• Aroma360, LLC v. Air Esscentials, Inc.Instituted
  PTAB · Oct 8, 2025 · IPR2025-00706 · APJ Eric C Jeschke · IPR · Institution

  The Board instituted inter partes review of claims 1, 4, and 7–10 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one challenged claim.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented shows a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. We thus institute inter partes review on all challenged claims on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63, 369–70 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant prior art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” Id. (internal quotation marks and citation omitted).” slip op. at 7

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

    “same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 12–13; see generally Prelim. Resp. At this stage of the proceeding and based on the current record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. 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 8

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Motivation foundInstituted

    “On the current record, this argument does not identify a deficiency in Petitioner’s position as to clauses 1C and 1D. Patent Owner implies that the structures recited in clauses 1C and 1D require functionality recited elsewhere in the claim—namely, forming a “fluid dispersion” (Prelim. Resp. 4)—but Patent Owner does not adequately present evidence supporting this implied claim construction. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (rejecting arguments “not based on limitations appearing in the claims”). Instead, Patent Owner cites to the entirety of claim 1 in support of these implied functional requirements. See Prelim. Resp. 4. Stated differently, Patent Owner has not adequately explained why any particular component (or collection of components) must perform the function of forming the “fluid dispersion” recited in clause 1G. Moreover, even assuming as correct Patent Owner’s assertion that Sevy “requires downstream separation,” Patent Owner has not explained why such a 8 In its Preliminary Response, Patent Owner appears to use different terms for the same concept: “downstream separation”; “post-formation correction”; and “post-atomization correction.” See, e.g., Prelim. Resp. 3 (“downstream separation”), 4 (“post-formation correction”), 5–6 (“post-atomization correction”). In any response, Patent Owner should clarify the scope of these terms. requirement would fall outside of the scope of claim 1. See Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1359 (Fed. Cir. 2018) (“‘[A]ttorney argument is not evidence’ and cannot rebut other admitted evidence.” (quoting Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017))). On the current record, we determine that Petitioner has made a sufficient showing that Sevy discloses or suggests the structures recited in clauses 1C and 1D.” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 10,583,449
• Aroma360, LLC v. Air Esscentials, Inc.Instituted
  PTAB · Oct 8, 2025 · IPR2025-00707 · APJ Eric C Jeschke · IPR · Institution

  Instituted inter partes review of claims 1 and 3–8 on all asserted grounds after finding a reasonable likelihood of prevailing on at least one challenged claim.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented shows a reasonable likelihood that Petitioner would prevail with respect to at least 1 As Paper 7 in this proceeding, Patent Owner mistakenly filed the Preliminary Response in a related proceeding. one of the challenged claims. We thus institute inter partes review on all challenged claims on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63, 369–70 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s proposed definition of the level of ordinary skill in the art, which appears generally consistent with the record at this stage of the proceeding, including the prior art. See GPAC Inc., 57 F.3d at 1579. We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Patent Owner does not argue at this stage of the proceedings that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would understand either the challenged patent or the prior art. For purposes of this Decision, we adopt the definition of the level of ordinary skill in the art proposed by Petitioner, as revised above.” slip op. at 8

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

    “Neither Petitioner nor Patent Owner propose constructions for any claim terms. Pet. 16–17; see generally Prelim. Resp. At this stage of the proceeding and based on the current record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. 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 9

  • Obviousness (§103) › Analogous artNot reached

    “At this stage of the proceeding, the record on the analogous art issue is incomplete. Petitioner seems to take the position that Kaiser is in the same “field” (Pet. 47), but Petitioner does not fully address the issue of analogous art. Although Petitioner was not required to anticipate this argument with its initial filing (see Sanofi-Aventis Deutschland GmbH v. Mylan Pharma., Inc., 66 F.4th 1373, 1379 (Fed. Cir. 2023)), Petitioner may wish to address this issue as appropriate in future briefing. We will consider the full record on this issue, if necessary, as part of our analysis in any final written decision. On the current record and in view of our decision to institute based on other grounds, we reach no conclusion as to whether Petitioner has made a sufficient showing that one of ordinary skill in the art would have combined Goubet and Kaiser as proposed.” slip op. at 23

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,092,918
• Front Line Medical Technologies, Inc. v. Prytime Medical Devices, Inc.All claims unpatentable
  PTAB · Oct 1, 2025 · PGR2024-00028 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1–10 are unpatentable as obvious over Fogarty and Chengod; the Board found that combination sufficient for every challenged claim.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “7. Conclusion Based on the entirety of the record, we determine that a person of” slip op. at 13

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

    “3. Analysis In our claim construction analysis “[w]e begin, as we often do, with” slip op. at 18

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownOther

    “the feature of the solid wire being “secured at a proximal-most end thereof within the proximal hub” was added during prosecution to overcome a rejection. Ex. 1002, 573-580. The prior art was distinguished because its guidewire “is configured to be steered and manipulated through the blood vessel, and subsequently removed, and, therefore, cannot be secured at a proximal end thereof to the luer hub 310.” Id., 578-79 (emphasis added). Accordingly, the prosecution history further demonstrates “secured” was not intended to cover removable attachment.” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “2. Patent Owner’s Arguments Concerning Claim 1 and Our Analysis a. Reasonable Expectation of Success in modifying catheters to less than 6 Fr Patent Owner asserts “Petitioner has failed to perform a proper obviousness analysis by not adequately demonstrating a reasonable expectation of success in modifying Fogarty.” PO Resp. 35. Patent Owner asserts “the category of ‘Fogarty catheters’ is broad and diverse” and “Dr. Resnick admits he has no idea whether Chengod’s or Deaton’s catheters have interior constructions similar to that of the cited Fogarty reference.” Id. at 35‒36 (citing Ex. 2002, 52:16‒57:1). Patent Owner asserts that Petitioner has therefore not demonstrated that a PHOSITA would have a reasonable expectation of success in modifying the particular catheter taught by the cited Fogarty patent (Ex. 1004) to the claimed size when considering the shaft has a spring coil and braid in addition to the outer tube and lumen. Id. Petitioner responds “(1) Fogarty did not indicate the catheter’s size; (2) Fogarty catheters smaller than 6 Fr were known and disclosed in Chengod (and Deaton); and (3) sizing Fogarty’s catheter less than 6 Fr would work (i.e., reasonable expectation of success) because it did work.” Pet. Reply 19. Petitioner asserts that Yassinzadeh “shows a catheter that is less than 6 Fr and that includes a similar spring coil construction as found in the Fogarty patent” where the “dilator 150 has a diameter of either 5 Fr or 6 Fr.” Id. at 19‒20 (citing Ex. 1033 ¶¶ 86‒97 (“Yassinzadeh”)). Petitioner asserts that Yassinzadeh’s “analogous construction being less than 6 Fr confirms a PHOSITA would have a reasonable expectation of success in sizing the catheter in Fogarty (Ex-1004) less than 6 Fr.” Id. at 20 (citing Ex. 1034 ¶ 97). Patent Owner responds “Petitioner fails to specify what” slip op. at 53

  Patent outcomesUS 11,857,737 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,857,737
• Amgen, Inc. v. Bristol-Myers Squibb CompanyAdverse judgment
  PTAB · Oct 1, 2025 · IPR2025-00603 · APJ Grace Karaffa Obermann · IPR · Adverse judgment

  The Board entered adverse judgment against Patent Owner based on its statutory disclaimer of claims 1–18, then terminated the proceeding.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “In other words, the Smith & Nephew decision makes plain that entry of adverse judgment (as opposed to a denial without adverse judgment) is appropriate in situations where a patentee seeks to regain, through continued prosecution, subject matter that is patentably indistinct from previously surrendered subject matter. Id. That is precisely the situation at hand. Claim 43, pending in the ’822 continuation application, is of the same or broader scope than disclaimed claim 1 of the ’529 patent, as shown in Petitioner’s claim chart:” slip op. at 4

  None
  Patents in suitUS 11,332,529
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Sep 8, 2025 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Institution

  The Board instituted PGR on claims 1, 2, 6–15, and 17–30 based on written-description and enablement challenges; it found the obviousness challenge insufficient at this stage.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1, 2, 6–15, and 17–30 of the ’520 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’520 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not be an expert in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10

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

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2055 ¶ 68. Indeed, when reproducing the definition from this column of the ’520 patent, Dr. Triggs-Raine does not include any text after the first period, stating that “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78. On this record, however, we find that this text is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44–47; see Ex. 2055 ¶ 67 (stating a “patent’s definition controls”). And Dr. Triggs-Raine states “the modified PH20 polypeptides have multiple credible uses, including ‘therapeutic uses of modified PH20 polypeptides that have the ability to degrade hyaluronan.’” Ex. 2055 ¶ 115.7 That is, Dr. Triggs-Raine recognizes hyaluronidase as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 15

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted

    “Thus, the ’520 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “21-42 changes, with each additional change (except at position 324) being to 1 of 19 other amino acids. But the up to 21-42 changes also can be at any of between 430 and 465 (or, in the case of the broadest claims, 474) different positions depending on which unmodified PH20 sequence is used.” Id. ¶ 120. Dr. Park calculates that “95% sequence identity to PH201-465 means that the protein can have 23 total changes,” and that where one of those changes is one of five choices at position 324 as required by claim 1, the number of possible PH20 polypeptides with twenty-two additional changes is “extremely large by all accounts, ranging from 1059 to 10112.” See” slip op. at 27

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,110,520
• 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
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Instituted
  PTAB · Aug 14, 2025 · IPR2025-00505 · APJ Jeffrey N Fredman · IPR · Institution

  The Board instituted inter partes review of claims 1–15 on all grounds, finding a reasonable likelihood that the claims would have been shown obvious over the asserted prior art.

  RulingsInstitution decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “However, Patent Owner has not shown that circumstances exist that would require dismissal of the proceeding as barred under § 315(b) if the unnamed party were added as a real party in interest. Patent Owner has also not alleged any discovery abuse at this time. We determine that we need not address whether Cipla is an unnamed RPI at this stage. The parties may further address this issue during the trial portion of the proceedings. As the Board explained in SharkNinja, it “better serves the interest of cost and efficiency” when the Board does not engage in the “extensive analysis” required to determine whether a party is an unnamed RPI if the result of that analysis has no material impact on the proceeding. SharkNinja v. iRobot Corp., IPR2020-00734, Paper 11 at 19–20 (PTAB Oct. 6, 2020) (precedential). Here, it is undisputed that Petitioner could have named Cipla as an RPI in its Petition without triggering a statutory bar or estoppel under 35 U.S.C. § 315.” slip op. at 5

  • Skill levelSkill level petitioner adoptedOther

    “Patent Owner states it disagrees with Petitioner’s “definition of a POSA but assumes their definition for purposes of the arguments presented herein.” Prelim. Resp. 6. At this stage in the proceeding, we find that Petitioner’s analysis reasonably establishes a level of ordinary skill in the art as it directly relates to those deciding treatments based on the prior art references. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See, e.g., Ex. 1003, 1817, author list. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 9

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

    “Thus, the ’552 patent teaches that patients may or may not receive some therapeutic benefit from the treatment and also recognizes that any therapeutic benefit may result in prolonging life, but not necessarily result in complete remission of the pancreatic tumor. This understanding is consistent with Dr. Ratain’s testimony that “[t]reating a patient is always with the attempt or intent to cause a therapeutic improvement of the patient, which, in the case of metastatic pancreatic cancer, could be reduced tumor growth or increased overall survival in the patient.” Ex. 1002 ¶ 50. We are unpersuaded, however, by Dr. Ratain’s statement equating “treatment with a saline control” with the claimed “treating metastatic adenocarcinoma,” because the claim is addressing a disease condition whereas the example in Figure 6A is clearly providing a control, without any expectation of therapeutic benefit. See id. ¶ 55. We are not persuaded, on this record, that because Patent Owner did not include the phrase “therapeutically effective amount” in the claims, the claims solely relate to “administering” the antineoplastic therapies without any resulting therapeutic benefit. Rather, on this record, we agree with Patent Owner that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. To the extent that Patent Owner’s position would require some” slip op. at 13

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

    “While we are aware that hindsight bias may plague determinations of obviousness, Graham, 383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. The evidence of record shows the prior art provides specific reasons to replace irinotecan with liposomal irinotecan in the treatment of pancreatic cancer, including improved sustained release, local bioactivation, increased efficacy, and reduced side effects. Ex. 1006, 9; Ex. 1008, 921; Ex. 1002 ¶¶ 91, 238, 239. These specific reasons, as supported by Dr. Ratain, provide specific support for the obviousness of modifying the Conroy Protocol for patients with toxicity to substitute a 60 mg/m2 dose of liposomal irinotecan for irinotecan, particularly in patients with the particular UGT1A1 allele identified by Bayever. Ex. 1006, 3.” slip op. at 37

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 11,344,552
• Ajinomoto Co., Inc. v. Abtis Co., Ltd.Instituted
  PTAB · Aug 8, 2025 · IPR2025-00283 · APJ Lilan Ren · IPR · Institution

  The Board instituted IPR on claim 11, finding a reasonable likelihood it would be shown unpatentable under § 102 over CA959 and under § 103 over the listed combinations.

  RulingsInstitution decision

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

    “In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner

    “In this case, claim 11, as it is currently written, depends from claim 1 and therefore requires that all of the limitations of claim 1, including the negative limitation of claim element 1.d, have written description support in negative limitation must be supported through an “express disclaimer or independent lexicography in the written description.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003). The parties agree that “the applications underlying the ’675 Patent are entirely silent regarding terminal aldehyde groups.” Pet. 17; see Prelim Resp. 9–10. Patent Owner’s argument that these underlying applications reasonably convey possession to a POSA does not cite to evidence in the record as support. See Prelim Resp. 9. Patent Owner argues that the specific structures recited in claim element 11.a “necessarily exclude[] the terminal groups contained in the negative limitation” (id. at 9–10) but does not sufficiently explain why there is the requisite “express disclaimer or independent lexicography” (Omega Eng’g, 334 F.3d at 1323) to exclude only these particular terminal functional groups but not others. Although the scope of claim 11 is limited to those structures specifically recited, the record before us does not sufficiently show why the inclusion of these structures in element 11.a excludes only the particular terminal functional groups in the negative limitation but not others. We preliminarily determine, based on the record before us, that Petitioner has adequately established that the provisional application does not provide written description support for claim 11 as it is currently written. Accordingly, at this stage of the proceeding, Petitioner has sufficiently 11 We note that Patent Owner represents that, “[t]o the extent the Board is inclined to hold that current Claim 11 is not adequately supported by the specification due to the negative limitation recited in disclaimed Claim 1, Patent Owner intends to amend Claim 11 into independent form and remove the reference to the negative limitation.” Prelim. Resp. 11 n.4. 2023, which is the filing date of the application that issued as the ’675 patent, for purposes of institution.” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted

    “1. CA959 The parties agree that CA959 is entitled to the same priority date as the provisional application, filed on March 8, 2019. Pet. 22; Prelim. Resp. 5. The parties agree that CA959 and ’675 patent contain essentially identical disclosures. Pet. 16; see Prelim. Resp. 9. 2. Analysis of Ground 1 At this stage of the proceeding, Patent Owner does not address Petitioner’s specific contentions with respect to the limitations of claim 11 (Pet. 31–34, 37). See generally Prelim. Resp. Based on our determination supra that claim 11 of the ’675 patent is entitled to the January 16, 2023 priority date and based on our review and consideration of the current record with regard to the alleged anticipation by CA959, we determine that Petitioner has sufficiently shown that CA959 discloses all elements of claim 11 for purposes of institution. See Pet. 31–34, 37 (and evidence cited therein). Based on the reasons provided supra, we determine that the information presented in the Petition demonstrates a reasonable likelihood of showing that claim 11 is anticipated under 35 U.S.C. § 102 by CA959.” slip op. at 16

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

    “Patent Owner does not cite any authority stating that in a proper obviousness analysis under 35 U.S.C. § 103, there is a bright line test for the frequency at which the phrase “motivation to combine” (or similar phrases) is repeated in the petition and/or testimony. Patent Owner’s argument regarding the purportedly low frequency in which Petitioner and/or Dr. Tumey uses such phrases (see Prelim. Resp. 12) does not rebut Petitioner’s testimonial and other evidence in support of Petitioner’s arguments regarding motivation. For example, Dr. Tumey testifies that as of 2019, “there was an expectation that site-specific conjugation would decrease off-target toxicity and improve the pharmacokinetic properties of the ADC, and thus there was a clear motivation in the art to pursue technologies that allowed site-specific conjugation.” Ex. 1002 ¶ 60. Dr. Tumey cites as support Exhibit 1027, which is an article titled “Antibody-Drug Conjugate-Based Therapeutics: State of the Science” in the Journal of the National Cancer Institute. Ex. 1002 ¶ 60 (citing Ex. 1027, pg. 538); Ex. 1027.” slip op. at 21

  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 11,896,675
• Itm Isotope Technologies Munich SE v. The Johns Hopkins UniversityInstituted
  PTAB · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution

  Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 of the ’201 patent.” slip op. at 2

  • Skill levelSkill level board ownOther

    “At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11

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

    “The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,938,201
• Globus Medical, Inc. v. Spinelogik, Inc.Instituted
  PTAB · Jul 14, 2025 · IPR2025-00226 · APJ Matthew S Meyers · IPR · Institution

  The Board instituted IPR of claims 1–5, 7, and 9 on all asserted grounds, finding a reasonable likelihood that Moskowitz and Steffee render at least one challenged claim obvious.

  RulingsInstitution decision

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

    “A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and “the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness when presented. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party who petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted).” slip op. at 7

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

    “Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have had to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. See Phillips, 415 F.3d at 1312–13. “In determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17).” slip op. at 9

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

    “according to what Petitioner purports to be Patent Owner’s “apparent construction” is relevant to only Petitioner’s challenge based on Moskowitz and the knowledge of a person of ordinary skill in the art (Ground 1). Here, Petitioner acknowledges that “even if a ‘curved’ channel has a narrower meaning requiring the channel to follow a curved path (instead of the straight path identified in the accused products), Petitioner demonstrates that the challenged claims are also unpatentable over at least Grounds 2 and 3.” Pet. 24–25. For purposes of this decision, we find Petitioner’s alternative construction to be consistent with the ’385 patent’s disclosure. See, e.g., Ex. 1001, 15:49–53 (“The anchoring member is advanced through the curved fusion member channel and into the vertebral body. As the fusion member channel is curved, the path that the anchoring member travels is also curved.”). We also find it to be consistent with the construction Petitioner advances in the related litigation. See Ex. 1029, 1 (Petitioner preliminarily construing “curved channel” to mean “channel that has a curved path”). However, because construing “curved,” as it appears in the term “curved channel,” is not necessary to determine whether Petitioner has made a sufficient showing to support institution, we determine that an express interpretation of this term is not needed at this stage of the proceeding. 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)). On this limited record, and at this early stage of the proceeding, the Board has not made a final determination on the construction of “curved,” as it appears in the term “curved channel.” The parties should consider developing this issue further during trial.” slip op. at 12

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

    “a) Motivation to Combine Petitioner asserts that one of ordinary skill in the art would have been “motivated to use Steffee’s curved anchors with Moskowitz’s screw box to minimize potential migration of the screw box after implantation.” Pet. 84 (citing id. at 88–90). According to Petitioner, “Steffee taught that forces tending to cause sagittal or lateral movement of the fastener (and thereby migration of the implant) can be minimized or eliminated by using a curved fastener that increases the entry angle of the fastener to near-perpendicular.” Id. at 88. Thus, Petitioner asserts that one of ordinary skill in the art would have been “motivated to use Steffee’s curved anchors with Moskowitz’s screw box to lower the forces (acting through Moskowitz’s existing screws) that tended to cause migration of fusion implants.” Id. (citing Ex. 1002 ¶ 169). Petitioner also points out that “Moskowitz’s anchors are threaded screws” (Pet. 89 (citing id. at 30–48)), and Petitioner asserts that one of ordinary skill in the art would have understood that such screws could strip (e.g., due to misalignment or over-torquing), which would reduce the stability of engagement between the fusion member and vertebrae. Ex. 1002 ¶ 170. Because the fasteners in Steffee do not contain threads, and further contained barbs to prevent the fastener from backing out (Ex. 1005, 2:61–68), a POSA would have understood that such fasteners would not be subject to such stripping. Ex. 1002 ¶ 170. Therefore, a POSA would have been motivated to use similar curved fasteners having barbs to eliminate the risk of stripping inherent when using Moskowitz’s screws. Id. Pet. 89. In addition, Petitioner contends that one of ordinary skill in the art would have “had a reasonable expectation of success in making this modification because it would only require the use of known machining techniques, and because the use of both curved anchors and curved channels had already been shown successful in spinal implants.” Id. at 84. Petitioner provides several reasons to support its contention. See id. at 90–91.” slip op. at 17

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,460,385

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.