• Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentable
  PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

  • Expert testimonyPetitioner expert creditedMixed

    “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

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

    “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 26

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

  Patent outcomesUS RE47,045 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
• Rimfrost As v. Aker Biomarine Antarctic AsNo claims unpatentable
  PTAB · May 18, 2022 · IPR2020-01534 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–20 were not shown unpatentable under § 103 because the petitioner did not establish that Bottino II taught the claimed free fatty acid limit.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) (citing Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379 (Fed. Cir. 1999)). To prove collateral estoppel, a party must show the following: (1) that in the prior action the party against whom estoppel is sought had a full and fair opportunity to litigate the issue: (2) the issue was actually litigated; (3) the controlling facts and applicable legal rules were the same in both actions; (4) resolution of the particular issue was essential to the final judgment in the first action; and (5) the identical issue was decided in the first action. See Comair Rotron, Inc. v. Nippon Densan Corp., 49 F.3d 1535, 1537 (Fed. Cir. 1995) (emphasis added). In considering collateral estoppel of adjudicated patent claims, the patent claims do not have to be identical; rather, “it is the identity of the issues that were litigated that determines whether collateral estoppel should apply.” Ohio Willow Wood, 735 F.3d at 1342. Here, Petitioner provides us with an overview of the similarity of the art used in the previous cases before us involving related patents to the ’567 patent and a general overview of the various components of allegedly “virtually identical krill oil compositions” without addressing a comparison of specific unpatentable claims of these related patents as compared to the specific claims at issue here. See Pet. 42–44. Notably, this overview of similar components of claimed krill oil compositions in the related patents does not address free fatty acids that are at the center of the dispute in this case. Id. Most notably, Petitioner fails to address the five criteria that we have listed above to establish that collateral estoppel applies in this case. Id. We agree with Patent Owner that this is a fatal flaw. Nowhere in the Petition does Petitioner provide an analysis of a previous Board decision where the issue of whether Bottino II teaches an extract with less than 3% free fatty acids w/w of said krill oil (an issue central to resolution of the case here) was litigated, resolved by the Board, and essential to the judgment in that previous case. See Pet. 42–44. Therefore, Petitioner cannot show that the identical issue was decided in any previous case before us. Petitioner’s discussion of the similarity of art previously applied and a generalized overview of different components of various challenged claims of related patents is insufficient. Because Petitioner failed to apply the correct framework, we find that collateral estoppel does not preclude Patent Owner from addressing the issues raised in this inter partes review.” slip op. at 16

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Petitioner makes arguments for the first time at oral hearing concerning our alleged previous reliance on Table 2 of Bottino II in finding claims of related patents unpatentable and provides new evidence of Patent Owner’s alleged failure to challenge the reliability of Table 2 of Bottino II. See Tr. 8:7–9:3; Petitioner’s Demonstratives, slide 8. We find that these belated arguments and evidence are inappropriately raised for the first time at oral argument, and we need not consider them. See Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019) (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.”) (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015)).” slip op. at 18

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s declarant, Dr. Jaczynski, accepted Petitioner’s definition of a POSITA, see Ex. 2001 ¶ 8, and further commented that “[t]he relevant field for the ’567 patent includes extraction of lipids from natural sources,” see id. ¶ 7. Dr. Jaczynski further stated that he considers himself to be an expert in the relevant field. Id. We find that Petitioner’s definition of a POSITA is consistent with the level of skill reflected in the Specification and the asserted prior art references, and apply it for purposes of this decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). We also find that both Dr. Tallon and Dr. Jaczynski are qualified to opine about how one of skill in the art would view the teachings of the asserted combinations of art in Petitioner’s challenges to the claims. See Ex. 1006 ¶¶ 7–21, Appendix D (Curriculum Vitae of Dr. Tallon); Ex. 2002, Appendix A (Curriculum Vitae of Dr.Jaczynski).” slip op. at 11

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

    “At this final stage of the proceeding, we again determine that no construction of any claim term for which Petitioner has proposed a 13 Petitioner points out that Dr. Tallon testified that his constructions would be the same under the Phillips standard. Reply 6, n.2 (citing Ex. 1086 ¶ 6). definition is necessary to resolve the disputes between the parties here as the limitation upon which we resolve this case does not involve these claim terms.” slip op. at 13

  Patent outcomesUS 10,010,567 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,010,567
• Laboratoire Francais Du Fractionnement Et Des Biotechnologies S.A. v. Novo Nordisk Healthcare AGNo claims unpatentable
  PTAB · Apr 13, 2022 · IPR2017-00028 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–15 were not shown unpatentable under the remaining Tolo anticipation and Eibl ’023 combination grounds; Patent Owner’s motion to exclude was granted in part.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “We agree that a motion to exclude is not the appropriate vehicle for consideration of whether a party has improperly raised new arguments. Our Trial Practice Guide delineates between a motion to exclude and a motion to strike, indicating that a motion to strike is the preferred mechanism “[i]f a party believes that a brief filed by the opposing party raises new issues, is accompanied by belatedly presented evidence, or otherwise exceeds the proper scope of reply or sur-reply . . . .” See Trial Practice Guide Update 17 (Aug. 2018); Patent Trial and Appeal Board Consolidated Trial Practice Guide 80 (Nov. 2019).10 Although a motion to exclude is pre-authorized in the Scheduling Order, see Paper 64, 4 (Supplemental Scheduling Order), a motion to strike is not, and Patent Owner did not request prior authorization to file its motion to strike. Petitioner did, however, have an opportunity to respond and did so respond to Patent Owner’s contentions that the allegedly new evidence and argument exceeded the proper scope of a reply. See Paper 87, 3–8. Therefore, we find that Petitioner had an appropriate opportunity, of which it took advantage, to respond to Patent Owner’s arguments regarding the alleged new arguments and evidence. Accordingly, we determine that Petitioner is not prejudiced by our consideration of Patent Owner’s motion to exclude as, in effect, a motion to strike.” slip op. at 11

  • Skill levelSkill level board ownDecided for patent owner

    “Owner’s proposed levels of skill in the art to be somewhat deficient. Paper 53, 8. We found that Petitioner’s proposed skill level does not address the specific problems concerning the nanofiltration of FVIIa that is the subject of the ’762 patent at issue in this proceeding. Id. We also found, however, that we were unaware of any basis in the record for Patent Owner’s contention that the hypothetical skilled artisan must be a “team” of scientists and engineers with two different areas of “expertise.” Id. Nonetheless, based on our consideration of the record, we found that the skilled artisan would need skills and knowledge with respect to both the biochemistry of coagulation factors (particularly FVII/FVIIa) and separation/purification/processing techniques used in the biotechnology industry for such proteins (particularly nanofiltration). Id. We agreed with both Petitioner and Patent Owner that such skills and knowledge may be obtained through some combination of education and industry/laboratory experience, wherein a skilled artisan with a doctorate degree (Ph.D.) could have fewer years of experience than required for a skilled artisan with a Master’s or Bachelor’s degree. Id. In general, we found that the “ordinary skill” level of a scientist or engineer in this art is relatively high. Id. As explained by Dr. Chtourou, “[e]xtensive academic training and laboratory experience are necessary for producing recombinant coagulation proteins and removing viruses from compositions of such proteins.” Id. at 8–9 (citing Ex. 1010 ¶ 27). We further took into account that this level of skill is also reflected in the prior art of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and we found that the parties’ declarants in this proceeding meet the requirements for this skill level. Id. at 8–9. The parties have not challenged these findings and we see no reason to depart from them for our analysis in this Decision.” slip op. at 22

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

    “As we stated in our Final Written Decision, Petitioner offered constructions for the following claim terms: “cell culture supernatant” and “Factor VII polypeptides.” See Paper 53, 9 (citing Pet. 10–15). We noted that Patent Owner did not disagree with Petitioner’s proposed construction for “cell culture supernatant,” and asserts that “Factor VII [poly]peptide[]” is expressly defined in the Specification of the ’762 patent. PO Resp. 6; see also Paper 67, 4. We previously found that no explicit construction of any claim term was necessary to resolve the issues in this case. No new claim construction issues have been raised in this proceeding, and we again find no explicit construction of any claim term is necessary in this proceeding. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 24

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “First, we begin with the unassailable fact that Tolo does not disclose expressly or inherently any particular concentration of FVII. See Ex. 1006, 7:25–34 (only mention of Factor VII in Tolo with no express statement concerning a concentration for FVII). In fact, we found in our Final Written Decision that: The record in this proceeding does not show persuasively that the skilled artisan would have reasonably expected that the same concentration disclosed in Example 3 of Tolo for IFN-α (0.04 mg/mL) could be successfully used for the nanofiltration of FVIIa. To the contrary, the evidence shows that IFN-α and FVIIa differ significantly in many respects, including molecular weight, size, and structure, such that the skilled [artisan] would not have necessarily considered them interchangeable in a nanofiltration process. Paper 53, 38 (citations omitted).” slip op. at 34

  Patent outcomesUS 9,102,762 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 9,102,762
• Illumina, Inc. v. Natera, Inc.No claims unpatentable
  PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

    “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

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

    “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

  • ExcludeMotion to exclude, deniedDenied

    “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

  • Strike new argumentNew argument disregardedDecided for patent owner

    “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

  Patent outcomesUS 8,682,592 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,682,592
• Natus Medical Inc. / Natus Neurology Inc. et al. v. Nox Medical EhfNo claims unpatentable
  PTAB · Mar 21, 2018 · IPR2016-01822 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–9 and 13 were not shown unpatentable under § 103 because McIntire did not teach the claimed conductor passing through the receiving hole while wrapped around the engaging member.

  RulingsFinal written decision

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

    “In defining the ordinary and customary meaning of “wrapped,” the dictionary definition provided by Patent Owner that appears the most apt when defining how the electrical wire or conductor engages the elongated member as described in the Specification of the ’532 patent is “[t]o coil or twist about or around something.” See PO Resp. 10–11 (quoting Ex. 2018 (The American Heritage Dictionary of the English Language)); see also Exs. 2016–2018. “Around” means “on all sides; about.” See Dictionary.com, available at www.dictionary.com/browse/around?s=t (last accessed March 16, 2018). In light of the teachings of the Specification of the ’532 patent and the referenced dictionary definitions of the terms “wrapped” and “around,” we interpret the claim phrase “wrapped around” to mean “following a path that substantially surrounds and encloses.”” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “skill of an ordinary artisan. Ex. 1002 ¶ 31. These alternatives are (1) a Bachelor’s degree in mechanical engineering, bio-medical engineering, or an equivalent field from an accredited university, and about one year of relevant experience in industry or academia, (2) an associate’s degree in mechanical design or an equivalent field from an accredited university, and about three years of relevant experience in designing medical devices, or (3) a master’s or doctorate degree in mechanical engineering, bio-medical engineering, or an equivalent field from an accredited university. Id. Mr. Oslan accepted this description with the caveat that an equivalent field is electrical engineering and that someone who holds a doctorate degree has more experience than the other two alternatives or someone with a master’s degree. The level of skill in the art is a factual determination that provides a primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999). Based upon our review of the record, we adopt Dr. Williams’ description of the level of skill in the art for an ordinary artisan, including Dr. Oslan’s caveat recognizing electrical engineering as an equivalent field. The level of ordinary skill in the art also is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 18

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Ex. 2013 ¶ 42. We find Mr. Oslan’s testimony to present credible alternatives to conductor 522 exiting the hole and wrapping around the underside of the retention plate, in the absence of any relevant discussion in McIntire itself. Dr. Williams testified that he considered alternatives to having the conductor wrap under the bottom side of the retention plate but dismissed them in view of the “straightforward way of wrapping it around.” Ex. 2010, 139:13–140:10. Dr. Williams did not provide any supporting facts or data for his reasoning concerning his evaluation of any of these alternatives; Dr. Williams simply presented the conclusory statement that McIntire’s Figure 13 teaches “conductor 552 that wraps around retention plate 544 while passing through opening 550.” Ex. 1002, 71 (Appendix); id. ¶ 87. Such an opinion is entitled to little weight. See 37 C.F.R. § 42.65(a).” slip op. at 28

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Because we find that Petitioner has not established that any embodiment or description in McIntire teaches an “engaging member engaging the conductor of the electrode belt by the conductor passing through the receiving hole while being wrapped around the engaging member,” we find that Petitioner has failed to show by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 26

  Patent outcomesUS 9,059,532 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,059,532
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

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

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

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

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.

  RulingsFinal written decision

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

    “filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43

  Patent outcomesUS 8,663,685 not shown unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,663,685

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.