under the substantial evidence standard. The Court found that the Board erred in failing to consider the entire record and did not provide any basis for that failure. In terms of the prior art status of the Xirallic® samples, the Court found that the Board failed to consider testimony regarding the availability of Xirallic® for customer order and the length of the quality control process. The Court could not “reasonably discern whether the Board followed a proper path” in determining that CQV failed to show by a preponderance of the evidence that the sample of Xirallic® constituted prior art. The Court remanded, suggesting that the Board carefully consider whether the sample of Xirallic® would have been publicly available as of the alleged critical dates.



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Construing Unambiguous Claim Language and Qualifying Challenged Expert as POSITA

by | Mar 20, 2025 |

Addressing the issues of claim construction and the requisite expert qualifications to testify on obviousness and anticipation, the US Court of Appeals for the Federal Circuit vacated a Patent Trial & Appeal Board decision invalidating half of the challenged patent’s claims and instructed the Board to clarify whether the patent owner’s expert was indeed qualified as a person of ordinary skill in the art (POSITA). Sierra Wireless, ULC v. Sisvel S.P.A., Case Nos. 23-1059; -1085; -1089; -1125 (Fed. Cir. Mar. 10, 2025) (Moore, CJ:  Schall, Taranto, JJ.)

Sisvel owns a patent directed to methods for retrieving data lost during wireless transmission. The prior art taught methods for flagging lost protocol data units (PDUs) so that the data transmitter could retry the transmission. Sisvel’s patent includes a timer that prescribes a period of time to elapse before alerting a transmitter of a missing PDU, allowing the transmission to be completed without notification. The patent has 10 claims, two of which are independent. The primary independent claim has four limitations, including one related to stopping the timer before a status report issues if the missing PDU is located and another related to issuing a status report upon the timer’s expiration. The limitations are linked by the word “and.”

Sierra Wireless initiated inter partes review (IPR), arguing that all 10 of the claims were both anticipated and obvious in light of the “Sachs” prior art patent. The Board found that half of the claims, including both independent claims, were anticipated and obvious. In finding that the other claims were not unpatentable, the Board relied on the testimony of Sisvel’s expert. Both parties appealed.

Sisvel raised two arguments in support of the claims the Board found unpatentable. First, Sisvel argued that the Board misconstrued the two above-noted limitations as mutually exclusive. Sisvel argued that the prior art had to teach both limitations to invalidate the claim. Second, Sisvel argued that the Board’s interpretation of Sachs’ teachings to include the first of the two limitations was unsupported by substantial evidence.

The Federal Circuit agreed. On the claim construction issue, the Court found that the two limitations in issue could not be mutually exclusive because the claim language linked them using the word “and.” To construe the limitations as mutually exclusive would be inconsistent with the unambiguous claim language. With regard to the prior art, the Court looked to Sachs Figure 5, which the Board relied upon in determining that the prior patent had taught the first limitation. Both the figure and the patent’s surrounding language made clear that the time referenced therein was dependent upon reordering of PDUs, not upon receiving missing ones. The Court thus vacated the Board’s invalidity determination as not supported by substantial evidence.

In its appeal, Sierra argued that the Board’s reliance on Sisvel’s expert’s testimony to find certain claims not unpatentable was an abuse of discretion. The Federal Circuit agreed, finding that the Board abused its discretion by not finding that the proposed expert qualified as a POSITA before relying [...]

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