- Samsung Bioepis Co., Ltd. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.Adverse judgmentPTAB · Jul 23, 2024 · IPR2024-00298 · APJ Ryan H Flax · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–30 after it disclaimed every challenged claim, terminating 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.” 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 · 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 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - 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
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.