• Transgene / Bioinvent International AB v. Replimune LimitedNo claims unpatentable
  PTAB · May 25, 2023 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Final written decision

  The Board held claim 13 not unpatentable over Silvestre or Du, Choi, and Zitvogel, finding insufficient motivation to combine and reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “or “POSITA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post-Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See PO Resp. 5. We adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the prior art. 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” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “claim terms of the ’513 patent for purposes of determining whether to institute trial. For purposes of our analysis in this Final Written Decision, however, we find that it would be useful to clarify the scope of “oncolytic virus.” We agree with Petitioner that the Specification defines an “oncolytic virus” as “a virus that infects and replicates in tumor cells, such that tumor cells are killed.” Ex. 1001, 9:10–12. The Specification further clarifies that “the virus is replication competent,” and is preferably selectively replication competent in tumor tissue. Id. at 9:12–13. “A patentee is free to be his own lexicographer.” Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, consistent with its express definition in the Specification, to be a virus that infects and replicates in tumor cells, such that tumor cells are killed, wherein such a virus is replication competent.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “but contends that “oncolytic virus” should not be construed to encompass “viral vectors” such as those disclosed in Zitvogel. PO Resp. 5. Although Petitioner does not expressly contend otherwise, we agree with Patent Owner that “oncolytic virus” would not encompass Zitvogel’s “viral vectors,” which are defined in that reference to be “replication-defective” or “replication-impaired.” Ex. 1004, 19:26–29. We do not construe any other claim terms. See Vivid Techs., Inc. v.” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Petitioner acknowledges that “while the bulk of Silvestre’s disclosure, including the working examples, is directed towards creating an oncolytic poxvirus, Silvestre discloses preparing modified oncolytic virus using other virus types, including HSV.” Pet. 44. It is undisputed, however, that Silvestre does not disclose a single embodiment of an oncolytic HSV that includes both a heterologous GM-CSF encoding gene and a heterologous CTLA-4 inhibitor encoding gene. Rather, Petitioner points to where each element could be found among broader lists of possible oncolytic virus classes, immune checkpoint targets, and therapeutic genes. Ex. 1002, 7:10– 15:49. As noted by Dr. Chiocca, if one were to randomly select any of the 11 We need not decide whether Silvestre anticipates independent claim 1, as the sole challenged claim 13 depends directly from claim 11. Thus, our determination that Petitioner has not shown that claim 11 is anticipated is sufficient to establish that Petitioner has not met its prerequisite burden for claim 13. Ex. 2009 ¶ 29. This type of picking and choosing is not anticipation. See Arkley, 455 F.2d at 587–88.” slip op. at 19

  Patent outcomesUS 10,947,513 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,947,513
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Penumbra, Inc. v. Rapidpulse, Inc.Instituted
  PTAB · Sep 9, 2022 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Institution

  The Board instituted review of claims 1–21 on all four § 103 grounds, finding a reasonable likelihood that at least one challenged claim would have been obvious.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “review under 35 U.S.C. § 314, which provides that an inter partes review may be instituted only upon a showing that “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). After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all challenged claims of the ’253 patent, based on all of the grounds identified in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “On the current record, we do not find that the disclosure of the ’011 provisional application is sufficient to provide written description support for the limitation of “substantially prevent[ing] forward flow.” The ’253 13 patent defines forward flow as “an amount of liquid in the lumen . . . that exits the distal end . . . in the distal direction” and “is defined as greater than 6 microliters of fluid.” Ex. 1001, 38:18–22. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not necessarily be apparent to one of ordinary skill in the art that such disclosure is referring to no greater than 6 microliters of fluid. Prelim. Resp. 31–32 (citing Ex. 1003 ¶¶ 16, 138).” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “Next, we note that Patent Owner does not appear to contest that Teigen gets priority back to the December 12, 2018, filing date of the ’708 provisional application. See e.g., Prelim. Resp. 25. As discussed above, because we find on the current record that the ’253 patent is only entitled to a priority date of July 18, 2019, Teigen is 35 U.S.C. §§ 102(a)(2) and (d)(2) art to the ’253 patent regardless of whether it can receive priority to the ’804 provisional application. However, we discuss the priority date of Teigen here in order to provide guidance to the parties. The ’804 provisional application discloses pulsated aspiration in which, at times, the valve to the vacuum pump is closed and the valve to the saline injection unit is open in order to more efficiently digest a clot that is 25 large or otherwise difficult to aspirate. Ex. 1008 ¶¶ 65, 69. According to the ’804 provisional, “[s]aline pulsated aspirations provide a ‘dynamic’ aspiration force” because “[i]nstead of aspirating clots with a static (constant) vacuum force, pulsated aspiration introduces an acceleration component to the mass transfer force which can help break up larger clots so that they can better fit in the catheter lumen.” Id. ¶ 64. We agree with Patent Owner that the ’804 provisional does not specifically mention “positive pressure.” We also understand, based on the current record, that a positive pressure could result at the distal end of the catheter when the vacuum pump is turned off and the saline injection unit is open to create an influx of saline into the catheter. However, we acknowledge Patent Owner and Dr. Finol’s contentions that such positive pressure is not necessarily inherent because catheters are somewhat compliant and there are many factors that influence the magnitude of a pressure pulse caused by introducing saline into the catheter. We also acknowledge their argument that such an ambient saline flow may not inherently produce a positive pressure sufficient to overcome the mean arterial pressure. These issues will be better resolved on a complete trial record. But, for the reasons stated above and based on the present record, we treat Teigen as prior art for purposes of this Decision.” slip op. at 25

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner, relying on the testimony of Mr. Brown, contends that a person of ordinary skill in the art (“POSA” or “POSITA”) as of the relevant date would be either: (1) a person with a B.S. in engineering or an equivalent field, with two to four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where necessary or desired, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where necessary, work or consult with others, including an engineer, to develop such a medical device. Pet. 16 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner does not address the definition of a POSA in its Preliminary Response.2 See Prelim. Resp.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,722,253
• Thorne Research, Inc v. Trustees Of Dartmouth CollegeNo claims unpatentable
  PTAB · Aug 10, 2022 · IPR2021-00491 · APJ John E Schneider · IPR · Final written decision

  Claims 1–3 were not shown unpatentable because the relied-upon portions of the Cell Article and PCT Publication were not shown to be the work of another and thus were not prior art.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 (2018). As discussed above, the ’807 patent meets all four criteria set forth above for each application in the priority chain of the PCT application listed on the face of the ’807 patent. Since the claim of priority arises under Section 120, the provisions of the Paris Convention and PCT do not apply.” slip op. at 12

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artNot shown unpatentable

    “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We are not persuaded by Petitioner’s arguments. Although the laboratory techniques and starting materials used by Drs. Brenner and Bieganowski may have been known in the art, that is not the claimed invention. The invention as recited in claim 1 is directed a composition comprising isolated NR combined with one or more of tryptophan, nicotinic acid, or nicotinamide and one of the recited carriers, wherein the composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. See Ex. 1001, col. 53. That the certain individual elements of the claimed composition may have been known elsewhere in the prior art does not lead to a conclusion that the relied-upon portions of the Cell Article are “by another.”” slip op. at 30

  Patent outcomesUS 8,197,807 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,197,807
• Freedom To Operate, Inc. v. Compass Pathfinder LimitedInstitution denied
  PTAB · Jun 22, 2022 · PGR2022-00018 · APJ Tina E Hulse · PGR · Institution

  The Board denied institution on claims 1–23 because Petitioner did not show it was more likely than not that any challenged claim was unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “post-grant review may not 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 considering the arguments and evidence presented by the parties, we determine Petitioner has not demonstrated that it is more likely than not that any of the claims challenged in the Petition are unpatentable.” slip op. at 2

  • PTAB / AIA Trials › Real party in interest / privityNot reached

    “G. Remaining Arguments Patent Owner also argues we should deny the Petition for failure to identify all real parties-in-interest in the Petition. Prelim. Resp. 31–44. Because we determine that Petitioner has not sufficiently established that in this Decision.” slip op. at 24

  • Skill levelSkill level petitioner adoptedOther

    “B. Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art “would have had an advanced degree (i.e., a Master’s degree with two or more years of experience, or a Ph.D.) in inorganic or organic chemistry, chemical engineering, pharmacology, or a related discipline” and “would be familiar with medicinal chemistry or pharmaceutical chemistry, and with analytical methods to characterize and differentiate solid forms of compounds, (‘DSC’) and thermogravimetric analysis (‘TGA’).” Pet. 27 (citing Ex. 1106 ¶ 38). Petitioner further contends that “[a]lternatively, one of ordinary skill could have less education and approximately five or more years of relevant experience.” Id. Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. See generally Prelim. Resp. Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. 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 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “We agree with Patent Owner’s proposed construction, as it is most consistent with the intrinsic evidence. The claim language makes clear that “Polymorph A” is “characterized by” the specific peaks set forth in the claims. Ex. 1101, claims 1, 8, 16. Thus, regardless of the alleged conventional definition of a “polymorph,” urged by Petitioner, the inventors are entitled to act as their own lexicographers to define “Polymorph A” according to the recited peaks on the XRPD diffractogram. See Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007) (“When a patentee defines a claim term, the patentee’s definition governs, even if it is contrary to the conventional meaning of the term.”). That the Specification consistently refers to “Polymorph A” as a proper noun and describes Polymorph A as “characterized by” the recited peaks in an XRPD diffractogram further highlights the inventors’ clear intent to act as their own lexicographer. See, e.g., Ex. 1101, 4:4–5:36; Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir. 2005) (“When a patentee acts away from their ordinary meaning, he must clearly express that intent in the written description.”). Finally, we agree with Patent Owner that the prosecution history of the parent ’257 patent is relevant to the construction of the claims of the ’259 patent, which is a continuation of the ’257 patent. Prelim. Resp. 6 (citing Iridescent Networks, Inc. v. AT&T Mobility, LLC, 933 F.3d 1345, 1350 (Fed. Cir. 2019) (“Statements made during prosecution of a parent application are relevant to construing terms in a patent resulting from a continuation application if such statements relate to the subject matter of the claims being construed.”)). During prosecution of the parent ’257 patent application, the examiner rejected original claim 1 as indefinite because it did not define “Polymorph A,” and required one to “refer to the specification to determine what is Polymorph A.” Ex. 2133, 7. Patent Owner then amended the claims to define Polymorph A by adding the specific XRPD peaks recited in claim 1. Ex. 2134, 2; see also id. at 6. Thus, we find the intrinsic evidence supports Patent Owner’s proposed construction.” slip op. at 9

  Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,954,259
• Freedom To Operate, Inc. v. Compass Pathfinder LimitedInstitution denied
  PTAB · Jun 22, 2022 · PGR2022-00012 · APJ Tina E Hulse · PGR · Institution

  The Board denied institution of PGR on claims 1–23 because Petitioner did not show it was more likely than not that any challenged claim was unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not 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 considering the arguments and evidence presented by the parties, we determine Petitioner has not demonstrated that it is more likely than not that any of the claims challenged in the Petition are unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had an advanced degree (i.e., a Master’s degree with two or more years of experience, or a Ph.D.) in inorganic or organic chemistry, chemical engineering, pharmacology, or a related discipline” and “would be familiar with medicinal chemistry or pharmaceutical chemistry, and with analytical methods to characterize and differentiate solid forms of compounds, particularly XRPD, but also including differential scanning calorimetry (‘DSC’) and thermogravimetric analysis (‘TGA’).” Pet. 28 (citing Ex. 1006 ¶ 35). Petitioner further contends that “[a]lternatively, one of ordinary skill could have less education and approximately five or more years of relevant experience.” Id. Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. See generally Prelim. Resp. Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. 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 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “We agree with Patent Owner’s proposed construction, as it is most consistent with the intrinsic evidence. The claim language makes clear that “Polymorph A” is “characterized by” the specific peaks set forth in claim 1. Ex. 1001, claim 1. Thus, regardless of the alleged conventional definition of a “polymorph,” urged by Petitioner, the inventors are entitled to act as their own lexicographers to define “Polymorph A” according to the recited peaks on the XRPD diffractogram. See Honeywell Int’l, Inc. v. Universal Avionics a claim term, the patentee’s definition governs, even if it is contrary to the conventional meaning of the term.”). That the Specification consistently refers to “Polymorph A” as a proper noun and describes Polymorph A as “characterized by” the recited peaks in an XRPD diffractogram further highlights the inventors’ clear intent to act as their own lexicographer. See, e.g., Ex. 1001, 4:4–5:36; Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir. 2005) (“When a patentee acts as his own lexicographer in redefining the meaning of particular claim terms away from their ordinary meaning, he must clearly express that intent in the written description.”). Finally, during prosecution of the ’257 patent application, the examiner rejected original claim 1 as indefinite because it did not define “Polymorph A,” and required one to “refer to the specification to determine what is Polymorph A.” Ex. 1060, 7. Patent Owner then amended the claims to define Polymorph A by adding the specific XRPD peaks recited in claim 1. Ex. 1062, 2; see also id. at 6. Thus, we find the intrinsic evidence supports Patent Owner’s proposed construction.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Having considered the parties’ respective arguments and evidence, we find Patent Owner has the better position. Although we agree with Petitioner that some degree of experimental error should be factored into the specific peaks of a diffractogram, the claim language already does so by expressly reciting a variance of “±0.1°2θ.” See Ex. 1001, claim 1. Construing the claims to include an additional degree of variance would effectively read out the “±0.1°2θ” limitation of the claims. See Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so.”). Moreover, we note that the express recitation of a specific variance distinguishes the ’257 patent claims from the claims of the Astrazeneca cases cited by Petitioner, which did not recite such a variance. See Pet. 11–12. In addition, the Specification consistently refers to a variance of ±0.1°2θ whenever it refers to peaks on a diffractogram. See generally Ex. 1001, 3:58–5:24. Petitioner acknowledges that the claims recite a range of peak locations, but argues that the Specification “does not explain the basis for the claimed range.” Pet. 10. Petitioner, however, does not explain why the Specification would need to explain that basis, particularly if a person of ordinary skill in the art would understand that ±0.1°2θ is an acceptable variance for XRPD.” slip op. at 13

  Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,947,257
• Transgene / Bioinvent International AB v. Replimune LimitedInstituted
  PTAB · Jun 16, 2022 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Institution

  The Board instituted PGR on claim 13, finding it more likely than not unpatentable as obvious over Silvestre or over Du, Choi, and Zitvogel.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “To institute a post-grant review, we must determine whether 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). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that the evidence and arguments presented in the Petition are sufficient to satisfy the “more likely than not” standard regarding the asserted unpatentability of claim 13 in the ’513 patent. Therefore, we authorize a post-grant review to be instituted as to claim 13.” slip op. at 3

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “1. Legal Framework Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an post-grant 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.” The Board evaluates two issues in addressing 35 U.S.C. § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). With respect to the first issue, previously “presented” art includes, among other things, “art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS), in the prosecution history of the challenged patent.” Id. at 7–8. With respect to the second issue, institution generally will be denied if a “petitioner fails to make a showing of material error,” and “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 8–9. “[T]his framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that a person of ordinary skill in the art (“POSA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post- Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See Prelim. Resp. 16–17. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the prior art. 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))). It is from the perspective of such a person of ordinary skill that we consider the claims and prior art.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “Based on the present record, we find that Petitioner has shown that it is more likely than not that inserting the GM-CSF gene and the CTLA-4 inhibitor encoding gene in a back-to-back orientation in relation to each other would have been known to a person of ordinary skill in the art. Petitioner’s expert Dr. Bell states that “[w]hen inserting two genes into a given locus, the simplest and most common way to do so is to insert them in a back-to-back orientation under control of separate regulatory elements.” Ex. 1007 ¶ 230. While Patent Owner is correct in stating that no sources are cited in paragraph 230, Dr. Bell does cite back to paragraphs 73–81 and 87– 88 of his own declaration. See id. In those paragraphs, Dr. Bell explains that the “deletion of endogenous nucleotides requires either pre-existing knowledge of the effect of disrupting the particular gene at the insertion site or requires a difficult and time-consuming trial-and-error process to gain such knowledge.” Id. ¶ 73 (citing Ex. 1035). Exhibit 1035 is a review article entitled “Unconventional viral gene expression mechanisms as therapeutic targets.” See Ex. 1035. Dr. Bell points to Figure 1 of this article as showing that certain viral genomes include genes that are overlapping and/or that encode polyproteins, which can add to a further level of difficulty in identifying a suitable insertion locus. Ex. 1007 ¶ 74 (citing Ex. 1035, 364, Fig. 1). Dr. Bell further explains that “inactivation of the neurovirulence factor ICP34.5 in HSV1 has been well-known to direct tumor-specific cell lysis, making HSV1 ICP34.5 knock-outs useful oncolytic virus vectors,” but also notes that “unless such a well-known insertion site is used, determining whether insertion of a heterologous gene at any particular site will be successful requires a difficult and time-consuming trial-and-error process.” Id. ¶ 77 (citing Ex. 1039, 292, Ex. 1040, 4–7, Ex. 1041, 575). Accordingly, within paragraphs 73–81 and 87–88, Dr. Bell provides evidentiary support for his conclusions in paragraph 230. See Ex. 1007 ¶¶ 73-81, 87-88. We are not persuaded by Patent Owner’s reliance upon the Arendi case to argue that Petitioner improperly relies upon common sense to supply a missing limitation. In Arendi, the court noted that “the Board’s presumption that adding a search for phone numbers to [the prior art refence] would be ‘common sense’ was conclusory and unsupported by substantial evidence, the missing limitation is not a ‘peripheral’ one, and there [was] nothing in the record to support the Board’s conclusion that supplying the missing limitation would be obvious to one of skill in the art.” 832 F.3d at 1366–67. But here, as noted above, Dr. Bell cites to several references in support of his rationale that one of ordinary skill in the art seeking to insert both the genes would have started with the known ICP34.5 locus rather than undertaking a rigorous trial-and-error process to find an altogether new insertion locus. We do not find the concern stated in Arendi about using common sense “as a wholesale substitute for reasoned analysis and evidentiary support” to be present in this case. See id. at 1362. Here, the “common sense” challenged by Patent Owner refers to the “common knowledge” of the ordinarily skilled artisan as of the invention referenced in the Petition and by Dr. Bell, and it is from such a person’s perspective that we must read Silvestre. Thus, based on the current record, we determine that Petitioner has provided sufficient evidence beyond merely a conclusory assertion of “common sense” to show that inserting the genes at issue in a back-to-back orientation would have been known in the art.7” slip op. at 14

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 10,947,513
• Sabinsa Corporation v. Franco CavaleriInstituted
  PTAB · Jun 15, 2022 · PGR2022-00015 · APJ Susan L C Mitchell · PGR · Institution

  Instituted PGR of claims 1–7 on all petition grounds; the Board found claims more likely than not indefinite because the claimed curcumin percentages lacked a clear measurement basis.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “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 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.” 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 comprise an individual with a Ph.D in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, or an M.S. or B.S. degree in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, with an additional 3–5 years of practical experience in pharmaceutical or nutraceutical product development of characterization.” Pet. 17 (citing Ex. 1019 ¶ 94 (Dr. Amiji Declaration)). 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 ’970 patent itself, 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 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “Petitioner asserts that the term “about” in relation to the percentages of curcumin I, II, and III in claims 2 and 5 of the ’970 patent “should be given its ordinary meaning of ‘approximately’ rather than a particular numerical range.” Pet. 18. On this record, we agree with Petitioner that “about” generally means “approximately,” but how much this term numerically affects the express boundaries for ranges set forth in the claims that the term “about” modifies is not clarified by the proposed construction. See Ortho-McNeil Pharmas., Inc. v. Caraco Pharma., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (“Although both parties and the district court seem to agree that the term “about” means “approximately,” the parties and the district court disagree over the numerical limits that that term imparts to the limitation “1:5” in this case.”).” slip op. at 10

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteInstituted

    “We agree with Dr. Amiji’s analysis and determine, based on the present record, that Petitioner has established that it is more likely than not that claims 1–7 are indefinite. Claims 1–7 are unclear because these claims do not specify how the percentages of curcumin I, II, or III, are to be measured, but instead only provide raw percentages for each curcumin species. See Ex. 1001, 14:10–49. The Specification of the ’970 patent mentions a weight-by-volume measure for curcumin species for only Examples 6 through 8, but as Dr. Amiji testifies, these Examples are formulated as capsules with optional fillers that may be liquid including water. See id. at 13:15–19, 34–38. The remaining Examples 4 and 5 setting” slip op. at 15

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,945,970
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. 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 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCInstituted
  PTAB · Apr 25, 2022 · IPR2022-00193 · APJ John G New · IPR · Institution

  Instituted IPR on claims 1–20 and all asserted grounds after finding a reasonable likelihood that Levi anticipates or renders obvious at least one challenged claim.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “prosthetic heart valve depicted in Figure 42 of Levi is necessarily a drafter’s error, we conclude that Petitioner has established a reasonable likelihood that it will prevail in demonstrating that Levi anticipates claims 1–8, 10–18, and 20 of the ’538 patent at trial. Furthermore, because we conclude that Petitioner is reasonably likely to prevail at trial in demonstrating that challenged claims 1–8, 10–18, and 20 are anticipated by Levi, we similarly find, and for the same reasons, that Petitioner has shown a reasonable likelihood of prevailing at trial in demonstrating that the challenged claims are obvious over Levi.14 See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (holding that “[i]t is well settled that ‘anticipation is the epitome of obviousness’” (quoting Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983))).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Other

    “proceeding, weighs in favor of showing that Petitioner has a reasonable likelihood of prevailing at trial on these grounds. Specifically, we find that Petitioner has sufficiently shown that Levi alone anticipates or renders obvious the challenged claims.13 We are not persuaded, at this stage of the proceedings, that a person of skill in the art would recognize that the exemplary embodiment depicted in Figure 42 of Levi depicting the “fibrous network extend[ing] over at least two circumferentially extending rows of grids formed in the open cell configuration” is necessarily a drafter’s error. Nowhere in the disclosures of Levi do we discern a requirement that the upper edge of the outer skirt 18 is, or must be, attached via stitches to 13 Unlike the claims in the other related cases, the claims of the ’538 patent do not require the fibers to be “radially” or “outwardly” extending. See, e.g., IPR2021-01527, Paper 15, 31–37. Accordingly, on this record, we find that Petitioner has sufficiently shown that Levi’s outer skirt formed of a woven PET material satisfies the claim requirements of a “fibrous network.” Patent Owner does not dispute that Levi’s outer skirt satisfies this aspect of the claims. struts 24, such that only a single row of the frame gridwork is covered. Rather, Levi’s Specification employs the conditional language “can be,” stating that “each projection 164 can be sutured to the second rung II of struts 24 of the frame 12” and that “projections 164 can be folded over respective struts of rung II and secured with sutures 168.” Ex. 1008, col. 13, ll. 58–61. This disclosure does not prohibit the projections 164 of the outer skirt 16 from being stitched to struts 26 of rung III (see id. at Fig. 5), as is depicted in Levi’s Figure 42. We acknowledge that Levi indicates that Figures 42 and 43 each show views of the exemplary heart valve depicted in Figure 1 of Levi. See Ex. 1008, col. 5, ll. 12–13. But, again, there is nothing in the disclosures of Levi that requires the upper edge projections 164 of the outer skirt 18 be stitched to the struts 24, as depicted in Figure 43, and not to the struts 26, as depicted in Figure 42. It would be reasonable that a person of ordinary skill in the art would regard these to be minor variations of the same embodiment, rather than necessarily being a drafter’s error. We find that this is a reasonable inference at this stage particularly because stitching the outer skirt 18 to struts 26 such that it “extends over at least two circumferentially extending rows of grids formed in the open cell configuration” is plainly depicted in Figure 42, and is not expressly or implicitly contradicted or prohibited by any of the disclosures of Levi. See, e.g., Default Proof Credit Card System, Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 1300 (Fed. Cir. 2005) (Figure in specification accorded little probative weight when it appeared to contradict language of the claim). In this instance, we find based on the present record that the disclosures of the Specification and the language of the claims in Levi do not contradict, preclude, or render inoperative the device depicted in Figure 42, and we accord that Figure probative weight in accordance with what it plainly depicts, rather than merely dismiss that figure as a self-evident drafter’s error. See Duramed Pharms., Inc. v. Watson Lab’ys, Inc., 413 F. App’x 289, 294 (Fed. Cir. 2011) (“A reference … is prior art for all that it discloses”).” slip op. at 28

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Based on the present record, we find that Petitioner has satisfied the threshold standard set forth in Hulu to identify, with particularity, evidence sufficient to establish a reasonable likelihood that the Walther and Cribier references were publicly accessible before the priority date of the ’172 patent. As noted by Petitioner, each of the references are articles published in known journals with dates and other indicia of publication on the face of the references themselves. The Hulu decision specifically notes that “the indicia on the face of a reference, such as printed dates and stamps, are considered as part of the totality of the evidence” that should be taken into account. Hulu, Paper 29 at 17–18; see also id. at 19 (noting that “[t]he face of Dougherty bears a copyright date of 1990, a printing date of November 1992, and an ISBN date of 8/94” and the fact that the book was from “an established publisher”). We also take into account that journal articles, unlike, perhaps, other disputed publications, are “the type[s] of document[s] intended for public dissemination,” and that the Walther and Cribier references “bear[] no designations, such as ‘draft’ or ‘confidential,’ that might suggest that [they were] not intended for public distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018). Additionally, we have considered the declaration of Dr. Hall-Ellis and the supporting evidence cited therein as further evidence of public accessibility.18 We find that it was appropriate for Petitioner to submit this evidence with its Preliminary Reply. Indeed, the Hulu case recognizes that a petitioner may provide additional evidence “in a reply to a patent owner preliminary response,” and “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu Paper 29 at 14–15. Here, we determined that Petitioner satisfied the good cause requirement of 37 C.F.R. § 42.108(c) for submitting its Preliminary Reply with the Hall-Ellis declaration and other supporting evidence in order to respond to Patent Owner’s challenges to the printed publication status of Walther and Cribier. See related case IPR2021-01528, Ex. 1071, 13–14, ll. 23–24 (Transcript of teleconference call from February 14, 2022). Accordingly, in view of the totality of the evidence currently in the record, we find that Petitioner has established a reasonable likelihood that 18 Contrary to Patent Owner’s arguments, we are not of the view that a librarian declaration is always necessary to show public accessibility of a journal article, especially where the article itself bears credible indicia of publication.” slip op. at 57

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther

    “Based on the present record, we determine that Petitioner has made a persuasive showing that a POSITA would have found it obvious to substitute the woven PET outer skirt taught by Levi with a fibrous material, such as the outer cloth taught by Walther or the compressible material taught by Spenser II, to arrive at a heart valve structure that meets the claimed structural requirements. We further determine that, on the present record, Petitioner has persuasively shown that a person of ordinary skill in the art would have been motivated to deliver such a modified device endovascularly, either using the transfemoral approach or through the common iliac artery, with a reasonable expectation of success. We find that the modification to Levi’s device proposed by Petitioner would entail the “simple substitution of one known element for another” to obtain predictable results. See KSR, 550 U.S. at 417. In this regard, we note that Walther’s outer cloth, Spenser II’s compressible material, and Levi’s outer skirt all serve similar functions of helping reduce paravalvular leakage for a prosthetic heart valve. Ex. 1007, 1; Ex. 1008, col. 14, ll. 7–9; Ex. 1011 ¶ 145. Walther and Spenser II provide an additional motivation to incorporate fibrous cloth materials as the outer layer insofar as they teach that the fibers may encourage blood coagulation and tissue ingrowth to further fill in the gaps and prevent leakage. Ex. 1007, 1; Ex. 1011 ¶ 145.” slip op. at 45

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 10,881,538

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.