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  • PTAB · Sep 16, 2024 · IPR2024-00122 · APJ Barbara A Parvis · IPR · Rehearing

    The Board granted the petitioner's request to withdraw its rehearing request and granted the joint motion to terminate the proceeding.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “agreement to jointly seek termination of this proceeding, and “[b]ased on the settlement, Petitioner hereby requests withdrawal of its Request for Rehearing.” Joint Motion 1. We “may enter non-final orders to administer the proceeding.” 37 C.F.R. § 42.5. Here, the Board has not decided the merits of Petitioner’s Request for Rehearing. Additionally, we stated in our Decision Denying Institution that “the Petition is denied, and no trial is instituted.” Paper 7, 22. Under these circumstances, therefore, we determine that it is appropriate to grant the request to withdraw Petitioner’s Request for Rehearing and terminate this proceeding as to the Parties. III. ORDER Accordingly, for the reasons discussed above, it is: ORDERED that Petitioner’s request for withdrawal of its Request for Rehearing (Paper 8) is granted; and” slip op. at 2

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

      “agreement to jointly seek termination of this proceeding, and “[b]ased on the settlement, Petitioner hereby requests withdrawal of its Request for Rehearing.” Joint Motion 1. We “may enter non-final orders to administer the proceeding.” 37 C.F.R. § 42.5. Here, the Board has not decided the merits of Petitioner’s Request for Rehearing. Additionally, we stated in our Decision Denying Institution that “the Petition is denied, and no trial is instituted.” Paper 7, 22. Under these circumstances, therefore, we determine that it is appropriate to grant the request to withdraw Petitioner’s Request for Rehearing and terminate this proceeding as to the Parties.” slip op. at 2

    None
    Patents in suitUS 11,061,190
  • PTAB · Apr 3, 2024 · IPR2022-00951 · APJ Stacey G White · IPR · Rehearing

    On rehearing, the Board held claim 3 unpatentable as obvious over Eray-WO799, revising the final written decision’s outcome for that claim.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “unrebutted expert testimony corroborated by two prior art patents describing RFID smart cards” and that this evidence “demonstrated that a conventional and obvious way to manufacture Eray-WO799’s smart card was by forming a card antenna on a card body before adding the chip.” Req. Reh’g 2 (citing Pet. 39–40; Paper 20 (“Reply”) at 31). Thus, Petitioner argues a person of ordinary skill in the art would have understood that an obvious and conventional way of manufacturing the card body of Eray- WO799 would have had unconnected ends as required by our construction. Id. Paragraph 149 of Dr. van der Weide’s declaration states that a person of ordinary skill in the art “would have understood that an obvious and conventional way to construct the smart card as shown in Eray-WO799 FIG. 12 would have been to form the turns S1, S2, SC3 and SC4 on or in the card body (e.g., by laying wire) before connecting the wire to (or forming) access terminals and connecting module M.” Ex. 1003 ¶ 149. In support of that because it was “directed to solving problems that occur during the manufacture of cards.” Dec. 42 (citing Ex. 1028, 1:25–2:53). Petitioner points out that “[w]hile Ryu discloses manufacturing techniques, Ryu also describes and claims a ‘communication system’ with a smart card and a reader.” Reh’g Req. 9 (citing Ex. 1028, code (57), claims 1–2). Petitioner is correct in noting that Ryu’s disclosures are not so narrow as we described in the Decision. As to Finn-089, we found that reference unhelpful because it was “directed to a process for the contacting of a wire conductor in the course of manufacture of a transponder unit.” Dec. 41–42 (citing Ex. 1015, 1:15–17). Petitioner asserts that we failed to acknowledge to the fact that Finn-089 was incorporated by reference in the ’240 patent noting that “[p]atents incorporated by reference ‘are effectively part of the host [patents] as if [they] were explicitly contained therein.’” Reh’g Req. 9 (citing X2Y Attenuators, LLC v. U.S. Int’l Trade Comm’n, 757 F.3d 1358, 1362–63 (Fed. Cir. 2014) (alterations in Rehearing Request)). On this record, we agree that we overlooked and misapprehended the import of Ryu and Finn-089 and if those references are given appropriate weight, they lend further credence to Dr. van der Weide’s testimony that one of ordinary skill in the art would have known that an obvious way to manufacture Eray-WO799 would have created an intermediate product with requisite free ends. Further, we adopt the full reasoning stated in the Dissent as to the unpatentability of claim 3 (Dec. 53–57). Therefore, we GRANT Petitioner’s Request for Rehearing slip op. at 6

    • Skill levelSkill level petitioner adoptedOther

      “As stated in our Final Written Decision, we adopted Petitioner’s definition of the person of ordinary skill in the art and found that the person of ordinary skill in the art would have possessed “a Bachelor’s degree in electrical engineering or a similar field, and 1–2 years of experience researching and developing antennas used in RFID applications.” Dec. 6–7 (citing Pet. 8; PO Resp. 18). Petitioner’s declarant, Dr. Daniel van der Weide, supported Petitioner’s definition, which was adopted for this proceeding. Ex. 1003 ¶ 25. Dr. van der Weide defined himself as “a person of more than ordinary skill in the art during the relevant timeframe” because “[b]y 2010, [he] held a Ph.D. in electrical engineering, and [he] had at least” slip op. at 4

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

      “unrebutted expert testimony corroborated by two prior art patents describing RFID smart cards” and that this evidence “demonstrated that a conventional and obvious way to manufacture Eray-WO799’s smart card was by forming a card antenna on a card body before adding the chip.” Req. Reh’g 2 (citing Pet. 39–40; Paper 20 (“Reply”) at 31). Thus, Petitioner argues a person of ordinary skill in the art would have understood that an obvious and conventional way of manufacturing the card body of Eray- WO799 would have had unconnected ends as required by our construction. Id. Paragraph 149 of Dr. van der Weide’s declaration states that a person of ordinary skill in the art “would have understood that an obvious and conventional way to construct the smart card as shown in Eray-WO799 FIG. 12 would have been to form the turns S1, S2, SC3 and SC4 on or in the card body (e.g., by laying wire) before connecting the wire to (or forming) access terminals and connecting module M.” Ex. 1003 ¶ 149. In support of that because it was “directed to solving problems that occur during the manufacture of cards.” Dec. 42 (citing Ex. 1028, 1:25–2:53). Petitioner points out that “[w]hile Ryu discloses manufacturing techniques, Ryu also describes and claims a ‘communication system’ with a smart card and a reader.” Reh’g Req. 9 (citing Ex. 1028, code (57), claims 1–2). Petitioner is correct in noting that Ryu’s disclosures are not so narrow as we described in the Decision. As to Finn-089, we found that reference unhelpful because it was “directed to a process for the contacting of a wire conductor in the course of manufacture of a transponder unit.” Dec. 41–42 (citing Ex. 1015, 1:15–17). Petitioner asserts that we failed to acknowledge to the fact that Finn-089 was incorporated by reference in the ’240 patent noting that “[p]atents incorporated by reference ‘are effectively part of the host [patents] as if [they] were explicitly contained therein.’” Reh’g Req. 9 (citing X2Y Attenuators, LLC v. U.S. Int’l Trade Comm’n, 757 F.3d 1358, 1362–63 (Fed. Cir. 2014) (alterations in Rehearing Request)). On this record, we agree that we overlooked and misapprehended the import of Ryu and Finn-089 and if those references are given appropriate weight, they lend further credence to Dr. van der Weide’s testimony that one of ordinary skill in the art would have known that an obvious way to manufacture Eray-WO799 would have created an intermediate product with requisite free ends. Further, we adopt the full reasoning stated in the Dissent as to the unpatentability of claim 3 (Dec. 53–57). Therefore, we GRANT Petitioner’s Request for Rehearing slip op. at 6

    § 103 obviousness
    Patents in suitUS 9,165,240
  • PTAB · Dec 20, 2023 · IPR2023-00050 · APJ Ulrike W Jenks · IPR · Rehearing

    The Board granted rehearing and instituted IPR on claims 17, 19, 20, and 22–29 on all petitioned grounds, finding a reasonable likelihood of success and declining § 325(d) denial.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “II. STANDARD OF REVIEW A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was 1 US 7,888,328 B2, issued Feb. 15, 2011 (Ex. 1029, “Bodor”). 2 Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (Ex. 1008, “Rice”). addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review 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 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)InstitutedInstituted

      “Having reconsidered the record before us, we are persuaded that Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis by administering cladribine to a patient in the same claimed total amounts for both induction and the maintenance period to support Petitioner’s challenge to claim 17.” slip op. at 4

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Having considered the record, we agree with Petitioner that the Office erred in its evaluation of the cited art (now asserted) as required by Advanced Bionics. Advanced Bionics cautions that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Paper 6, 9. Here, both Examiner and Patent Owner interpret Bodor to disclose administering the same dose of cladribine in both the induction and maintenance phase. Claim 17 encompasses administering the same dose of cladribine – 1.7 mg/kg – in both the induction and maintenance phase. By interpreting claim 17 as requiring a maintenance dose that is lower than the induction dose, we agree with Petitioner that Examiner misapprehended the scope of claim 17. We, therefore, decline to exercise our discretion to deny institution under § 325(d).” slip op. at 12

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted

      “the claims. “All that is required is that the total dose reach a stated level in each period, and Bodor discloses a total dose within that range for what a person of ordinary skill in the art would understand to be an average patient.” Req. Reh’g 14 (emphasis omitted) (citing Pet. 42–50). Dr. Greenberg testifies that Bodor’s total dosage of cladribine ranges from 100–140 mg in the two-month treatment period. Ex. 1005 ¶ 104. The issue, as presented by Petitioner, is that the ’903 patent claims simply use a different way of reciting a total dose of cladribine administered during the treatment phase when compared to the methods and dosage taught by Bodor. We agree with Petitioner that the method and cladribine dosage in the ’903 patent claims overlap with the method and dosage taught by Bodor. To determine the total amount of cladribine administered as claimed in the ’903 patent requires knowledge of the weight of the patient. In the Petition, Petitioner relied on a patient weighing 70 kilograms (≈ 154 pounds) to be an acceptable average human weight as understood in the medical community. Pet. 32 (citing Ex. 1005 ¶ 105). Patients, however, come in all shapes and sizes as recognized in the ’903 patent disclosure and further supported by Dr. Greenberg’s testimony and referenced exhibit. See Ex. 1001, 3:8 (“patients of about 52 and about 75 kilos); see also Ex. 1005 ¶ 106 (“the average weight of individuals in the United States is higher than the global average, with an overall average weight (men and women combined) of roughly 177 lbs in 2002.”); Ex. 1030 (“the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age increased from 140.2 pounds in 1960 to 164.3 pounds in 2002.”). To arrive at the average weight of 177 pounds means that there are patients in the population that are above and below that average. See generally Ex. 1030.” slip op. at 6

    § 103 obviousnessDiscretionary denial
    Patents in suitUS 8,377,903
  • PTAB · Dec 20, 2023 · IPR2023-00049 · APJ Ulrike W Jenks · IPR · Rehearing

    The Board granted rehearing and instituted IPR on claims 36, 38, 39, and 41–48 on all petition grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review 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 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 3

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

      “Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating multiple sclerosis by administering cladribine to a patient in the same claimed total amount for both the induction period and maintenance period to support Petitioner’s challenge to claim 36.” slip op. at 4

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

      “To summarize, Bodor teaches two treatment regimens for treating multiple sclerosis with a cladribine-cyclodextrin complex. 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex . . . would be administered [orally] once per day for a period of five to seven days in the first month, repeated for another period of five to seven days in the second month, followed by ten months of no treatment. Alternatively the patient would be treated with 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex in the instant dosage form once per day for a period of five to seven days per month for a total of six months, followed by eighteen months of no treatment. Ex. 1029, 13:20–30. Petitioner acknowledges that Bodor does not explicitly suggest applying the same regimen again after a cladribine-free period but finds that repeating the treatment protocol is reasonably inferred. Pet. 33 (citing Ex. 1005 ¶¶ 109, 111–113), see id. at 48 (citing Ex. 1005 ¶¶ 168–170); Ex. 1029, 18:45–19:3, 20:1–20 (Examples 4 and 5 each describing that treatment days are separated by cladribine-free days); Ex. 1003 at 389; Ex. 1004 at 141. Bodor also teaches that the dosing regimen can be tailored to suit the needs of the patient. Specifically, Bodor teaches that “one of skill will appreciate that the therapeutically effective amount of cladribine administered . . . may be lowered or increased by fine tuning and/or by administering cladribine . . . with another active ingredient.” Ex. 1029, 13:31–35, see also id. 13:37–40 (“Therapeutically effective amounts may be easily determined . . . empirically by starting at relatively low amounts and by step-wise increasing with concurrent evaluation of beneficial effect.”). Based on these disclosures, we agree with Petitioner that it would be reasonable to infer from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated. Pet. 33; see also Ex. 1005 ¶¶ 109–123, 119 (“common practice in the industry when prescribing a second round of an” slip op. at 4

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

      “(1) [determining] 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 [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 9

    § 103 obviousnessDiscretionary denial
    Patents in suitUS 7,713,947
  • PTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing

    On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3

    § 112 disclosure
    Patents in suitUS 10,993,942
  • PTAB · Feb 14, 2023 · PGR2021-00030 · APJ Christopher M Kaiser · PGR · Rehearing

    The Board granted Petitioner’s third rehearing request and instituted PGR of claims 1–5, 9, and 10, finding the petition presented compelling evidence of unpatentability.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “The Guidance Memo defines “[c]ompelling, meritorious challenges” as “those in which the evidence, if unrebutted in trial, would plainly lead to a conclusion that one or more claims are unpatentable by a preponderance of the evidence.” Guidance Memo 4. The phrase “plainly lead to a conclusion that one or more claims are unpatentable” was further clarified in the Director’s precedential decision in OpenSky Industries, LLC v. VLSI Technology, LLC, as only satisfied when “it is highly likely that the petitioner would prevail with respect to at least one challenged claim.” IPR2021-01064, Paper 102 at 49–50 (PTAB Oct. 3, 2022) (Decision by the Director) (precedential). Thus, a compelling challenge is one “in which the 8 evidence, if unrebutted in trial, would” render it “highly likely that the petitioner would” show “that one or more claims are unpatentable by a preponderance of the evidence.” Id.; Guidance Memo 4.” slip op. at 8

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

      “one claim is unpatentable and that one of Petitioner’s challenges presents strong merits—are sufficient to show that the likelihood of Petitioner’s success at trial falls within the uncertain bounds of “highly likely.”5 Accordingly, we determine that the Petition “presents compelling evidence of unpatentability” as that phrase is defined in the Guidance Memo and the OpenSky decision. For this reason, we erred by “discretionarily deny[ing] institution in view of [the] parallel district court [proceeding].” Guidance Memo 2. We grant Petitioner’s request for rehearing and do not exercise discretion to deny institution. We acknowledge that instituting review in this proceeding when the district court already has reached its result requires the parties to duplicate the efforts they have put into the district court proceeding and requires us to duplicate the efforts of the district court and its jury. We are not insensitive to the fact that such a situation “can increase, rather than limit, litigation costs,” contrary to what “Congress designed the America Invents Act (AIA) 5 Our determination that Petitioner is “highly likely” to succeed in proving at least one claim unpatentable on at least one ground should not be understood to mean that we have prejudged the outcome of the trial. In particular, under OpenSky and the Guidance Memo, a compelling challenge is one “in which the evidence, if unrebutted in trial, would” render it “highly likely that the petitioner would” show “that one or more claims are unpatentable by a preponderance of the evidence.” OpenSky, IPR2021-01064, Paper 102 at 49–50; Guidance Memo 4. Thus, in making our compelling-challenge determination, we are not permitted to consider any rebuttal evidence that has been entered, let alone any rebuttal evidence that may be entered during the trial. Our final determination will not be so limited and will be made based upon the full arguments and evidence developed during the trial. 11 post-grant proceedings” to accomplish. Guidance Memo 1. But the Guidance Memo is unequivocal: “the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Id. at 2. In the absence of such discretionary denial, we institute trial for the reasons discussed in the Institution Decision. Inst. Dec. 16–41.” slip op. at 11

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

      “likely” one, are not entirely clear, and this case likely falls somewhere near that boundary. We note first that the standard for instituting trial in a post-grant review requires a showing that “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.” 35 U.S.C. § 324(a). We previously held that this standard had been met in the present case. Inst. Dec. 3. In particular, we determined that Petitioner had made the necessary “threshold showing” as to its arguments that (1) “the claimed subject matter [was] not enabled for the full scope as claimed,” and (2) “Ogitani anticipates at least one of the challenged claims.” Id. at 26, 40. Moreover, “[w]e previously described ‘Petitioner’s argument that the claims lack enablement’ as presenting ‘strong merits.’” Second Denial Dec. 6 (quoting Inst. Dec. 3). slip op. at 9

    Discretionary denial
    Patents in suitUS 10,808,039
  • PTAB · Jul 15, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing

    Patent Owner’s rehearing request was granted, and institution was denied for all challenged claims based on changed circumstances in the parallel district court proceeding under Fintiv.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that a rehearing of our prior institution decision is appropriate due to the changed circumstances of: (1) the statutory disclaimer of claims 6–8 of the ’039 patent, (2) Patent Owner’s request for adverse judgment of related proceeding PGR2021-00042, and (3) the additional investment in the parallel proceeding by the district court and the parties, including the completion of a jury trial that resulted in a jury verdict not finding invalidity of the challenged claims. We further agree with Patent Owner that “[c]ontinuing with this proceeding would result in duplicative efforts and potentially conflicting results between the district court and the Board.” Reh’g Req. 9. It is the combination of these changed circumstances, rather than any one of them individually, that compels the result we reach.” slip op. at 7

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

      “In considering the parties’ positions and the evidence of record, we note that we have been instructed not to exercise discretion to deny a petition when “the information presented at the institution stage presents a compelling unpatentability challenge.” Guidance Memo 4–5. We previously described “Petitioner’s argument that the claims lack enablement” as presenting “strong merits.” Paper 17, 3. Despite that determination, we believe the record as it stands currently does not “present[] a compelling unpatentability challenge” on the lack-of-enablement issue. Guidance Memo 4–5. The district court already has substantially completed its review of the enablement issue, and a jury has determined that the claims do not lack enablement. Given this new information, we cannot conclude that Petitioner’s enablement case is compelling.” slip op. at 6

    • Adverse judgmentOther
    Discretionary denial
    Patents in suitUS 10,808,039
  • PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing

    The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

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

      “35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,808,039
  • 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 · Nov 10, 2020 · PGR2018-00092 · APJ Sheridan K Snedden · PGR · Rehearing

    The Board granted the petitioner’s rehearing request, vacated the final written decision, and will issue a revised decision after overlooking Varenna 2012 in Grounds 5–7.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must (1) “specifically identify all matters the party believes the Board misapprehended or overlooked” and (2) identify the place “where each matter was previously addressed.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768.” slip op. at 2

    None
    Patents in suitUS 9,820,999
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