- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the 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. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner contends that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,934,356 - 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 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11
- Strike new argumentNew argument consideredDenied
“9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65
Patent outcomesUS 10,137,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,137,001 - Life Spine, Inc. v. Globus Medical, Inc.Some claims unpatentablePTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.
RulingsFinal written decision- Expert testimonyOther
“improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66
- Strike new argumentNew argument consideredDenied
“provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106
Patent outcomesUS 8,845,731 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,845,731 - Syngenta Crop Protection AG v. Upl Ltd.InstitutedPTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution
Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “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 provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant 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); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, we “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. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,445,727 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00384 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1, 2, 4–9, and 12–19 are unpatentable under § 103 over Chia, Akorn, and Kondritzer; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a liquid ophthalmic formulation of a small amount of atropine that is stabilized using buffers that can be stored for at least two weeks under certain temperature and humidity conditions. See Ex. 1001, 97:32–44 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known as “the oldest and most effective pharmacological treatment to inhibit the development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See id. ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 22. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25–26. In reply, Petitioner asserts that the ordinary meaning of “about” is” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Reply 1 (“As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 9; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here.” slip op. at 31
Patent outcomesUS 10,842,787 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,842,787 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00414 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7 and 11–20 are unpatentable as obvious over Chia and Akorn; the Board did not reach the Wu and Akorn ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a kit with a vial of a pharmaceutical composition of atropine, water, and buffer, and instructions for use. See Ex. 1001, 99:12–19 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known 7 Although Patent Owner disagrees with Petitioner’s definition of a POSA, Patent Owner does not provide its own definition apart from including expertise in ophthalmic formulation. See PO Resp. 4–7. development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See Ex. 1002 ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4). None of this chemistry concerning the stability of atropine or its administration in the eye is remarkable or not well understood by a POSA as defined by Petitioner. See PO Resp. 10 (stating “the stability of atropine was understood to be a ‘predictable function,’ and a ‘routine matter,’ of temperature and solution pH”), 40–41 (same). We see no reason why someone with drug formulation experience, but not specific experience with ophthalmic solutions, would not qualify as a POSA. Therefore, we continue to apply Petitioner’s definition of a POSA in this final written decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 21. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25. In reply, Petitioner asserts that the ordinary meaning of “about” is “approximately,” and the ordinary meaning of “buffering agent” or “buffer” “is nothing more than an excipient that helps control pH.” Reply 2. Petitioner asserts that Patent Owner agrees with the definition of “buffering agent” and “buffer” by stating that “[t]he patent uses terms buffer and buffering in their normal sense, which entails providing pH control or maintenance.” Id. (quoting PO Resp. 28). Based upon our review of the evidence of record, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”). Insofar as the parties dispute whether Akorn discloses a buffer, we address those contentions in our discussion below of the challenged claims.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Opp. to Mot. to Exclude 8 (“Moreover, public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on that site at least by July 24, 2014. See EX1057, 3.”) As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 10–22; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest. Petitioner also provides further evidence that the Akorn label was published on July 24, 2014, through a response by the National Library of Medicine (“NLM”) to a Freedom of Information Act request. See Ex. 1071. confirmation that the substance of the Akorn label was posted on July 24, 2014, on the DailyMed website. Id. The National Institutes of Health (“NIH”) responded that version 7 of the Akorn label was published on DailyMed on July 24, 2014, and provided the URL that is reflected in the Akorn label in Exhibit 1057 from the DailyMed website. See Ex. 1072, 6; Ex. 1057, 4–7. NIH also confirmed that NLM “received version 7 of this label from the FDA on 07/24/2014 @ 2:15:04 PM,” “published version 7 on DailyMed on the same day, 07/24/2014 @ 14:59:48 PM,” and confirmed that “NLM does not make changes to the content contained within any SPL [or structured product labeling] records that it receives from the FDA.” Ex. 1072, 6. We find that Petitioner has provided more than sufficient evidence that the Akorn label reflected in Ex. 1004 was publicly available before the critical date. For the reasons set forth above, we determine that Petitioner has shown by a preponderance of the evidence that Akorn, Ex. 1004, is a printed publication that was publicly available before the critical date.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“We agree with Petitioner here that Patent Owner’s concerns about the sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here. Also, the district court’s findings are not as definitive as Patent Owner states. The patent owner in the district court case attempted to prove infringement by the doctrine of equivalents for a formulation that did not expressly contain a buffer, but that it argued inherently contained a buffer from the chemical disassociation of the active ingredient in the product. See Ex. 2010, 64–65. The district court found that patent owner failed to prove case is in stark contrast with the underlying facts of this proceeding in which the prior art formulation expressly contains the same buffers as claimed in the ’145 patent. See Ex. 1001, 99:33–35 (claim 5); Ex. 1004, 3. (c) Conclusion Based on the foregoing, we deny Patent Owner’s motion to exclude Exhibit 1002, Dr. Byrn’s testimony.” slip op. at 28
Patent outcomesUS 10,940,145 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,940,145
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.