• US Conec Ltd. v. Senko Advanced Components, Inc.Rehearing granted
  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
• Infineon Technologies AG v. Amatech Group LimitedRehearing granted
  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
• Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing granted
  PTAB · Feb 5, 2024 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Rehearing

  Rehearing was granted and IPR instituted on claims 1–28 because the petition showed a reasonable likelihood that claim 1 was obvious over Linnarsson, McCloskey, and ordinary skill.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can provide a distinction based on a ‘polynucleotide sequence.’” Req. 6 (quoting Dec. 14 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we erroneously determined that the proposed modification could not achieve the claim language, stating the following: Petitioner’s proposal appears to defeat satisfaction of another portion of claim 1, namely a “second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.” Ex. 1001, 30:62–64. For if the second tag is “added to the CDS or TSO after extension,” as opposed to the sample polynucleotide, as Petitioner argues (Pet. 39 (emphasis added)), it would appear that the second tag would be incapable of distinguishing any sample polynucleotide from other sample polynucleotides. Rather, the second tag would be ligated to each and every extension product bearing a CDS or TSO without regard to the sequence of any sample polynucleotide. Dec. 16. We now reconsider whether to institute.” slip op. at 2

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

    “Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis. 2. Advanced Bionics Part Two Patent Owner argues that the Petition “fails to show any error in the Examiner’s application during prosecution of the prior art teachings Petitioner now purports to invoke from . . . McCloskey.” Prelim Resp. 23; see also id. at 24–25 (“Revisiting the same art and arguments already overcome during prosecution is a waste of the Board’s limited resources and would unfairly burden PO.”). However, Petitioner argued that “the Examiner committed major error in Examination by erroneously stating that the prior art fails to teach a dual tagging approach when, in fact, this approach is plainly taught in both McCloskey and McCloskey II.” Pet. 67. The record supports Petitioner’s position, and we agree that the error was material to patentability. See Ex. 1005, 131 (Notice of Allowance). Accordingly, and having considered all of the Becton, Dickinson factors, we do not exercise discretionary denial.” slip op. at 12

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

    “We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey with the knowledge of a person of ordinary skill in the art to obtain the claimed subject matter. 8. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 21

  • Obviousness (§103) › Analogous artNot reached

    “the three references is analogous art to the ’013 patent as opposed to each other. Prelim. Resp. 46 (citing Pet. 35; Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi- Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’013 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 10,697,013
• Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing granted
  PTAB · Feb 5, 2024 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Rehearing

  Rehearing granted and IPR instituted on claims 1–26; the Board found a reasonable likelihood that claim 1 would have been obvious over Linnarsson and McCloskey.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can ‘provide a distinction based on a polynucleotide’s sequence.’” Req. 6 (quoting Dec. 15 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we denied the Petition because “adding a second tag sequence to Linnarsson’s CDS and/or TSO would do nothing to achieve such a distinction,” i.e., “a distinction based on a polynucleotide’s sequence.” Id. at 15. That was error. We now reconsider whether to institute.” slip op. at 2

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

    “the ’197 patent. See Ex. 1001, code (56) (listing McCloskey II under “References Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis.” slip op. at 11

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

    “We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey to obtain the claimed subject matter. 6. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 18

  • Obviousness (§103) › Analogous artNot reached

    “GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi-Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’197 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 10,240,197
• Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing granted
  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
• Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing granted
  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
• Incyte Corporation v. Concert Pharmaceuticals, Inc.Rehearing granted
  PTAB · Apr 9, 2018 · IPR2017-01256 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted Incyte’s rehearing request and instituted review of claims 1–15 on Ground 3, finding it had applied overly restrictive standards for lead compound analysis and combining references.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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. When rehearing a decision on a petition, 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 an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3

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

    “Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3

  None
  Patents in suitUS 9,249,149
• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Rehearing

  Patent Owner’s rehearing request was granted as to the Pinchasi–Flechter combination analysis; rehearing was denied on the remaining issues, and a modified final written decision was entered.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 6 (citing Dec. 29). Upon review of the Decision, we agree that the analysis in the cited portion of our Decision does not conflate efficacy with tolerability. See Final Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.C.5 of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

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

    “As explained above, we were not persuaded that the prior art suggested decreased tolerability. Indeed, in light of the prior art references each stating that the dosage regimens were well tolerated, we were persuaded that a person of ordinary skill in the art would have had a reason to combine the cited references to reach the claimed dosing regimen with a reasonable expectation of success.” slip op. at 7

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,969,302
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter motivation issue, denied rehearing on the remaining issues, vacated the prior Final Written Decision, and entered a modified decision concurrently.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “§ 42.71 (d), which requires the party requesting rehearing to “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.”” slip op. at 2

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

    “Patent Owner first asserts that we “misconstrued data in Flechter illustrating that alternate day dosing was as effective as daily dosing and found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 32). Upon review of the Decision, we agree. See Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.F of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient” slip op. at 8

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “Dr. Ziemssen, however, qualifies this comparison and explains that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination, retracting reliance on Flechter’s efficacy data, and denied rehearing on the remaining issues.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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.” slip op. at 2

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

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with Flechter’s alternateday dosing schedule would conclude that such a regimen would likely exacerbate the frequency of injection site reactions, as Patent Owner asserts. See PO Resp. 36.” slip op. at 4

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data, Patent Owner and its declarant, Dr. Tjalf Ziemssen, M.D., Ph.D., compare Flechter’s data reporting adverse events in its patients with Meiner’s data reporting adverse events in a different cohort of patients. PO Resp. 35–36; Ex. 2135 ¶ 89. From that comparison, Patent Owner argues that Flechter’s data allegedly teaches that alternate-day administration is less tolerable than daily administration. Reh’g Req. 8.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  § 103 obviousness
  Patents in suitUS 8,969,302

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.