- 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 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Nov 14, 2023 · IPR2023-01030 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–29 would have been obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that the information presented does not show a reasonable likelihood that Petitioner would prevail with respect to any claim. See 35 U.S.C. § 314(a). Accordingly, we deny the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 15–16. Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally, Prelim. Resp. For this Decision, we adopt and apply Petitioner’s proposal for the level of skill in the art, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Petitioner proposes constructions of four limitations: “insertional enzyme complex,” “nucleic acid insert element,” “adapter sequence,” “barcode sequence,” and “tagged fragments.” Pet. 20–23. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 15. We determine that none of the four limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“express construction of the term “chromatin.” The ’207 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:58–64. This is the meaning that we apply in this Decision.” slip op. at 8
Claim construction§ 103 obviousnesscites GrahamPatents in suitUS 10,619,207 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - 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 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Oct 19, 2023 · IPR2023-00878 · APJ Michael J Fitzpatrick · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that Grunenwald anticipates claim 1 or that the asserted combinations cure its failure to disclose contacting chromatin.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review requires that “the information presented in the petition filed under section 311 and any response filed under section 313 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that the information presented does not show a reasonable likelihood that Petitioner would prevail with respect to any claim. See 35 U.S.C. § 314(a). Accordingly, we deny the Petition.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Petitioner proposes constructions of four limitations: “insertional enzyme complex,” “nucleic acid insert element,” “adapter sequence,” and “barcode sequence.” Pet. 21–25. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 16. We determine that none of the four limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’995 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:41–42. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 27 (citing Ex. 1003 ¶¶98, 161); Prelim. Resp. 34 (“Grunenwald defines ‘transposase’ to include any transposase, thus including those that comprise antibodies that are specific to a protein that is part of said chromatin.” (citing Ex. 1003 ¶93)).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“express construction of the term “chromatin.” The ’995 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:54–60. This is the meaning that we apply in this Decision.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“B. Ground 1 Petitioner asserts that Grunenwald anticipates independent claim 1, as well some of the dependent claims. Pet. 25. “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Patent Owner argues that Grunenwald fails to anticipate claim 1, which failure undermines the entire Petition. Prelim. Resp. 16–17 (“Petitioner has failed to show that Grunenwald discloses each and every limitation as arranged in the claims, including, e.g., ‘contacting chromatin of a genome region,’ and thus cannot meet its burden as to any claim in Ground 1.” (quoting claim 1)), 38 (“Petitioner cannot meet its burden as to Grounds 2–8 for the same reasons Petitioner cannot meet its burden for Ground 1.”). Accordingly, we turn first to claim 1.” slip op. at 7
Claim construction§ 102 anticipationPatents in suitUS 10,150,995 - PTAB · Oct 13, 2023 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted IPR on claims 1–6; the Board found a reasonable likelihood that claim 1 would be unpatentable as obvious over Linnarsson and McCloskey.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In sum, on the record presented, it appears that Petitioner is correct in stating that “no arguments were made during examination with respect to McCloskey or any similar reference disclosing an oligonucleotide with two tags.” Pet. 70 (underlining added).” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable on this ground.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposes constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, for its part, states that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. On the record before us, and for purposes of institution, we find there is no need to provide an express construction of any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 21–22 (citations omitted). At this stage of the proceeding, Patent Owner does not dispute the level of skill proposed by Petitioner. Because Petitioner’s formulation of the level of ordinary skill in the art appears consistent with the disclosure of the ’981 patent and the asserted prior art, and because there is no argument to the contrary at this stage of the proceeding, we apply Petitioner’s formulation in our analysis below.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,155,981 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - 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
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.