- PTAB · Dec 8, 2023 · IPR2023-00933 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claim 1 under all four asserted grounds, finding a reasonable likelihood that the claim is anticipated or obvious.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The two proposed definitions of the ordinarily skilled artisan are very similar, except that Patent Owner’s description more-specifically defines the field of experience of the artisan. At this stage in the proceedings, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, as being both generally unopposed by Patent Owner and inclusive of Patent Owner’s supplemental definition. It appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” includes Patent Owner’s proposed level of experience. Pet. 12–13. We also take into account the level of skill in the art reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Our decision whether to institute does not turn on which party’s definition of the skilled artisan is used, and our determinations would be unchanged if we applied Patent Owner’s supplemented definition. Further, we note that evidence may be presented as the case progresses to support some other proposed definition of the skilled artisan, which may influence our determination of this issue. C.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“CLAIM CONSTRUCTION Petitioner states, “Petitioner does not believe claim construction is necessary at this time.” Pet. 15. Patent Owner does not mention claim construction at this stage of the proceeding. See generally Prelim. Resp. At this stage in the proceedings, and for the purposes of this decision, we find it unnecessary to construe the language of claim 1 because the claim language is readily understandable on its face and there is no dispute. 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))). As the case continues, we may determine that certain claim language should be interpreted. D.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In view of the unique record before us, we agree with Patent Owner that all of the references relied on by Petitioner here, “were previously presented to the Office” as required by § 325(d) and Advanced Bionics. Prelim. Resp. 19. Accordingly, we proceed to part two of the analysis.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied discretionary otherDenied
“DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a) AND FINTIV Patent Owner points to § 314(a) as a basis for denying institution, but provides no substantive argument or evidence on this point. See Prelim. Resp. 17–32; see generally Prelim. Sur-Reply 6. Under certain circumstances, the Board may apply our discretion under 35 U.S.C. § 314(a) to deny institution in light of a parallel district court proceeding involving the same patent. See, e.g., Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential). But, as noted by Petitioner, the patent at issue here “has never been asserted in any litigation.” Pet. 49. Accordingly, we also decline to exercise our discretion under Section 314(a) to deny institution.” slip op. at 61
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,732,149 - PTAB · Dec 1, 2023 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Remand
The Board granted PGR of claims 1–19, finding claim 1 more likely than not anticipated by Grigoriadis and claims 1–19 more likely than not lacking written-description support.
RulingsRemand decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Patent Owner Preliminary Response, and the cited evidence in light of the Director’s Decision, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“Independent claim 1 recites a method of treating CAH by reducing an A4 level “from baseline” after administering a CRF1 receptor antagonist to a CAH patient. See Ex. 1001, 47:51–48:5. The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, 41:55–59. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’201 patent. See Ex. 1037, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.5 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced from baseline” as meaning “a reduction in A4 level compared to an A4 level measurement made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,007,201 - PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166 - PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - Celltrion, Inc. v. Chugai Seiyaku Kabushiki Kaisha, Genentech, Inc., And Hoffmann-La Roche Inc.All claims unpatentablePTAB · Aug 29, 2023 · IPR2022-00579 · APJ John G New · IPR · Final written decision
Claims 1–8 are unpatentable as obvious over NCT ’653, Kivitz, and Morichika; NCT ’653 alone does not anticipate claims 1 or 5.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“We are not persuaded that a person of ordinary skill in the art could be thought of as a “team of individuals.” We find no support in Sankyo for Patent Owner’s contention that “a person of ordinary skill in the art can have the knowledge and experience of multiple individuals working across different arts.” See PO Resp. 8. Rather, in Sankyo, the Federal Circuit looked to the qualifications of the inventors of the patent at issue, all of whom were specialists in drug and ear treatments and noted that others working in the same field as the inventors were of the same skill level. Sankyo, 501 F.3d at 1257. Finding that such specialty training was a 9 requisite for ordinary skill in the art, the court defined the level of ordinary skill in the art in that case as “a person engaged in developing pharmaceutical formulations and treatment methods for the ear or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.” Id. We conclude that there is, as Petitioner acknowledges, little substantial difference between the qualifications of the “team” proposed by the parties, and those of the individual skilled artisan defined in our Decision to Institute. Such an individual would have had not only several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis, but would additionally have access to individuals skilled in clinical medicine, pharmacokinetics and formulation. Indeed, Petitioner’s expert, Dr. Shah, acknowledges that an individual person of skill in the art “would have had access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Ex. 1032 ¶ 27. This is consistent with our prior definition. We consequently adopt, for this Final Written Decision, the definition of a person of ordinary skill in the art as defined in our Decision to Institute and quoted above because it appears consistent with the problems addressed in the ’677 Patent and the prior art of record. See Dec. 6. Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Regardless of the level of skill adopted, our analysis and findings would remain the same.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Fixed dose” Petitioner asserts that the claim term “fixed dose” is defined in the Specification as “a dosage of a drug, such as an anti-IL-6R antibody which is administered without regard to the patient’s weight or body surface area (BSE), i.e., it is not administered as either a mg/kg or mg/m2 dose.” Pet. 27 (quoting Ex. 1001, col. 15, ll. 15–18). Patent Owner does not dispute this definition. PO Resp. 9 n.9. Because the term “fixed dose” is defined by the 11 Specification and is not disputed by the parties, we determine, based on the current record, that this term requires no further construction. slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“natural reading of this claim language shows a functional limitation that simply requires that the claimed subcutaneous administration device be capable of containing and delivering to a patient a fixed dose of the drug. As such, we conclude that this functional language is limiting upon the claim. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363 (1999) (holding that functional language is limiting upon an apparatus claim). We decline to adopt, however, Patent Owner’s construction of a patient as being a person “with an IL-6-mediated disorder” or requiring the claimed device to “safely and effectively deliver that amount of drug subcutaneously to a patient” and to accommodate the risk of serious immunogenic reactions due to aggregation and viscosity[,] … as well as the obstacles of aggregation instability, injection difficulties, and patient discomfort.” See PO Resp. 12. To adopt these definitions is to impermissibly extend the scope of the claims through claim construction beyond the language of the claims, which do not recite this language. To require that the patient be in need of treatment for an IL-6 mediated disease, as suggested by Patent Owner, is to place an additional limitation on the device that is not functional, but rather relates to the nature of the individual receiving the subcutaneous administration. To the contrary, we interpret this functional language as requiring the claimed device to be capable of delivering the contained dosage to any “patient” whether or not they have a specific medical condition or without respect to ancillary conditions or concerns that may apply. If the device is capable of delivering the dosage subcutaneously to any patient, that is 15 sufficient for this functional limitation, and we decline to import additional limitations into the claim, as Patent Owner urges us to do. We therefore construe the claim phrase “delivers to a patient” as a functional limitation of the claims that requires that the claimed device be capable of subcutaneously delivering the dose contained within it to a person.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable
“device, which contains and delivers to a patient a 162 mg fixed dose” of tocilizumab within the four corners of NCT ’653, we next inquire whether NCT ’653 inherently discloses the claimed device. A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”). There can be little logical doubt that NCT ’653 necessarily teaches “a subcutaneous administration device” for the simple reason that the reference teaches that randomized subjects receive “tocilizumab 162 mg [subcutaneously]” and a person of ordinary skill in the art would have understood that a suitable device is required to do this. But the claims also 27 require that the subcutaneous administration device also “contains and delivers to a patient a 162 mg fixed dose of tocilizumab.” Petitioner contends that a person of ordinary skill in the art would have understood that the “subcutaneous administration device” used in the study contained and delivered a 162 mg fixed dose of tocilizumab to the patient. Pet. 31. We are not persuaded, however, that an ordinarily skilled artisan would understand that NCT ’653 necessarily discloses that the subcutaneous administration device was one capable of containing and delivering 162 mg of tocilizumab. Certainly, it would be logical for a person of ordinary skill in the art to assume that a device used to administer the dose was capable of delivering the whole dose in a single administered injection. But the reference does not rule out the possibility that another method could be used, e.g., two injections, each from a device capable of containing and delivering a dose only of 81 mg. Such an administration, though perhaps unlikely, is not categorically excluded by the disclosures of NCT ’653. As such, we conclude that NCT ’653 does not inherently disclose “a subcutaneous administration device, which contains and delivers to a patient a 162 mg fixed dose” of tocilizumab because it does not disclose that the subcutaneous administration device[s] necessarily “contains and delivers” the 162 mg fixed dose. Because we find that NCT ’653 neither expressly not inherently discloses all of the limitations of claims 1 and 5, we conclude that the reference does not anticipate independent claims 1 and 5. Consequently, 28 Petitioner has failed to meet its burden of showing, by a preponderance of the evidence, that claims 1 and 5 are unpatentable under 35 U.S.C. § 102.” slip op. at 27
Patent outcomesUS 10,874,677 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,874,677 - Celltrion, Inc. v. Chugai Seiyaku Kabushiki Kaisha, Genentech, Inc., And Hoffmann-La Roche Inc.All claims unpatentablePTAB · Aug 29, 2023 · IPR2022-00578 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–12 are unpatentable: claims 1–3 and 6–11 are anticipated by NCT ’653, and claims 4, 5, and 12 are obvious over combinations including NCT ’653.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“of individuals” is not conventional. Dec. Inst. 8. We therefore found a POSA “would have been an individual with an M.D. specializing in the treatment of autoimmune disorders and having several years of experience treating patients with such disorders, including rheumatoid arthritis, or having several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis.” Id. We also clarified that such a POSA “may alternatively (or also) have a Ph.D. and would have access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Id. Patent Owner agrees with Petitioner’s definition and notes that a POSA according to our definition from the Institution Decision “would be unable to develop [the claimed inventions] without assistance from other individuals.” PO Resp. 7–8 (citing Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256–57 (Fed. Cir. 2007). Patent Owner, however, fails to consider the full scope of our definition. Specifically, Patent Owner does not account for the clarification that a POSA “would have access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Dec. Inst. 8. When considering our complete definition, we do not discern a substantive difference between our definition and the parties’ definition of a POSA. Petitioner appears to agree. Pet. Reply. 1 n.1 (“The challenged claims are unpatentable no matter which definition of a POSA is used.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“Here, the Specification reveals that “per dose” does not mean “per injection.” Indeed, the Specification treats those terms differently. For example, in describing “the invention,” the Specification repeatedly follows “per dose” with an exemplary parenthetical or clause specifying the frequency of administration. For example, the Specification states that “the invention concerns a method of treating an IL-6-mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose (e.g. administered every week or every two weeks).” See Ex. 1001, 4:33–38 (emphasis added); see also id. at 5:4–8 (stating “[t]he invention also concerns a method of treating an IL-6-mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 324 mg per dose or 648 mg per dose (e.g. every four weeks or once every month)”) (emphasis added); 24:54–59 (stating “the invention provides a method of treating an IL-6 mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose (e.g. every week, every two weeks, or every ten days)”) (emphasis added). Thus, the Specification repeatedly interprets the term “per dose” to describe the frequency of the dose, and not the number of injections to administer the dose. In contrast, when specifying a single injection, the Specification uses the terms “per injection” or a “single dose.” For example, the Specification states, “[a]vailable subcutaneous formulation is in a 1 mL prefilled syringe delivering 0.9 mL 162 mg TCZ per injection.” Id. at 49:55–56 (emphasis dose of 0.9 mL corresponding to a dose of TCZ 162 mg TCZ”) (emphasis added). Thus, although the Specification makes clear when a single injection is used by stating “per injection” or “single dose,” the ’264 Patent does not use either of those terms in the claims.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). Where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., treating rheumatoid arthritis), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. Moreover, as Patent Owner notes, the preamble provides antecedent basis for terms in the body of the claims. That is, the preamble recites “treating rheumatoid arthritis (RA) in a patient” and the claims recite “administering to the patient” (claims 1 and 10), “the RA patient” (claims 3– 5), and “administering to the RA patient one or more additional drug which treats the RA” (claim 6). Thus, considering the claims as a whole and the invention described in the patent, we determine the preamble of the claims to be limiting. See Eli Lilly, 8 F.4th at 1343 (finding preamble limiting where it provides antecedent basis for terms in the body of the claims). slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for patent owner
“benefit.” Ex. 2009 ¶ 54. Patent Owner and Dr. Silverman, however, ignore the other half of the Specification’s definition of “treatment,” which states: “‘Treatment’ of a subject herein refers to both therapeutic treatment and prophylactic or preventative measures.” See Ex. 1001, 15:1–2 (emphasis added). Thus, limiting the definition of “treatment” to mean only “therapeutic treatment,” as Patent Owner asserts, is inconsistent with the express definition in the Specification and, therefore, incorrect on its face. See Phillips, 415 F.3d at 1316 (stating “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). Moreover, the Specification defines the term “effective amount” as “an amount of the antibody that is effective for treating the IL-6 disorder.” Id. at 15:3–4. If “treatment” of the IL-6 disorder required efficacy, it would not be necessary for the Specification to define an “effective amount” for treating the disorder separately, as efficacy would be implicit in the term “treatment.” Consistent with this, the Specification defines certain subjects as “inadequate responder[s]” to various medications because they have experienced “an inadequate response to previous or current treatment . . . because of toxicity or inadequate efficacy.” Id. at 14:46–61 (emphasis added). Thus, the Specification uses the term “treatment” to encompass treating a patient with a certain medication, regardless of safety or efficacy.” slip op. at 19
Patent outcomesUS 8,580,264 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,580,264 - PTAB · Aug 8, 2023 · IPR2023-00546 · APJ Robert A Pollock · IPR · Institution
Instituted IPR on claims 1–5, 9–11, 13, 18, 19, and 28–30; Petitioner showed a reasonable likelihood of unpatentability under each asserted Ley and Newman anticipation and obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1061 ¶ 37) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 9. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’611 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art. C. Claim Construction” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, step (a) in the body of claim 1 entails obtaining sequence data from at least one biological sample from a subject. In step (b) the sequence data is used in to identify a set of genetic variants present in the biological sample. Step (c) entails creating a probe set corresponding to identified genetic variants. In step (d) the probe set is used to selectively enrich or amplify those variants if present in a second biological sample from the same or related individual, and thereby create a sequencing library. This library is sequenced in step (e) to identify the presence or absence of at least a subset of the genetic variants identified in step (b). As such, steps (a) through (e) define a complete invention, with the preamble merely stating a 4 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“nucleic acid probe molecules” Claim step 1(c) recites “obtaining a probe set comprising a plurality of nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’611 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 17–18 (citing Ex. 1061 ¶ 98; Ex. 1001, 4:54–55, 5:16–18, 6:64–67). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity. slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,450,611 - PTAB · Aug 8, 2023 · IPR2023-00545 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–9, 13–19, and 21–29 on all three grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’783 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”). C. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . 3) an understanding of clinical applications of sequencing technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1020 ¶¶ 35) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 11. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’783 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, steps (a) through (c) in the body of claim 1 require the use of “a personalized probe set” to identify the presence or absence of genetic variants in a subject, whereupon this information is used to generate a report in step (d). We presently read the body of claim 1 to define a 7 Pointing to isolated passages in the Specification, Patent Owner further contends that, “methods that existed at the time of invention were specific to a particular disease or cancer rather than personalized to a specific subject’s family genetics,” whereas the claimed method “is directed to personalized genetic testing and is ‘better focused on the personal characteristics of the subject.’” Prelim. Resp. 20–21 (citing Ex. 1001, 4:37–47, 31:27–28). We find this argument confusing, as we do not presently read the challenged claims as limited to a “subject’s family genetics.” 8 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. complete invention, with the preamble merely stating a purpose or intended use, or, in another sense, simply the result of carrying out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2) “nucleic acid probe molecules” Claim 1 recites the use of “nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’783 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 15 (citing Ex. 1020 ¶ 95; Ex. 1001, 4:60–61, 5:23–25, 7:5–8, 7:25–26). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,299,783 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is 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 itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310
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.