• Hugel, Inc. v. Medytox Inc.Institution denied
  PTAB · Aug 28, 2023 · IPR2023-00604 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution: Ground 1 did not show claims 1–9 likely obvious over Jung and Ton; it denied Ground 2 under § 325(d).

  RulingsInstitution decision

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

    “Petitioner “has the burden from the outset to show with particularity why the patent it challenges is unpatentable.” Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also SAS Inst., Inc. v. Iancu, 138 S.Ct. 1348, 1355 (2018) (“in an inter partes review, the petitioner is the master of its complaint”). A petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify, “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). What is missing from both the Petition and the supporting testimony is an adequate explanation of how or why a POSA would have understood that Jung teaches the isolation of a botulinum toxin type A macro complex in particular, when Jung is silent as to the form of the toxin being produced. In this case, it is not enough to simply cite evidence; an explanation of the significance of that evidence is necessary. Based on our review of the record, we find that there is insufficient explanation and insufficient supporting evidence that Jung teaches isolating a botulinum toxin type A macro complex. Petitioner’s statements, and Dr. Bates’s testimony, that Jung teaches isolating a botulinum toxin, and that botulinum toxins “naturally comprise[] a complex with a variety of non-toxic proteins bound thereto” that can be intermediate, large, or macro in size, are conclusory because they do not explain why the form of toxin ultimately isolated in Jung is a macro complex. Therefore, Petitioner does not sufficiently show that the combination of Jung and Ton discloses “[a] method of isolating a botulinum toxin type A macro complex from a botulinum containing solution” or “separating the botulinum toxin type A macro complex from the cation exchange chromatography medium” as required by claim 1 of the ’598 patent.” slip op. at 13

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

    “the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” The Board uses a two-part framework for evaluating arguments under § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In applying this framework, we consider the Becton, Dickinson10 factors that address discretion to deny institution when a petition presents the same or substantially the same prior art or arguments previously presented to the Office, including:” slip op. at 17

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

    “To support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.” (citation and internal quotation marks omitted)). Here, the Petition lacks an adequate explanation as to why a POSA reading Kim ’741 would have looked to Jung for its teachings regarding anion exchange chromatography, and how a POSA would have combined the teachings of Kim ’741 and Jung in the manner claimed. Because we are not persuaded that Petitioner sufficiently establishes a motivation to combine Kim ’741 and Jung with respect to the anion exchange chromatography limitation of claim 1, we are not persuaded that Petitioner’s alternative assertion of Jung for this limitation warrants reconsideration of the prior art and arguments previously considered by the Office. Accordingly, we find that the Examiner’s failure to consider Jung in combination with Kim ’741 with respect to the anion exchange chromatography limitation of claim 1 is not an error that weighs in favor of institution.” slip op. at 29

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “the graduate degree.” Pet. 17 (citing Ex. 1021 ¶ 22). Patent Owner states that, for purposes of its Preliminary Response, it does not challenge Petitioner’s proposed definition of a POSA. Prelim. Resp. 20. For purposes of this Decision, and based on the current record, we adopt the uncontested assessment offered by Petitioner.” slip op. at 6

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 11,331,598
• LG Electronics Inc. / LG Electronics USA, Inc. v. Image Processing Technologies, LLCInstitution denied
  PTAB · May 11, 2023 · IPR2023-00104 · APJ Barbara A Benoit · IPR · Institution

  The Board denied institution on claim 1, finding the petition presented the same or substantially the same art or arguments previously considered by the Office.

  RulingsInstitution decision

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

    “under 35 U.S.C. § 325(d) to deny institution of an inter partes review. See 37 C.F.R. § 42.4(a) (The Director delegated her authority to determine whether trial should be instituted to the Board.). Section 325(d) of Title 35 of the United States Code states, in relevant part: “In determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We use a two-part framework for evaluating arguments under § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 12

  • Prior constructionPrior construction adoptedDecided for petitioner

    “applied the construction of “the [at least two] calculation units being configured to form a histogram representative of the parameter” (the “common parameter” limitation) as meaning “the histogram calculation units being configured to each form a histogram representative of at least one common parameter.” Ex. 1005 (IPR 336 Final Written Decision), 12– 14; see Ex. 1006 (IPR 1189 Decision Denying Institution), 9; Ex. 1007 (Reexam 056 Decision finding claim 1 patentable), 8.” slip op. at 11

  Claim constructionDiscretionary denialcites Phillips · Graham
  Patents in suitUS 6,959,293
• ROKU, Inc.Institution denied
  PTAB · May 5, 2023 · IPR2022-01552 · APJ Christopher L Ogden · IPR · Institution

  The Board denied institution of IPR challenging claims 17–21, 25–35, 59–69, 85–89, and 93–99 because the Fintiv factors favored discretionary denial.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “Wireless, Inc., the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Ex. 2011, 3 (footnote omitted) (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential)). Roku’s stipulation, however, falls far short of a Sotera-type stipulation that would bar Roku from pursuing any grounds in the parallel district court proceeding that could have reasonably been raised before the Board. Thus, while Roku’s stipulation would prevent some overlap between this proceeding and the parallel district court proceeding, the scope of the stipulation does not rise to the level contemplated in the Fintiv Memo. Thus, although we find that the fourth Fintiv factor weighs somewhat against discretionary denial of institution, this does not end our analysis because Roku has declined to submit a Sotera-type stipulation.” slip op. at 14

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

    “§ 42.4(a), we may only institute an inter partes review when “the information presented in the petition . . . and any response . . . 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) (2018); see also 37 C.F.R. § 42.108(c) (2022). However, institution of inter partes review is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons below, we exercise our discretion not to institute an inter partes review.” slip op. at 2

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

    “In particular, we find it a close issue whether Ozawa discloses a “portable device” as recited in unchallenged independent claims 1, 39, and 73, which is also part of the challenged dependent claims. In claims 1 and 39, the term “portable device” is introduced in the preamble and appears throughout the claims. See Ex. 1101, 32:46–33:30, 36:32–37:11. In claim 73, a “portable device” is recited as an element of the claimed system. See id. at 39:44–40:20. In its Petition, Roku assumes, for its arguments, that the claim preambles, including the term “portable,” are limiting. See Pet. 24, 27–28. In its Preliminary Response, IOENGINE argues that “[t]he term ‘portable device’ is limiting because it provides antecedent basis for 11 instances in the body of claim 1,” and because the specification specifically focused on portability as an important feature of the invention. Prelim. Resp. 11–13. We agree with IOENGINE that the claim preambles are limiting at least to the extent that “portable” is a necessary feature of the portable device recited in the claims. We also point out that in the parallel district court litigation, the court specifically held that the preambles of claims 1, 39, and 73 are limiting. See Ex. 2008, 29–31. We agree with the district court’s analysis.” slip op. at 16

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

    “In light of IOENGINE’s preliminary arguments, we find the issue of whether Ozawa discloses a “portable device” to be a close issue. The 9 IOENGINE erroneously identifies the Preliminary Infringement Contentions as Exhibit 1116 rather than Exhibit 1118. evidence does not plainly support Roku’s position at this stage, and the question would need to be further developed at trial. Because the “portable device” limitation is part of all challenged claims, Roku would need to prevail on this issue to prevail on any claim at trial. Thus, we determine that Roku has not, at this stage, presented a “compelling, meritorious challenge[]” to any claim of the ’584 patent. Ex. 2011, 4. Accordingly, we find that the sixth Fintiv factor does not weigh against discretionary denial.” slip op. at 17

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,972,584
• ROKU, Inc. v. Ioengine, LLCInstitution denied
  PTAB · May 5, 2023 · IPR2022-01551 · APJ Christopher L Ogden · IPR · Institution

  The Board denied institution on all challenged claims under Fintiv, citing the advanced parallel district court case and finding no compelling merits challenge.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied

    “We agree with IOENGINE that trial in the parallel district court proceeding is likely to be about six months prior to the due date for our final written decision if we were to institute an inter partes review. Because the district court would address issues relating to the validity of the ’584 patent well before we would issue a final written decision, we find that the second Fintiv factor weighs heavily in favor of discretionary denial of institution.” slip op. at 11

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

    “We agree with IOENGINE that the claim preambles are limiting at least to the extent that “portable” is a necessary feature of the portable device recited in the claims. We also point out that in the parallel district 5 Our compelling-merits analysis relies on the parties’ agreed understanding of the level of ordinary skill in the pertinent art, which Roku articulates in its Petition. Pet. 15 (citing Ex. 1003 ¶ 60); Prelim. Resp. 8–9; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–1313 (Fed. Cir. 2005) (en banc) (the level of ordinary skill is pertinent to claim construction); Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17–18 (1966) (the level of ordinary skill is one of the factors to consider when determining obviousness). court litigation, the court specifically held that the preambles of claims 1, 39, and 73 are limiting. See Ex. 2008, 29–31. We agree with the district court’s analysis.” slip op. at 15

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

    “In light of IOENGINE’s preliminary arguments, we find the issue of whether Ozawa discloses a “portable device” to be a close issue. The evidence does not plainly support Roku’s position at this stage, and the question would need to be further developed at trial. Because the “portable device” limitation is part of all challenged claims, Roku would need to prevail on this issue to prevail on any claim at trial. Thus, we determine that Roku has not, at this stage, presented a “compelling, meritorious challenge[]” to any claim of the ’584 patent. Ex. 2011, 4. Accordingly, we find that the sixth Fintiv factor does not weigh against discretionary denial.” slip op. at 17

  Claim constructionDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,972,584
• 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
• Nokia Of America Corporation / Ericsson Inc. v. Godo Kaisha IP Bridge 1Institution denied
  PTAB · Nov 2, 2022 · IPR2022-00755 · APJ John D Hamann · IPR · Institution

  The Board denied institution under § 314(a), finding the Fintiv factors favored denial and that the challenges to claims 14–19 were not compelling.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

    “Accordingly, this factor weighs heavily in favor of exercising our discretion to deny the Petition.” slip op. at 10

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

    “In sum, we find that Petitioner’s arguments, and Dr. Fuja’s cited testimony, are not compelling. Accordingly, Petitioner’s showing as to independent claim 14 is less than a “compelling, meritorious challenge[].” In addition, claims 15–19 depend from claim 14, and Petitioner’s arguments for these dependent claims do not cure the above deficiencies for independent claim 14. Pet. 26– 31. Likewise, Petitioner’s arguments for dependent claims 15 and 18 for the remaining ground (Kotecha combined with R1-081126) do not cure the above deficiencies for independent claim 14. Pet. 31–34. Thus, Petitioner’s showing of unpatentability is not compelling for any of the challenged claims for any of the asserted grounds. VII. CONCLUSION For the foregoing reasons, we exercise our discretion to deny the Petition. VIII. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied and no trial is instituted.” slip op. at 25

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

    “We find that Petitioner’s arguments are not compelling. First, we have doubts as to whether Kotecha (i) teaches a scheme “which utilizes a CQI trigger, a particular MCS value, and other fields present in the uplink grant” or (ii) “encourages [one of ordinary skill in the art] to use fields in addition to the MCS field.” Pet. 23–24. Rather, it appears that Kotecha teaches in its discussion regarding using a CQI trigger and a particular MCS value that “different fields, other than the MCS field, may be reused according to [Kotecha’s] disclosure to clearly signal whether an uplink grant is for only CQI or CQI and data.” See Ex. 1004, 4:23–43 (emphasis added). Hence, Kotecha teaches using other fields in lieu of—not in addition to—the MCS field. Id. Moreover, Kotecha’s teachings regarding using “one or more fields” to indicate only CQI or CQI and data identify the CQI request and MCS fields, as examples, without identifying additional fields, nor requiring the use of these fields. See id. at 7:19–22, 8:15–20, Fig. 6. Thus, these teachings also do not provide compelling support for Petitioner’s arguments that Kotecha encourages adding a third field to the CQI request and MCS fields combination. Id. Second, we find uncompelling Petitioner’s argument that one of ordinary skill in the art “would have been motivated to try using the . . . (RB) assignment field as a further indication of whether to multiplex CQI with data,” which “is one of only seven other possible fields for [one of ordinary skill in the art] to consider.” Pet. 25. This argument is premised on Kotecha encouraging using a third field—and only a third field—in addition to the CQI request and MCS fields, which, as we discuss above, Kotecha does not. Rather, choosing any three, for example, of the nine fields in the uplink grant would yield 84 possible combinations. See Ex. 1004, 1:25–34 (listing nine fields); Ex. 1003 ¶ 78 (testifying that “Kotecha identifies nine fields in the uplink grant”). Yet more combinations are possible if combinations having other numbers of fields are employed. “[T]he breadth of these choices and the numerous combinations indicate that these disclosures would not have rendered the claimed invention obvious to try.” Leo Pharm. Prod., Ltd. v. Rea, 726 F.3d 1346, 1356 (Fed. Cir. 2013) (citing Rolls–Royce PLC v. United Techs. Corp., 603 F.3d 1325, 1339 (Fed. Cir. 2010)). Nor does Petitioner cite to any guidance provided in Kotecha about which combinations of fields would likely be successful in arguing that the claimed three field combination would have been obvious to try. See In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (“[W]here a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness.”).” slip op. at 22

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Third, we do not find compelling Dr. Fuja’s cited testimony, which in our view, and taken as a whole, risks using impermissible hindsight to reconstruct the invention of claim 14. See Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017) (“[W]e cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.”); In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (“It is impermissible to use the claimed invention as an instruction manual or ‘template’ to piece together the teachings of the prior art so that the claimed invention is rendered obvious.” (citation omitted)). For example, the testimony appears to be predicated incorrectly on Kotecha teaching using a third field (i.e., the resource assignment field) in addition to the CQI request and MCS fields, and the testimony instead tracks the claimed three field combination of claim 14. Ex. 1003 ¶¶ 77–79. Moreover, Dr. Fuja opines that “it would have been obvious for [one of ordinary skill in the art] to use the resource assignment field in the uplink grant in addition to the CQI request bit and the MCS field because doing so provides additional flexibility and greater efficiency at no additional cost.” Ex. 1003 ¶ 79. We find this testimony to be conclusory as there is no factual support underlying Dr. Fuja’s opinion that one of ordinary skill in the art would have found such to be obvious. Id. ¶¶ 77–83. Also, claim 14 recites more than just reusing the resource assignment field to indicate whether data should be multiplexed with the CQI report. Ex. 1001, 24:7–14. Rather, claim 14 also recites evaluating whether the indicated number of resource blocks “is smaller than or equal to a determined number of resource blocks.” Id. Kotecha does not teach this, nor does Dr. Fuja address it in a compelling way. See Ex. 1003 ¶¶ 77–83.” slip op. at 23

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,385,239
• Ericsson Inc. / Nokia Of America Corporation v. Godo Kaisha IP Bridge 1Institution denied
  PTAB · Nov 2, 2022 · IPR2022-00725 · APJ David C Mckone · IPR · Institution

  The Board denied institution for claims 1–6 and 11–16 under § 314(a), finding the Fintiv factors favored denial and the challenges were not compelling.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”); 35 U.S.C. § 314(a). The Board has held that the advanced state of a parallel district court action is a factor that may weigh in favor of denying a petition under § 314(a). See NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8 at 20 (PTAB Sept. 12, 2018) (precedential); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 58 & n.2 (Nov. 2019) (“Trial Practice Guide”)2. We consider the following factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding”: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103. Because the ’000 patent claims a filing date before March 16, 2013, the effective date of the relevant amendment, the pre-AIA version of § 103 applies. 2 Available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf. 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). In evaluating these factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 5

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

    “implemented by a base station. As Petitioner points out, Classon describes a multicarrier communications system that includes a “base site” and “receiving platforms” (also referred to as “transmission targets”), which we find are a base station and mobile stations. Pet. 19–20 (citing Ex. 1005, code (57), ¶¶ 23, 27, 28, 31, Fig. 4). The parties dispute whether Classon (in light of the background knowledge of a skilled artisan or, in light of TR 25.858) teaches transmitting control information indicating whether a mobile station is to transmit one channel quality indicator (CQI) for each subcarrier block within a communication frequency band or one CQI for all subcarrier blocks within the communication frequency band instead of multiple CQIs for multiple subcarrier blocks within the communication frequency band, as recited in claim 1 (and similarly recited in claim 11). For the reasons given below, the case Petitioner advances is less than compelling.” slip op. at 21

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

    “Patent Owner’s argument has merit. Paragraphs 37–40 of Classon describe the base station determining what mode to use for communication based on the information (including CQI information) sent by the mobile units. Paragraph 41 states that “such channel quality information will preferably already be available to the base site” but that, if it is not available, “the base site can transmit 73 a message to the relevant transmission target or targets and request a reply that includes the relevant channel quality information.” Also, paragraph 41 states that “[w]ays in which such information can be provided to the base site will be described below in more detail.” This appears to be a reference to Classon’s description of the mobile stations, not the base station, determining that they are of “type 1” or “type 2” and sending channel quality information to the base station based on that determination, after which the base station determines whether to use the first mode or second mode in communications. Ex. 1005 ¶¶ 45–51. Thus, rather than supporting Petitioner’s position, the context around paragraph 41 appears in friction with that position. Petitioner does not explain how the base station determines a transmission mode (and thus a requested amount of CQI information) without first having that information from the mobile stations. Instead, it is reasonable to read paragraph 41 as requesting of the mobile stations information that the mobile stations deem appropriate; in other words, that the mobile stations determine whether to send a CQI value for each subcarrier or information on average channel quality. Even if it is sufficient to go forward on a theory that Classon implicitly teaches the claimed control message, the evidence Petitioner advances for this position is not compelling.” slip op. at 23

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “III. DISCRETIONARY DENIAL UNDER 35 U.S.C. § 325(D) Petitioner argues that we should not deny the Petition under 35 U.S.C. § 325(d). Pet. 56. Patent Owner argues that we should. Prelim. Resp. 23– 28. Because we deny the Petition for other reasons, we do not reach whether we should exercise our discretion to deny the Petition under § 325(d).” slip op. at 29

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 9,137,000
• Alarm.Com, Inc. v. Vivint, Inc.Institution denied
  PTAB · Nov 1, 2022 · IPR2022-00728 · APJ Charles J Boudreau · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented during prosecution and no material Office error was shown.

  RulingsInstitution decision

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

    “GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”), the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 325(d): “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6 at 8.” slip op. at 17

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

    “After considering the Petition and associated evidence, we exercise” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on our review of the record at this stage, we find that Petitioner’s proposal is consistent with the level of skill reflected in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology as factors that may be considered in determining the level of ordinary skill in the art). See also 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”). Accordingly, for purposes of this decision and to the extent necessary, we adopt Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 12

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

    “Petitioner does not propose constructions for any claim terms. See Pet. 6 (citing 37 C.F.R. § 42.100(b)). On this record, we determine that no terms or phrases in the claims require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 and only to the extent necessary to resolve the controversy’ . . . .” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12

  Claim constructionDiscretionary denial
  Patents in suitUS 9,349,262
• Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution denied
  PTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.

  RulingsInstitution decision

  • Skill levelSkill level board ownOther

    “In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17

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

    “As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19

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

    “reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,464,140

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.