• Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentable
  PTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision

  The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27

  Patent outcomesUS 11,896,675 not shown unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,896,675
• Therabody, Inc. v. Hyperice IP Subco, LLCNo claims unpatentable
  PTAB · May 11, 2026 · PGR2025-00013 · APJ Alyssa A Finamore · PGR · Final written decision

  Claims 1–16 and 18 were not shown unpatentable because the asserted prior art did not establish the claimed quick-connect system during reciprocation, and Clark was not analogous art.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art may reflect the level of ordinary skill in the art. Id.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “During oral argument, Petitioner confirmed it would not object to the Board adopting the construction that Petitioner proposes in the district court litigation. JUDGE MARSCHALL: I think the Petitioner wouldn’t object if we adopted the construction that Petitioner proposed in the district court, especially the “designed to” construction, correct? MR. BERG: No. We wouldn’t object to that. And we think that our Petition is on all fours with that construction. Tr. 81:12–16. As Petitioner does not object to adopting its construction from the district court litigation, we construe claim element 1[e] in accordance with Petitioner’s construction from the district court litigation.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “The invention, a reciprocating massage device, is in a predictable field, namely the electro-mechanical arts. Also, there is no evidence that the recited quick-connect system is complex, even considering Patent Owner’s alleged understanding of it. Rather, Dr. Pratt testifies that many different types of connectors, whether they require alignment or not, were known. Ex. 1002 ¶¶ 54–58. Given the predictability of the electro-mechanical arts and lack of complexity of the recited quick-connect system, a low level of detail is required to satisfy the written description requirement. See RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., 92 F.4th 1085, 1090 (Fed. Cir. 2024) (“Given the predictability of electro-mechanical inventions such as the one at issue here, and the lack of complexity of the particular claim limitation at issue—i.e., reciting the length of a heating member—‘a lower level of detail is required to satisfy the written description requirement than for unpredictable arts.’” (quoting Hologic, Inc. v. Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir. 2018)). In view of the low level of detail required to satisfy the written description requirement, Petitioner has not persuaded us that the Specification’s example of a quick-connect system configured to secure the massaging head as the piston reciprocates fails to provide sufficient written description support for the “quick-connect system” recited in independent claims 1 and 18.” slip op. at 14

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable

    “Contrary to Petitioner’s assertion, the Specification provides guidance as to what amount of deviation from a perfect cylinder is still “substantially cylindrical.” The Specification describes: Quick-connect system 600 includes a piston 602 that has a hollow-end bore 608 for receiving the shaft 621 of a massaging head 620. Located within the bore 608 of piston 602 is a cylindrical seat 604. Cylindrical seat 604 retains a magnet 606. Magnet 606 is illustrated with its north pole located flush with the seat and facing toward the opening in bore 608. Massaging head 620 includes a shaft 621 having a cylindrical pocket 622 at the distal end. Located within the cylindrical pocket 622 is a magnet 624. Magnet 624 is positioned so that its south pole is located at the distal end of shaft 621. Accordingly, when the shaft 621 of massaging head 620 is slid into opening in bore 608, the magnets 606 and 624 are attracted to one another and magnetically hold massaging head 620 firmly in place. Ex. 1001, 6:57–7:3. In view of the description of quick-connect system 600, the Specification sets forth a standard for ascertaining whether the bore and the seat located within the bore are “substantially cylindrical.” To wit, the bore and the seat within the bore are “substantially cylindrical” when the massaging head and magnet are respectively received therein so that the magnet in the seat and the magnet in the pocket of the massaging head can magnetically hold the massaging head firmly in place. Furthermore, Dr. Pratt testifies that “[m]agnetic connectors comprise a magnet on at least one of the two objects to be joined. These types of connectors are ubiquitous even today for driving threaded fasteners.” Ex. 1002 ¶ 56. Dr. Pratt also testifies that a POSITA would understand how to take into account certain variances, like runout. Ex. 2033, 25:3–17. Dr. Pratt’s testimony shows that magnetic connectors are well known and that a POSITA would be able to determine whether the bore and the seat within the bore were “substantially cylindrical” for a secure connection of the massaging head. In view of the foregoing, Petitioner has not persuaded us that the claim term “substantially cylindrical” recited in claims 13–16 fails to inform, with reasonable certainty, the shapes of the bore and the structure within the bore. Petitioner has not proven, by a preponderance of the evidence, that any of claims 13–16 are unpatentable under 35 U.S.C. § 112(b) as indefinite.” slip op. at 19

  Patent outcomesUS 11,938,082 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,938,082
• Therabody, Inc. v. Hyperice IP Subco, LLCNo claims unpatentable
  PTAB · Apr 20, 2026 · PGR2024-00053 · APJ Alyssa A Finamore · PGR · Final written decision

  Petitioner did not prove claims 34–38, 40, 41, 43–46, and 58–60 unpatentable under § 112(a), § 112(b), or any asserted § 103 ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties’ proffered definitions for the level of ordinary skill in the art differ in the details of the experience a POSITA would possess. Petitioner’s definition requires experience with rotating or reciprocating mechanisms, whereas Patent Owner’s definition requires experience with devices for human use and interaction. These differences, however, do not affect our analysis of the issues in this case. For purposes of this Decision, we adopt Petitioner’s definition of 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 constructionDecided for petitioner

    “During oral argument, Petitioner confirmed it would not object to the Board adopting the construction that Petitioner proposes in the district court litigation. JUDGE MARSCHALL: I think the Petitioner wouldn’t object if we adopted the construction that Petitioner proposed in the district court, especially the “designed to” construction, correct? MR. BERG: No. We wouldn’t object to that. And we think that our Petition is on all fours with that construction. Tr. 81:12–16. As Petitioner does not object to adopting its construction from the district court litigation, we construe claim element 34[e] in accordance with Petitioner’s construction from the district court litigation.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “The invention, a reciprocating massage device, is in a predictable field, namely the electro-mechanical arts. Also, there is no evidence that the recited quick release connector is complex, even considering Patent Owner’s alleged understanding of it. Rather, Dr. Pratt testifies that a POSITA would be able to recognize a quick release connector for a particular application. According to Dr. Pratt, A person of ordinary skill in the art would consider a number of factors, depending on the context and specific application of the connector, to determine whether a connector provides a “quick release.” Such factors could include whether the connector is designed to manually and easily connect and disconnect two objects, and whether tools are necessary to do so. Other factors to be considered may be based on the specific application or operating environment. Ex. 1002 ¶ 58. Given the predictability of the electro-mechanical arts and lack of complexity of the recited quick release connector, a low level of detail is required to satisfy the written description requirement. See RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., 92 F.4th 1085, 1090 (Fed. Cir. 2024) (“Given the predictability of electro-mechanical inventions such as the one at issue here, and the lack of complexity of the particular claim limitation at issue—i.e., reciting the length of a heating member—‘a lower level of detail is required to satisfy the written description requirement than for unpredictable arts.’” (quoting Hologic, Inc. v. Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir. 2018)). In view of the low level of detail required to satisfy the written description requirement, Petitioner has not persuaded us that the Specification’s example of a quick release connector configured to secure the massaging head as the piston reciprocates fails to provide sufficient written description support for the “quick release connector . . . configured to secure a first massaging head while the piston reciprocates a predetermined stroke length at the first speed” recited in claim element 34[e]. 4. Conclusion for Written Description For the reasons set forth above in sections II.C.1–3, Petitioner has not persuaded us that any aspect of claim element 34[e] lacks written description support. Petitioner has not proven, by a preponderance of the evidence, that independent claim 34, as well as any of claims 35–38, 40, 41, 43–46, and 58–60 depending therefrom, are unpatentable under 35 U.S.C. § 112(a).” slip op. at 18

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable

    “Contrary to Petitioner’s assertion, the Specification provides guidance as to what amount of deviation from a perfect cylinder is still “substantially cylindrical.” The Specification describes that quick-connect system 600 includes two magnets with opposite poles facing each other: magnet 606 in the distal end of piston 602 and magnet 624 located in cylindrical pocket 622 of massaging head 620. Ex. 1001, 6:57–67, Figs. 6, 6A. The Specification further describes that “when the shaft 621 of massaging head 620 is slid into opening in bore 608, the magnets 606 and 624 are attracted to one another and magnetically hold massaging head 620 firmly in place.” Id. at 6:67–7:3. In view of the description of quick-connect system 600, the Specification sets forth a standard for ascertaining whether the pocket is “substantially cylindrical.” To wit, the pocket is “substantially cylindrical” when the pocket receives a magnet therein so that the magnets can magnetically hold the massaging head firmly in place. Furthermore, Dr. Pratt testifies that “[m]agnetic connectors comprise a magnet on at least one of the two objects to be joined. These types of connectors are ubiquitous even today for driving threaded fasteners.” Ex. 1002 ¶ 55. Dr. Pratt also testifies that a POSITA would understand how to take into account certain variances, like runout. Ex. 2033, 25:3–17. Dr. Pratt’s testimony shows that magnetic connectors are well known and that a POSITA would be able to determine whether the pocket was “substantially cylindrical” for a secure connection of the massaging head. In view of the foregoing, Petitioner has not persuaded us that the claim term “substantially cylindrical” recited in independent claim 34 fails to inform, with reasonable certainty, the shape of the pocket. Petitioner has not proven, by a preponderance of the evidence, that independent claim 34, as well as claims 35–38, 40, 41, 43–46, and 58–60 depending therefrom, are unpatentable under 35 U.S.C. § 112(b) as indefinite.” slip op. at 21

  Patent outcomesUS 11,857,482 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,857,482
• MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Jan 27, 2026 · IPR2023-00016 · APJ Michael A Valek · IPR · Remand

  On remand, the Board held claims 1–6 not shown unpatentable because unexpected results outweighed the prima facie obviousness case, and granted Patent Owner’s motion to exclude.

  RulingsRemand decision

  • RemandOther

    “the Court of Appeals for the Federal Circuit (“Federal Circuit”)See Paper 83 (“CAFC Decision”). The Federal Circuit did not disturb our determination that Petitioner “established a prima facie case of obviousness.” See CAFC Dec. 6–8. However, it took issue with the unexpected results analysis in the Decision, explaining that “without more explanation from the Board as to its determination that the experiments [offered by Patent Owner to show unexpected results] compared the challenged claims to the closest prior art, we cannot reach a judgment on MSN’s challenges to the Board’s holding of non-obviousness.” Id. at 14. Accordingly, the Federal Circuit vacated the Decision and remanded the case for further consideration of the unexpected results evidence. Id.” slip op. at 2

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 35

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “We find Patent Owner’s evidence persuasive to show that the Glu3 substitution results in an unexpected improvement in interconversion stability. As explained above, RP-HPLC was a known technique for separating the topoisomers of human uroguanylin. Ex. 2010, 230–231; Ex. 2011, 27–28; Ex. 2020, 223; Ex. 2028, TRUL00018269; see also Ex. 1063 ¶¶ 37, 40 (Petitioner’s expert confirming same). It was also known that one of human uroguanylin’s topoisomers was biologically active, whereas the other, i.e., what we and the parties refer to as the “inactive” topoisomer, had significantly less or no activity at the same concentration. Ex. 2011, 31 (“compound I shows significant activity in the cGMP producing assay, whereas compound II is practically inactive”); see also Ex. 2010, 238–239 (Fig. 8) (showing the “A isomer” had a potency “with a minimal concentration between 10-7and 10-8 M,” but that the B isomer “had virtually no effect on cGMP level at 10-6 M”); Ex. 2074, 48 (compound II “showed maximal 10% of the activity of compound I at 10-6 M”). The chromatograph for uroguanylin in Patent Owner’s data is consistent with these teachings, showing two peaks representing the active and inactive topoisomers. Compare Ex. 2028, TRUL00018269 (Fig. 1) with Ex. 2011, 28 (Fig. 2). The chromatograph for SP-304 shows a markedly different result, i.e., a “single peak,” which was confirmed “using the cGMP T84 cell assay” to represent “the fully active conformer of SP-304.” Ex. 2028, TRUL00018269; Ex. 2024 ¶¶ 208–209. We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 34

  • ExcludeMotion to exclude, grantedGranted

    “motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding.” slip op. at 58

  Patent outcomesUS 7,041,786 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 7,041,786
• MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand

  Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.

  RulingsRemand decision

  • RemandOther

    “More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner

    “In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner

    “same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10

  • ExcludeMotion to exclude, grantedGranted

    “motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58

  Patent outcomesUS 7,041,786 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,041,786
• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, Inc.No claims unpatentable
  PTAB · Dec 10, 2025 · IPR2024-01186 · APJ Brian D Range · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because Kwatra does not teach or suggest minimizing rotational velocity and acceleration as required by the claims.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art (POSITA) would have the following characteristics: “a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing or digital cameras.” Pet. 6 (citing Ex. 1002 ¶¶ 36–37). Petitioner states that, “[a]lternatively, a POSITA would have four years of experience working on image or video processing 6 Patent Owner asserts objective evidence of nonobviousness. Prelim. Resp. 19–27. or digital cameras.” Id. Petitioner further contends “[a]n advanced graduate degree in the disciplines cited above may make up for the work experience indicated above.” Id. Patent Owner does not dispute the level of ordinary skill in the art. Prelim Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’894 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 10

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

    “Petitioner “does not believe any terms require a formal construction.” Pet. 6. Patent Owner agrees “no claim terms presently require construction to resolve any current dispute between the parties.” PO Resp. 15. We do not discern a need to construe explicitly any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11

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

    “Kwatra teaches, at Equation 7, minimizing velocity and acceleration of a function representing camera path (P). FF ¶¶ 6, 8–9. Kwatra does not state that this camera path function considers rotation. Rather, the words “camera path” suggest x, y, z movement of the camera rather than rotation of the camera. Dr. Foroosh’s testimony that Kwatra’s minimization of a smoothed camera path does not result in minimizing rotational velocity and acceleration is credible because this testimony is consistent with Kwatra as a whole and consistent with the other evidence of record. Id. ¶ 10. Kwatra recognizes that image rotation angle (“θ”) may not remain smooth. Id. ¶ 12. But rather than attempting to minimize velocity and acceleration of rotation of the camera housing, Kwatra states that applying a smoothness constraint on rotation angle “may be non-linear.” Id. ¶ 13. Consistent with Kwatra, Dr. Foroosh credibly explains the difficulty of applying linear techniques to rotation. Id. Thus, Kwatra proposes instead constraining the sine and cosine of theta. Id. ¶ 14. The Kwatra provisional application is part of the Kwatra reference (id. ¶ 15), and it similarly opts for simpler schemes rather than estimating all parameters for all frames jointly. Id. ¶ 16. The provisional explains that the rotational component is relatively small such that non-linear computations minimizing velocity and rotation can be avoided. Id. ¶¶ 17–18. The testimony of Patent Owner’s witness, Dr. Foroosh, explaining the provisional is credible (Ex. 2018 ¶ 72) because it is consistent with Kwatra’s complete disclosure. Dr. Foroosh’s testimony is more credible than the testimony of Petitioner’s witness, Dr. Katsaggelos, because Dr. Katsaggelos did not review the Kwatra provisional application and, thus, did not review the entire disclosure of Kwatra. Id. ¶ 19; see also In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (obviousness analysis considers whether “the claimed inventions are rendered obvious by the teachings of the prior art as a whole” (emphasis added)).” slip op. at 28

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “(id. ¶ 15), and it similarly opts for simpler schemes rather than estimating all parameters for all frames jointly. Id. ¶ 16. The provisional explains that the rotational component is relatively small such that non-linear computations minimizing velocity and rotation can be avoided. Id. ¶¶ 17–18. The testimony of Patent Owner’s witness, Dr. Foroosh, explaining the provisional is credible (Ex. 2018 ¶ 72) because it is consistent with Kwatra’s complete disclosure. Dr. Foroosh’s testimony is more credible than the testimony of Petitioner’s witness, Dr. Katsaggelos, because Dr. Katsaggelos did not review the Kwatra provisional application and, thus, did not review the entire disclosure of Kwatra. Id. ¶ 19; see also In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (obviousness analysis considers whether “the claimed inventions are rendered obvious by the teachings of the prior art as a whole” (emphasis added)).” slip op. at 28

  Patent outcomesUS 10,574,894 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,574,894
• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-01165 · APJ William V Saindon · IPR · Final written decision

  Claims 1–21 were not shown unpatentable because Zhou does not teach the claimed low-light high-pass or stickiness parameter limitations.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “4. Conclusion for the Prior Art Analysis In sum, we find that Zhou does not disclose the low-light high-pass parameter or the stickiness parameter. Petitioner’s grounds for both independent claims 1 and 16 rely on Zhou for teaching a low-light high-pass parameter or a stickiness parameter. Pet. 23–28, 64. Because we find Zhou does not teach these limitations, all of Petitioner’s grounds fall for this reason. III. CONCLUSION For the reasons given above, we determine that Petitioner has not established by a preponderance of the evidence that any claim of the ’840 patent would have been obvious in view of the prior art cited.” slip op. at 18

  • Skill levelSkill level petitioner adoptedOther

    “A person of ordinary skill in the art (POSITA) in the field of the ’840 patent would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras. Alternatively, a POSITA would have four years of experience working on image or video processing, or digital cameras. An advanced graduate degree in the disciplines cited above may make up for the work experience indicated above. Pet. 6 (citing Ex. 1002 ¶ 32). Patent Owner applies the same standard. PO Resp. 26–27. We use this agreed-upon standard for purposes of this Decision.” slip op. at 7

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “We review this testimony based on the strength of the underlying factual basis. 37 C.F.R. § 42.65(a); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value . . ..”). Here, the underlying factual basis is not very strong for either witness. That said, we find that Dr. Foroosh’s testimony is more logically sound and consistent with the ’840 patent disclosure. Based on our reading of the specification, we find a clear indication that “stickiness” has to do with the past. In order to control “the extent by which preceding portion(s) . . . impacts determination of the smoothed trajectory” (emphasis added), one must control the degree by which the past frames impact determination. And to control the degree of the past’s influence, one must, as a consequence, favor the past over the future. That is, the frame of reference of the stickiness parameter is the past. The specification could have used a time-agnostic term, like a “nearness” or “adjacency” parameter, but it did not. Thus, the fact that “stickiness” is used in conjunction with “preceding” indicates that it deals with a preference for preceding frames. On this basis, we find Dr. Katsaggelos’s testimony less persuasive than Dr. Foroosh’s.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “That said, we do not construe a stickiness parameter as prohibiting consideration of future frames. Instead, we determine that the stickiness parameter’s value determines the impact of the preceding portions, versus the following portions. The ’840 patent recognizes this, when it says that a stickiness parameter value of “1,” representing a “lazy” stabilizer that maximally favors the past, would not override a violation of the margin constraint based on the look-ahead (i.e., would not allow the viewing window to fall out of bounds in the event of large future motion). See Ex. 1001, 22:26–30; see also id. at 12:61–13:29 (acknowledging that favoring the past may lead to a conflict with the viewing window determination), 15:39–60 (adjusting the viewing window to ensure it does not violate a margin constraint). Thus, while a past-favoring parameter by necessity favors the past over the future, it does not prohibit consideration of the future. In view of the above, we construe the claimed “stickiness parameter” as a parameter that controls the extent by which preceding portions of the trajectory impacts determination of the smoothed trajectory, with an understanding that in order to favor preceding portions, to some extent, the parameter must relatively disfavor following portions.” slip op. at 10

  Patent outcomesUS 10,958,840 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,958,840
• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-01164 · APJ William V Saindon · IPR · Final written decision

  Claims 1–21 were not shown unpatentable because Shi does not disclose the claimed low-light high-pass parameter required by the asserted obviousness grounds.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Given the teachings of the specification, we agree with Patent Owner that a low-light high-pass parameter is a parameter of a smoothing function that favors high frequencies (high pass) when exposure times are long (low light). See Tr. 42:10–18 (Patent Owner’s counsel stating that “high-pass” means “there’s a bias or preference for high frequencies”); Ex. 2020, 93:23– 94:15 (Petitioner’s declarant, Dr. Katsaggelos, agreeing that a high-pass system attenuates the low frequency of a signal). Although we acknowledge Petitioner’s position that the specification provides other ways or considerations in implementing a smoothing function, based on our above analysis of the specification, we find that the specification describes the lowlight high-pass parameter as a specific component of a smoothing function. See, e.g., Ex. 1001, 21:17–25 (setting out several parameters besides the low-light high-pass parameter used in trajectory smoothing).” slip op. at 10

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

    “position and a real device position. Id. at 18:27–40. In other words, the blur is addressed by analyzing the image to identify motion and then shifting the image. Shi, however, does not disclose how its parameter is based on low light (or the long exposure times indicative of low light). In its Petition, Petitioner asserts that a person of ordinary skill in the art would understand that “blurs can be caused by low light conditions.” Pet. 28 (citing Ex. 1003 ¶ 111). Although this is true, that does not mean that Shi’s blurs are identified by a parameter that considers low light. As we just described, Shi identifies the blur by quantifying the amount of motion of the points in an image, not by identifying low light. This is simply a different way to determine the presence of motion blur. In Shi, blur is measured, whereas in the ’840 patent, it is inferred based on low-light conditions (e.g., by observing the exposure time). See, e.g., Ex. 1007, 18:7– 26; Ex. 1001, 19:12–26. In its Reply, Petitioner does not point to any further disclosures. Accordingly, we find that Shi does not disclose the “low-light” aspect of the claimed low-light high-pass parameter. This is sufficient to determine that Petitioner’s ground does not meet all claim limitations. Similarly, we find that Shi does not disclose the “high-pass” aspect of the parameter. Shi’s blur compensation uses a spherical interpolation to modify the image. Ex. 1007, 18:27–40. The low-light high-pass parameter, as we have construed the term, allows more high frequencies. To allow more high frequencies, this necessarily means either allowing fewer low frequencies, or allowing more high frequences as opposed to some counterfactual situation in which fewer high frequencies were going to be allowed. See Ex. 2020, 94:23–95:15; Ex. 2022. We are directed to no persuasive evidence from Petitioner that Shi’s spherical interpolation favors high frequencies over low frequencies. Accord Ex. 2018 ¶ 107 (Patent Owner’s expert stating that Shi’s spherical interpolation “reintroduce[es] both high- and low-frequency motion”). Even if Shi allows the viewing window to track the camera position “consistent with the natural blur in the image” (Ex. 1007, 17:63–67), we are not provided with sufficient evidence to conclude by a preponderance of the evidence that providing a similar visual goal as a high-pass parameter (Ex. 1001, 22:16–18, “the output motion may include high frequencies that mask motion blur”) is the same as having a high-pass parameter. Again, merely preserving high frequencies is not the same as having a “high-pass parameter” because, as construed, a “high-pass parameter” also involves some degree of attenuation of low frequencies or relative increase of high frequencies. Accordingly, we find that Shi does not disclose the “high-pass” aspect of the claimed low-light high-pass parameter.” slip op. at 18

  Patent outcomesUS 10,958,840 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,958,840
• Sarepta Therapeutics, Inc. v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Aug 20, 2025 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Final written decision

  The Board held claim 8 not shown unpatentable under each of three §103 grounds because Petitioner failed to establish motivation to combine the references with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In addressing the level of ordinary skill in the art, Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had at least a Ph.D. in biochemistry, molecular biology, or a related field and between one and four years of post-doctoral experience in the field of gene therapy. Alternatively, a POSA would have had at least a Master’s or Bachelor’s Degree in biochemistry, molecular biology, or a related field, with a corresponding number of additional years of experience in the field of gene therapy. Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not challenge Petitioner’s definition. PO Resp. 10. On this complete record, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’274 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (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

    “Petitioner asserts that the ’274 patent “does not specify a particular program or set of program parameters that should be used to align sequences and calculate percent identity for purposes of determining whether a particular test sequence falls within the scope of the claims.” Pet. 21. Petitioner asserts that it analyzed the percent identity claim elements, as Patent Owner did in the parallel District Court litigation, Penn-II, “using the Clustal program at default settings to generate amino acid sequence alignments and calculate percent identity values.” Id. at 21–22. Petitioner, however, does not ask for any particular construction of any claim term. See id. Patent Owner states that it “does not challenge Petitioner’s articulation of the lack of a need for claim construction.” PO Resp. 10. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior: EX1007, ¶ 253. Notably, AAV8 was shown to have over fifty percent (50%) greater expression in liver than AAVrh10. As I discuss more below, a skilled artisan in 2005 would not have expected a single amino acid substitution to significantly alter tropism in order to target to a different tissue. Thus, in my opinion, in 2005, a skilled artisan with the goal of targeting the liver would have selected the best known vector for delivery to liver at that time—AAV8. Ex. 2027 ¶ 42. We also agree with Dr. Samulski’s opinion that a POSA would have selected the best vector for liver, AAV8, instead of modifying another vector to increase tropism to liver. Dr. Samulski testifies: In my opinion, a skilled artisan in 2005 would not have looked solely to modify a vector to try to improve tropism to a particular tissue. As discussed throughout this declaration, changing tropism is difficult to predict, and a skilled artisan would not have had a reasonable expectation that changes could be made to improve or alter tropism. A skilled artisan would also have been concerned that changes, even small ones, could negatively impact other properties of the capsid protein. Therefore, rather than seek to modify a vector, a skilled artisan” slip op. at 29

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

    “The ’772 Publication, however, does not indicate as Petitioner asserts that a new variant is necessary to improve the efficiency of gene transfer to liver; the ’772 Publication indicates that AAV8 fulfills that need. See Ex. 1007 ¶ 250. In the paragraph that Petitioner relies upon for the alleged need to improve the efficiency of gene transfer to the liver, the ’772 Publication states in full: The tropism of each new vector is favorable for in vivo applications. AAV2/7 vectors appear to transduce skeletal muscle as efficiently as AAV2/1, which is the serotype that confers the highest level of transduction in skeletal muscle of the primate AAVs tested to date. Importantly, AAV2/8 provides a substantial advantage over the other serotypes in terms of efficiency of gene transfer to liver that until now has been relatively disappointing in terms of the numbers of hapatocytes stably transduced. AAV2/8 consistently achieved a 10 to 100-fold improvement in gene transfer efficiency as compared to the other vectors. The basis for the improved efficiency of AAV2/8 is unclear, although it presumably is due to uptake via a different receptor that is more active on the basolateral surface of hepatocytes. This improved efficiency will be quite useful in the development of liver-directed gene transfer where the number of transduced cells is critical, such as in urea cycle disorders and familial hypercholesterolemia. Id. (citations omitted) (emphasis added). According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior:” slip op. at 28

  Patent outcomesUS 11,680,274 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,680,274
• Microsoft Corporation / Affirmed Networks, Inc. v. Lemko CorporationNo claims unpatentable
  PTAB · Aug 30, 2024 · IPR2023-00529 · APJ Brian D Range · IPR · Final written decision

  Claims 1–8, 11–16, and 21 were not proven unpatentable over Mauer and Waylett because the asserted combinations did not teach key claim limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. LEVEL OF ORDINARY SKILL Petitioner defines the person of ordinary skill in the art as follows: As of February 2006, a person of ordinary skill in the art (“POSITA”) would have been a person with a degree in 1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Because the challenged claims of the ’414 patent have an effective filing date before the effective date of the applicable AIA amendments, we refer to the pre-AIA version of 35 U.S.C. § 103 throughout this Decision. 2 Mauer et al., U.S. Patent No. 7,395,085 B1, issued July 1, 2008 (Ex. 1005, “Mauer”). 3 Waylett et al., U.S. Patent No. 8,184,603 B2, issued May 22, 2012 (Ex. 1006, “Waylett”). computer science, electrical or computer engineering, physics, or a similar discipline . . . [and] would also have at least two years of relevant experience including, for example, work related to telecommunications networks. Pet. 3 (citing Ex. 1003 ¶ 54). The institution decision adopted Petitioner’s definition of a person having ordinary skill in the art. Dec. on Inst. 11–12. Patent Owner applied this definition for its response. Resp. 19. Petitioner’s undisputed definition of a person of ordinary skill in the art is reasonable and consistent with the prior art and ’414 patent specification. Based on the record before us, we adopt Petitioner’s undisputed proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

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

    “Petitioner does not submit constructions for any claim terms. According to Petitioner, “[t]he Board construes claims under the same standard used in civil actions in federal district court. The district court for the related litigation has not yet construed the claim terms.” Pet. 7. The parties provided briefing regarding construction of “distributed mobile architecture (DMA).” Resp. 19–34; Pet. Reply 1–3; PO Sur-reply 11–14. But we do not need to construe “distributed mobile architecture (DMA)” to resolve this inter partes review. We thus do not construe this claim term. We also do not discern a need to construe explicitly any other claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We discuss the meaning of ’414 patent claims to the extent necessary to resolve the issues we address below. Id.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “a) Combination of Mauer and Waylett In support of both Ground 1 and Ground 2, Petitioner argues that a person of ordinary skill in the art would have been motivated to combine Mauer’s and Waylett’s disclosures, “using Waylett’s Network-in-a-box 224 in each of Mauer’s WWAN 14 and WLAN 12, resulting in at least two DMA systems.” Pet. 11–13. Asserting that “Mauer teaches providing sufficient network coverage by use of different kinds of networks, network interfaces, and protocols,” Petitioner contends that a person of ordinary skill in the art would have recognized that “Waylett discloses an inexpensive way to implement the same networks used in Mauer’s WWAN 14 and WLAN 12.” Id. Citing similarities in Mauer’s and Waylett’s systems, Petitioner argues that “a POSITA would have been able to modify Mauer’s WWAN 14 and WLAN 12 networks so that each network uses Waylett’s NIB 224.” Id. at 14. According to Petitioner, the combination would have included a number of beneficial features from Mauer. Id. at 14–15. Petitioner further advances three reasons that a person of ordinary skill would have had to combine the references’ teaching. Id. at 15–16. First, asserting that Waylett discloses cost benefits and Mauer discloses “an improved method and system for notifying mobile stations,” Petitioner contends the “references each provide reasoning” to combine their disclosures. Id. at 15. Second, Petitioner argues that a person of ordinary skill in the art would have been motivated to “improve Mauer’s distributed wireless network system by consolidating it into a single box, making it compact in design allowing for faster deployment.” Id. at 16. “Third, Waylett’s NIB would help mitigate the shared concern of Mauer—that is, reaching a mobile station as it roams or moves outside of the service or coverage area.” Id.” slip op. at 24

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

    “Petitioner does not establish that Mauer sends calls to voicemail based on the two determinations claim 1 recites. Resp. 55–56. In particular, as we explain above, claim 1 requires making use of the DPR after first determining the second mobile subscriber is not located within a first wireless coverage area based on HLR and VLR information and also determining that the second mobile subscriber is not located within a second wireless coverage area based on certain CLR information. The Petition, at best, attempts to establish that Mauer directs to voicemail when a “communication session cannot be established over the first or second wireless network.” Pet. 37. But a general determination that a “communication session cannot be established” does not teach or suggest claim 1’s specific requirements that first, the DPR is utilized in the specific circumstance that the second mobile subscriber is not located within the first wireless coverage area (with this determination being made based on HLR and VLR information), and second, that the DPR is also not located within the second wireless coverage area (with this determination being made based on CLR information). See PO Sur-Reply 8–9; Ex. 2001 ¶¶ 111–113. For the reasons above, Petitioner does not establish by a preponderance of the evidence that the combined art teaches or suggests the final “when” recitation of claim 1.” slip op. at 29

  Patent outcomesUS 7,653,414 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,653,414

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.