- 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 - Universal Electronics, Inc. / Gemstar Technology (Qinzhou) Co. Ltd. et al. v. ROKU, Inc.Some claims unpatentablePTAB · Oct 23, 2023 · IPR2022-00818 · APJ Patrick M Boucher · IPR · Final written decision
Claims 1–5, 8–10, and 14 are unpatentable over RadioShack; claim 11 was not shown unpatentable over Wouters and Verzulli because the combination did not disclose the claimed combining and installing steps.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“disseminated to the interested public, ‘public accessibility’ has been called the touch-stone in determining whether a reference constitutes a ‘printed publication’ . . . .” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). A reference is considered “publicly accessible” if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Id. at 1355–56 (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). Petitioner treats this requirement as having two aspects, namely (1) whether a person of ordinary skill could reasonably have found RemoteCentral.com and (2) whether such a skilled artisan could reasonably have found RadioShack on RemoteCentral.com. Reply 8–13; see also Tr. 33:25–34:8 (Patent Owner asserting that there are two aspects to the analysis on public accessibility: “The first is whether a [person of ordinary skill in the art] would have known to arrive at the website containing the prior art reference. The second one is . . . , [a]ssuming the [person of ordinary skill in the art] would have done so, would the [person of ordinary skill in the art], exercising reasonable diligence, have located the prior art reference on the site? And these are separate and distinct requirements, and if you fail one of them, the document is not publicly accessible.”).” slip op. at 27
- Strike new argumentNew argument consideredDecided for petitioner
“addressed squarely by the principles set forth in Hulu, which addresses the standards at the institution stage and during the trial for evaluating evidence proffered to show asserted art qualifies as a printed publication. Specifically, after a petitioner has presented “evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent,” such that trial is instituted, “some limited opportunities exist for the petitioner to present new evidence later.” Hulu at 13–14. These “limited opportunities” include “in a reply to the patent owner response,” provided that the additional evidence is “responsive to the prior briefing” and provided that the additional evidence does not require “completely reopen[ing] the record, by, for example, changing theories after filing a petition.” Id. at 14–15. Although Patent Owner contends that “[t]his is not an example of permissible rebuttal evidence, but rather a belated attempt to fill a gap in the evidence in the Petition,” we disagree. See Sur-reply 6. Rather, the 7 Patent Owner appears to refer incorrectly to Exhibit 1040 instead of Exhibit 1041 when identifying “articles allegedly referring to RemoteCentral.com.” See Sur-reply 5–6. progression within the instant proceeding comports well with the Hulu framework. During the preliminary proceeding, Petitioner came forth with “evidence sufficient to establish a reasonable likelihood that [RadioShack] was publicly accessible before the critical date of the challenged patent,” just as Hulu demands. Hulu at 13; Inst. Dec. 23 (“[W]e determine that Petitioner’s showing regarding public accessibility of RadioShack is sufficient under the standard we apply at this stage of the proceeding.”). Patent Owner challenges RadioShack’s status as a printed publication in its Response, just as Hulu contemplates. Hulu at 15; PO Resp. 28–41. And Petitioner submits additional evidence that replies to that challenge without changing its theory that RadioShack qualifies as a printed publication by virtue of its accessibility on the RemoteCentral.com web site and in light of date indicia on RadioShack itself.8 See Hulu at 15–16; Reply 7–13. Moreover, in determining that Petitioner’s additional evidence directed at RemoteCentral.com is properly considered, we are further mindful of the Federal Circuit’s endorsement that “the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the patent owner.” Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1830–81 (Fed. 8 In its Reply, Petitioner also relies on evidence of publication of RadioShack on Radio Shack’s own public website and on “a third location,” hifi-remote.com. Reply 14. As we discuss below, we determine that the presence of RadioShack on RemoteCentral.com is sufficient to qualify RadioShack as a printed publication. We therefore do not reach the issue of whether presence on either the Radio Shack web site or on hifi-remote.com is an improper new theory raised by Petitioner in its Reply. See Tr. 8:13– 9:23 (Petitioner discussing whether reliance on hifi-remote.com presents a different theory than set forth in the Petition). Cir. 2018); see also Vidstream LLC v. Twitter, Inc., 981 F.3d 1060, 1065 (Fed. Cir. 2020) (“The Board denied VidStream’s Motion to Exclude, holding that it was appropriate to permit Twitter to respond to VidStream’s challenge [to the status of Bradford as a printed publication] by providing additional evidence to establish the Bradford publication date. We conclude that the Board acted appropriately, for the Board permitted both sides to provide evidence concerning the reference date of the Bradford book, in pursuit of the correct answer.”). We accordingly give due weight to Petitioner’s additional evidence of RadioShack’s accessibility on the RemoteCentral.com web site.” slip op. at 25
- ExcludeMotion to exclude, deniedDenied
“1 Patent Owner objected to Petitioner’s demonstrative slides 45 and 68 as presenting a new argument that was not previously made with respect to challenged claims 2 and 10. Paper 27; see Paper 26 (Petitioner’s demonstratives), 45, 68. At the oral hearing, we reserved ruling on the objections. Tr. 5:23–6:3. Both slides reproduce the same portions of Exhibits 1002 and 1025, with the statement that “A press and hold for an auto-scan or brand-scan is admitted prior art.” Paper 26, 45, 68. As explained below, we do not reach the predicate position upon which the objections are based. See Tr. 5:8–11 (Petitioner stating that “this Board only needs to resolve this objection if it accepts Roku’s claim construction argument that the claims cover a press and hold of a single button, but that they do not cover pressing multiple buttons to present that argument in the alternative. So, if you reject that argument, you don’t even have to resolve the objection.”). We accordingly dismiss the objections as moot.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with this assessment, and the parties do not specifically advocate for one articulation over the other in this proceeding. See Pet. 8 (Petitioner asserting that “[t]he Challenged Claims are unpatentable under both proposed levels”); PO Resp. 5 (Patent Owner stating its “position that the challenged claims are unpatentable under either proposed level of ordinary skill”). We adopt Patent Owner’s proposed statement of the level of ordinary skill as advanced in the related ITC Investigation. But we note that we would reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that all challenged claims are unpatentable were we to adopt Petitioner’s proposal instead.” slip op. at 12
Patent outcomesUS 8,378,875 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,378,875 - 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 - 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 · Aug 8, 2023 · IPR2023-00546 · APJ Robert A Pollock · IPR · Institution
Instituted IPR on claims 1–5, 9–11, 13, 18, 19, and 28–30; Petitioner showed a reasonable likelihood of unpatentability under each asserted Ley and Newman anticipation and obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, 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) (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 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1061 ¶ 37) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 9. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’611 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art. C. Claim Construction” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, step (a) in the body of claim 1 entails obtaining sequence data from at least one biological sample from a subject. In step (b) the sequence data is used in to identify a set of genetic variants present in the biological sample. Step (c) entails creating a probe set corresponding to identified genetic variants. In step (d) the probe set is used to selectively enrich or amplify those variants if present in a second biological sample from the same or related individual, and thereby create a sequencing library. This library is sequenced in step (e) to identify the presence or absence of at least a subset of the genetic variants identified in step (b). As such, steps (a) through (e) define a complete invention, with the preamble merely stating a 4 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“nucleic acid probe molecules” Claim step 1(c) recites “obtaining a probe set comprising a plurality of nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’611 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 17–18 (citing Ex. 1061 ¶ 98; Ex. 1001, 4:54–55, 5:16–18, 6:64–67). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity. slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,450,611 - PTAB · Aug 8, 2023 · IPR2023-00545 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–9, 13–19, and 21–29 on all three 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
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’783 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”). C. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . 3) an understanding of clinical applications of sequencing technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1020 ¶¶ 35) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 11. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’783 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, steps (a) through (c) in the body of claim 1 require the use of “a personalized probe set” to identify the presence or absence of genetic variants in a subject, whereupon this information is used to generate a report in step (d). We presently read the body of claim 1 to define a 7 Pointing to isolated passages in the Specification, Patent Owner further contends that, “methods that existed at the time of invention were specific to a particular disease or cancer rather than personalized to a specific subject’s family genetics,” whereas the claimed method “is directed to personalized genetic testing and is ‘better focused on the personal characteristics of the subject.’” Prelim. Resp. 20–21 (citing Ex. 1001, 4:37–47, 31:27–28). We find this argument confusing, as we do not presently read the challenged claims as limited to a “subject’s family genetics.” 8 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. complete invention, with the preamble merely stating a purpose or intended use, or, in another sense, simply the result of carrying out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2) “nucleic acid probe molecules” Claim 1 recites the use of “nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’783 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 15 (citing Ex. 1020 ¶ 95; Ex. 1001, 4:60–61, 5:23–25, 7:5–8, 7:25–26). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,299,783 - PTAB · Aug 2, 2023 · IPR2023-00455 · APJ Daniel J Galligan · IPR · Institution
The Board instituted inter partes review of claims 1–29 on all asserted grounds, finding a reasonable likelihood of success on the Perego and JESD79-2 obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“institution under 35 U.S.C. § 314(a) because the factors identified in Apple, Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”), weigh in favor of denying institution in view of the district court litigation. Prelim. Resp. 53–56. A Memorandum from Director Vidal titled Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (USPTO June 21, 2022) (“Interim Procedure”)6 provides that “the PTAB will not deny institution of an IPR or PGR under Fintiv . . . where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure 9. Petitioner has submitted such a stipulation for all claims in this proceeding, which are all of the claims of the ’215 patent. Ex. 1093; Paper 8 at 1; Paper 9 at 1. Thus, we do not exercise discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In evaluating arguments under Section 325(d), we use a two-part framework, determining, first, “whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office.” Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). If either condition of the first part of the framework is satisfied, we then determine “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Id.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record, we are sufficiently persuaded by Petitioner’s argument that a person of ordinary skill in the art would have combined the teachings of Perego and JESD79-2. As Petitioner correctly points out (Pet. 32), Perego discloses using DDR2 memory devices. Ex. 1071, 10:56–59 (“Other memory devices may be implemented on module 400, for example, Double Data Rate 2 (DDR2) DRAM devices and Synchronous DRAM (SDRAM) devices.”). On this record, we find this teaching to use DDR2 sufficiently supports Petitioner’s rationale to combine Perego with JESD79-2, which is the JEDEC DDR2 SDRAM Specification. Ex. 1064, 1 (cover page); see also Prelim. Resp. 44 (parenthetical noting that “JESD79-2 is a specification for individual DDR2 SDRAMs”). As to Patent Owner’s argument that Rambus memories lack a chip select network (Prelim. Resp. 25–26), the reference on which Patent Owner relies discloses that chip select information is still used in the particular Rambus devices described. See Ex. 1069, 11 (“[I]n the Rambus bus organization, all addresses, commands, data, and chip-select information are sent on the same bus lines.”), 12 (“[T]he example system uses a total of nine (9) lines to carry all necessary information, including addresses, commands, chip-select information, and data.”). Thus, on this record, Patent Owner’s focus on the lack of a chip select network, which is not recited in the claims of the ’215 patent, appears misplaced. We address Patent Owner’s more specific arguments below in the discussion of individual claim recitations.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Claim 21 is method claim and recites similar structure in the preamble. Petitioner cites this claim language in support of its position that a rank can have just one memory device. Pet. 28 (citing Ex. 1001, 37:32–38 (portion of claim reproduced above)). On this record, we determine that the claim language supports Petitioner’s position. Claim 1 recites “at least one first memory integrated circuit in the first rank and at least one second memory integrated circuit in the second rank.” This language is met if there is one memory integrated circuit in each rank because “at least one” includes just one. On this record, we disagree with Patent Owner’s argument that this claim language “do[es] not define the term ‘rank’” but, rather, “provide[s] context that a claimed ‘buffer’ can be, but need not be, coupled to multiple memory devices in the rank.” See Prelim. Resp. 9–10. Claim 1 recites “a buffer coupled between the at least one first memory integrated circuit and the memory bus, and between the at least one second memory integrated circuit and the memory bus,” and it further recites “enabl[ing] communication of the first data burst between the at least one first memory integrated circuit and the memory controller through the buffer” and “enabl[ing] communication of the second data burst between the at least one second memory integrated circuit and the memory controller through the buffer.” If there is only one memory device in each rank, then the buffer will only be connected to the one memory device in each rank. If two memory devices are the “at least one first memory integrated circuit in the first rank” then the buffer would be “coupled between the [two memory devices] and the memory bus.”” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 9,858,215 - PTAB · Aug 2, 2023 · IPR2023-00454 · APJ Daniel J Galligan · IPR · Institution
The Board instituted IPR on claims 1–15 on all asserted grounds, finding a reasonable likelihood that Samsung would show at least one claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (USPTO June 21, 2022) (“Interim Procedure”)6 provides that “the PTAB will not deny institution of an IPR or PGR under Fintiv . . . where a petitioner stipulates not to pursue in a parallel district 2 US 7,363,422 B2, issued Apr. 22, 2008 (Ex. 1071). 3 Joint Electron Devices Engineering Council (JEDEC) DDR2 SDRAM Specification (JESD79-2), September 2003 (Ex. 1064). 4 US 2006/0277355 A1, published Dec. 7, 2006 (Ex. 1073). 5 US 7,024,518 B2, issued Apr. 4, 2006 (Ex. 1078). 6 Available at https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf. court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure 9. Petitioner has submitted such a stipulation for all claims in this proceeding, which are all of the claims of the ’417 patent. Ex. 1093; Paper 8 at 1; Paper 9 at 1. Thus, we do not exercise discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In evaluating arguments under Section 325(d), we use a two-part framework, determining, first, “whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office.” Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, 7 Chapter 31 (35 U.S.C. §§ 311–319) relates to inter partes review. IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). If either condition of the first part of the framework is satisfied, we then determine “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Id.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“competent evidence” to show that “the overall CAS latency of the memory module is greater than an actual operational CAS latency of each of the memory devices,” as recited in claim 1. Prelim. Resp. 44. We disagree. Petitioner presents detailed testimony from Dr. Wolfe explaining how Perego’s registered data transfers would have introduced delay. In particular, Dr. Wolfe, citing Perego’s disclosures of data latches and an internal clock to generate synchronizing clock signals (Ex. 1071, 12:65–13:5, 17:61–63, Fig. C), provides the following testimony: A Skilled Artisan would have understood from these disclosures that Perego’s latching of the data signals and the use of internal synchronizing clock signals adds a predetermined amount of time delay for each data transfer through the buffer because the output of the latch needs to be in synchronization with an internal clock. A Skilled Artisan would have understood that such registering of the data signals would require the addition of a fixed time delay, such as one clock cycle, for each registered data transfer through the circuitry with respect to the actual operational CAS latency of each of the plurality of memory integrated circuits. Ex. 1003 ¶ 360. Dr. Wolfe further explains how Perego’s “latching delays in the buffer device of Perego increase the overall CAS latency of the memory module compared to the CAS latency of the memory devices.” Ex. 1003 ¶ 362 (citing Ex. 1071, 12:65–13:5, 18:65–19:3, Figs. 5B, 5C). On this record, we find Petitioner’s evidence sufficiently persuasive to show that Perego teaches that “data transfers through the circuitry are registered for an amount of time delay such that the overall CAS latency of the memory module is greater than an actual operational CAS latency of each of the memory devices,” as recited in claim 1. We are sufficiently persuaded by Petitioner’s contentions for the” slip op. at 33
- Skill levelSkill level board ownOther
“To the extent necessary, and for purposes of this Decision, we accept the uncontested assessment offered by Petitioner, except that we delete the qualifier “at least” to eliminate vagueness as to the amount of experience. The qualifier expands the range indefinitely without an upper bound, and thus precludes a meaningful indication of the level of ordinary skill in the art.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 11,093,417
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.