• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  PTAB · Mar 23, 2023 · IPR2022-01527 · APJ David Cotta · IPR · Institution

  Institution was denied for claims 1, 2, 4, 5, 7, 8, 10, and 11 because the petition did not show a reasonable likelihood of success on any asserted anticipation or obviousness ground.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1, 2, 4, 5, 7, 8, 10, and 11 of the ’554 patent.” slip op. at 2

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24 ,2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to provide” slip op. at 18

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

    “a) Alleged express disclosure The evidence of record does not support Petitioner’s contention that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose what effect such treatment has on the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that “stimulation at IAF + 1 Hz triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 24. EEG power is, however, distinct from frequency. See e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses changing the frequency at which peak alpha power is observed.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “1. Claim 1 Petitioner relies on the same evidence discussed in connection with Grounds 1 and 2 to establish disclosure of the intrinsic frequency limitation. Pet. 39 (“For the reasons provided above in Grounds 1 and 2, both Klimesch and Jin disclose this element [the intrinsic frequency limitation] of claim 1. In particular, the recited movement is the natural, inherent consequence of applying a magnetic field to the human brain at or near the subject’s peak frequency in the alpha band”). We have already determined that this evidence is insufficient to support that Klimesch or Jin discloses the intrinsic frequency limitation. Accordingly, we determine that Petitioner has not established a reasonable likelihood that it will prevail in showing that the combination of Klimesch and Jin renders claim 1 obvious.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,480,554
• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  PTAB · Mar 23, 2023 · IPR2022-01550 · APJ Devon Zastrow Newman · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claim 39 was anticipated by Klimesch or Jin.

  RulingsInstitution decision

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

    “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 Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 39 of the ’354 patent.” slip op. at 2

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

    “Claim 39 describes a device used to treat a subject by creating an electromagnetic field to “tune” the brain and affect mood, focus, and cognition of human subjects. Ex. 1001, 62:62–63:34. Briefly, claim 39 recites a device that creates an electromagnetic field using an electromagnet. A first processor “tunes” the brain by firing the magnetic field. The first or a second processor moves one of the recited frequency characteristics in the brain to a preselected different frequency. The term “moves” in claim 39 describes a function of the first or second processor, which provides the means by which the brain frequency is shifted. See MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 1312–1315 (reviewing cases applying and distinguishing reasoning in IPXL Holdings, 430 F.3d at 1383– 84. Unlike IPXL Holdings, there is no confusion here as to when infringement of this claim would occur; infringement occurs when one makes, uses, offers to sell, or sells the claimed apparatus, which is capable of use for treatment. For this reason, we find that the recitation “wherein the first processor or a second processor moves” in claim 39 does not recite a method step, but rather describes the function of the recited structure – the first or second processor – that is capable of performing the recited (a) through (e) steps. MasterMine, 874 F.3d at 1315–16 (“the claims at issue here merely claim that the system ‘possess[es] the recited structure [which is] capable of performing the recited functions.’”) (alterations in original). As a result, we agree with Patent Owner that the recitation “wherein the first processor or a second processor moves” is limiting.7 For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order, Ex. 2001.” slip op. at 11

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

    “(1) Alleged express disclosure The evidence of record does not support that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose whether the treatment moves the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that stimulation at IAF + 1 Hz “triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 27. Enhancing EEG power is, however, distinct from moving frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses moving the frequency at which peak alpha power is observed. Petitioner also directs us to Klimesch’s disclosure that rTMS at IAF + 1 Hz resulted in “a significant increase in lower-2 and upper alpha desynchronization (ERD) during mental rotation.” Ex. 1005, 1132 (cited at Pet. 27–28). But ERD is also distinct from frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis showing ERD as the difference in alpha power when subjects are performing a task as compared to when subjects are in a state of alert wakefulness). Thus, an increase in ERD does not support that Klimesch discloses changing the frequency at which peak alpha power is observed. As Petitioner does not direct us to any other disclosure in Klimesch that supports moving the intrinsic frequency, Petitioner is unlikely to prevail in establishing that Klimesch expressly discloses the intrinsic frequency limitation.12” slip op. at 18

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

    “Ex. 1001, 34:56–35:5. Although this disclosure supports that the intrinsic frequency can be shifted up or down by applying a “specific magnetic field close to the head,” it does not teach that the intrinsic frequency necessarily shifts every time a magnetic field above or below the patient’s peak alpha frequency is applied. Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999) (“Inherency may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.”). In addition, Petitioner does not direct us to disclosure in the ’354 patent supporting that stimulation at IAF + 1 Hz under the circumstances disclosed in Klimesch, will necessarily shift the intrinsic frequency. See, Ex. 1003 ¶ 20 (testimony of Dr. Silvetz identifying factors that impact how the brain responds to rTMS); Ex. 1001, 40:19–32 (describing “parameters that require optimization for rTMS,” including: “[f]requency, “[i]ntensity, “[d]uration,” and “[s]ite of stimulation”).” slip op. at 21

  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 8,475,354
• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  PTAB · Mar 23, 2023 · IPR2022-01526 · APJ David Cotta · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claim 1 was anticipated by Klimesch or Jin, or obvious over their combination.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 1 of the ’259 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends that the person of ordinary skill in the art (“POSA”) would have had “a medical degree plus at least two years of academic and/or industry experience in the field of TMS.” Pet. 10. According to Petitioner, “[a]dditional professional and/or technical experience could substitute for education, and vice versa.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA for purposes of its preliminary response. See generally, Prelim. Resp. Petitioner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’259 patent. Accordingly, for purposes of this Decision, we accept Petitioner’s proposed definition of the person of ordinary skill in the art. 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)).” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to prove prior knowledge or use, it must be regarded with suspicion and subjected to close scrutiny.”). peak alpha frequency moves the peak frequency to a higher frequency is not specific to the conditions under which rTMS was administered in Klimesch. This is problematic because Dr. Silvetz also testifies that the brain’s response to rTMS varies depending on the conditions under which it was administered. Ex. 1003 ¶ 20 (“The brain’s natural response varies depending on factors such as: a) the location of the electromagnet; b) the frequency of stimulation; c) the duration of stimulation; d) the number of stimulation pulses administered; e) the amplitude of the pulses administered; and f) the patient’s physiology.”). In summary, given that it not accompanied by supporting evidence, does not provide any technical reasoning, and is not specific to Klimesch, we give little weight to Dr. Silvetz’s testimony in determining whether Petitioner has established a reasonable likelihood that Klimesch inherently discloses the intrinsic frequency limitation. We do not determine here that Dr. Silvetz’s testimony is incorrect, only that it is insufficiently supported by evidence and technical reasoning to be accorded substantial weight.” slip op. at 18

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

    “Although the parties have briefed construction of the terms “preselected intrinsic frequency” and “preselected Q-factor” (Pet. 13–20; Prelim. Resp. 11–16), there does not appear to be any dispute regarding the “preselected” aspect of these claim terms. Pet. 18, 20 (proposing that “preselected intrinsic frequency” and “preselected Q-factor” be construed to require “a fixed target [intrinsic frequency/Q-factor] . . . chosen before treatment”); Prelim. Resp. 16 (proposing that the Board should adopt the district court’s claim construction: “a targeted [intrinsic frequency/Q-factor] chosen before treatment”); Reply 4 (“the parties to the IPRs have agreed that, for the purposes of these IPRs, the Board should accept the claim construction as adopted by the district court”). Accordingly, we do not find it necessary to construe any claim terms in order to resolve this proceeding. See Vivid Techs. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,446,259
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).

  RulingsInstitution decision

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

    “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2

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

    “tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49

  • Adverse judgmentAdverse judgmentOther

    “D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. 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 ’742 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 9

  Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · Graham
  Patents in suitUS 11,191,742
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution

  The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.

  RulingsInstitution decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

    “ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. 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 ’029 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 12

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

    “whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments (Advanced Bionics, Paper 6 at 10). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21

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

    “Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,471,029
• Neuroderm Ltd. v. Abbvie Inc.Instituted
  PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

  The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

  RulingsInstitution decision

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

    “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

  • Skill levelSkill level board ownOther

    “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

  • Expert testimonyPetitioner expert creditedOther

    “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

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

    “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,091,507
• 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

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.