- PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - PTAB · Sep 19, 2023 · IPR2018-00767 · APJ Sheila F Mcshane · IPR · Remand
The Board held that judicial estoppel and waiver preclude reliance on the inventorship certificates, leaving the prior final written decisions finding claims 1–3, 8, 11, and 17 unpatentable unchanged.
RulingsRemand decision- RemandOther
“For the foregoing reasons, we determine that judicial estoppel and waiver apply. Accordingly, the certificates of correction for inventorship have no impact on the Final Written Decisions in these cases. We also note that if judicial estoppel and waiver had been found not to apply and these proceedings were recommenced under changed inventorship, Petitioner should be permitted the opportunity to respond to Patent Owner’s new inventorship of the patents-at-issue at least by being allowed additional briefing in order to comply with due process and the Administrative Procedure Act (APA). See Pet. Remand Br. 1. Additionally, if judicial estoppel and waiver had been found not to apply, we also would likely have to determine whether the source code evidence, in view of the related testimonial evidence and argument that is already in the trial record, supports the actual reduction to practice prior to Janevski’s effective date, as Patent Owner argues it does. See Paper 13, 28–31; Paper 22, 12–22. Amongst other things, this determination would likely entail resolving a claim construction dispute between the parties that may affect the determination of whether the source code practices the claimed invention. See Paper 22, 15–16. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Patent Owner’s certificates of correction of inventorship have no impact on the Final Written Decisions.” slip op. at 25
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“Here, unlike Egenera, Patent Owner represented and provided evidence on its asserted correct inventorship directly to the Board. As discussed, Patent Owner asserted and provided evidence that Messrs. Balassanian and Bradley were the inventors of the patents and Mr. Carpenter implemented the invention. Paper 13, 19–20; Ex. 2001 ¶¶ 6, 33, 42, 46; see also Ex. 1019, 59:9–18. Patent Owner’s representations were not contested by Petitioner during trial, and Patent Owner’s representations were further consistent with the argument and evidence developed and considered by the Board during trial. Now, Patent Owner’s position on inventorship is inconsistent with its earlier position and Petitioner would be prejudiced absent estoppel. Accordingly, in this particular circumstance, judicial estoppel applies. Judicial estoppel is an equitable doctrine that prohibits a party from taking inconsistent positions in the same or related proceedings and its purpose is “to protect the integrity of the judicial process.”” slip op. at 20
- BurdenDecided for petitioner
“We agree with Petitioner that after Patent Owner was unsuccessful at trial due to the failure of its own evidence, Patent Owner now seeks to have the evidence reconsidered under changed inventorship. Pet. Remand Br. 8– 9. Patent Owner had in its sole possession the evidence of inventorship, and we believe that under these circumstances, Patent Owner should be held to the consequences of its choices as to the representations and evidence of antedating that it presented at trial. To hold otherwise would result in prejudice to Petitioner. We consider the potential prejudice to be significant; as discussed, redoing these proceedings would require Petitioner to expend additional resources. Further, under these specific circumstances where Patent Owner has made the inventorship change under its volition, Patent Owner would be afforded the unfair advantage of a “do-over,” absent the application of judicial estoppel. Accordingly, under these specific circumstances, we determine that judicial estoppel applies precluding Patent Owner from relying on the certificates of correction of inventorship in these proceedings.” slip op. at 21
NonePatents in suitUS 8,942,252 - PTAB · Sep 19, 2023 · IPR2018-00766 · APJ Sheila F Mcshane · IPR · Remand
On remand, the Board held that judicial estoppel and waiver bar reliance on the inventorship certificates, which have no impact on the final written decisions.
RulingsRemand decision- RemandDecided for petitioner
“For the foregoing reasons, we determine that judicial estoppel and waiver apply. Accordingly, the certificates of correction for inventorship have no impact on the Final Written Decisions in these cases.” slip op. at 25
- PTAB / AIA Trials › Discretionary denialNot reached
“review on the grounds presented in the Petition as to whether claims 1–3, 6– 9, 12, 16, 19, and 23–25 of the ’791 patent are anticipated by Janevski2 or would have been obvious over Janevski alone and in combination with other prior art. IPR766, Paper 10. On September 19, 2018, in IPR767, we also instituted inter partes review on the grounds presented in the Petition as to whether claims 1–3, 8, 11, and 17 of the ’252 patent would have been obvious in view of Janevski alone and in combination with other prior art. IPR767, Paper 8.” slip op. at 3
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“B. Judicial Estoppel Petitioner argues that judicial estoppel applies here to preclude the retroactive effect of § 256. Pet. Remand Br. 6–9. Petitioner asserts that judicial estoppel applies against a party when: (1) the party takes a later position that is “clearly inconsistent” with an earlier position; (2) the party succeeds in persuading a court to adopt the earlier position (which thus poses a “risk of inconsistent court determinations”); and (3) the party seeking to assert an inconsistent position would derive an unfair advantage or impose an unfair detriment on the opposing party if not estopped. Id. at 7 (citing Transclean Corp. v. Jiffy Lube Intern., Inc., 474 F.3d 1298, 1307 (Fed. Cir. 2007)). Petitioner contends that all three factors are met because Patent Owner asserted that Mr. Balassanian and Mr. Bradley were inventors and communicated the invention to Carpenter for his subsequent reduction to practice, the Board accepted the premise for the purposes of making findings of fact and rulings of law, and Patent Owner now seeks to derive the unfair advantage of revisiting the Final Written Decisions. Id. at 7–9.” slip op. at 11
Discretionary denialPatents in suitUS 7,391,791 - PTAB · Jan 8, 2018 · IPR2017-01692 · APJ Jameson Lee · IPR · Order
The Board granted the parties’ joint motion to terminate the proceedings before institution and granted both requests to keep the settlement agreements confidential.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Under the circumstances, we grant the parties’ Motion to Terminate, Motion to File the Settlement Agreement as Confidential, and Motion to File the Final Settlement Agreement as Confidential in each proceeding. These proceedings are in their early stages: a decision on institution has not issued,” slip op. at 2
NonePatents in suitUS 6,138,147
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.