- Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2024-00260 · APJ Ryan H Flax · IPR · Adverse judgment
Adverse judgment was entered against Patent Owner as to claims 1–30 after it disclaimed all challenged claims, and the proceeding was terminated.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.72, “[t]he Board may terminate a trial without rendering a final written decision, where appropriate . . . .” Further, 37 C.F.R. § 42.73(b)(1) and (2) together state that, “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent [and] [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Thus, in disclaiming every claim in the ’572 patent, Patent Owner has constructively requested adverse judgement. Ex. 3005. We grant Patent Owner’s request. Several exhibits filed in this proceeding were done so under seal as” slip op. at 2
NonePatents in suitUS 11,253,572 - Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2023-00884 · APJ Ryan H Flax · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–30 after their disclaimer and terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.72, “[t]he Board may terminate a trial without rendering a final written decision, where appropriate . . . .” Further, 37 C.F.R. § 42.73(b)(1) and (2) together state that, “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . [d]isclaimer of the involved application or patent [and] [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Thus, in disclaiming every claim in the ’572 patent, Patent Owner has constructively requested adverse judgement. Ex. 3005. We grant Patent Owner’s request. Several exhibits filed in this proceeding were done so under seal as” slip op. at 2
NonePatents in suitUS 11,253,572 - PTAB · Jul 23, 2024 · IPR2024-00669 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–8 and 11, finding a reasonable likelihood of success on at least one claim under the Saadat grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’077 patent’s challenged claims. Also, we decline to deny the Petition on a discretionary basis. Therefore, we institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“As discussed below (Section IV.D), we determine at this stage that Saadat is prior art. There is no argument from Patent Owner that Saadat was presented previously to the Office. Pet. 96 (Petitioner’s unrebutted argument that Saadat was not previously considered by the Examiner). And, beyond the unsuccessful attempt to antedate and, thus, disqualify Saadat as prior art, at this stage of the proceeding Patent Owner offers no argument or evidence to rebut Petitioner’s contention that Saadat anticipates and renders obvious the ’077 patent’s claims under Grounds 1–3. See generally Prelim. Resp. 8–26 (Patent Owner’s priority date arguments). For the above reasons, we find that Patent Owner has not shown that substantially the same prior art or arguments (i.e., Saadat and arguments based thereon) were previously presented to the Office and, thus, Patent Owner has not satisfied step one of Advanced Bionics’ two-step framework. Advanced Bionics, Paper 6 at 8. On this record, even if we accept Patent Owner’s contentions about the Office’s prior consideration of Makower or Fang (art asserted under Grounds 5 and 6), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat—issues we discuss in more detail below.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not propose an alternate definition of the POSA’s qualifications or contest Petitioner’s definition. See generally Prelim. Resp. We apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner similarly does not propose any express claim construction for any of the challenged claims at this time. See generally Prelim. Resp. and based on our review of the record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Realtime Data, 912 F.3d at 1375.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,679,077 - PTAB · Jul 23, 2024 · IPR2024-00280 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 2, 5, 8–10, 12, and 14 on all petitioned grounds after finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“On the record before us, however, we do not discern how the specification of the ’011 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to an apparatus for treatment of a nasal condition by altering nasopharyngeal cells in the target tissue such that nasal congestion is reduced. Ex. 1001, claim 1. As noted by Petitioner, the ’011 patent specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 26–27. Rather, the ’011 patent specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:9–18, 8:6–13, 8:40–62, 21:43– 53.4 In the ’011 patent specification, energy is applied only to achieve cell membrane permeabilization or poration and effectuate the delivery of 4 The Specification describes, for instance, using botulinum toxin to block acetylcholine release from cells in the nasal membranes that are responsible for mucus hypersecretion even without energy-mediated delivery, but describing that use of energy to permeabilize the cells allows for more targeted delivery of the toxin. Ex. 1001, 21:43–53; 2:9–18 (explaining, as background, that acetylcholine is a neurotransmitter, the release of which is blocked by botulinum toxin); see also id. at 8:20–37 (disclosing that the “nasopharynx comprises a cluster of goblet cells which are responsible for mucus secretion and which are susceptible to the disabling mechanism of the botulinum toxin and other neurotoxins” and, further, by controlling the delivery area of the energy and toxin, “only those cells in the nasal membrane that are exposed to both the toxin and the applied energy will preferentially be permeabilized or porated to receive the toxin within the cytoplasm of the cell”). note that the challenged claims do not recite administering neurotoxins, but instead only require supplying energy “to alter nasopharyngeal cells in the target tissue such that nasal congestion is reduced.” Id. at claim 1.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“anticipated by Saadat. Pet. 32. In support of its assertion that Saadat anticipates the challenged claims, Petitioner provides a detailed discussion explaining how each claim limitation of claims 1, 2, 5, 8–10, 12, and 14 is disclosed by Saadat “arranged as in the claims.” Id. at 32–50 (citing Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016)). Petitioner’s contentions are supported by the declaration of Dr. Bu-Saba. Ex. 1002 ¶¶ 88–139. In particular, Petitioner contends that Saadat discloses an RF ablation probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 33–46 (citing Ex. 1002 ¶¶ 88–124). Petitioner also contends that “Saadat explains its RF ablation alters nasopharyngeal cells to reduce or eliminate rhinitis symptoms, including congestion.” Id. at 43–44 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶¶ 117–118). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’011 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4, 2019, from a nonprovisional application filed May 17, 2018. Thus, under 35 U.S.C. § 102(a)(1), Saadat qualifies as prior art to the challenged claims. In view of the foregoing, we determine that Petitioner has established a reasonable likelihood of showing that Saadat anticipates at least one of the challenged claims of the ’011 patent. Accordingly, we institute an inter partes review of claims 1, 2, 5, 8–10, 12, and 14 of the ’011 patent.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Whether a skilled artisan would have been motivated to combine the art’s teachings with a reasonable expectation of success in arriving at the claimed subject matter is a fact-intensive inquiry. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”); Par Pharm., Inc. v. TWi Pharma., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (“The presence or absence of a reasonable expectation of success is also a question of fact.”). Petitioner supports its challenge with evidence-backed reasoning, including the testimony of Dr. Bu-Saba, and Patent Owner’s responsive attorney argument is unavailing at this stage. See, e.g., Ex. 1002 ¶¶ 169–170 (testifying, inter alia, that Makower and Fang both teach applying RF energy to the nasopharyngeal passage to disrupt nerves and treat rhinitis, with Makower detailing an electrosurgical device and uses thereof and Fang elaborating on a therapeutic result that would be expected from use of such a device, thus suggesting the skilled artisan’s consideration of the art’s combined teachings). We will revisit Petitioner’s asserted reasons for combining Makower and Fang as appropriate on a fully-developed record. At this stage, however, Petitioner has put forth sufficient evidence and reasoning to meet its institution burden and proceed to trial, especially as we have already” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Patent Owner argues that we should exercise our discretion under 35 U.S.C. § 325(d) to deny institution because the same or substantially the same prior art or arguments previously were presented to the Office. Prelim. Resp. 27–35. On this record, even if we agreed with Patent Owner’s contentions about the Office’s prior consideration of Makower, Fang, or Edwards (the Ground 4 art), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue as explained above and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat. Discretionary denial of the entire petition is, thus, unjustified.” slip op. at 39
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,894,011 - PTAB · Jul 23, 2024 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3, 7, 9, 10, and 17–25 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–3, 7, 9, 10, and 17–25 of the ’675 patent are unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Specification of the ’675 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to treating a nasal condition comprising “delivering energy to the target tissue” to reduce mucus secretion or congestion. Ex. 1001, claims 1 and 17. As noted by Petitioner, the ’675 patent Specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 24–25. Rather, the ’675 patent Specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:25–34, 8:18–21, 8:38–60, achieve cell membrane permeabilization or poration and effectuate the delivery of neurotoxin into to target cells. See, e.g., id. at 4:49–51, 8:4–21. Here, we note that the challenged claims do not recite administering neurotoxins, but instead only require the delivery of energy to the target tissue to administer therapy.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 30 (citing Ex. 1002 ¶¶ 85–99). Petitioner also contends that “Saadat explains that RF ablation disrupts neural activity to reduce or eliminate rhinitis symptoms, including mucus secretion and congestion.” Id. at 36 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶ 103). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’675 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons discussed above, we determine that the Specification of the ’675 patent fails to provide adequate written description support for the challenged claims, and thus, the challenged claims are entitled to an effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4,” slip op. at 33
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,610,675 - Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Sun Pharmaceutical Industries Ltd. / Sun Pharmaceutical Industries, Inc. v. Novo Nordisk A/SInstitutedPTAB · May 28, 2024 · IPR2024-00107 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Sun’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“The Director set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation or any alleged “behind the scenes” participation by Petitioner such as paying for experts, participating in expert reports or deposition preparation “in connection with any of the stipulated grounds.” See Paper 14, 1. Petitioner has filed such a stipulation. See Ex. 1099. Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the original statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Mylan IPR, Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.9” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Institution deniedPTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,767,366 - PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,672,803 - PTAB · Apr 25, 2024 · IPR2024-00009 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petition grounds, declined discretionary denial, and granted joinder with IPR2023-00724.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Director Vidal set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation. Petitioner has filed such a stipulation. Reply 2 (“Petitioners stipulate that, if instituted, they will not pursue in the parallel district court proceeding the same grounds as in the Petition or any grounds that could have reasonably been raised therein”). Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the current statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.10” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter parties review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462
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.