• 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 · 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
• 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
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as 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 › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Extractiontek Sales LLC v. Gene Pool Technologies, Inc.No claims unpatentable
  PTAB · Oct 23, 2023 · IPR2022-00832 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–19 were not shown unpatentable under the six §103 grounds because Petitioner failed to articulate an adequately supported reason to combine Hebert with Britt or Buese.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “On the full trial record, we adopt Petitioner’s proposed level of ordinary skill in the art, with Patent Owner’s additions. The additions are consistent with the evidence of record. For example, we find that adding chemistry and biology degrees is appropriate in view of Dr. Miller’s testimony that college-level chemistry and biology courses typically include training on extractive technologies. Ex. 1021 (Miller Tr.), 38:9–39:18. We also agree with Patent Owner that the educational level of the inventors may be considered (see Env’t Designs, Ltd., 713 F.2d at 696), and on this record, we accept Patent Owner and Dr. Miller’s undisputed representation that “named inventor Jason Wasserman had a bachelor’s degree in Agricultural Science and Sustainable Agriculture, a life sciences degree.” Ex. 2008 (Miller Decl.) ¶ 42; PO Resp. 4. Thus, for the reasons above, we define a person of ordinary skill in the art as someone who would have had (1) a bachelor’s degree in chemistry, biology, mechanical engineering, chemical engineering, petroleum engineering, or an equivalent field of physical science, life science, or engineering; and some academic or industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices; or (2) at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices.” slip op. at 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Mr. Chess. First, as noted above, his declaration simply parrots the arguments in the Petition and thus does not add any analysis not already discussed above. See, e.g., TQ Delta, LLC v. CISCO Sys., Inc., 942 F.3d 1352, 1359 (Fed. Cir. 2019) (“conclusory expert testimony is inadequate to support an obviousness determination”); InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1353–54 (Fed. Cir. 2014) (reversing district court’s judgment of invalidity because the expert testimony “failed to provide any meaningful explanation for why one of ordinary skill in the art would be motivated to combine these references at the time of this invention”); Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9, 15 (PTAB Aug. 24, 2022) (precedential). Second, we agree with Patent Owner that Mr. Chess’s opinion on motivation to combine is entitled to little, if any, weight in view of his crossexamination testimony, which expressly undermined any reason to combine Britt and Hebert. See PO Resp. 2–3, 12. When specifically asked to explain paragraph 73 of his Declaration regarding his opinion articulating a motivation to combine Britt and Hebert, Mr. Chess responded: “I’m personally not motivated to combine anything from any of these guys together. I think they’re all knuckleheads and didn’t know what they were doing, to be frank.” Id. at 24 (quoting Ex. 2009 (Chess Depo. Tr.), 185:2–6, see also 181:11–12 and 183:5 (directing Mr. Chess to paragraph 73 of his Declaration)). Petitioner attempts to rehabilitate this testimony by arguing that during cross-examination, Mr. Chess identified “inefficiencies” that” slip op. at 29

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

    “We agree with Petitioner that “exposing . . . for a predetermined period of time” should “be given [its] plain and ordinary meaning.” Reply 7–8. To the extent the plain and ordinary meaning needs elaboration, we adopt the agreed-upon construction of “predetermined period of time” from the related district court litigation, i.e., a “period of time determined in advance.”12 Ex. 3001, 11. For clarity, we note that nothing in this plain and ordinary meaning limits the term to a batch process or excludes a continuous process. We do not see any basis to read into this limitation requirements that the source material contact a volume of solvent within a closed or sealed container. See Sur-reply 4. Although the Specification indicates that the step of exposing the source material to the solvent for a predetermined period of time may take place in a canister that is “closed to fluid communication,” Patent 12 Patent Owner appears to acquiesce to this construction in this case, stating that “Patent Owner is not proposing a different construction of the limitation ‘predetermined period of time,” which the parties to the District Court action agreed means ‘period of time determined in advance.’” Sur-reply 3–4. Owner has not pointed us to any persuasive intrinsic evidence indicating that the exposing step must take place in a canister that is “closed to fluid communication.” The Specification “uses the broad permissive term ‘may’ when describing a ‘user may use the output valves to direct the extract mixture contained in an associated canister to extract container.’” Reply 10 (quoting Ex. 1001, 5:37–39, emphasis Petitioner’s). Accordingly, Patent Owner does not persuade us that the intrinsic record “strongly support[s] that ‘exposing the source material to the solvent for a predetermined period of time to create an extract mixture’” requires a batch process or excludes a continuous process. See PO Resp. 6. 2. Conclusion We determine that “exposing . . . for a predetermined period of time” should be given its plain and ordinary meaning, i.e., “exposing . . . for a period of time determined in advance.”” slip op. at 16

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

    “The failing in Petitioner’s arguments is that the Petition never identifies what “rationale” Hebert allegedly provides for a person of ordinary skill in the art “to expose the source material to the solvent for a predetermined period of time.” Pet. 14. We have examined each citation and argument in the Petition, but find no articulation of a reason why a person of ordinary skill in the art would have applied this teaching in Hebert to Britt and Buese’s processes. We walk through each citation and argument below.13” slip op. at 24

  Patent outcomesUS 9,145,532 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,145,532

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.