• Apple, Inc. v. Alivecor, Inc.All claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-00970 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–20 are unpatentable: claims 1–6, 10–16, and 20 as obvious over Shmueli and Osorio; claims 7–9 and 17–19 as obvious over those references and Hu 1997.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “truncates the full extent of Petitioner’s ITC definition, which further states that “a hypothetical person of ordinary skill in the art could also be a person with a medical degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or analyzing their data (in the context of industry, in biomedical academic research, or in practice treating patients)”. Ex. 2004, 6; Tr. 40:13–41:10. Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as POSITAs,” is well taken. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 25

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedOther

    “the art even under Patent Owner’s then-proposed definition. See DI 26–28. Despite Patent Owner’s subsequent position that the ordinarily skilled artisan should have an engineering degree and “design experience” in developing wearable cardiac sensors, the arguments and evidence adduced at trial do not alter our initial determination. See, e.g., PO Resp. 37–41; Reply 27–28; Sur-reply 22–24; see generally Tr. 40:25–46:19, 55:2–56:13. Rather, we agree with Petitioner’s argument in support of Dr. Chaitman’s qualifications, that this proceeding involves “piecing together known technologies and . . . the analysis of cardiac data” including PPG data, ECG data and activity level. Tr. 38:4–18. Thus, one of ordinary skill in the art with an understanding of cardiac monitoring technology “would understand how these types of data work, how they interplay and how the data could be processed on these devices.” Id.” slip op. at 26

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “meaning to the terms “arrhythmia,” “alert,” and “heart rate monitor.” PO Resp. 32 (citing Ex. 2010, 12–13). We understand “arrhythmia” as used in the context of the ’499 patent refers to “a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” Id. at 31–36 (quoting Ex. 1001, 1:31–33). This term does not appear to be in dispute. See Tr. 21:18–22:3 (“[Board”]: . . . Patent Owner raised the issue of claim construction for the term arrhythmia. Is there any dispute there? [Petitioner’s counsel]: Honestly, Your Honor, we considered that -- put a lot of energy into considering it. We don’t believe so.”); see also id. at 53:24–54:2 (“[Board]: . . . Your claim construction of arrhythmia is merely a matter of precision and clarification rather than a contested point; is that correct? [Patent Owner’s counsel]: I believe that’s largely correct.”). With the above understanding, we apply the plain and ordinary meaning to all claim terms. D. Ground 1: Obviousness over Shmueli and Osorio” slip op. at 27

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

    “In light of the above, and all the evidence adduced at trial, we agree with Petitioner that one of ordinary skill in the art would have understood Shmueli to teach or disclose methods and systems for “determining the presence of an arrhythmia,” as required by the challenged claims.” slip op. at 36

  Patent outcomesUS 9,572,499 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,572,499
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00928 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–6 are unpatentable as anticipated by Stafford and obvious over Stafford, alone or with Manno and Schuettrumpf.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See DI 11 (citing Ex. 1003 ¶ 48; Ex. 1094 ¶ 19). We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “In the Petition, Petitioner proposed constructions for five terms: “vector,” “percentage identity,” “promoter,” and “percentage homology,” and “polypeptide precursor.” Pet. 12–14. In our Decision on Institution, we determined that we did not need to explicitly construe any claim terms at that stage of the proceeding. DI 12. Patent Owner “does not believe any term requires construction for this proceeding.” PO Resp. 13. Considering the arguments and evidence of record, we agree with Patent Owner and apply the plain and ordinary meaning to all claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12

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

    “In sum, Stafford discloses (and claims) preferred Factor IX variants for the treatment of hemophilia B, wherein arginine 338 is replaced with, at most, one of three amino acids having similar properties: alanine, leucine, or valine. Ex. 1004, 5, claims 3–5, 10, 14; Ex. 1094 ¶ 104. Stafford further discloses vectors and associated control elements that “may be used in gene therapy to administer the expression cassette to targeted [sic] cells within the patient and produce the Factor IX in the patient.” Ex. 1004, 6–7. In addition to listing various general classes of potential expression vectors, Stafford specifically names four DNA-based viruses including AAV for the construction of vectors: “papillomavirus, adenovirus, adeno-associated virus, [and] cytomegalovirus.” Id.; Ex. 1003 ¶¶ 41, 77–78, 315. Because Stafford’s claims 15 and 17–19 describe a DNA viral vector encoding a FIX variant (of which Stafford names four), and because Stafford specifies three (if not two) preferred amino acid variants, “a POSA would have faced twelve possible combinations of DNA vector and preferred FIX variant for gene therapy.” See Ex. 1003 ¶¶ 321–323.8 Moreover, crediting 8 As previously noted, Dr. Wang misstates, in part, the dependency of Stafford’s claims. See DI 27 (citing Ex. 1003 ¶ 323). Although Stafford’s Dr. Wang’s testimony that, as of the time of the invention, “AAV vectors were considered the leading candidate for useful human gene therapy vectors, and were being used routinely in the hemophilia B field” (Ex. 1003 ¶ 39; see also id. at ¶¶ 32–36, 88, 323), we find that one of ordinary skill in the art would read Stafford as disclosing all elements of claim 1, “arranged as in the claim.” See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). As noted above, Patent Owner does not separately argue dependent claims 3–6. We have reviewed Petitioner’s evidence and argument, and agree with Petitioner that Stafford discloses all limitations of claims 3–6.” slip op. at 26

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “recited in the challenged claims. In sum, considering the record as a whole, we agree with Dr. Wang’s testimony that one of ordinary skill in the art would have found the challenged claims obvious in view of Stafford. Ex. 1003 ¶¶ 348–370. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be expressed. As discussed above, Stafford discloses successful expression of R338A in vitro. As Dr. Wang explains, given that Stafford demonstrated in vitro expression for numerous other variants in the 330–338 helix region of FIX, only R338P showed reduced expression, and unlike leucine, “proline [P] is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113–116, 225; see also Ex. 1100 ¶¶ 117–121. As such, we agree with Dr. Wang that one of ordinary skill in the art would not have expected difficulties in the expression of R338L. We also find unavailing Patent Owner’s argument that a person of ordinary skill would not have expected in vivo expression of FIX-R338L at levels similar to that of wild-type FIX. To the contrary, Schuettrumpf supports a conclusion that a person of ordinary skill would have expected that gene therapy with FIX-R338A expressed in vivo from liver cells at levels similar to wild-type FIX. See Reply 13 (citing Ex. 1005, 2, 4; Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113–116, 225). As Dr. Wang testified, this would have suggested to a person of ordinary skill that FIX-R338L would express at a similar level. Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113– 16; see also Ex. 1001, 4:45–58 (’180 patent’s teaching that it was expected that conservative amino acid substitutions (e.g. alanine and leucine) “would not change phenotype of the proteins”). We do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be active. To the contrary, we credit Dr. Wang’s testimony that one of ordinary skill in the art would have expected the R338L variant to exhibit higher activity than wild-type Fix based, for example, on Stafford and Schuettrumpf showing that R338A exhibited higher activity in vitro and in vivo, respectively, and the similarities between alanine and leucine. See, e.g., Ex. 1003 ¶¶ 40, 42, 158, 219, 383, Ex. 1100 ¶¶ 101–112; see also Ex. 1094 ¶¶ 41–45, Ex. 1100 ¶¶ 23–36 (Dr. Pederson’s explanation of why one of ordinary skill would have expected replacing arginine 338 with leucine would have a similar effect as replacing it with alanine). Stafford’s disclosure that numerous mutations in the FIX 330–337” slip op. at 44

  Patent outcomesUS 10,465,180 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,465,180
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00926 · APJ Julia Heaney · IPR · Final written decision

  Claims 2, 4–6, 11–13, 17, and 18 are unpatentable as obvious over Stafford and Manno; claims 2, 5, 6, 11–13, 17, and 18 are also anticipated or obvious over Monahan.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering;” and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 9

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

    “We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of the coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner

    “the earlier application must disclose the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” 35 U.S.C. §§ 119(e), 120. Section 112(a) requires that the specification contain a written description of the claimed invention. 35 U.S.C. § 112(a). “[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement is met when the specification “conveys to those skilled in the art that the inventor had possession of” and “actually invented” the claimed subject matter. Id. The purpose of the written description requirement is to ensure that a patent’s claims “do[] not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The Federal Circuit has stated: The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997).” slip op. at 21

  Patent outcomesUS 9,982,248 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,982,248
• Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentable
  PTAB · Nov 15, 2022 · IPR2021-00925 · APJ Julia Heaney · IPR · Final written decision

  Claims 1, 3, 7–10, 14–16, 19, and 20 are unpatentable as obvious over Stafford and Manno, and Stafford, Manno, and Schuettrumpf.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. Dec. Inst. 22; see Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include (1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 8

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

    “We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of this coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “Accordingly, Patent Owner has failed to show that it is entitled to a presumption of a nexus between the objective evidence and the claimed invention. Patent Owner argues that it “need not rely on such presumption [of nexus]” under the Polaris and Fox Factory analysis. PO Resp. 67. Although Patent Owner does not fully explain its position, we note that Fox Factory provides, “[a] finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Fox Factory, 994 F.3d at 1374 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, we find that Patent Owner presents insufficient evidence to establish a nexus by this alternative route. Patent Owner does not present argument as to the “unique characteristics” of the claimed invention, or provide evidence to support such an analysis. See PO Resp. 66–67; PO Sur-reply 26–28. In addition, as discussed above, Patent Owner’s evidence is broadly directed to FIX- R338L, which was in the prior art and does not suggest non-obviousness of the claimed invention as a whole. In summary, Patent Owner does not meet its burden to show a presumption of nexus or show a nexus to the alleged long-felt need for an effective gene therapy for hemophilia B, industry praise, and unexpectedly superior efficacy of AAV-FIX-R338L. Weighing the evidence and arguments presented, we determine that even if there is some nexus, it is weak. See Merck & Cie, 808 F.3d at 837 (Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). The failure to show a nexus is fatal to Patent Owner’s contentions regarding objective indicia.” slip op. at 26

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “We also find Dr. Pedersen’s opinion with regard to a leucine substitution in FIX-R338 more credible than Dr. Spiegel’s, who states “there is no such thing as ‘conservative amino acid substitutions’ in the sense Dr. Pedersen asserts.” Ex. 2101 ¶ 72. The ’248 patent itself refers to “conservative amino acid substitutions” and states “[i]t is expected that substitutions between these homologous amino acids [including alanine and leucine] would not change the phenotype of the proteins.” Ex. 1001, 4:48– 61. Although Dr. Spiegel notes that substitution is context dependent and “the specification recognizes ... various properties of each unique amino acid all contribute to the amino acid’s interactions” (Ex. 2101 ¶ 75, citing Ex. 1001, 4:48–61; Ex. 1002, 4:45–58; Ex. 1039, 51), his opinions do not account for the knowledge of a person of ordinary skill in the art as to the properties of alanine and leucine and the structure of FIX. See Ex. 1101 ¶¶ 36–39. Further, Dr. Spiegel’s surface-exposure opinion (see, e.g., Ex. 2101 ¶ 99) is undercut by Stafford’s teaching that the 330–338 region of wild-type FIX contains two solvent-exposed leucines. Ex. 1101 ¶ 41 (citing Ex. 1004, 34). Dr. Spiegel’s opinion that a leucine substitution would reduce solubility or increase susceptibility to aggregation also lacks credibility because it is based on the protein hemoglobin S, and not on a modification to FIX positions 330–338. Ex. 2101 ¶ 62; Ex. 1103, 78:15–18; see Ex. 1101 ¶ 60. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art would have had serious concerns whether R338L would be expressed, based on Stafford. As discussed above, Stafford discloses successful expression of R338A in vitro, and as Dr. Wang explains, the understanding of a person of ordinary skill of similarities between R338A and R338L would have supported the understanding that R338L would express at a similar level to R338A, given Stafford’s disclosure that only R338P showed reduced expression, and unlike leucine, “proline is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113– 116. Stafford’s disclosure that mutations at 330–337 cause severe hemophilia due to loss of FIX activity (Ex. 1004, 19:16–20) does not support Patent Owner’s argument, because Patent Owner’s experts do not persuasively explain why the risk of severe hemophilia from single amino acid substitutions at positions 330–337 would be predictive of a similar risk at position 338. See Ex. 1100 ¶¶ 115–119; Ex. 1101 ¶¶ 48–51. As such, we agree with Dr. Wang that a person of ordinary skill in the art would not have expected difficulties in expression of R338L.” slip op. at 38

  Patent outcomesUS 9,982,248 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,982,248
• 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
• New World Medical, Inc. v. Microsurgical Technology, Inc.All claims unpatentable
  PTAB · Mar 11, 2022 · IPR2020-01573 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–10 are unpatentable as obvious over Quintana and Lee; the Board did not reach the other asserted grounds.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it “little weight,” as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider Dr. Condon’s testimony here.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “A [person of ordinary skill in the art] would have: (1) a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery; or (2) an undergraduate or graduate degree in biomedical or mechanical engineering and at least five years of work experience in the area of ophthalmology, including familiarity with ophthalmic anatomy and glaucoma surgery. Ex.1003, ¶27. Pet. 23–24 (citing Ex. 1003 ¶ 27). Patent Owner states that it “agrees with the Board’s preliminary acceptance in its institution decision of Petitioner’s proposed definition of a [person of ordinary skill in the art] for purposes of this IPR.” Resp. 11, n.6. We accept, as has Patent Owner, Petitioner’s proposed definition of the person of ordinary skill in the art, or ordinarily skilled artisan, which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’729 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B.” slip op. at 20

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

    “We decline to expressly adopt any proposed construction of the claim language. Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). Based on the evidence of record, the term “ab interno” is a well- understood term of art in the ophthalmological field. See, e.g., Ex. 1005, 1; Ex. 1013, 1; Ex. 1018, 1; Ex. 1020, 1. The ’729 patent does not expressly assign a special meaning to the term “ab interno.” Ex. 1001. As Patent Owner states, quoting Petitioner’s witness Dr. Netland, “[p]ersons of ordinary skill in the art would have understood the term ‘ab interno’ to generally mean from the inside . . . .” Resp. 31 (quoting Ex. 1003 ¶ 74 (emphasis in original)). We find that the record supports that the person of ordinary skill in the art would have understood this term and that it needs no special interpretation. The language “dual blade device” is readily understandable on its face; dual refers to two, and blade, in context, refers to a cutting part. The evidence of record does not indicate that this term has any special meaning different than what the plain language in context would suggest. The ’729 patent does not expressly assign a special meaning to the language “dual blade device.” Ex. 1001. We find that the record supports that the person of ordinary skill in the art would have understood this term and that it needs no special interpretation. To summarize, we find there is no need to expressly interpret the claim language in any way different from its ordinary meaning as would have been understood by the person of ordinary skill in the art. This is consistent with our preliminary determinations as set forth in our Institution Decision (at 15–17) and the parties’ understanding of the claims at trial. See generally Resp.; Reply; Sur-Reply; see also Hr’g Tr. 50:9–10 (Petitioner adopting the Board’s understanding of dual blade), 53:17–22 (Petitioner adopting the Board’s understanding of ab interno), 70:17–18 (Patent Owner adopting the Board’s understanding of dual blade). C.” slip op. at 22

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

    “As noted above, we do not agree with Patent Owner’s arguments and, for reasons below, we agree with Petitioner that Quintana and Lee would have been combined with a reasonable expectation of success. Quintana, Lee, and the invention claimed by the ’729 patent each are directed to the same field of endeavor, i.e., glaucoma eye surgery and tools for such procedures or, even more particularly, eye surgery tools for stripping trabecular network to treat glaucoma. See Ex. 1001, Abstract, 1:35–39, 1:66–2:3, 6:43–7:6 (claim 1); Ex. 1003 ¶¶ 91–103, 175, 181, 192; Ex. 1004, 3–3; Ex. 1006, Abstract, 3:50–57. We agree with Petitioner that the ordinarily skilled artisan would have looked to Quintana and Lee’s teachings together and would have, for example, modified Quintana’s device or procedure in view of Lee for the advantages expressed by the references themselves, such as providing sharp cutting edges to better excise tissue. Quintana’s disclosed device, a bent-tip hypodermic needle, is a simple tool, and the reference explains its use to strip delicate trabecular meshwork tissue to treat glaucoma. Ex. 1004, 3–4. Quintana is not explicit about some features of its bent-tip needle, for example, just how sharp its cutting edges are, or how exactly the device should enter the eye’s anatomy to strip the trabecular meshwork tissue. Id. Thus, if supporting information was desired, the ordinarily skilled artisan would certainly have looked to Lee for details for a trabecular meshwork stripping tool and method because that is exactly what Lee teaches designing and using a tool for. See supra Section I.F; see also Ex. 1003 ¶ 181 (discussing Lee’s ab interno goniotomy surgery with a dual blade device). “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. Here, ordinarily skilled artisans would have recognized that the advantageous structures and techniques of Lee would improve Quintana’s device and methods because Lee clarifies, for example, that ab interno techniques were well known as useful for goniectomy procedures and were established to be successful and improved patient comfort, recovery time, and safety, and because Lee also clarifies that using a sharp, dual blade device for such a procedure enables the extraction of large intact tissue samples of trabecular meshwork. See, e.g., Ex. 1003 ¶¶ 174–176, 181. These advantages of Lee’s device and technique would also have improved Quintana’s trabecular meshwork stripping goniotrabeculotomy device and technique. Id. The obviousness analysis “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. We do not find that it would have taken much, if any, creativity on the part of the ordinarily skilled artisan to have modified, if necessary, Quintana’s tool and its use (e.g., to have two sharp sides and to use it in an ab interno procedure) in view of Lee because each reference teaches a very simple device and explains its use. Such modification to Quintana, however, would likely not have been necessary because, as discussed herein (see infra Section II.D.1.b), Quintana teaches its device has sharp sides and is used in an ab interno procedure. The simplicity of Quintana’s device and the straightforwardness of Lee’s disclosure supports Petitioner’s position that the ordinarily skilled artisan would have had a reasonable expectation of success as “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416; see, e.g., Ex. 1003 ¶¶ 175, 181 (testifying that modifying Quintana in view of Lee would amount to simple substitutions of known procedures or structural features and ordinarily skilled artisans would have expected success). For the reasons above and the rationale set forth in the aforementioned” slip op. at 29

  Patent outcomesUS 9,107,729 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,107,729
• New World Medical, Inc. v. The Regents Of The University Of CaliforniaAll claims unpatentable
  PTAB · Mar 11, 2022 · IPR2021-00066 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–11 are unpatentable: claims 1–11 are anticipated by Quintana and obvious over Quintana; the Board did not reach the Jacobi ground.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Patent Owner filed a motion to exclude evidence (Paper 38); Petitioner opposed (Paper 41); and Patent Owner filed a reply in support of its motion (Paper 43). Petitioner also filed a motion to exclude evidence (Paper 39); Patent Owner opposed (Paper 40); and Petitioner filed a reply in support of its motion (Paper 42). We addressed (and denied) the parties’ motions to exclude in Paper 49.” slip op. at 3

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it little weight, as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider and analyze Dr. Condon’s testimony here.” slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 22 (citing Ex. 1003 ¶ 24). On page 18 of our Institution Decision, we provisionally accepted Petitioner’s proposed definition, which was not opposed by Patent Owner, and is consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’544 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). As Patent Owner expressly agrees with our analysis, we apply Petitioner’s proposed definition here. See PO Resp. 11, n.4. C.” slip op. at 25

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “1. “A device useable to create an opening in the trabecular meshwork of the eye” Independent claim 1 is directed to “[a] device useable to create an opening in the trabecular meshwork of the eye” and having a “foot member . . . advanceable, tip first, through Schlemm’s Canal to facilitate performance of a surgical procedure using the surgical instrument.” Ex. 1001, 23:4–5, 23:18–20. As an initial matter, we consider the preamble of claim 1 limiting here because a device that “create[s] an opening in the trabecular meshwork” recites or, at a minimum, implies, “essential structure or steps” required for the insertion and advancement of the instrument through Schlemm’s Canal as set forth in [1.d]. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).8” slip op. at 26

  Patent outcomesUS 9,999,544 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,999,544
• Xilinx, Inc. / Taiwan Semiconductor Manufacturing Co. Ltd. v. Arbor Global Strategies LLCAll claims unpatentable
  PTAB · Mar 2, 2022 · IPR2020-01571 · APJ Sharon Fenick · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious: claims 1–6 over Zavracky, Chiricescu, and Akasaka; claims 7–12 with Satoh; and claims 13–30 with Trimberger.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Level of Ordinary Skill in the Art Relying on the testimony of Dr. Franzon, Petitioner contends that [t]he person of ordinary skill in the art (“POSITA”) at the time of the alleged invention of the ’226 patent would have been a person with a Bachelor’s Degree in Electrical Engineering or Computer Engineering, with at least two years of industry experience in integrated circuit design, packaging, or fabrication. Pet. 5 (citing Ex. 1002 ¶¶ 58–60). Patent Owner asserts that [a] person of ordinary skill in the art (“POSITA”) around December 5, 2001 (the earliest effective filing date of the ’226 Patent) would have had a Bachelor’s degree in Electrical Engineering or a related field, and either (1) two or more years of industry experience; and/or (2) an advanced degree in Electrical Engineering or related field. PO Resp. 10 (citing Ex. 2006 ¶ 25). As we did in the Decision on Institution, we adopt Petitioner’s proposed level of ordinary skill in the art, which comports with the teachings of the ’226 patent and the asserted prior art. See Dec. on Inst. 21. Patent Owner’s proposed level overlaps substantially with Petitioner’s proposed level. Even if we adopted Patent Owner’s proposed level, the outcome would remain the same. C.” slip op. at 9

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “Both of these limitations listed above recite “means” and further recite a function, thus creating a presumption that 35 U.S.C. § 112, ¶ 6 applies. See 35 U.S.C. § 112, ¶ 6 (“An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.”); see also Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (en banc in relevant part) (quoting Personalized Media Commc’ns, LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703 (Fed. Cir. 1998)) (holding that “use of the word ‘means’ creates a presumption that § 112, ¶ 6 applies”). We agree with the parties that these limitations are means-plus-function limitations subject to 35 U.S.C. § 112, ¶ 6. Pet. 11, 13; PO Resp. 11.” slip op. at 10

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

    “Patent Owner, in focusing on this portion of the ’226 patent disclosure, does not adequately explain why buffer cells and configuration memory cells must be included in the proper construction of “wide configuration data port,” and seeks to import a functional description of the use of a wide configuration data port (“that allows parallel updating of logic cells in a programmable array through use of buffer cells”) into the claim construction. PO Resp. 15–17; PO Sur-reply 2–4. While the discussion in the ’226 patent describes an example of a wide configuration data port used in a specific way that aligns with Patent Owner’s proposal (Ex. 1001, 4:45– 59), other examples of the use of a wide configuration data port are included (id. at 4:59–65), and therefore we do not agree that one of ordinary skill would understand this use to be part of the construction of the term. We agree with Petitioner that the proper construction of the term does not require buffer cells. See Pet. Reply 4–6. Rather, we note that the specification of the ’226 patent contrasts loading of data to an FPGA in a byte serial fashion through a narrow port, which “results in [] long reconfiguration times,” with the use of a wide configuration data port, and therefore we determine that one of ordinary skill would understand the wide configuration data port, in contrast to the byte serial “relatively narrow” port, to include parallel connections between cells in the dies. See Ex. 1001, 4:3– 9. This additionally is consistent with certain arguments by Patent Owner, for example in the Patent Owner’s Response, which opens with a discussion of the “innovative” processor’s arrangement of die-area contacts, such as through-silicon vias, “into a wide configuration data port” and we find that description more consistent with the proper construction of this term. PO Resp. 1–2; see also PO Sur-reply 2–3 (“Arbor’s experts have been consistent that the word ‘wide’ in this term requires a sufficient number, and appropriate arrangement, of connections between the memory die and the programmable array to permit parallel updating of the array.”)” slip op. at 15

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Decided for petitioner

    “While corresponding structure need not include all things necessary to enable the claimed invention to work, it must include all structure that actually performs the recited function.” Default Proof Credit Card Sys. Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 1298 (Fed. Cir. 2005). Conversely, structural features that do not actually perform the recited function do not constitute corresponding structure and thus do not serve as claim limitations. Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., Inc., 145 F.3d 1303, 1308–09, (Fed. Cir. 1998); see B. Braun Med., Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir. 1997) (“[S]tructure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.”). Patent Owner’s arguments regarding buffer cells connected with memory configuration cells using die-area interconnections requires that the buffer cells be located on a different die than the memory configuration cells, but the ’226 patent discloses only that “[t]he buffer cells 88 are preferably a portion of the memory die 66” and not that they always are on the memory die, and also that the significantly increased number of connections to the cache memory die may allow the cache memory die to replace configuration bit storage on the FPGA die. Ex. 1001, 4:50–54, 4:59–63. Thus, we decline to require in the corresponding structure that buffer cells or configuration memory are included on any die element. Rather, we find that what is disclosed as actually performing the recited function of “reconfiguring the programmable array within one clock cycle” is “a wide configuration data port and contact points formed throughout the area of the first integrated circuit die element and another integrated circuit die element.” The support for this is found in the ’226 patent’s comparison of the long reconfiguration times through a narrow port (Ex. 1001, 4:3–9) with the time to reconfigure through a wide configuration data port with a significantly increased number of connections (id. at 4:45– 65), and the implementation of this in a module that has multiple dies “which have a number of corresponding contact points, or holes, 70 formed throughout the area of the [die] package” (id. at 4:9–20). The use of a wide configuration data port, as per our construction, implicates two die elements. This was reflected in our preliminary claim construction, for which the corresponding structure described “contact points distributed through the first integrated circuit die element and the third integrated circuit die element.” Dec. on Inst. 29. As the function is “reconfiguring the programmable array within one clock cycle,” one of the die elements is the first integrated circuit die element, which includes the programmable array. slip op. at 19

  Patent outcomesUS 6,781,226 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,781,226
• Xilinx, Inc. v. Arbor Global Strategies, LLCAll claims unpatentable
  PTAB · Mar 2, 2022 · IPR2021-00737 · APJ Karl D Easthom · IPR · Final written decision

  Claims 1–38 are unpatentable as obvious under §103(a): claims 1–34, 36, and 38 over Zavracky, Chiricescu, and Akasaka; claim 35 with Satoh; and claim 37 with Alexander.

  RulingsFinal written decision

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

    “4. Petitioner’s Showing, Claims 1–22, 36, and 38 Claim 1’s preamble recites “[a] processor module comprising.”” slip op. at 29

  • Expert testimonyOther

    “incorporation-by-reference of pages of evidence that Patent Owner attributes to Petitioner. Also, the cited three pages of Exhibit 2014 are in the middle of an industry article, and the pages are densely packed two-column pages that facially appear to have at least the same number of words in some of the complained-about citations to multiple paragraphs that Petitioner provides to Dr. Souri’s Reply Declaration. Here, Patent Owner leaves it to the Board to dig into the cited pages of Exhibit 2014 to find the alleged TSV interconnection issues and place it in context to the background information in the whole article. In reaching our decision, we exercised judgment as to all the evidence cited by the parties for its relevance, context, and substance, and weighed it accordingly.” slip op. at 123

  Patent outcomesUS RE42,035 unpatentable
  § 103 obviousnesscites KSR · Graham
• Xilinx, Inc. v. Arbor Global Strategies, LLCAll claims unpatentable
  PTAB · Mar 2, 2022 · IPR2020-01570 · APJ Karl D Easthom · IPR · Final written decision

  The Board held claims 1–38 unpatentable under §103 over the listed combinations of prior art.

  RulingsFinal written decision

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

    “Accordingly, as we noted in the Institution Decision, in light of Lin’s teachings and absent explicit explanation during prosecution by the Examiner, the rejection and reasons for allowance provide further support the understanding that the “functional to accelerate” limitations require a number of contacts extending throughout the thickness of the wafers in a vertical direction (vias) within the periphery of the die to allow multiple short paths for data transfer between the memory and process[ing element].” slip op. at 20

  Patent outcomesUS RE42,035 unpatentable
  § 103 obviousnesscites KSR · Graham

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.