- PTAB · Jun 20, 2023 · PGR2023-00008 · APJ Kristina M Kalan · PGR · Institution
The Board instituted post-grant review of claims 1–13 on all petitioned grounds, finding it more likely than not that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute post-grant review, we must determine that the information presented in the Petition, “if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons discussed below, after considering the parties’ submissions and the evidence of record, we determine that Petitioner has demonstrated that it is more likely than not that at least one of the challenged claims of the ’624 patent is unpatentable. Thus, we institute post-grant review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“evaluated the subject matter of Riis during examination of the ’624 patent, we agree that Riis was before the Office, as discussed in connection with our analysis of the first part of the Advanced Bionics framework, above. Examiner T presumably was aware of Riis by virtue of having initialed an IDS containing Riis in the ’624 patent’s application and also by virtue of having initialed an IDS containing Riis in the ’067 Application, but Examiner T did not apply Riis in connection with the examination of the ’624 patent. On this record, Patent Owner also fails to show that the claims of the child application leading to the ’624 patent are substantially similar to those of the parent ’814 patent in which Examiner S considered Riis, and, thus, consideration of Riis during the prosecution of the ’814 patent does not equate to consideration of Riis during the prosecution of the ’624 patent. Regarding Patent Owner’s argument (2) that Petitioner fails to sufficiently show how the Examiner erred in evaluating the prior art, we find Petitioner’s arguments demonstrate that Examiner T, the examiner of the ’624 patent, did not apply Riis (or Wypych or Tatarka) during the examination of the’624 patent. As Petitioner argues, the error lies in that “the Examiner failed to consider the relevance of Riis as it applied to the pending method claims,” because although “Riis was considered during examination of the parent ’999 application, Riis was not similarly considered during examination of the ’018 application which led to the ’624 patent.” Pet. 76–77. We determine that the circumstances here demonstrate that the Examiner erred in evaluating the prior art.” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityNot reached
“35 U.S.C. § 322(a)(2) to deny institution, arguing that the Petition fails to identify every RPI. Prelim. Resp. 10–11, 56–60. Patent Owner argues that the Petition “should also have identified its parent corporation, Huhtamäki Oyj . . . as well as the related corporation Huhtamaki, Inc. . . . as RPIs to comply with the statutory requirements for a PGR.” Id. at 10. On this record, we determine that we need not address whether Huhtamäki Oyj and Huhtamaki, Inc. are unnamed RPIs because, even if they were, it would not create a time bar or estoppel under 35 U.S.C. § 325. See SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (PTAB Oct. 6, 2020) (precedential); Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00739, Paper 38 at 6 (PTAB Mar. 4, 2016) (precedential) (Board’s jurisdiction to consider a petition does not require a “correct” identification of all RPIs in a petition); see also Blue Coat Sys., Inc. v. Finjan, Inc., IPR2016-01444, Paper 11 at 10 (PTAB July 18, 2017) (“evidence [of failure to identify all RPIs] is, at best, suggestive regarding an issue that is not jurisdictional”); Mayne Pharma Int’l Pty. Ltd. v. Merck Sharp & Dohme Corp., 927 F.3d 1232, 1240 (Fed. Cir. 2019) (“[I]f a petition fails to identify all real parties in interest . . . the Director can, and does, allow the petitioner to add a real party in interest.” (quoting Wi-Fi One, LLC v. Broadcom Corp., 878 F.3d 1364, 1374 n.9 (Fed. Cir. 2018) (en banc))). Here, notwithstanding the arguments devoted to the RPI issue in the Preliminary Response, Preliminary Reply, and Preliminary Sur-Reply, we are not persuaded that Petitioner is barred or estopped from this proceeding, or that Petitioner purposefully omitted Huhtamäki Oyj or Huhtamaki, Inc. to gain some advantage. As Petitioner argues, the “RPI analysis is not necessary at institution, because Patent Owner has not alleged Petitioner would be time barred or otherwise estopped based on unnamed RPIs.” Prelim. Reply 5 (quoting SharkNinja, IPR2020-00734, Paper 11 at 18). As SharkNinja states, certain Board decisions go through extensive analysis to determine whether parties should have been named as RPIs, whereas other Board decisions determine that “such a lengthy exercise is unnecessary for the purposes of rendering a decision on institution of trial.” SharkNinja, IPR2020-00734, Paper 11 at 19. Here, as in SharkNinja, we find the latter approach better serves the interest of cost and efficiency. Thus, at this time and on this record, we will not consider whether Huhtamäki Oyj or Huhtamaki, Inc. must be named as RPIs.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention “would have had a relevant technical degree in Chemical Engineering, Polymer Science, Materials Science, or the like, and 2–3 years of experience in laminate or film manufacture or similar packaging manufacture and that less experience may be necessary with additional education and vice versa.” Pet. 17 (citing Ex. 1003 ¶¶ 66–72). In its 4 Neither Patent Owner nor Petitioner appear to present any evidence directed to secondary considerations. See generally Pet.; Prelim. Resp.; Prelim. Reply; Prelim. Sur-Reply. Preliminary Response, Patent Owner does not contest Petitioner’s asserted level of ordinary skill in the art. See generally Prelim. Resp. We adopt Petitioner’s definition, which is consistent with the level of skill in the art at the time of the invention as reflected by the prior art and the ’624 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 17
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham · NautilusPatents in suitUS 11,260,624 - PTAB · Jan 13, 2023 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–28 based on both asserted grounds: anticipation by Eltoukhy and obviousness over Eltoukhy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is 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 provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“reads having the same SMI tag and “is agnostic to whether the reads are paired or unpaired.” Pet. 17. We are persuaded by this argument and find the first grouping does not relate to sorting sequence reads into groups of paired reads and unpaired reads, as claimed. See 1152 DDI, 21. Regarding the second grouping, even if we accept that it describes sorting sequence reads into paired reads,4 we find Patent Owner has not shown sufficiently that it describes sorting sequence reads into unpaired reads, as claimed.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“3. Effective Filing Date of the Challenged Claims In an IPR, although Petitioner has the ultimate burden of persuasion to prove unpatentability, Patent Owner must demonstrate entitlement to a priority date when Patent Owner relies on that priority date to overcome an anticipation or obviousness argument. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379–80 (Fed. Cir. 2015); see also In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier priority date because the patentee claims priority. Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.” (citations omitted)). On the current record, and for purposes of this Decision, we find Patent Owner has not shown sufficiently that the claims of the ’951 patent are entitled to an effective filing date earlier than July 26, 2017, the filing date of the ’785 application. Thus, Eltoukhy qualifies as prior art. See Pet. 13–34. For this analysis, we focus on step (d) of claim 1, “sorting sequence reads into paired sequence reads and unpaired sequence reads” (“the sorting limitation”).” slip op. at 11
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,752,951 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.Institution deniedPTAB · Sep 15, 2022 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that any of claims 1–19 was unpatentable on the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we deny institution of a post-grant review.1” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001[,] col. 42, ll. 12–16.6 This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration [submitted by Patent Owner during prosecution], and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4. Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“From mere disclosure of crincerfont, Petitioner asks us to find a particular treatment protocol using this drug and the outcomes of such treatment as taught by non-prior art Auchus 2021 are inherent in the drug itself. Such outcomes of such treatment as is the subject of the challenged claims here may be inherent in a particular treatment regimen using a particular drug, but it is too far of a leap to say that disclosure of the drug itself would render inherent any treatment outcome using any treatment protocol. For the reasons set forth above, we determine that Petitioner has failed to establish that it is more likely than not that Grigoriadis anticipates claim 1 of the ’201 patent. Because the remaining claims challenged in this ground depend either directly or indirectly on claim 1, we similarly conclude that Petitioner has not established a likelihood of prevailing with respect to these dependent claims, claims 2–4, 7–9, 11–15, 18.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,007,201 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Aug 1, 2022 · IPR2022-00449 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the written-description priority arguments were substantially the same as those considered by the Office, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Based on this record, we find Petitioner’s arguments challenging written description support are the same or substantially the same as those considered by the examiner during the prosecution of the ’045 application. 4. Material Error Having found that the condition in the first part of the two-prong framework is satisfied, we next evaluate whether Petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, 8. Based on the current record, we determine Petitioner has not met its burden to show the examiner materially erred.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“Specifically, Petitioner argues that the ’785 application lacks written description support for “converting” or “attaching” tags to “circulating DNA molecules,” as recited in independent claims 1 and 20. Id. at 17–30. Patent Owner argues that we should deny institution under § 325(d) “because the Office already found that the specification provides § 112 support for tagging circulating DNA.” Prelim. Resp. 10. For the reasons explained below, we find Patent Owner’s arguments persuasive.5 5 As another basis for its priority arguments, Petitioner contends that the ’785 application does not enable methods for “converting” or “attaching” tags to “circulating DNA molecules.” Pet. 30. Patent Owner asserts that “[t]he Petition gives enablement only cursory treatment.” Prelim. Resp. 36. We agree with Patent Owner. Petitioner disposes of the entire enablement argument in a single seven-line paragraph. See Pet. 30. It provides no meaningful analyses of the factors set forth in In re Wands, 858 F.2d 731,” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Petitioner’s anticipation and obviousness grounds rest on the priority date of the challenged claims. Because we decline to reconsider Petitioner’s challenge of priority date based on lack of written description support, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’699 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied.” slip op. at 18
§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,689,699 - Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution deniedPTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution
The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908
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.