• Charles River Laboratories, Inc. v. Seikagaku CorporationInstituted
  PTAB · Sep 9, 2025 · PGR2025-00023 · APJ Michael J Fitzpatrick · PGR · Institution

  Instituted PGR on claims 1–9 because the Board found it more likely than not that at least one challenged claim is unpatentable over the ’629 publication.

  RulingsInstitution decision

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

    “Institution of a post-grant review requires that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable” or that “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” 35 U.S.C. § 324(a)–(b). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Accordingly, we grant the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “III. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends a person of ordinary skill in the art (“POSITA”) would have a Ph.D. degree in biological, chemical or biochemical engineering, molecular biology, or biochemistry and at least two years of experience in the field of utilizing or assessing horseshoe crab zymogen proteins (lysate, purified native and/or recombinantly produced) for endotoxin detection and quantitation. More education could substitute for experience to a certain extent, and vice versa. Pet. 22 (citing Ex. 1003 ¶¶48–49). Patent Owner does not dispute Petitioner’s description of a POSITA in its Preliminary Response. Prelim. Resp. 10. 1 In addition to other changes to Title 35, the AIA introduced amendments to 35 U.S.C. § 102. Because Patent Owner concedes that the ’725 application “contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013” (Ex. 1022), the AIA version of § 102 applies to the ’109 patent. AIA § 3(n)(1)(B); Ex. 1001, 1:11–14 (claiming priority to the ’725 application). 2 US 2019/0241629 A1, published August 8, 2019 (“the ’629 publication” (Ex. 1015)). At this stage, we find Petitioner’s description of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23; Prelim. Resp. 10. We determine that no express claim construction is necessary based on the present record.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “To show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23– 24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in which a POSA would have understood the prior art, or what a POSA would have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description.” slip op. at 12

  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Trove Brands, LLC v. Camelbak Products, LLCInstitution denied
  PTAB · May 22, 2025 · IPR2025-00146 · APJ Linda E Horner · IPR · Institution

  The Board denied institution because Trove did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has not shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we deny the Petition and do not institute an inter partes review of claims 1, 3, 5–8, and 10–19 of the ’879 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 10

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

    “Petitioner and Patent Owner propose constructions for the term “user release mechanism,” as recited in claim 1. Pet. 20–23; Prelim. Resp. 27–30. Patent Owner also proposes constructions for “automatically disengage the first and second catch structures,” as recited in claim 1. Prelim. Resp. 30– 32. For purposes of this particular Decision, we determine that no term requires construction to decide whether to institute inter partes review of the ’879 patent. 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.’”) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11

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

    “First, Petitioner’s reason to modify Kiyota “to provide the advantage of a bite actuated mouthpiece” (Pet. 42) does not explain why one would use Choi’s mount 100. Petitioner has not clearly established that to use a bite-actuated mouthpiece requires mount 100. Choi describes that “cap assembly 14 may include a mount 100 to which the bite-actuated mouthpiece is removably mounted, or secured.” Ex. 1005 ¶ 46. This description suggests that mount 100 is not a required component for a bite-actuated mouthpiece. Our understanding is supported by Patent Owner’s expert, who testified that using Choi’s mount as a “rigid collar member” in Kiyota’s mouthpiece assembly does not require combining its bite-actuated valve because “the bite-actuated portion has nothing to do with the alleged rigid collar member portion.” Ex. 2001 ¶ 119 (citing Ex. 1005 ¶ 46); see also Prelim. Resp. 55. Thus, Petitioner has not adequately supported this first reason to modify Kiyota to use Choi’s mount 100.” slip op. at 22

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,165,879
• Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCAll claims unpatentable
  PTAB · Jun 6, 2024 · IPR2023-00173 · APJ Arthur M Peslak · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious: claims 1–2 over Stanesic, Rothkop, and Cicotte; claims 3–6 over that combination with Lee, Fisker, Gruenwald, or Fu, respectively.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner

    “tray is “deeply concave” but fails to direct us to any part of the Specification using the term “deeply concave” let alone a clearly stated definition of “deeply concave” in the context of a vehicle floor tray. The response to office action, cited by Patent Owner, refers to the tray as concave not deeply concave and thus, does not support Patent Owner’s proposed construction. Ex. 2097, 11. For these reasons, to the extent that Patent Owner relies on the prosecution history as a disclaimer of the full scope of claims, we find that the cited response to the office action does not constitute “a clear and unmistakable disclaimer of claim scope.” Uship, 714 F. 3d at 1315.” slip op. at 18

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

    “As explained below in our conclusion on motivation to combine, we” slip op. at 56

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “argument that Fu is not analogous art. PO Resp. 51. Dr. Kurfess first testifies that an ordinarily skilled artisan “never would have looked to Fu, or anything related to those fields, let alone micro-devices such as hearing aid shells to solve problems related to the automotive industry.” Ex. 2023 ¶ 144. Dr. Kurfess then testifies that “Fu is a disclosure for a hearing aid shell . . . and a [person of ordinary skill in the art] . . . would not consider the art of medical devices when trying to solve problems with vehicle floor mats.” Id. ¶ 188. Lastly, Dr. Kurfess testifies that “I completely disagree with Mr. Perreault’s conclusion that ‘a [person of ordinary skill in the art]” slip op. at 97

  Patent outcomesUS 9,138,917 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,138,917
• Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCAll claims unpatentable
  PTAB · Jun 6, 2024 · IPR2023-00172 · APJ Arthur M Peslak · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over the stated combinations of Stanesic, Rothkop, and the respective additional references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, industrial design, or a closely related field, or equivalent formal training, education, or practical experience in a field relating to product design, CAD, or manufacturing.” Pet. 13 (citing Ex. 1003 ¶¶ 27–28). Petitioner further contends that the person of ordinary skill in the art “would also have a minimum of three to five years of experience in plastics engineering, CAD, manufacturing, plastic product design, or a related industry,” but that “a higher level of training or practical experience might make up for less education, and vice-versa.” Id. Patent Owner contends that a person of ordinary skill in the art would have “a Bachelor of Science in mechanical engineering, industrial design, or a closely related field, or equivalent formal training education or practical experience in a field relating to product design, CAD, or manufacturing.” PO Resp. 9. Patent Owner further contends that such an ordinarily skilled artisan “would also have two or more years of manufacturing/industrial experience in the automotive aftermarket art.” Id. Petitioner replies that its “level of skill is more appropriate given the claims’ focus on three-dimensional scanning and modeling (which apply to many industries).” Pet. Reply 9 (citing Ex. 1001, claim 1; Ex. 1055 ¶¶ 7– 13). According to Petitioner, however, “the claims would have been obvious even under [Patent Owner]’s proposed skill level.” Id. (citing Ex. 1055 ¶ 13). Petitioner refers to Dr. Kurfess’s declaration testimony as admitting that three-dimensional scanning and modeling are pertinent to the ’655 patent. Id. at 10 (citing Ex. 2023 ¶ 18). In the Sur-reply, Patent Owner contends that Petitioner’s definition of” slip op. at 12

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

    “[A] conclusion of obviousness requires a reasonable expectation of success.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1365 (Fed. Cir. 2016) (citing KSR, 550 U.S. at 421). Further, “the ‘predictable result’ discussed in KSR refers not only to the expectation that prior art elements are capable of being physically combined, but also that the combination would have worked for its intended purpose.” DePuy Spine, 567 F.3d at 1326 (citations omitted). “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988) (citations omitted). With these principles in mind, we evaluate the parties’ respective contentions. Patent Owner’s argument that there is no reasonable expectation of success in the proposed combination revolve around the scanning of a vehicle footwell. The ’655 patent describes that “points on the vehicle foot well for which the floor tray is to be manufactured are digitally measured and captured. Preferably this step uses a coordinate measuring machine (CMM).” Ex. 1001, 16:41–44. Further, the “FARO® Arm has been efficacious in obtaining these data using a contact method.” Id. at 16:47–48. The company manufacturing the FARO Arm was “[f]ounded in 1982 to provide portable CMMs in the medical industry” and “transitioned to the worldwide industrial market in 1993.” Ex. 1003 ¶ 49. Patent Owner does slip op. at 49

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “argument that Fu is not analogous art. PO Resp. 51. Dr. Kurfess first testifies that an ordinarily skilled artisan “never would have looked to Fu, or anything related to those fields, let alone micro-devices such as hearing aid shells to solve problems related to the automotive industry.” Ex. 2023 ¶ 144. Dr. Kurfess then testifies that “Fu is a disclosure for a hearing aid shell . . . and a [person of ordinary skill in the art] . . . would not consider the art of medical devices when trying to solve problems with vehicle floor mats.” Id. ¶ 188. Lastly, Dr. Kurfess testifies that “I completely disagree with Mr. Perreault’s conclusion that ‘a [person of ordinary skill in the art] would have been motivated to turn to Fu as an effective way to implement Stanesic’s reservoir’” and “[c]ommon sense dictates that a prior art disclosure for a custom hearing-aid would not inform a [person of ordinary” slip op. at 98

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

    “Collateral estoppel precludes a party from relitigating an issue when: (1) a prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in the prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party.” slip op. at 109

  Patent outcomesUS 8,899,655 unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,899,655
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00074 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 2, 5–8, 11, and 15 were not shown unpatentable because the cited May references did not sufficiently disclose or guide a skilled artisan to the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See PO Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference not prior artNot shown unpatentable

    “represents the inventors’ own work, and thus the May Thesis is not prior art to the ’061 patent. PO Resp. 14–15. The May Thesis is authored by Chad May, who is a listed inventor of the ’061 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’061 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) based on the July 1, 2002 priority date. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that the Challenged Claims are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., July 1, 2002. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to the Challenged Claims under 35 U.S.C. §102(b).” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 39–40 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of TNS9’s HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 143–156. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes, such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 156, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisaged” by a skilled artisan as argued by Petitioner. Pet. 39–40.” slip op. at 16

  Patent outcomesUS 8,058,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,058,061
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00070 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 10, 19, and 22 were not shown unpatentable because the May Thesis was not prior art and the May Article and May Abstract did not establish the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’179 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “the ’179 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’179 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) for challenged claims 1, 19, and 22. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that claims 1, 19, and 22 are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., the July 1, 2002, for claims 1, 19, and 22 challenged with this reference. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to challenged claims 1, 19, and 22 under 35 U.S.C. §102(b). Petitioner has not established that the May Thesis is prior art to claims” slip op. at 11

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

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 30–31 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of [TNS9’s] HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the claimed LCR fragment. According to Dr. Bungert, the process for making the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 112–117. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 117, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisage[d]” by a skilled artisan as argued by Petitioner. Pet. 30–31.” slip op. at 16

  Patent outcomesUS 7,541,179 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,541,179
• Painteq, LLC v. Orthocision, Inc.All claims unpatentable
  PTAB · Dec 1, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–23 are unpatentable as obvious over Vestgaarden-981, Vestgaarden-818, and Lins, with Paltzer additionally applied to claims 6, 7, and 10–23.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s description of the level of ordinary skill in the art is sufficiently supported by the record. Therefore, we apply that understanding in our analysis herein.” slip op. at 9

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

    “Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. We agree that no express construction is required for this decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 9

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

    “We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 (limitation 18.b.2 “plurality of blunt tangs on a distal end”). For this reason, the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 10

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

    “We find that Petitioner has articulated sufficient reasoning with rational underpinning for combining the asserted references. Vestgaarden- 818 expressly incorporates the teachings of Vestgaarden-981, providing a motivation to use the implant and related tools taught in Vestgaarden-981 in its method for fusing a SI joint. Ex. 1010, 4:10–16. Moreover, we credit Dr. Bovinet’s testimony describing additional reasons for combining Vestgaarden-981’s implant and surgical implants with Vestgaaren-818’s method. Ex. 1002 ¶¶ 67–74. Petitioner’s reasoning for combining Lins’s guidance slots and protrusions is also supported by the evidence of record. Ex. 1002 ¶¶ 77–84. In particular, Dr. Bovinet persuasively testifies that a POSA would have motivated to make this combination because it “enables a surgeon to visually align the guide protrusions on a shaft with the guidance slots of the working channel,” which is “a major improvement” over the flat portion depth stop taught in Vestgaarden-981. Id. ¶ 83; see also id. ¶ 84 (“As someone who has personally performed hundreds of SI joint fusion surgeries, I can attest that the guide protrusions and guidance slots taught in Lins would offer a surgeon a significantly better user experience” as compared to Vestgaarden- 981’s flat portions). Finally, Petitioner has demonstrated that the combination would have produced a “predictable result” and therefore that a (citing Ex. 1002 ¶¶ 76, 85).” slip op. at 21

  Patent outcomesUS 11,083,511 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosure
  Patents in suitUS 11,083,511
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41

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

    “Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15

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

    “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• DGL Group, Ltd. v. Hangzhou Chic Intelligent Technology Co., Ltd.All claims unpatentable
  PTAB · Oct 2, 2023 · IPR2022-00844 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1 and 4–25 are unpatentable as obvious over the Chen/Guangjing-based combinations; the Board did not reach the alternative Kickstarter-based grounds.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “In its petition, DGL adopts the definition of the level of skill in the art as proposed by Hangzhou in the parallel district court litigation. Pet. 11 (citing Ex. 1016, 8). There, Hangzhou asserted that one skilled in the art— would have at least (1) a bachelor’s degree in mechanical engineering, electrical engineering, computer science, or a related field, or equivalent experience, and (2) at least two years of experience in the area of: (i) robotics or feedback control for electromechanical systems; (ii) mechanical design, dynamic analysis, and/or control design for mechatronic systems, or (iii) equivalent experience in (i) or (ii). Ex. 1016, at 8. Hangzhou agrees that the above definition from the parallel litigation should control. See PO Resp. 4–5. Because the parties’ definition of the level of skill in the art appears consistent with the level reflected by the prior art, we adopt it for purposes of our analysis.” slip op. at 7

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

    “Here, the parties summarize their claim construction positions from the parallel district court litigation for three claim terms: “electric balance vehicle,” “controller,” and the various iterations of the “control” limitation of the claims, i.e., “control the hub motors,” “controls the motors,” and “controlling the first and second hub motors.” Compare Pet. 22–23, with PO Resp. 8–9. At the same time, however, the parties state that an express claim construction is not needed for purposes of this inter partes review. See PO Resp. 8–9 (submitting “no construction was necessary.”); Pet. Reply 1 (submitting that “[c]laim construction is not required in this inter partes review.”). Nonetheless, the parties note their agreement that “electric balance vehicle” means “electric self-balancing vehicle.” PO Resp. 8; Pet. Reply 1. We find the parties’ construction of that term is reasonable and adopt it for purposes of our analysis. As for the other two claim terms, we agree with the parties that no further construction is needed to decide this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute).” slip op. at 7

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

    “Resp. 25–29. In doing so, Hangzhou makes the mistake of arguing the references individually without ever acknowledging the combination of their teachings as a whole. For instance, Hangzhou argues that the asserted combination is improper “because Chen at least does not disclose the inner cover.” PO Resp. 24. But DGL never argued that Chen discloses an inner cover. Instead, DGL observed that one skilled in the art “would have been inclined to employ the inner cover of Guangjing with the electric balance vehicle of Chen because of the benefits expressly taught by Guangjing: improved structural strength, lighter weight, lower battery load, faster response speed, and longer batter[y] run-time,” which “would have merely been the predictable result of using the elements of Guangjing according to their known function.” Pet. 29 (quoting Ex. 1003 ¶ 83) (emphases added). Similarly, Hangzhou argues that the asserted combination is improper because “Guangjing discloses controlling the device through the use of a steering rod” (PO Resp. 25–26) and “[i]ncluding the steering mechanism of Guangjing would be necessary for the user to control turning of the device” (id. at 24). But, again, DGL never proposed using Guangjing’s steering mechanism in the asserted combination. Instead, DGL argued that one skilled in the art would have modified each of the foot platforms in Chen to include an inner cover, thereby preserving the rotatable relationship of the two foot platforms and their ability to independently turn and otherwise operate the wheels as originally intended by Chen. See Pet. 30 (citing Ex. 1003 ¶ 85). We also disagree with Hangzhou’s contention that the asserted combination “would lead to an inoperative result.” PO Resp. 24. Apparently, Hangzhou believes that “combining the single piece, non- rotatable-frame of Guangjing, with that of Chen would result in a device capable of only moving directly forward or directly backward.” Id. (emphasis added). But that argument relies on the false premise that Guangjing’s single-piece framework would extend the length of both of Chen’s foot platforms, while ignoring DGL’s express position that one skilled in the art would necessarily account for the rotatable relationship of Chen’s foot platforms when incorporating Guangjing’s teaching of an inner cover. See Pet. 30 (citing Ex. 1003 ¶¶ 85–86); Pet. Reply 3–4 (same). Indeed, in undertaking the combination, it would have been unthinkable for one skilled in the art to destroy the very essence of Chen’s invention— independently rotatable foot platforms for steering the vehicle. More reasonably, one skilled in the art, seeing Guangjing’s teaching of an inner cover for improving the structural strength of a self-balancing vehicle, would have immediately envisaged installing an inner cover into each of Chen’s foot platforms in a manner that preserved the ability of the user to steer the vehicle via the rotatable foot platforms. In that regard, we find the testimony of DGL’s expert more persuasive and credible than Hangzhou’s expert. Compare Ex. 1003 ¶¶ 83–86, with Ex. 2006 ¶¶ 31–33, 36.” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “away” from structures like Guangjing’s inner framework. PO Resp. 30. According to Hangzhou, Guangjing’s inner framework equates to the “prior art” device that Chen disparages, which includes “a multi-component parallelogram structure” that “adds to the weight, bulk, complexity, and potential for mechanical failure.” Id. at 29 (quoting Ex. 1004 ¶ 5). We disagree. In quoting Chen, Hangzhou omits that the “multi-component” structure disparaged by Chen is used “to coordinate/link movement of the two platform sections and the wheels,” which reasonably refers to a mechanical linkage for steering the vehicle. Ex. 1004 ¶ 5. Chen’s disparagement of a multi-part steering linkage does not, in our view, teach away from using a static cover or frame to strengthen the underside of the foot platform itself, as taught by Guangjing. Nor can Hangzhou reasonably argue that Guangjing’s inner cover would add to the vehicle’s weight or bulk, given Guangjing’s express disclosure that the inner framework “reduc[es] the overall weight of the vehicle body.” Ex. 1006, 2:15–16; see also id. at 2:27–29 (“the weight is slightly lighter”). Similarly, Hangzhou argues that Chen’s disclosure of the platform sections being formed of “metal, sturdy plastic, or other suitable material” that is “reinforced” means that Chen “specifically teaches away from including additional structures, which would include an inner cover.” PO Resp. 29–30 (citing Ex. 1004 ¶ 18). Again, we disagree. Chen simply states that “[t]he housing may be molded and incorporate strengthening reinforcements” and “[t]he housing may be formed of metal, sturdy plastic or other suitable material.” Ex. 1004 ¶ 18 (emphasis added). Thus, these are not requirements in Chen. At most, Chen is describing a preferred embodiment. However, “[a] reference does not teach away ‘if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed.’” Huawei Techs. Co. v. Iancu, 813 F. App’x 588, 591–92 (Fed. Cir. 2020) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)). Here, while Chen may indicate a “general preference” for the use of strengthening reinforcements or certain materials, nothing in Chen criticizes, discredits, or otherwise discourages the use of Guangjing’s inner cover. Indeed, in our view, one skilled in the art would have recognized that replacing Chen’s molded strengthening reinforcements in each of the foot platforms with an inner cover, as taught by Guangjing, is nothing more than substituting one strength-enhancing structure for another equivalent structure. Accordingly, Chen does not teach away from employing the inner cover of Guangjing in the electric balance vehicle of Chen.” slip op. at 13

  Patent outcomesUS 10,597,107 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,597,107
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  PTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.

  RulingsFinal written decision

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

    “(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33

  • Expert testimonyPetitioner expert creditedOther

    “be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50

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

    “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

  • ExcludeMotion to exclude, deniedMixed

    “A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107

  Patent outcomesUS 11,028,161 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,028,161

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.