- Catalyst Orthoscience Inc. v. Shoulder Innovations, Inc.Institution deniedPTAB · Apr 24, 2025 · PGR2025-00001 · APJ James A Tartal · PGR · Institution
The Board denied institution of post-grant review of claims 1–22, exercising its discretion under § 324(a) based on the Fintiv factors.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv 5−6. We consider these factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. at 6. In” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“parties, we do not find the merits to be particularly strong on the current record. For example, limitation [1-4] recites, in part, “a locking nut having . . . an external thread on an outside surface of the locking nut.” Ex. 1001, 9:46–47. In alleging obviousness based in part on Orphanos, Petitioner equates the claimed “locking nut” to Orphanos’s collet 230 in a first embodiment of Orphanos, or Orphanos’s collet portion 1052 in a second embodiment of Orphanos. Pet. 37–38. Petitioner acknowledges that the collet and collet portion do not have external threads, but rather are designed to have a snap-fit engagement with the inner sidewall of the baseplate’s central throughbore. Id. at 38. Petitioner argues that modifying the collet and collet portion to have external threads would have been obvious to the skilled artisan in view of Orphanos’s teachings and the knowledge of a person having ordinary skill in the art. Pet. 38–42 (arguing, inter alia, that it would have been “a substitution of a known part for a known problem” and “obvious as a matter of design choice”). Petitioner does not allege that replacing the snap-fit coupling with external threads would either: (1) result in any advantages; or (2) preserve any of Orphanos’s stated benefits of its snap-fit arrangement. See Pet. 34–37. That Petitioner describes no advantages to making its proposed modification potentially undermines Petitioner’s case that the skilled artisan would have done so. Cf. Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANot reached
“Petitioner’s arguments regarding the central post and locking nut include an implicit claim construction argument that these components need not be separate structures. Pet. 74, 76–81. Patent Owner, on the other hand, would have us interpret the claim to require that they be separate structures. Patent Owner raises credible evidence to support its theory. Specifically, Patent Owner directs us to the language of claim 1, which separately recites “a central screw” and “a locking nut.” Prelim. Resp. 51; see Ex. 1001, 9:44–53. Patent Owner further contends, in view of the claim language, that the claimed central post and locking nut are separate and distinct components. According to Patent Owner, however, Lefebvre’s main head and anchor rod portions are parts of a single monolithic anchoring screw. Prelim. Resp. 53–58. Where a claim lists elements separately, there is a rebuttable presumption that these elements have separate and distinct physical structures. See Google LLC v. EcoFactor, Inc., 92 F.4th 1049, 1058 (Fed. Cir. 2024) (citing Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1231–1232 (Fed. Cir. 2011)). The presumption may be rebutted by the intrinsic record. Id. At this stage, however, Petitioner does not address that claim 1 appears to separately recite a central post and a locking nut, and does not direct us to any portion of the intrinsic record that might rebut the presumption that these elements are, therefore, separate and distinct structures. See Pet. 73–77. Petitioner also argues that the claim terms “baseplate central channel” and “central channel . . . configured to interface with the baseplate” are indefinite. Pet. 95–102. Patent Owner argues that the plain and ordinary meaning of the terms is clear and that Petitioner “had no problem” arguing how the asserted art purportedly rendered the claims obvious. Prelim. Resp. 69–77.” slip op. at 17
- Disclosure Requirements (§112) › Definiteness (Nautilus)Not reached
“Petitioner also argues that the claim terms “baseplate central channel” and “central channel . . . configured to interface with the baseplate” are indefinite. Pet. 95–102. Patent Owner argues that the plain and ordinary meaning of the terms is clear and that Petitioner “had no problem” arguing how the asserted art purportedly rendered the claims obvious. Prelim. Resp. 69–77. In sum, even if Petitioner’s contentions show it is more likely than not that at least one of the claims challenged in the Petition is unpatentable, we find Patent Owner’s arguments identify credible weaknesses in Petitioner’s contentions. Accordingly, we find that that the sixth Fintiv factor is neutral and does not weigh against discretionary denial.” slip op. at 18
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 12,023,254 - Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution deniedPTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,078,265 - Boston Scientific Corporation v. Uab Research FoundationInstitution deniedPTAB · Sep 24, 2015 · IPR2015-00918 · APJ James A Worth · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–20 anticipated by KenKnight ’967, which was not prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“To institute an inter partes review, we must determine that the argument and evidence presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we do not institute an inter partes review for the challenged claims.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“We agree with Patent Owner, and we determine that the ’261 Application sets forth a device “configured for” “delivering antitachycardia pacing to said heart,” as recited by independent claims 1, 7, and 14. Petitioner has not persuaded us that the ’261 Application fails to disclose the claimed structure. Indeed, the ’261 Application discloses the same configuration of electrodes that deliver electrical impulses of the same energy and characteristics as the ’563 patent. Ex. 1002, 9:3–9, 12:30–32, Fig. 1. As noted by Patent Owner, the ’261 Application makes plain that it is directed to the treatment of “all forms of cardiac tachyarrythmias,” including “ventricular tachycardia.” See id. at 7:4–9.2” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“We agree with Patent Owner, and we determine that the ’261 Application sets forth a device “configured for” “delivering antitachycardia pacing to said heart,” as recited by independent claims 1, 7, and 14. Petitioner has not persuaded us that the ’261 Application fails to disclose the claimed structure. Indeed, the ’261 Application discloses the same configuration of electrodes that deliver electrical impulses of the same energy and characteristics as the ’563 patent. Ex. 1002, 9:3–9, 12:30–32, Fig. 1. As noted by Patent Owner, the ’261 Application makes plain that it is directed to the treatment of “all forms of cardiac tachyarrythmias,” including “ventricular tachycardia.” See id. at 7:4–9.2” slip op. at 8
§ 102 anticipation§ 112 disclosurePatents in suitUS 6,266,563
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.