- PTAB · Dec 8, 2023 · IPR2023-00998 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–3 over all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and accompanying evidence under 35 U.S.C. § 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . 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(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition and Preliminary Response, Reply, and Sur-Reply, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’880 patent is unpatentable. Accordingly, we institute an inter partes review as to all the challenged claims of the ’880 patent on all the grounds of unpatentability set forth in the Petition. We note that there are disputed issues in this proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary denial; however,” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not presently dispute this definition “except to clarify that the POSA would have at least two years of experience in engineering monoclonal antibodies for human therapeutic use, either in the laboratory or industry.” Prelim. Resp. 48; see also id. at 48–49 (arguing that Petitioner cannot prove unpatentability of the challenged claims under either party’s definition). 23 At this stage in the proceeding, we accept and use Petitioner’s proposed definition of the skilled artisan, as being both (largely) unopposed by Patent Owner and inclusive of Patent Owner’s additional qualification. In this respect, it appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” encompasses Patent Owner’s proposed modification, and is consistent with the level of skill in the art reflected in the prior art of record. 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)). Our decision whether to institute, however, does not turn on which party’s definition of the skilled artisan is used, and our determinations would be unchanged if we applied Patent Owner’s definition. Further, we note that evidence may be presented as the case progresses to support some other proposed definition of the skilled artisan, which may influence our determination of this issue. C. Claim Construction” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Neither party requests the construction of any claim term. See, e.g., Pet. 18. We need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). At this stage in the proceeding, we find it unnecessary to construe the language of any challenged claim because the claim language is readily understandable to the person of ordinary skill in the art on its face, within the context of the claims.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“TPO mimetic peptide graft in Fab clone X4b has been transplanted into the heavy chain CDR3 region of another antibody framework, 5G1.1. . . . Construction of 5G1.1 is described in U.S. Application Ser. No. 08/487,283, incorporated herein by reference.” Prelim. Resp. 50 (emphasis added); Ex. 1004 ¶ 191. It is not disputed here that U.S. Patent Application 08/487,283 issued as Evans. See Ex. 1005, code (21); see generally Prelim. Resp. The portion of Evans relating to “Construction of 5G1.1” (Ex. 1004 28 ¶ 191, emphasis added) appears to be (or at least includes) Example 11, which is titled “Construction and Expression of Recombinant mAbs.” Ex. 1005, 42:55–58 (emphasis added). According to Dr. Ravetch, “Evans’[s] Example 11 teaches construction of . . . humanized 5G1.1 scFv constructs.” Ex. 1003 ¶ 177. And, none of the other Evans Examples addressing an anti- C5 antibody or a 5G1.1 antibody designate their respective disclosure as relating to “construction,” as per the title of Example 11 and the sentence of Bowdish expressly incorporating Evans. See Ex. 1005, 33:1–42:54 (Examples 1–10); Ex. 1003 ¶ 177. Thus, on this record, we find that Petitioner’s pointing to the antibodies (or fragments) of Evans’s Example 11 for use as a starting point for Bowdish’s invention to be more reasonable than Patent Owner’s arguments that antibodies would have been selected from some other Example. Furthermore, Patent Owner does not dispute that, if Bowdish and Evans are read as asserted by Petitioner and Dr. Ravetch, the antibody sequences of claim 2, i.e., SEQ ID NO: 2 and SEQ ID NO: 4, are disclosed. Petitioner’s reading is also consistent with the Specification of the ’880 patent, which cites Evans (among others) for the proposition that “[s]uitable anti-C5 antibodies are known to those of skill in the art” and, in particular, that Evans discloses “antibodies which are specific to human complement . . . . includ[ing] a preferred whole antibody (now named eculizumab),” and “methods of engineering such antibodies.” Ex. 1001, 10:57–65, 12:13–21, 12:43–47. Therefore, we do not find any error in Petitioner’s assertion that Bowdish/Evans discloses the antibody of claim 2.” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,718,880 - PTAB · Dec 8, 2023 · IPR2023-00933 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claim 1 under all four asserted grounds, finding a reasonable likelihood that the claim is anticipated or obvious.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The two proposed definitions of the ordinarily skilled artisan are very similar, except that Patent Owner’s description more-specifically defines the field of experience of the artisan. At this stage in the proceedings, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, as being both generally unopposed by Patent Owner and inclusive of Patent Owner’s supplemental definition. It appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” includes Patent Owner’s proposed level of experience. Pet. 12–13. We also take into account the level of skill in the art reflected in the prior art of record. 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)). Our decision whether to institute does not turn on which party’s definition of the skilled artisan is used, and our determinations would be unchanged if we applied Patent Owner’s supplemented definition. Further, we note that evidence may be presented as the case progresses to support some other proposed definition of the skilled artisan, which may influence our determination of this issue. C.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“CLAIM CONSTRUCTION Petitioner states, “Petitioner does not believe claim construction is necessary at this time.” Pet. 15. Patent Owner does not mention claim construction at this stage of the proceeding. See generally Prelim. Resp. At this stage in the proceedings, and for the purposes of this decision, we find it unnecessary to construe the language of claim 1 because the claim language is readily understandable on its face and there is no dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). As the case continues, we may determine that certain claim language should be interpreted. D.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In view of the unique record before us, we agree with Patent Owner that all of the references relied on by Petitioner here, “were previously presented to the Office” as required by § 325(d) and Advanced Bionics. Prelim. Resp. 19. Accordingly, we proceed to part two of the analysis.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied discretionary otherDenied
“DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a) AND FINTIV Patent Owner points to § 314(a) as a basis for denying institution, but provides no substantive argument or evidence on this point. See Prelim. Resp. 17–32; see generally Prelim. Sur-Reply 6. Under certain circumstances, the Board may apply our discretion under 35 U.S.C. § 314(a) to deny institution in light of a parallel district court proceeding involving the same patent. See, e.g., Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential). But, as noted by Petitioner, the patent at issue here “has never been asserted in any litigation.” Pet. 49. Accordingly, we also decline to exercise our discretion under Section 314(a) to deny institution.” slip op. at 61
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,732,149 - PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166 - PTAB · Nov 16, 2023 · IPR2023-01035 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–6, 8–10, and 22–28, finding a reasonable likelihood that Petitioner would prevail on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’048 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner takes no position on” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this stage of the proceeding, we determine Petitioner’s construction is most consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the resulting bio-alkene is “about 5 to about 20.” Ex. 1001, claim 1 (emphasis added). We agree with Petitioner that use of the term “about” indicates a lack of specificity with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20” does not require precisely 5 to 20 carbons. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses at least a carbon chain length of 4, and “about 20” at the upper end of the range encompasses at least a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the parent application supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8” to “carbon chain length of 7.” See Ex. 1006, 335. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“institution under 35 U.S.C. § 325(d) for only these grounds (i.e., Grounds 5 and 6). Prelim. Resp. 19–25. Specifically, Patent Owner argues that Wright was considered by the Office and Petitioner has failed to demonstrate that the Office erred in any material way. Id. Even if we found Patent Owner’s arguments persuasive, after the Supreme Court’s decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), we are compelled to proceed with this inter partes review on all grounds raised in the Petition because we find above. See Guidance on the impact of SAS on AIA trial proceedings, available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sasaia-trial (“If the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”). Thus, we find Patent Owner’s § 325(d) arguments to be moot.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,995,048 - PTAB · Oct 20, 2023 · IPR2023-00739 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 10–12, 18, 19, 21, and 26–28 are obvious over the 2009 Press Release and Shams.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Release nor Shams expressly teaches the dosing regimen of “2 mg approximately every 4 weeks for the first 5 injections followed by 2 mg approximately once every 8 weeks or once every 2 months,” as recited in the independent claims. However, the question guiding our analysis is not one of anticipation, but of obviousness. Specifically, the question is whether the differences between the claimed subject matter 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 said subject matter pertains. KSR, 550 U.S. at 406. We therefore turn to that analysis.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“We conclude that, on the record as presently developed, Petitioner has demonstrated a reasonable likelihood of success in demonstrating that a person of ordinary skill in the art would have found it obvious to modify the dosage regiment of the 2009 Press Release by adding a single dose at week twelve, in view of the teachings of Shams, to arrive at the claimed invention. We find that a person of ordinary skill in the art would have considered this addition of a single dose to be routine optimization to ensure, as Dr. Chaum relates, “to determine the optimal number of initial injections, before moving to eight-week dosing.” Ex. 1002 ¶ 151. Furthermore, and at this stage of the proceeding, we agree with Petitioner that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the 2009 Press Release dosing protocol to include an additional dose at week twelve to ensure sufficient “drying” of the inner wall of the retina prior to increasing the interval of the doses two eight weeks/two months.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“claimed method. A reference teaches away when “a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner points to Shams’ Example 1, which it cites as representing Genentech’s PIER Phase IIIb study. See Prelim. Resp. 18. The PIER study, argues Patent Owner involved three monthly loading doses of a different VEGF antagonist (ranibizumab) followed by quarterly dosing, and, according to Patent Owner, was widely perceived as a failure. Id. Patent Owner contends that, based upon this single example, a person of ordinary skill in the art would have been discouraged from following the teachings of Shams. Id. We disagree. As we have explained above, the disclosures of Shams encompass a larger variety of regimen options than merely that embodied in Example 1. Shams is directed expressly to “methods including administering … a number of first individual doses of a VEGF antagonist, followed by administering … a number of second individual doses of the antagonist, wherein the second individual doses are administered less frequently than the first individual doses.” Ex. 1010, 4–5; see also id., claim 1. Furthermore, Shams expressly teaches that “[t]he doses may be administered according to any time schedule which is appropriate for treatment of the disease or condition.” Id. at 22. We find that these broad teachings of Shams would, rather than discouraging a skilled artisan from following its teachings, encourage a person of ordinary skill in the art to optimize the number of first and second individual doses to maximize the therapeutic effect of the regimen of VEGF antagonist dosage administration. Shams places no express limits upon the number of first individual doses and, as we have explained above, the addition of a single additional dose at week twelve would fall well within the scope of Shams’ disclosures.” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“A method for treating….” Petitioner initially accepts, for the purposes of this Decision, that the preamble of claim 1 is limiting, and agrees with the Board’s prior rejection, in the related IPR2021-00881 Final Written Decision, of Patent Owner’s position that the preamble requires a particular level of efficacy. Pet. 16 (citing Ex. 1002 ¶¶ 82–91). Specifically, Petitioner notes that the Board found that administering a compound—the recited VEGF antagonist—“to [a] patient for the purpose of improving or providing a beneficial effect on their angiogenic eye disorder” satisfies the “treating” portion of the preamble. Id. at 17 (quoting Ex. 1025, 19; and citing id. at 23; Ex. 1053, 9– 10; Ex. 1054). Patent Owner states that, for the purposes of this Decision only, it does not contest Petitioner’s proposed construction. Prelim. Resp. 11. Therefore, for the same reasons we explained in the Final Written Decision in related IPR2022-00881 concerning a related patent having claims with language similar to the presently challenged claims, and for the purposes of this Decision, we adopt Petitioner’s proposed construction of “a method for treating….” slip op. at 8
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,888,601 - PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See 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 (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 that 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) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, 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 ’343 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)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, 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 ’122 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 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - PTAB · Sep 22, 2023 · IPR2023-00481 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 17, 19, 20, and 22–27 because Hopewell showed a reasonable likelihood that the claims would have been obvious over Bodor and Stelmasiak.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 17 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Because we agree that Bodor and Stelmasiak were presented previously to the Office, we turn to part two of the Advanced Bionics framework—whether there was a material error by the Office.” slip op. at 54
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Analogous artInstituted
“reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if needed). Moreover, Petitioner provides evidence-backed reasoning supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;16 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage 16 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 17. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 17. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in treating RRMS with cladribine administration, including in oral and parenteral forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’903 patent describe the use of cladribine for treating MS, including RRMS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”). slip op. at 33
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,377,903
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.