• Thorne Research, Inc. v. Trustees Of Dartmouth CollegeAll claims unpatentable
  PTAB · May 31, 2022 · IPR2021-00268 · APJ John E Schneider · IPR · Final written decision

  Claim 2 is unpatentable as anticipated by Stamler and, alternatively, obvious over Stamler.

  RulingsFinal written decision

  • BurdenDecided for petitioner

    “2. Anticipation2 “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “[U]nless a reference discloses within the four corners of the document not only all of the 2 As noted above, the pre-AIA provisions of 35 U.S.C. apply to the ’086 patent. the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 8

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

    “Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 . As discussed above and in our Decision to Institute, the ’086 patent meets this criterion. While we agree with Petitioner that the face of the ’086 patent does not include a citation of the ‘701 application, the specification does contain a clear claim of priority back to the ’701 application. Ex. 1001, col. 1. ll. 7–13; Ex. 1004 1.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “the art offered by Patent Owner in the ’1795 IPR, which, as noted above, also involved the ’086 patent, should apply to this proceeding, namely “someone with a Ph.D. in biochemistry or similar field in the pharmaceutical sciences, with familiarity and experience with pharmacokinetics.” Pet. 33. Patent Owner does not dispute Petitioner’s definition and, indeed, Patent Owner’s expert, Dr. Amiji, used the same definition in his analysis. Ex. 2014 ¶ 21. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention and supports Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14

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

    “We have considered the arguments presented by the parties, and find that our initial construction is proper for the reasons set forth in the ’1795 proceeding. Ex. 1018 12–14. We decline to adopt Patent Owner’s construction that calls for an isolation step separate from the process used to manufacture synthetic NR.” slip op. at 16

  Patent outcomesUS 8,383,086 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,383,086
• Ricetec, Inc. v. BASF SEInstituted
  PTAB · Mar 11, 2022 · PGR2021-00114 · APJ Tina E Hulse · PGR · Institution

  The Board instituted PGR on claims 1–17 on all petition grounds, finding the claims more likely than not unpatentable over Hinga and related art.

  RulingsInstitution decision

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

    “post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a person of ordinary skill in the art must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of research experience, Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during a doctoral program). On this record, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find on this record that Dr. Shaner and Dr. Burgos are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 5–15; Ex. 2003 ¶¶ 5–17.” slip op. at 6

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

    “Patent Owner states that it “agrees that the claim terms of the ’346 Patent should be given their ordinary and customary meaning.” Prelim Resp. 20. We interpret Patent Owner’s statement to mean that it agrees with Petitioner’s proposed constructions of “endogenous non-transfected mutant” and “effective amount.” Because Petitioner’s construction of “endogenous non-transfected mutant” is consistent with the ’346 patent’s express construction of the term, that construction in this proceeding.” slip op. at 7

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

    “limitation of each of the challenged claims is not adequately supported by the Mankin Application. Although the Mankin Application does generally describe herbicidal compositions that “comprise an herbicidal effective amount” of at least one ACCase herbicide (Ex. 2034 ¶ 233), that generic disclosure is not sufficient written description support for the specific effective amount recited in the claims. Indeed, we agree with Petitioner that the Mankin Application does not disclose any effective amounts of quizalofop within the claimed range, let alone one that causes less than 10% injury. See Ex. 1002 ¶¶ 90, 91. 94; Ex. 1013 ¶¶ 128, 237 (Table 1), 248, Fig. 17.” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,096,346
• Ricetec, Inc. v. BASF SEInstituted
  PTAB · Mar 11, 2022 · PGR2021-00113 · APJ Tina E Hulse · PGR · Institution

  The Board instituted PGR on claims 1–15 because Petitioner showed it is more likely than not that at least one challenged claim is unpatentable over Hinga or Hinga2013.

  RulingsInstitution decision

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

    “We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “We find Petitioner has shown sufficiently that the “effective amount” limitation of each of the challenged claims is not adequately supported by the Mankin Application. Although the Mankin Application does generally describe herbicidal compositions that “comprise an herbicidal effective amount” of at least one ACCase herbicide (Ex. 2034 ¶ 233), that generic disclosure is not sufficient written description support for the specific effective amounts recited in the claims. Indeed, we agree with Petitioner that the Mankin Application does not disclose any effective amounts of any of the recited herbicides within the claimed ranges, let alone one that causes less than 10% injury. See Ex. 1002 ¶¶ 90, 91. 94; Ex. 1013 ¶¶ 128, 237 (Table 1), 248, Fig. 17. description is satisfied because the Mankin Application’s disclosure of an herbicide tolerance study for a DIM herbicide would have led a person of ordinary skill in the art to the specific effective amounts of the FOP herbicides recited in the claims. Prelim. Resp. 72–73. Nor are we persuaded that there is adequate written description support because a person of ordinary skill in the art would have been able to ascertain the effective amounts for each herbicide based on the knowledge in the art. Id. at 73. That is not the test for written description. “It is not sufficient for purposes of the written description requirement of § 112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Rather, “[e]ach application in the chain must describe the claimed features.” Id.” slip op. at 15

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “We note that Petitioner does not appear to consider the knowledge of a person of ordinary skill in the art in evaluating the amount of guidance needed to enable the claimed invention. As our reviewing court states, “[a] patent need not teach, and preferably omits, what is well known in the art.” Falkner v. Inglis, 448 F.3d 1357, 1365 (Fed. Cir. 2006) (citation omitted). Although the ’345 patent does not provide a specific working example of the G2096S mutation, we are not persuaded on this record that that necessarily weighs heavily in favor of undue experimentation given the prior knowledge in the art that that mutation confers herbicide tolerance to rice plants and the deposit of the G2096S mutation seed, as taught by Hinga and Hinga2013. Ex. 1003 ¶ 21; Ex. 1004 ¶ 54.” slip op. at 26

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 31

  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,096,345
• Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationAll claims unpatentable
  PTAB · Jan 31, 2022 · PGR2020-00076 · APJ Erica A Franklin · PGR · Final written decision

  Claims 1–16 are unpatentable under § 112(a) for lack of written description; the Board did not reach the remaining grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As noted by the Drs. Nordgren and HogenEsch, the differences in these descriptions are “relatively minor.” See Ex. 1038, 238:21–24; Ex. 1039 ¶ 42. Dr. Nordgren explains that even under the higher skill level required by Patent Owner’s description of a POSITA, his opinions would not change. Id. at 1039 ¶ 42. Based upon our review, the differences in Petitioner’s and Patent Owner’s proposed definitions do not impact Petitioner’s grounds for unpatentability or Patent Owner’s responsive arguments. Nor does our consideration of the issues presented turn on which proposed definition is applied. In any event, having considered the evidence and the arguments, we find Patent Owner’s rationale for its more narrow description of the level of ordinary skill in the art to be persuasive and Patent Owner’s description of a person of ordinary skill in the art, while maintaining that the prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

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

    “In the Patent Owner Response, Patent Owner asserts that Petitioner’s proposed construction is actually a subject matter eligibility argument. PO Resp. 23. According to Patent Owner, “[t]he term ‘porcine circovirus type 3 recombinant protein’ has a plain and ordinary meaning of ‘genetically engineered PCV3 protein.’” Id. (citing Ex. 2052 ¶¶ 91–92). Having considered the positions of both parties, and the evidence of record, we find that for purposes of this Decision, the ordinary and customary meaning of the claim term “porcine circovirus type 3 recombinant protein,” is a PCV3 protein obtained by genetic engineering, and specifically by recombinant technology, wherein the recombinant protein may either have the same structure and same amino acid sequence as variation therein. See Ex. 1026 ¶¶ 217–218; Ex. 1038, 264:2–9, 266:13– 267:3). 2.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “In the Patent Owner Response, Patent Owner asserts that “[a] POSITA would have understood ‘the nucleotide sequence encoding [ORF1, ORF2 or ORF3]’ to mean ‘a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.’” PO Resp. 24 (citing Ex. 2052 ¶¶ 93–96). In support of that position, Patent Owner refers to the following Specification description: [a] preferred PCV3 ORF2 protein is that of SEQ ID NO. 6, but it is understood by those of skill in the art that this sequence, as well as those for ORF1 and ORF3 could vary by as much as 10% in sequence homology and still retain the antigenic characteristics that render it useful in immunogenic compositions. Patent Owner asserts, according to that Specification description, “the sequences described and identified by SEQ ID Nos. in the patent for PCV3 ORF1, ORF2 and ORF3 are representative sequences, and ‘ORF1,’ ‘ORF2’ and ‘ORF3’ in the patent also refers to those sequences with at least 90% sequence homology.” Id. (citing Ex. 2052 ¶ 95; Ex. 2006, 107:9–17). Further, Patent Owner asserts this interpretation is consistent with the language of the other claims. In particular, Patent Owner refers to the limitation in claim 1 reciting that the composition comprises a PCV3 recombinant protein selected from “ORF1, ORF2 and ORF3, wherein said protein is encoded by a nucleotide sequence having at least 90% sequence homology with a sequence selected from the group consisting of SEQ ID NO. 3, SEQ ID NO. 5, SEQ ID NO. 7.” Id. (quoting Ex. 1001, 71:14–21). Having considered the positions of the parties, and the evidence of record, we agree with Patent Owner that the Specification provides clarity and meaning for the use of the terms ORF1, ORF2, and ORF3, which are not set forth or defined in claim 4, from which claim 5 depends, or in claim 5. Petitioner, in its alternative argument regarding the construction of the phrase involving those terms in claim 5, agrees to some extent. See Pet. 26. For purposes of this Decision, and for the reasons discussed by Patent Owner, we construe the claim phrase “nucleotide sequence encoding ORF1, . . . ORF2, and . . . ORF3” recited in claim 5 as meaning “a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.”” slip op. at 13

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

    “We do not find that description to be adequate. Essentially, the Specification description that the sequences for PCV3 ORF 1, 2, and 3, could vary by as much as 10% sequence homology just rephrases what is claimed in terms of those sequences having at least 90% sequence homology, adding only that antigenic characteristics are retained that render it useful for immunogenic compositions. A claim, however, “does not become more descriptive by its repetition,” see Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568), and “a definition of a useful result rather than a definition of what achieves that result” does not sufficiently Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002)). As noted by Petitioner and Dr. Nordgren, the ’351 patent discloses nucleotide and amino acid sequences corresponding only to the naturally-occurring PCV3 ORFs 1–3. PO Resp. 52; Ex. 1026 ¶ 168. While those sequences may be characterized as “reference” sequences, as they reflect sequences with 100% homology with PCV3 ORFs 1–3, Patent Owner has not demonstrated that they are “representative” sequences for the broad range of sequences claimed. We find that the Specification does not reasonably convey that the inventor made or was otherwise in possession of any of the remaining members of the genus with at least 90% sequence or amino acid homology with ORFs 1–3. PO Resp. 53; Ex. 1026 ¶ 168. We find that Dr. Nordgren credibly characterizes the Specification, as follows: [T]he ’351 Patent outlines a preliminary research plan to eventually make and use the broad range of claimed proteins. That is, the inventor provides a number of DNA and primer sequences that could be used to clone homologous DNA sequences into an expression vector, and theorizes that proteins expressed from sequences having 90% sequence homology will be antigenic. Critically, however, the ’351 Patent does not disclose which of the thousands of different claimed homologous sequences, if any, the inventor possessed, much less had discovered to be antigenic. Instead, the inventor merely proposes, without any factual support, that PCV3-derived amino acid sequences “could vary by as much as 10% in sequence homology and still retain the[ir] antigenic characteristics.” Ex. 1001 at 8:49-56. A POSITA would not credit that unsupported speculation, and therefore would not believe that the inventors possessed such a wide range of proteins.” slip op. at 33

  Patent outcomesUS 10,450,351 unpatentable
  Claim construction§ 112 disclosurecites Graham
  Patents in suitUS 10,450,351
• Commonwealth Scientific And Industrial Research Organisation v. BASF Plant Science Company GmbHAll claims unpatentable
  PTAB · Oct 1, 2021 · PGR2020-00057 · APJ Robert A Pollock · PGR · Final written decision

  Claims 1–17 are unpatentable based on lack of written description, lack of enablement, and anticipation or obviousness over Bauer, Napier, and Petrie I; the Petrie II obviousness ground was not proven.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Although the precise definition of the person of ordinary skill in the art is not dispositive of Petitioner’s grounds, we find it useful in framing the field of the invention. While we agree with Petitioner’s emphasis on plant recombinant DNA techniques, Patent Owner’s focus on plant genetics and plant lipids is well taken. As noted in the Patent Owner Response, the challenged claims are “directed to plant seed oils produced by a transgenic 10 Petitioner does not contest Patent Owner’s assertions regarding the similarities between the subject matter of the ’870 patent and the patents at issue in the Virginia litigation but asserts that its arguments in the Virginia litigation differed from those presented here, that those arguments were not accepted by the judge, and that “CSIRO ended up giving BASF a covenant not to sue on every single patent that had the language ‘at least a number with no upper limit.’” See Ex. 2005, 5–16; Ex. 2003, 14–16; Tr. 75:25– 76:11. plant,” whereas the portions of the Specification most relevant to those claims describe “genetically modified plants capable of producing certain oils, lipids, and fatty acids, and the genetic techniques related thereto.” PO Resp. 24–25 (citing Ex. 2012 ¶ 54); see also section I.D, above. Considering the above, as well as the ’870 patent and cited art, we view a person of ordinary skill in the relevant art as having a working knowledge of plant recombinant DNA techniques, a Ph.D. in plant molecular biology, lipid biochemistry, or lipid metabolism, and three years of work experience (excluding Ph.D. thesis studies) in lipid biochemistry or lipid metabolism as applied to plants. B.” slip op. at 17

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

    “In light of the above, the many variables affecting DHA production render the functional upper bound of “at least 1% docosahexaenoic acid (DHA)” a moving target. We thus return to the intrinsic evidence and the plain language of the independent claims. Applying the ordinary and customary meaning in accord with Phillips, we adopt Petitioner’s proposed construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). See Pet. 30; Ex. 1002 ¶ 57. For similar reasons, and because Patent Owner does not expressly argue the meaning of the remaining terms, we further adopt Petitioner’s proposed construction of “a ratio of DHA to [DPA] of at least 2,” as covering a ratio from 2 up to infinity; and “a conversion rate of DPA to DHA of at least 75%,” as covering a conversion rate of 75% to 100%. See Pet. 30–31; Ex. 1002 ¶ 57; Dec. 13–14. We further adopt Petitioner’s uncontested explanation that the “ratio of DHA to DPA of 2.9” recited in claims 6 and 15 indicates “an implicit upper limit of 73.6% DHA.” See Pet. 56 n.15.” slip op. at 29

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

    “We consider, first, the evidence of record under our construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). Patent Owner argues that such levels are “impossible” and does not contest Petitioner’s assertion that the challenged claims are unpatentable for lack of written description under this construction. PO Resp. 27, 28. Indeed, Dr. Sederoff admitted that the ’870 patent neither describes nor enables one 15 The arguments and evidence adduced in this proceeding do not address whether the conversion of 18:2 and 18:3 to DHA could be accomplished using a subset of the enzyme activities shown in Figure 1 by omitting some of the enzymes that permit formation of alternative intermediates. To the extent this is possible, it would not alter the thrust of our reasoning throughout this Decision. of ordinary skill in the art to make a transgenic Brassica plant (as recited in claims 5 and 13) that produces more than 50% DHA. Ex. 1016, 64:23–66:2, 67:24–68:4. But although reaching the upper limit of “at least 1% docosahexaenoic acid (DHA)” may be impossible under any of the constructions considered herein, the Federal Circuit “repeatedly and consistently has recognized that courts may not redraft claims, whether to make them operable or to sustain their validity.” Chef Am., Inc. v. Lamb- Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (collecting cases). For the above reasons, we find that a preponderance of the evidence supports Petitioner’s contention that claims 1–17 do not comply with the written description requirement as set forth in Ground 1 under our construction of “at least 1% docosahexaenoic acid (DHA),” with respect to any plant including Arabidopsis. Considering claims 5 and 13, in particular, the ’870 patent does not describe a transgenic Brassica plant that produces more than 50% DHA.” slip op. at 35

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “In view of the above, we find that one of ordinary skill in the art would have understood that even in high copy number lines, unpredictable effects such as gene silencing could prevent the accumulation of high levels of enzymes such as those listed in Table 4 of the ’870 patent. Moreover, even if high enzyme levels were achieved, the extent to which those enzymes would catalyze the desired reactions would have been unknown. Accordingly, from a quantitative standpoint, the evidence adduced points to a high level of unpredictability in the art. Focusing on the last step of the pathway illustrated in Figure 1 of the ’870 patent, Patent Owner also asserts that the ordinarily skilled artisan “knew how to introduce multiple additional copies of the key enzyme responsible for the rapid and efficient conversion of DPA to DHA, the Δ4 desaturase from Emiliana huxleyi, to achieve ratios of DHA to DPA approaching infinity, and conversion rates approaching 100%.” Sur-reply 21 (citing Ex. 2021 ¶¶ 136, 142 (stating that “no technical limitation prevents reaching a ratio nearing infinity,” i.e., 100% conversion of DPA to DHA)). Ex. 2012 ¶¶ 100, 113, 136, 142. Although we accept that the ordinarily skilled artisan could understand how and why to carry out those steps, the evidence discussed above persuades us that achieving the stated conversion efficiency for this step alone would have entailed undue experimentation. Considering that Patent Owner’s proposed construction requires, not just one, but every step of the pathway illustrated in Figure 1 proceed with (or at least near) 100% efficiency, the evidence of record persuades us that it would have required undue experimentation to achieve the claimed invention under any construction of “at least 1%” DHA advanced in this proceeding. In light of the above, and considering all the evidence, we find that a” slip op. at 61

  Patent outcomesUS 10,351,870 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,351,870
• Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution denied
  PTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.

  RulingsInstitution decision

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

    “review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,106,603
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Hospira, Inc. v. Genentech, Inc.Institution denied
  PTAB · Jul 27, 2017 · IPR2017-00739 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on claims 1–11 and 14–17 under § 325(d), finding the priority issue and Nabholtz ground had been considered during prosecution.

  RulingsInstitution decision

  • BurdenDecided for patent owner

    “Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “established priority for those claims based upon the parent application’s specific disclosure of using growth inhibitory agents as part of the present invention. (Ex. 1119-5 at 179 (citing Ex. 1121 at 20 (16:11- 24), 39 (35:6-14), 41 (37:9-18).) Based upon that disclosure, the examiner agreed that the claims reciting a combination with “a further growth inhibitory agent” were supported by, and thus entitled to priority to, the parent applications. (Ex. 1119-5 at 41; id. at 292-93; Ex. 1119- 6 at 245.) Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner

    “combination are needed to demonstrate that they can be usefully combined,’” flatly contradicts Patent Owner’s position that the ’649 Application and ’346 Provisional Application adequately disclose the claimed invention. Pet. 17–18 (citing Ex. 1119-5, 308–09). We do not find Petitioner’s argument persuasive. As an initial matter, Petition fails to address the “Wands” factors in its enablement analysis. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).” slip op. at 15

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “As discussed in section II(B), above, the Examiner considered fully the written description and enablement issues underlying Applicant’s claim to priority in allowing the claims to issue, and Petitioner has not presented new evidence or arguments that would convince us that the Examiner’s determination was unreasonable. The Examiner’s decision to withdraw the rejection under 35 U.S.C. § 102(b) over Nabholtz was expressly predicated on that priority determination, which removed Nabholtz as prior art. In Ground I of this Petition, Petitioner also asserts that the claims are unpatentable under § 102(b) over Nabholtz, thus raising “the same or substantially the same prior art or arguments previously [] presented to the Office” as contemplated under 35 U.S.C. § 325(d). Under the circumstances of this case, we exercise our discretion under § 325(d) and decline to institute inter partes review based on Ground I.” slip op. at 18

  § 102 anticipation§ 112 disclosureDiscretionary denial
  Patents in suitUS 7,892,549
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Galderma Laboratories, Inc.Institution denied
  PTAB · Feb 16, 2016 · IPR2015-01778 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because the petitioner did not show a reasonable likelihood that claims 1, 7, 8, 14, 15, and 20 were unpatentable over the asserted references.

  RulingsInstitution decision

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

    “CONCLUSION Petitioner does not convince us that non-provisional parent applications of the ’506 patent (as represented by the specification of the ’506 patent) fail to provide adequate written descriptive support for the challenged claims. Accordingly, we do not agree with Petitioner’s contention that the ‘506 patent is not entitled to the benefit of the April 5, 2002, filing date of the earliest of those applications under 35 U.S.C. § 120 such that Ashley ’572, Ashley ’267, and/or ORACEA would qualify as prior art.10 Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1, 7, 8, 14, 15, and 20 are unpatentable in view of the asserted references. ORDER Accordingly, it is ORDERED that the Petition is denied as to all challenged claims of the ’506 patent.” slip op. at 17

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “We do not find Petitioner’s arguments persuasive. As an initial matter, we note that Petitioner has not established that the term “acne rosacea” was “antiquated and outdated” as of the earliest filing date of the chain of applications leading to issuance of the ’506 patent. Nor does Petitioner establish that one of ordinary skill in the art would not have understood that term to indicate rosacea—a condition commonly known to encompass inflammatory papules and pustules, albeit not comedones. See Pet. 22; Prelim. Resp. 18–19; Ex. 1004 ¶ 13; Ex. 1034, 144. To the extent a dermatologist would not, as Petitioner argues, “have lumped [acne vulgaris and rosacea] together in a single genus,” does not persuade us that written description is lacking. An inventor may choose to be his own lexicographer and give terms uncommon meanings if “done with reasonable clarity, deliberativeness, and precision.” See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the present case, we find no ambiguity in the ’506 patent’s definition of the invention as directed to the treatment of “all known types of acne,” including both acne vulgaris and rosacea. See Ex. 1001, 4:31–43. The ’506 patent characterizes the genus acne as “a disorder of the skin characterized by papules, pustules . . . and other blemishes or skin lesions,” and notes that rosacea evinces specific characteristics of “inflammatory lesions (erythema) and permanent dilation of blood vessels (telangiectasia).” Id. at 4:23–30, 41–43. We are not persuaded that written description is lacking because not all of the symptoms attributed to the genus acne apply to rosacea, or that a symptom specific to rosacea (i.e, telangiectasia) may only be treated surgically. See Pet. 23. Rather, we find it sufficient that the specification teaches the treatment of papules and pustules of the genus “acne”—expressly defined by the inventor as including rosacea.” slip op. at 11

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “CONCLUSION Petitioner does not convince us that non-provisional parent applications of the ’506 patent (as represented by the specification of the ’506 patent) fail to provide adequate written descriptive support for the challenged claims. Accordingly, we do not agree with Petitioner’s contention that the ‘506 patent is not entitled to the benefit of the April 5, 2002, filing date of the earliest of those applications under 35 U.S.C. § 120 such that Ashley ’572, Ashley ’267, and/or ORACEA would qualify as prior art.10 Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1, 7, 8, 14, 15, and 20 are unpatentable in view of the asserted references.” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “i. Rosacea The parties agree that the ’506 patent identifies rosacea (“acne rosacea”) as a form of acne. Pet. 30–31; Prelim. Resp. 7. Although Petitioner contends that one of ordinary skill in the art would not classify rosacea as a form of acne (Pet. 22; Ex. 1004 ¶¶ 12, 13), we apply the inventor’s clearly expressed definition that “acne include[s] . . . acne rosacea” (Ex. 1001 4:31–41). With respect to the symptoms of rosacea, however, neither party contends that uncommon meanings apply. Pet. 30– 31; Prelim. Resp. 6–8. We therefore construe rosacea as a form of acne having symptoms including papules, pustules, erythema, and telangiectasia, where the predominant lesions are papules and pustules. See Ex. 1001, 4:23–43; Ex. 1004, ¶¶ 7, 19 (“‘The predominant lesions [in rosacea] are papules and pustules.’ ([Ex. 1056] at 680; see also Exh. 1046, at 852, 958; Exh. 1047, at 1023, 1175.).”” slip op. at 9

  Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
  Patents in suitUS 8,603,506

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.