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  • PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing

    Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

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

      “3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24

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

      “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted

      “skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,808,039
  • PTAB · Sep 15, 2020 · IPR2020-00043 · APJ Kara L Szpondowski · IPR · Rehearing

    The Board granted rehearing but denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim.

    RulingsRehearing decision
    • RehearingRehearing, grantedRehearing, deniedGranted in part

      “We have considered Petitioner’s Request for Rehearing and, for the reasons set forth below, we grant Petitioner’s Request for Rehearing, but we are not persuaded to change our ultimate conclusion to deny institution of inter partes review. II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus.” slip op. at 3

    • Other 314aInstitution denied discretionary otherDenied

      “III. DISCUSSION OF THE REQUEST FOR REHEARING On May 4, 2020, we issued our Decision denying institution of inter partes review based upon: (1) the advanced stage of the California District Court proceeding; (2) the investment of time and resources by the District Court and the parties in the California District Court proceeding; (3) overlap in the invalidity theories that Petitioner is pursuing here and in the California District Court proceeding; and (4) overlap in the claims challenged in the California District Court proceeding. Inst. Dec. 6–12. In the Decision, we did not reach any of the ten substantive grounds for patentability. See generally Inst. Dec. Rather, the denial of institution was solely based on our findings under 35 U.S.C. § 314(a). Id.” slip op. at 4

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

      “review under 35 U.S.C. §314(a) and 37 C.F.R. §42.4. Institution of an inter partes review is authorized 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) (2012); see also 37 C.F.R. § 42.4(a) (2019) (“The Board institutes the trial on behalf of the Director.”) For the reasons set forth below, upon considering the arguments and evidence of record, we are not persuaded to change our ultimate conclusion to deny institution of inter partes review.7” slip op. at 5

    • BurdenDenied

      “The 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. 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.22(a) (content of petitions); 37 C.F.R. 42.104 (content of petition). Petitioner’s conclusory statements, without more, are irreparably lacking in detail. Petitioner does not provide any analysis to support the assertion of obviousness over Oki. In fact, Petitioner instead asserts that Oki discloses all of the limitations in each of claims 1, 2, 4–7, 9, 15, 16, and 18, so it is unclear what modification, if any, is required to Oki, or even the basis of Petitioner’s obviousness grounds. E.g., Pet. 28– 33. Petitioner does not clearly point out the differences between the claimed invention and Oki. Nor does Petitioner explain why a person of ordinary skill in the art would have found the claimed subject matter obvious in spite of those differences. Petitioner has not provided sufficient reasoning or facts on which to base a conclusion that a person of ordinary skill in the art would have found it obvious, in light of Oki’s disclosure, to modify Oki to meet the claim limitations. Accordingly, Petitioner fails to demonstrate a reasonable likelihood that it would prevail on this ground of unpatentability.” slip op. at 28

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 8,223,117
  • PTAB · Jul 23, 2019 · IPR2017-02158 · APJ Christopher G Paulraj · IPR · Rehearing

    The Board accepted Patent Owners’ rehearing request as timely but denied rehearing, finding no overlooked or misapprehended issue requiring modification of the final written decision.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “layer is being removed (i.e., Example 1). Id. at 2–3. We are not persuaded that we misapprehended or overlooked the evidence of record regarding whether Baumgärtel requires the use of pigments for rejuvenation. As we noted in our Final Written Decision, Example 1 of Baumgärtel does not mention the use of any pigments yet discusses the removal of the yellowed/damaged surface layer of white siding using a composition containing 99% dichloromethane. Paper 29, 42. Although the amendment in the Proposed Substitute Claims required both color and luster to be restored, it did not otherwise modify our construction of “rejuvenating,” which encompasses either “remov[ing] or transform[ing] the chalky surface that develops on vinyl siding that is exposed to sunlight and other environmental conditions.” Id. at 15 (emphasis added). The teaching in Baumgärtel’s Example 1 of removing the surface layer using a 99% dichloromethane solution satisfies our construction of “rejuvenating.” We, therefore, did not misapprehend or overlook Patent Owners’ evidence and arguments in determining that Example 1 of Baumgärtel anticipates the Proposed Substitute Claims.” slip op. at 7

    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted

      “Under 37 C.F.R. § 42.5(c)(3), “[a] late action will be excused on a showing of good cause or upon a Board decision that consideration on the merits would be in the interests of justice.” 37 C.F.R. § 42.5(c)(3) (emphasis added). Patent Owners have presented evidence tending to show that their counsel believed that the Request for Rehearing was timely filed on May 8, 2019. See Exs. 2011–2013. It does not appear, however, that they attached any document with their filing before clicking the submit button on PTAB E2E. In this regard, we note that the email generated by the PTAB E2E system and sent to counsel of record on May 8, 2019 clearly stated “THERE WERE NO DOCUMENTS SUBMITTED WITH THIS REQUEST.” Ex. 3001. Patent Owners have not explained why they did not take immediate action after receiving that email to determine whether the Request for Rehearing was actually filed.1 Indeed, Patent Owners remained” slip op. at 4

    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingDecided for petitioner

      “http://www.uspto.gov/ip/boards/bpai/prps.jsp#heading-5 (emphasis added). 2 We are also not persuaded that the filing of a Notice of Appeal (Paper 33) by Patent Owners divested the Board of jurisdiction to decide the merits of the Request for Rehearing. The Federal Circuit’s decision in In re Graves, 69 F.3d 1147 (Fed. Cir. 1995), is instructive on this point. There, the applicant had filed a notice of appeal to the Federal Circuit after the Board entered its initial decision but before the Board’s decision on a request for reconsideration. Id. at 1150. Because the notice of appeal was filed too late if based on the initial decision, the court determined that the Board’s initial” slip op. at 5

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

      “misapprehended evidence and arguments showing that Dr. Storey’s experiment was not based on Example 1 of Baumgärtel, and thus insufficient for Petitioners to meet their burden of showing inherent anticipation. Ex. 2010, 4–6. But, as set forth in our Final Written Decision, we fully considered the evidence of record and determined that the experiments conducted by Dr. Storey further support a finding of inherent anticipation by Baumgärtel. Paper 29, 43 (citing Ex. 1022 ¶¶ 12–36). We recognized that the 99.5% pure dichloromethane used by Dr. Storey for his experiments did not include the 1% of additional ingredients identified in Example 1, but took into account Dr. Storey’s unrebutted testimony that those additional ingredients in such small proportions would not have materially affected the rejuvenation characteristics of dichloromethane. Id. at 43–44 (citing Ex. 1005 ¶¶ 81–82). As we noted, Patent Owners did not cross-examine Dr. Storey as to his declaration testimony in this proceeding; nor did Patent Owners’ expert Dr. Grulke address these points in his own declaration. Id. at 44. Thus, we are not persuaded that we misapprehended or overlooked the cited testimony of Dr. Storey regarding inherent anticipation.” slip op. at 7

    § 102 anticipation
    Patents in suitUS 6,669,991
  • PTAB · Jan 25, 2018 · IPR2017-01395 · APJ Daniel N Fishman · IPR · Rehearing

    The Board partly granted Intel’s rehearing request to recognize the Stansbury Declaration as a compliant sworn affidavit, but otherwise denied rehearing and left institution denied.

    RulingsRehearing decision
    • RehearingRehearing, grantedRehearing, deniedGranted in part

      “When considering a request for rehearing, we review the Decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the Decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d). A request for rehearing is not an opportunity to present new arguments. See id. An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

      “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). In the Decision, the Board determined that the record before it was insufficient to show that Stevens21 is a prior art printed publication under 35 U.S.C. §§ 102, 311(b) with respect to the ’948 patent. Stevens2 is one of the references relied upon in the sole asserted ground of unpatentability in the Petition. Accordingly, the Board concluded that Petitioner did not slip op. at 2

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

      “Stevens2 was published no later than April 7, 1995 and is prior art under 102(b).” Pet. 45 n.9 (citing Ex. 1063 in support thereof (the “Stansbury Declaration”)). The Petition, per se, provides no other evidence or argument to establish a threshold showing that Stevens2 is a printed publication— publicly accessible by an interested person of ordinary skill in the art before the critical date. slip op. at 3

    • Expert testimonyOther

      “attested that Stevens2 was ‘standard reference book on TCP/IP’ that was ‘widely cited and relied upon,’ ‘well known resources to a [person of ordinary skill in the art]’ (Petition at 15 (citing Ex.1003 at ¶¶21-88, including ¶¶27, 60, and FN3), 45 (citing Ex.1003 at ¶1212), FN9).” Req. 12. Initially we observe the Petition cites these paragraphs of Dr. Horst’s Declaration as part of the “Background Of Technology” discussion rather than as support for public accessibility of Stevens2. See Pet. 15–24. Furthermore, incorporating by reference such a substantial portion of Dr. Horst’s Declaration (paragraphs 21–88) is improper under our rules. See 37 C.F.R. § 42.6(a)(3). Regardless, even if we consider Dr. Horst’s description of well-known background material (including Stevens2) as support for public accessibility of Stevens2, his testimony does not indicate” slip op. at 5

    § 102 anticipation
    Patents in suitUS 8,805,948
  • PTAB · Mar 24, 2017 · IPR2016-01223 · APJ Jennifer S Bisk · IPR · Rehearing

    The Board reconsidered its analysis but denied institution because Petitioner did not show McNeill disclosed or rendered obvious the claimed analog signal acquisition channel.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted in part

      “When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision[,]” which party “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). We grant Petitioner’s request insofar as we have reconsidered our analysis of whether Petitioner has shown that the prior art discloses the claimed “analog acquisition channel,” but we decline to modify our previous decision. slip op. at 2

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

      “inherency. First, Petitioner’s expert states that “[i]t is implicit and inherent for a scanner to have an analog signal acquisition channel for receiving a signal from analog source.” Reh’g Req. 4 (quoting Ex. 1306 ¶ 98). This sentence is exactly, word for word, the same as the sentence in the Petition it is relied upon to support. Pet. 35. Repetition of this legal conclusion in a declaration signed by a technical expert adds nothing to Petitioner’s attorney argument. It is not persuasive evidence. Second, both the Petition and the expert state that “[a] typical scanner at the priority date of the ’746 patent had a CCD and analog to digital circuitry to produce a digital representation of an image.” Pet. 35; Ex. 1306 ¶ 98. This statement does not adequately support a finding that the scanner discussed in McNeill necessarily discloses an analog signal acquisition channel. “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.” In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). This evidence goes only to a typical scanner, not all scanners. Petitioner has not directed us to any other evidence supporting a finding of inherency. And as noted in our Institution Decision (Inst. Dec. 11), the Petition does not address why a person of ordinary skill in the art would find the addition of an analog signal acquisition channel obvious based on McNeill’s disclosure. The closest Petitioner gets to addressing this issue is in a statement that says “[a]dding an analog sensor to the ‘exemplary system’ of McNeill is inherent, but if it is not, a POSITA would find it obvious to do so.” Pet. 35. This vague and conclusory statement, part of a section of the brief which does not even reference the term “analog signal acquisition channel,” is insufficient to show that Petitioner is reasonably likely to prevail in showing that a limitation of the claim, not expressly disclosed in the reference, would have been obvious.” slip op. at 4

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

      “the claimed “analog signal acquisition channel,” such an element is inherently disclosed by McNeill’s scanner. Reh’g Req. 3–5. Because McNeill’s scanner produces analog signals and then transmits those signals to an analog-to-digital converter, Petitioner asserts the scanner must “necessarily” include a channel connecting the analog sensor. Id. at 5 (citing Ex. 1306 ¶ 98. However, Petitioner’s evidence does not adequately support a finding of inherency. Petitioner relies on expert testimony to support its assertion of inherency. First, Petitioner’s expert states that “[i]t is implicit and inherent for a scanner to have an analog signal acquisition channel for receiving a signal from analog source.” Reh’g Req. 4 (quoting Ex. 1306 ¶ 98). This sentence is exactly, word for word, the same as the sentence in the Petition it is relied upon to support. Pet. 35. Repetition of this legal conclusion in a declaration signed by a technical expert adds nothing to Petitioner’s attorney argument. It is not persuasive evidence. Second, both the Petition and the expert state that “[a] typical scanner at the priority date of the ’746 patent had a CCD and analog to digital circuitry to produce a digital representation of an image.” Pet. 35; Ex. 1306 ¶ 98. This statement does not adequately support a finding that the scanner discussed in McNeill necessarily discloses an analog signal acquisition channel. “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.” In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). This evidence goes only to a typical scanner, not all scanners. Petitioner has not directed us to any other evidence supporting a finding of inherency.” slip op. at 4

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

      “And as noted in our Institution Decision (Inst. Dec. 11), the Petition does not address why a person of ordinary skill in the art would find the addition of an analog signal acquisition channel obvious based on McNeill’s disclosure. The closest Petitioner gets to addressing this issue is in a statement that says “[a]dding an analog sensor to the ‘exemplary system’ of McNeill is inherent, but if it is not, a POSITA would find it obvious to do so.” Pet. 35. This vague and conclusory statement, part of a section of the brief which does not even reference the term “analog signal acquisition channel,” is insufficient to show that Petitioner is reasonably likely to prevail in showing that a limitation of the claim, not expressly disclosed in the reference, would have been obvious.” slip op. at 5

    § 102 anticipation§ 103 obviousness
    Patents in suitUS 8,504,746
  • PTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing

    On rehearing, the Board modified its decision and held claims 1–20 unpatentable as obvious over Pinchasi with the 1996 SBOA and over Pinchasi with Flechter.

    RulingsRehearing decision
    • RehearingGranted in part

      “we entered a Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Patent Owner filed a request for rehearing of our decision. Paper 87. In a concurrently issued Order, we grant-in-part Patent Owner’s request and vacate our original decision. Paper 89. We hereby issue this modified Final Written Decision.” slip op. at 2

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “in the art. Petitioner contends that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or an M.D. with experience in clinical pharmacology. Pet. 13. In its Preliminary Response, Patent Owner asserted that a skilled artisan would have had knowledge of, and experience with, both MS and GA. Prelim. Resp. 33–34. In the Decision to Institute, we agreed with Patent Owner. Dec. 9. We noted that Dr. Green, one of Petitioner’s declarants, states that a person of ordinary skill in the art would have had “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither party contests our findings of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination. Thus, we reiterate that in addition to the qualifications specified by Petitioner, a person of ordinary skill in the art would also have experience treating MS with GA.” slip op. at 8

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “As an initial matter, we note that, in its Preliminary Response, Patent Owner challenged the status of the 1996 SBOA as a printed publication under 35 U.S.C. § 102(b). Prelim. Resp. 47–48. In the Decision to Institute, we determined that, based on the record available then, the 1996 SBOA constitutes prior art under § 102(b). Dec. 12–13. In its Response, Patent Owner does not dispute this finding. Having considered the complete record developed at trial, we reiterate that Petitioner has presented sufficient evidence (see Ex. 1007) to show that the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008). See Dec. 12–13. Thus, the 1996 SBOA constitutes prior art under § 102(b).” slip op. at 9

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

      “Upon considering the evidence as a whole, we also find that an ordinary artisan would have been motivated to administer GA three times over a period of seven days to increase patient compliance. We note again that Pinchasi teaches administering 40 mg GA every other day, which equates to seven doses over two weeks. Ex. 1005, 9. Thus, the difference between the challenged claims (three doses over a period of seven days, or six doses over two weeks) and the prior art is one less injection every two weeks. Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 101. The desirability of less frequent injections is supported by the 1996 SBOA, in which the reviewer recommended that Teva evaluate the necessity of daily injections as opposed to more infrequent intermittent administration of Copaxone®. Ex. 1007, 252.” slip op. at 13

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,232,250
  • PTAB · Aug 24, 2015 · IPR2014-01516 · APJ Hyun J Jung · IPR · Rehearing

    The Board granted rehearing only to reconsider constructions of “selecting” and “comparing,” but denied modification of its decision denying institution on claims 1–16.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted in part

      “decision is abuse of discretion. 37 C.F.R. § 42.71(c). The requirements are set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. We grant Petitioner’s request insofar as we have reconsidered our interpretation of the challenged claim terms, but we decline to modify our previous decision.” slip op. at 2

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

      “reasonable interpretation of “selecting the file based on whether content of the file matches a file type indicated by a name of the file” in view of the Specification of the ’298 patent includes “a sequence of linked examinations of the indicated file type and file content that demonstrates a mismatch.” Also, as we determined previously, the portions of Chen relied on in the Petition describe examining the file content and file extension, but not comparing the file content to the file extension. Dec. 11. Thus, after considering our previous analysis in view of Petitioner’s proposed interpretation, we determine that Petitioner has not demonstrated Chen discloses “selecting the file based on whether content of the file matches a file type indicated by a name of the file,” as recited by independent claims 1, 10, and 16. Accordingly, we are not persuaded to modify our decision denying institution based on Petitioner’s challenge of claims 1, 2, 6, 7, 9–11, and 16 as anticipated by Chen and Petitioner’s challenge of claims 3–5, 8, and 12– 15 as obvious over Chen and either Ji, Korn, Kim, or admitted prior art, which do not address the deficiency regarding the “selecting” step.” slip op. at 7

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

      “Id. at 3. In the cited portion, the ’298 patent states that “the retrieved file is examined to determine whether the file structure is as expected for a file of the indicated type.” Ex. 1004, 7:5–7. The ’298 patent also states that “[a]lternatively, files can be checked to ensure that they actually contain the type of data described by the file type marker.” Id. 7:9–10. The ’298 patent, thus, supports Petitioner’s interpretation that “a selection based on whether a file content matches the file type indicated by the file name may be accomplished by a direct comparison between two items,” because it describes a direct comparison. The same portions of the ’298 patent, however, do not support Petitioner’s interpretation that the “selecting” step also includes “a sequence of linked examinations of the indicated file type and file content that demonstrates a mismatch” because it does not describe an examination of file type and a separate examination of file content that, when linked, demonstrate a mismatch. We determine that, in view of the Specification of the ’298 patent, one of ordinary skill in the art would interpret the “selecting” step of independent claims 1, 10, and 16 to include examining files “to determine whether the file structure is as expected for a file of the type indicated,” checking files “to ensure that they actually contain the type of data described by the file type marker,” and other, similar alternatives. Petitioner provides no reasoning that the Specification of the ’298 patent further describes separate examinations that demonstrate a mismatch. Petitioner’s arguments, therefore, do not persuade us that the broadest, reasonable interpretation of the “selecting” step in view of the Specification of the ’298 patent further includes “a sequence of linked examinations of the indicated file type and file content that demonstrates a mismatch.” Finally, an interpretation of the “selecting” step that includes “a sequence of linked examinations of the indicated file type and file content that demonstrates a mismatch” would render meaningless, or superfluous, the term “matches” as recited by independent claims 1, 10, and 16. Separate examinations of file type and file content that demonstrate a mismatch allows for no matching at all. Thus, Petitioner does not persuade us to adopt this particular interpretation of the “selecting” step.” slip op. at 5

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

      “reasonable interpretation of “selecting the file based on whether content of the file matches a file type indicated by a name of the file” in view of the Specification of the ’298 patent includes “a sequence of linked examinations of the indicated file type and file content that demonstrates a mismatch.” Also, as we determined previously, the portions of Chen relied on in the Petition describe examining the file content and file extension, but not comparing the file content to the file extension. Dec. 11. Thus, after considering our previous analysis in view of Petitioner’s proposed interpretation, we determine that Petitioner has not demonstrated Chen discloses “selecting the file based on whether content of the file matches a file type indicated by a name of the file,” as recited by independent claims 1, 10, and 16. Accordingly, we are not persuaded to modify our decision denying institution based on Petitioner’s challenge of claims 1, 2, 6, 7, 9–11, and 16 as anticipated by Chen and Petitioner’s challenge of claims 3–5, 8, and 12– 15 as obvious over Chen and either Ji, Korn, Kim, or admitted prior art, which do not address the deficiency regarding the “selecting” step.” slip op. at 7

    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 7,757,298
  • PTAB · Jun 26, 2015 · IPR2015-00171 · APJ Linda M Gaudette · IPR · Rehearing

    Rehearing was granted in part, instituting review of claims 42–44, 47–51, 53, 55, and 56 for anticipation and claim 57 for obviousness.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted in part

      “the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

      “Because Petitioner has shown Mr. Cooper’s testimony is supported by underlying factual evidence, and is not based solely on an unsupported assumption and the Miura Declaration, we determine Mr. Cooper’s testimony provides persuasive support for Petitioner’s contention that DME is inherently present in an overhead distillation stream of the ’095 patent process, and that claim 42 is anticipated by the ’095 patent. We have also reviewed the Petition’s analysis of dependent claims 43, 44, 47–51, 53, 55, and 56, and conclude Petitioner has provided sufficient explanation and evidence to support a reasonable likelihood that the additional limitations of these claims are described in the ’095 patent. See Pet. 27–35. In sum, at this stage of the proceeding, Petitioner has established a reasonable likelihood that it would prevail on the merits in showing claims 42–44, 47–51, 53, 55, and 56 are anticipated by the ’095 patent. Therefore, the Request for Rehearing is granted and trial is instituted as to this challenge.” slip op. at 5

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureReference is prior artInherency foundInstituted

      “the Petition, and overlooked the fact that Mr. Cooper’s opinion is also based on his own calculations and data in two published articles. See Ex. 1003 ¶ 99. Specifically, Mr. Cooper approximates reactor DME equilibrium concentrations in the ’095 patent examples and explains how these approximations were obtained using readily available data, specifically identifying data in two published articles. Ex. 1003 ¶ 99 (citing Exs. 1029, 1030). Mr. Cooper goes on to explain why, based on the reactor contents and distillation conditions in the ’095 patent examples, DME and acetaldehyde would be present in the overhead distillation streams. Id. ¶¶ 101–102. Because Petitioner has shown Mr. Cooper’s testimony is supported by underlying factual evidence, and is not based solely on an unsupported assumption and the Miura Declaration, we determine Mr. Cooper’s testimony provides persuasive support for Petitioner’s contention that DME is inherently present in an overhead distillation stream of the ’095 patent process, and that claim 42 is anticipated by the ’095 patent. We have also reviewed the Petition’s analysis of dependent claims 43, 44, 47–51, 53, 55, and 56, and conclude Petitioner has provided sufficient explanation and evidence to support a reasonable likelihood that the additional limitations of these claims are described in the ’095 patent. See Pet. 27–35. In sum, at this stage of the proceeding, Petitioner has established a reasonable likelihood that it would prevail on the merits in showing claims 42–44, 47–51, 53, 55, and 56 are anticipated by the ’095 patent. Therefore, the Request for Rehearing is granted and trial is instituted as to this challenge.” slip op. at 4

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

      “terms, and we agree, for purposes of this decision, that claim 42 does not require a specific quantity of DME in the distillation overhead. We do not agree with Petitioner, however, that the Singh and ’507 patent disclosures are identical with respect to the addition of water to distillation column 22. As indicated in our Decision, both Singh and the ’507 patent describe adding small amounts of water to column 22 for the purpose of inhibiting impurity formation. See Dec. 5–6. The ’507 patent, however, includes additional description of adding water to column 22 for the purpose of producing DME in the distillation overhead. See id. at 7 (citing Ex. 1002, col. 11). This additional description of adding water to produce DME in the distillation overhead does not refer back to the description of adding water as an inhibitor (see Ex. 1002, 10:9–32), or otherwise indicate that the small amounts of water used to inhibit impurity formation in the ’507 patent and Singh processes would produce DME in a distillation overhead. In addition, for the reasons explained in our Decision (Dec. 25–26), Petitioner has not persuaded us that the prosecution history of the ’507 patent includes an admission by Patent Owner that the addition of any amount of water to the distillation step would result in DME in an overhead stream. See Req. Reh’g 10. In sum, Petitioner has not convinced us that our Decision was based on an erroneous claim interpretation or that we overlooked evidence that the addition of any amount of water in the steps common to the Singh and the ’507 patent processes would necessarily result in the presence of DME in a distillation overhead. With respect to Petitioner’s assertions regarding Akinori, we note the Petition relied on Akinori as evidence that DME was necessarily produced in the ’095 patent process. See Pet. 43. Petitioner did not explain how Akinori was relevant to show the presence of DME in the distillation overhead of Singh. For the above reasons, the Request for Rehearing is denied as to the challenge based on Singh in view of the ’095 patent and Akinori.” slip op. at 7

    § 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 8,076,507

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.