• Agrofresh Solutions, Inc. v. Lytone Enterprise, Inc.All claims unpatentable
  PTAB · Jul 25, 2022 · IPR2021-00451 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 3 and 11 are unpatentable as obvious over Hisano and Daly, and over Daly and Hisano, because the skilled artisan would have been motivated to combine the teachings with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “definition focuses on chemistry and materials science without a specific focus to the application of that knowledge to the subject matter of the invention, while Patent Owner’s proposal permits the artisan’s degree to be in horticulture or plant science, requires at least 2–4 years of experience in the area of postharvest biology and technology, and specifically requires “working with encapsulated gaseous agents such as the 1-MCP encapsulation complex.” PO Resp. 14. It is not clear on the record before us nor does Patent Owner’s expert explain why the additional, specific expertise in postharvest biology and technology would have been required to understand the teachings of the ’185 patent in a manner necessary to apply them. Moreover, the proposed additional skill level does not appear to be necessary in light of the skill level reflected by the asserted prior art. See specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985)). For instance, Hisano measures preservation visually, by ascertaining whether the flowers looked fresh or appeared to have been harmed by effects of the chemicals added, and whether the water the flowers were stored in was cloudy. Ex. 1004 ¶ 24. This observation does not require specific expertise in postharvest biology and technology. Petitioner’s assessment appears consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding, although we agree with Patent Owner that a degree in plant physiology, horticulture, plant science or the like along with work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds would provide sufficient expertise to understand the teachings of the ’185 patent in a manner necessary to apply them. Accordingly, we adopt the following definition of the skilled artisan for purposes of this Decision: a bachelor’s degree in chemistry, chemical engineering, materials science, plant physiology, horticulture, plant science or the like, and 1–2 years of work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds, such as those used to inhibit ethylene response in plants.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction neededDecided for petitioner

    “Neither party advances any claim terms for construction. Pet. 20; PO Resp. 15. We find that no express construction is necessary for purposes of rendering this Decision and apply the plain meaning of all terms. 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 13

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/TrialPracticeGuide Consolidated).” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “We find that the ordinarily skilled artisan would have looked at Hisano as an analogous reference and would have been motivated to try scaling up its smaller-scale solution of effervescent tablets for delivery on a larger scale than single flower vases. We further find that the artisan would not have been deterred by Hisano’s lack of embodiments including gas agents and disclosing local use only that would have prevented use of 1- MCP directly with plants. Ex. 2013 ¶¶ 52–54. In particular, because Daly suggested the molecularly encapsulated 1-MCP could be made in powder form (Ex. 1005, 11:1–11), which is the form Petitioner suggested for use in the proposed obviousness combination (e.g., Pet 36–37), we are not persuaded by Patent Owner’s arguments regarding concerns the skilled artisan would have had about working with 1-MCP gas that is released into the atmosphere where the atmosphere becomes the treatment medium as opposed to a liquid medium. agent, along with Daly’s teachings that 1-MCP is a known substitute for STS without STS’s toxic waste byproduct would have motivated the artisan to explore use of 1-MCP. Daly’s teaching of using a cyclodextrin cage-stabilized and powdered version of 1-MCP to inhibit ethylene binding in plants would have motivated the skilled artisan to try this stabilized version in Hisano’s effervescent tablet preparation because of the benefits of effervescent ingredients for dissolution and dispersion, to treat plants on a larger scale. See Ex. 1005 11:1–20; Ex. 1006 ¶¶ 29, 110–115; Ex. 1035 ¶¶ 11–18. Hisano instructs the artisan about optimization by creating tablets with a proper “effervescence component: freshness preserving component to a weight ratio of between 6.5:3.5 and 5.0:5.0 to create a large, compact tablet agent that can secure some degree of the freshness preserving component” while also stabilizing the tablet for transportation and adjusting the ratios of components to affect the “target quality, effervescence effects, and dissolution time, etc. of the final product.” Ex. 1004 ¶¶ 12, 14. These additional teachings would have led the skilled artisan to understand that an effervescent tablet dosage made with cyclodextrin-stabilized 1-MCP could be made for larger scale production and use. In particular, we find that the artisan would have been motivated to combine the teachings of Hisano and Daly because of 1) Daly’s teaching that STS is problematic for use in inhibiting ethylene in plants due to difficulties in silver waste byproduct disposal, leading to “a great desire among postharvest physiologists to find alternatives to STS” (Ex. 1005, 2:42–64); 2) Daly’s teachings that cyclopropene and its derivatives, including 1-MCP, are “commercially acceptable replacement[s] for STS”) (id. at 1005) and that powder complexes provided advantages over 3) Hisano’s teaching that an ethylene suppressing agent could be delivered via an effervescent tablet, which when dissolved in water, creates “generated carbonic acid gas [that] will promote assimilation action, which will be effective for cultivating, and preserving the freshness of, the cut flowers (plants).” Ex. 1004 ¶ 25; see also Ex. 1006 ¶¶ 113–115 (opining that the skilled artisan would have understood encapsulated 1-MCP, a powder-based form, to be one of a finite number of safer substitutes for STS that could be incorporated into an effervescent tablet using methods known to the skilled artisan at the time); Ex. 1013 at 9 (identifying 1-MCP as a newly discovered “ethylene inhibitor [that acts] as a binding site competitor and is very promising as a postharvest treatment for both potted plants and fresh cut flowers [giving] ethylene protection equal to that obtained from STS, but without silver” and noting that a “company plans to sell the product in a powder form that will release MCP gas when mixed with water”). The art suggested finding substitutes for STS, meaning that the skilled artisan would have looked for likely substitutes such as this stable form of 1-MCP for use in various delivery methods. See, e.g., In re Kerkhoven, 626 F.2d 846, 850 (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”).” slip op. at 25

  Patent outcomesUS 6,897,185 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,897,185
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 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 have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

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

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Restem, LLC. v. Jadi Cell, LLCInstituted
  PTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution

  The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’176 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 11

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

    “Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13

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

    “the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,803,176
• 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
• Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentable
  PTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8

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

    “We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34

  Patent outcomesUS 9,693,961 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 9,693,961

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.