- Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2018-00187 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board found proposed substitute claims 48 and 49 unpatentable as obvious over GSK-711, Merck-086, and Hausdorff, and denied the motion to amend as to those claims.
RulingsRemand decision- RemandOther
“I. INTRODUCTION This case was remanded to the Board by the United States Court of Appeals for the Federal Circuit with instructions that we address the patentability of Patent Owner’s proposed substitute claims 48 and 49 to U.S. Patent No. 9,492,559 B2 (Ex. 1001, “the ’559 patent”). Pfizer Inc. v. Sanofi Pasteur Inc., 94 F.4th 1341 (Fed. Cir. 2024); see Paper 15 (Patent Owner’s Motion to Amend, “Mot. Amend.”). The Court stated that: we affirm in toto the Board’s decision at issue in Appeals 2019- 1875 and 2019-1876. We further affirm the Board’s decisions at issue in Appeals 2019-1871, 2019-1873, and 2019-2224 as to claims 1–45 and proposed substitute claims 46, 47, and 50–52. Claims 1–45 are therefore unpatentable. But we vacate the Board’s denials of Pfizer’s motions to amend in those decisions as to proposed substitute claims 48 and 49 and remand for further proceedings consistent with this opinion. Pfizer, 94 F.4th at 1354.3 We therefore limit our analysis to proposed substitute claims 48 and 49 (the “Challenged Claims”) of the ’559 patent. For the reasons discussed herein, we determine that Petitioner has shown, by a preponderance of the evidence, that the Challenged Claims are unpatentable. 3 The same issues on remand in IPR2018-00187 remain for IPR2017-02131 and IPR2017-02132, and all three of these pending cases are addressed together in both the Federal Circuit’s Decision from which these proceedings are remanded, and in this consolidated Final Decision, because the issues presented are substantively identical. See Pfizer, 94 F.4th 1341, 1350–54. We generally cite to the record of the IPR2018-00187 proceeding, as it is representative, and will specifically note when we cite to the record in either of the IPR2017-02131 or IPR2017-02132 proceedings.” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“V. CONCLUSION We conclude on remand that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 48 and 49 are unpatentable as obvious over the combination of GSK-711, Merck-086, and Hausdorff, in view of the knowledge of the ordinary artisan. Motion to Amend Outcome19 Claim(s) Original Claims Cancelled by Amendment Substitute Claims Proposed in the Amendment 48, 49 Substitute Claims: Motion to Amend Granted Substitute Claims: Motion to Amend Denied 48, 49” slip op. at 33
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In that regard, an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. In KSR, the Supreme Court also stated that an invention may be found obvious if trying a course of conduct would have been obvious to a person having ordinary skill: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103. Id. at 421. “KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless ‘the improvement is more than the predictable use of prior art elements according to their established have an M.S. degree and at least 4 years of relevant experience.” Pet. 26 (citing Ex. 1005 ¶ 77). Patent Owner “does not dispute Sanofi’s proposed level of skill for the person having ordinary skill in the art.” PO Response 8. We agree with the parties regarding the level of ordinary skill in the art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). 13 Neither Petitioner nor Patent Owner presents evidence on the fourth Graham factor.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02131 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend proposed substitute claims 48 and 49, finding them obvious over GSK-711, Merck-086, and Hausdorff in view of ordinary skill.
RulingsRemand decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“of success in obtaining a 2-log increase, we find Table 3 of Hausdorff shows that a composition with thirteen of the fourteen serotypes that were required by proposed substitute claim 46, conjugated with CRM197, produced an immune response with more than a 2-log increase above baseline serum IgG levels in New Zealand White Rabbits after administration of the two equal doses with or without the aluminum salt adjuvant. Ex. 2027 ¶ 231, Table 3. Thus, we find there would have been a reasonable expectation of success in the inclusion of serotypes 22F, 33F, 8, 10A, 11A, 12F, and 15B in Hausdorff’s pneumococcal vaccine composition while retaining the 2-log increased immune response of the thirteen serotypes and also retaining a 2- log increase in the immune response to the added serotypes. We note that Patent Owner does not identify any particularized evidence drawn to the seven serotypes recited in the challenged claims showing any expected difference in the behavior of these serotypes from the fourteen serotypes already included in the Hausdorff composition.” slip op. at 26
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Sanofi Pasteur Inc. / SK Chemicals Co., Ltd. et al. v. Pfizer Inc.All claims unpatentablePTAB · Jun 10, 2024 · IPR2017-02132 · APJ Jeffrey N Fredman · IPR · Remand
On remand, the Board denied the motion to amend because proposed substitute claims 48 and 49 were obvious over GSK-711, Merck-086, and Hausdorff.
RulingsRemand decision- RemandOther
“in which it: (1) affirmed our Final Written Decisions to the extent that claims 1–45 of the ’559 patent and proposed substitute claims 46, 47, and 50–52 were found unpatentable and (2) vacated our Final Written Decisions as to proposed substitute claims 48 and 49 of the ’559 patent and remanded for further proceedings consistent with its decision. Pfizer, 94 F.4th at 1354. The Federal Circuit determined that we abused our discretion because “[i]t does not appear that the Board considered whether, once incorporated, it would have been reasonably expected that the compositions exhibit the claimed 2-log IgG increase across all serotypes5 recited in proposed claims 48 and 49.” Id. at 1353. The Federal Circuit explained that it “is hornbook law that administrative agencies must provide a ‘reasoned basis’ for their actions that is sufficient to permit meaningful judicial review.” Id. The Federal Circuit therefore remanded for the Board to address whether the record provided sufficient evidence to support an obviousness finding for the 2-log IgG increase required by proposed substitute claims 48 and 49 of the ’559 patent. Id. at 1352–53. On May 15, 2024, we conducted a conference call with the parties where the parties agreed that no further briefing or evidence was necessary to address the remand. Paper 83.” slip op. at 4
- Skill levelSkill level board ownDecided for petitioner
“12 Petitioner states that the person of ordinary skill in the art at the time of the invention “would have had a Ph.D. or equivalent degree in chemistry, immunology, or other biological sciences or an MD and at least 2 years of experience in glycoconjugate vaccine research and development, or would objective indicia of obviousness or non-obviousness.13 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“II. ANALYSIS A. Claim Interpretation As discussed in the Final Written Decision, and left undisturbed by the Federal Circuit Decision, upon review of the parties’ arguments and the evidence before us, we maintain our conclusion that the claim term “immunogenic,” as it is used in the ’559 patent and recited by proposed substitute claims 46, 48, and 49, requires that a functional antibody be elicited against each immunogen contained in the respective composition. Paper 61, 7–9. Consequently, for proposed substitute claims 48 and 49, the term “immunogenic” requires that functional antibodies be elicited against each immunogen specifically recited and required.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“(1) Prior Art Teaches the Disputed Claim Limitation We agree with Petitioner that the asserted prior art teaches the claim limitations. We find Merck-086 teaches “a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197.” Ex. 1008 ¶ 2; see also 02131 Ex. 1006, 1:7–11. That is, Merck-086 teaches a multivalent composition that lacks one of the capsular polysaccharides required by proposed substitute claim 48, i.e., serotype 15B, and that lacks the capsular polysaccharides of serotypes 12F, 10A, 11A, and 8 required by proposed substitute claim 49. We find GSK-711 teaches “the multivalent pneumococcal vaccine of the invention will be selected from the following serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15[B], 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.” Ex. 1007, 7:1–3; see also 02131 Ex. 1007, 8:29–31. GSK 2008 also teaches conjugation of polysaccharides to the carrier protein CRM197. See Ex. 1007, 10:4–6; see also 02131 Ex. 1007, 10:12–15.” slip op. at 23
Patent outcomesUS 9,492,559 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,492,559 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. 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)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Mar 13, 2024 · IPR2023-01347 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claim 16 on both asserted obviousness grounds, finding a reasonable likelihood that Petitioner would show the claim unpatentable.
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 in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that claim 16 of the ’344 patent is unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Based on the preliminary record, we are persuaded by Petitioner’s contention that claim 16 does not comply with the written description requirement for the reasons set forth in the Petition (Pet. 11–17), summarized above. More specifically, on the current record, we do not recognize the ’344 patent to disclose a representative number of API, solvent and co-former combinations having the necessary recited features. We do not understand the ’344 patent to disclose structural features common to the recited solvents and co-formers such that a POSA could “visualize or recognize” the members of the claimed genus. Ariad, 598 F.3d at 1350. We recognize that a POSA’s perspective is key to the written description inquiry and many factors may inform the adequacy of a specification’s disclosure, including existing knowledge in the field and the content of the prior art. See Ariad, 598 F.3d at 1351. On the current record, however, we do not find evidence that a POSA would have considered the recited mechanisms to form supramolecular synthons via non-covalent hydrogen bonding by pairing solvents and co-formers having certain functionalities a concept that was well-known in the art. effective filing date for claim 16 is February 13, 2014, the filing date of the ’344 patent.2” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner contends that a POSA would have been motivated to combine Ueto with Li, Martindale, Zaworotko, and Remington “to improve physicochemical properties of the co-crystal components.” Id. at 49. In particular, furosemide was known as of 2014 to have low water solubility (Ex. 1506, Martindale at 1421; Ex. 1503, Appel ¶ 58; Ex. 1502, Rogers ¶¶ 232–34, 236), and water solubility, along with bioavailability, were properties that co-crystals had the potential to improve. Ex. 1507, Ueto at 485; Ex. 1503, Appel ¶ 59; Ex. 1502, Rogers ¶¶ 234, 236. As such, a POSA would have been motivated to pursue studies with the Ueto co-crystals, including the furosemide/nicotinamide/water co-crystal. Pet. 49. In view of the foregoing, we determine that Petitioner has established a reasonable likelihood of showing that the combination of Ueto, Li, Martindale, Zaworotko, and Remington renders obvious claim 16 for the purposes of our preliminary findings. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing. Accordingly, we institute a inter partes review of claim 16 of the ’344 patent.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner proposes constructions for the terms “active pharmaceutical ingredient (API)”, “API homosynthons”, “carbonyl”, “carboxamide”, “co-former”, and “supramolecular synthon.” Pet. 9–10. According to Petitioner, “[t]he parties agree that co-former is used synonymously with cocrystal former and that a co-former is a component of a co-crystal.” Id. at 9. Petitioner represents that the proposed constructions have been agreed to between the parties in parallel litigation, or agreed upon such that “the disputed portions are not relevant to [the] issues raised in this Petition.” Id. at 8. We have reviewed each of these constructions and adopt Petitioner’s proposed construction for the purposes of this Decision. Petitioner’s construction aligns with the plain words of the claim, is consistent with the prosecution history of the ’344 patent, and finds support in the uncontroverted testimony of Dr. Rogers. Ex. 1502 ¶¶ 52–63; Ex. 1516, 256–58, 261–63. Petitioner construes the term “co-crystal” to mean “a multiple- component, single crystalline phase, having a fixed stoichiometry of its component compounds.” Id. at 10. Petitioner states that the proposed construction of the term “co-crystal” is “currently disputed in parallel litigation between the parties; however, because claim 16 is unpatentable under Patent Owners’ constructions, Petitioner adopts those constructions solely for the purpose of this Petition.” Id. at 8–9. We adopt Petitioner’s proposed construction of “co-crystal” for the purposes of this Decision. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Mar 13, 2024 · IPR2023-01346 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 10, 11, and 18 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“priority to the filing date of a prior application only “for an invention disclosed [in the prior application] in the manner provided by” 35 U.S.C. § 112. This requires that the earlier application provides written description support for the invention claimed by the later application. See Paice LLC v. Ford Motor Co., 881 F.3d 894, 906 (Fed. Cir. 2018); PowerOasis, Inc. v. T- Mobile USA, Inc., 522 F.3d 1299, 1306–11 (Fed. Cir. 2008); Augustine Medical, Inc. v. Gaymar Indus., Inc., 181 F.3d 1291, 1302–03 (Fed. Cir. 1999). The test for sufficiency of a written description under 35 U.S.C. § 112, ¶ 1, is whether the earlier application’s disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description “test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. As articulated in Ariad, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350 (citations omitted). One test of whether a claimed genus finds adequate support involves identifying in the specification “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (citing Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997)).” slip op. at 6
- 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 in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’344 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“To anticipate a claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). 2 We note that Petitioner additionally challenges the Priority Applications for lack of enablement. Having found that the ’344 patent lacks written description support for all Challenged Claims, however, we need not address Petitioner’s enablement challenge in order to decide whether to institute. one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Because Petitioner’s presently unopposed definition is consistent with the ’344 patent and the prior art of record, we adopt that definition in deciding whether to institute trial. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 15
§ 102 anticipation§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - Xinial Systems GmbH & Co. KG v. Medmix Switzerland AGAll claims unpatentablePTAB · Feb 21, 2024 · IPR2022-01462 · APJ Jeffrey N Fredman · IPR · Final written decision
Claims 1–3, 9–13, 16, and 17 are unpatentable as obvious over the listed combinations of Keller ’574, Yu, and Heusser.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“VII. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“VIII. CLAIM CONSTRUCTION We interpret claim terms using “the same claim construction standard” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness.9 Graham, 383 U.S. at 17–18. The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 16
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Decided for patent owner
“Demonstratives are not evidence. See PTAB Consolidated Trial Practice Guide, 84 (Nov. 2019) (“Demonstrative exhibits used at the final hearing are aids to oral argument and not evidence . . . .”). In this Final Written Decision, we rely on the arguments properly presented in the parties’ briefs and the evidence of record, not on the demonstratives. Therefore, we overrule Patent Owner’s objections as being moot.” slip op. at 88
Patent outcomesUS 9,010,578 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,010,578 - PTAB · Feb 5, 2024 · IPR2023-01251 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all asserted grounds challenging claims 1–12, 14–28, and 30, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION For the foregoing reasons, we determine that the information presented establishes a reasonable likelihood that Petitioner would prevail in showing that at least one of the challenged claims of the ’056 patent is unpatentable. At this preliminary stage, we have not made a final determination regarding the patentability of any challenged claim or any underlying factual and legal issues. See TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) (noting that “there is a significant difference between a petitioner’s burden to establish a ‘reasonable likelihood of success’ at institution, and actually proving invalidity by a preponderance of the evidence at trial”). Any final decision in this proceeding will be based on the full trial record.” slip op. at 48
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 13 (citing Ex. 1008 (Gross Decl.) ¶ 51). Patent Owner indicates that it does not dispute this portion of Petitioner’s proposal. See Prelim. Resp. 24. Petitioner also posits that “[t]he POSITA may be part of an interdisciplinary team with others having relevant experience and/or with clinicians involved in diagnosis, treatment, and patient management relevant to the use of medical devices for monitoring physiological signals” and “would have been aware of commercially available glucose monitoring systems (e.g., the Medtronic Paradigm® REAL-Time) through scientific journals and magazines,” “would have known the importance of data reliability to glucose monitoring, including anticipating that errors (e.g., communication or calibration failures) would result in missing or inaccurate glucose data,” and would have accounted for missing data using technical concepts known at the time, including programming glucose monitoring systems to detect failures that result in data being unavailable for display (e.g., due to a calibration error or loss of communication), preserving this data in memory, regenerating it once the system recovered, and displaying regenerated data. Pet. 13–14 (citing Ex. 1008 (Gross Decl.) ¶¶ 52, 54–61). Patent Owner does not specifically comment on or dispute this portion of Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s full proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. 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 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes that any claim term requires an express construction. See Pet. 14; Prelim. Resp. 24. We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We determine that Petitioner’s proffered reason to combine is sufficient for purposes of institution. Petitioner does not merely rely on the fact that Patel-2008, Mastrototaro, Shahmirian, and Causey are from same field of study or address the same problem. Instead, Petitioner points to Patel-2008’s express discussion of the utility of Mastrototaro, Shahmirian, and Causey’s teachings, together with the fact that all of the references apparently discuss different components of the same system (i.e., the Medtronic MiniMed continuous glucose monitoring system). See, e.g., Pet. 83–84; Ex. 1008 (Gross Decl.) ¶¶ 55, 70–71. On this record, we find for purposes of institution that Dr. Gross sufficiently establishes that “POSITAs would have been motivated to combine the sensor and transmitter of Mastrototaro, the communications of Shahmirian, and the monitor control programs of Causey to effectuate a diabetes management system with the monitoring, communication, and display functionalities disclosed in Patel-2008,” and “to convey as much accurate glucose information to a user as possible without providing inaccurate information.” Ex. 1008 (Gross Decl.) ¶¶ 190–93. Patent Owner’s argument that “nothing in Patel-2008 teaches or suggests incorporating these disparate teachings into a single system” (Prelim. Resp. 47–48) is unavailing. First, as noted above, Patel-2008 expressly teaches using in its system components described in Mastrototaro, Shahmirian, and Causey. Second, even if Patent Owner were correct that Patel-2008 lacks a teaching or suggestion to incorporate Mastrototaro, Shahmirian, and Causey’s teachings into Patel-2008’s system, Patel-2008 itself need not express a reason to combine. Rather, “[a]ny motivation to combine references, whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient to combine those references to arrive at the claimed [invention].” Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d 1364, 1370–71 (Fed. Cir. 2017). As noted above, we find that Petitioner’s rationales are sufficiently supported by Dr. Gross and the cited references for purposes of institution.” slip op. at 43
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,298,056 - Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitutedPTAB · Jan 17, 2024 · IPR2023-01045 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 5–9, 15, and 16 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Parallel petitionsInstitutedInstituted
“Upon consideration of the specific circumstances under which Petitioner filed two petitions, we decline to exercise our discretion to deny institution in this proceeding. We agree with Petitioner that a large number of claims have been asserted against it in district court and that addressing those 34 claims may necessitate filing two separate petitions.2 See TPG at 59 (“[T]he Board recognizes that there may be circumstances in which more than one petition may be necessary, including, for example, when the patent owner has asserted a large number of claims in litigation.”) The fact that the same claims are not challenged between the two petitions weighs in favor of declining to exercise our discretion to deny institution. See Gen. Plastic Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 16–17 (PTAB 2 We recognize that Patent Owner has now disclaimed claim 4 and 10–14, however, that disclaimer was entered after the filing date of the Petition. Ex. 2010. dismissed one petition or the other, some claims of the [’288] patent would be left uncovered by any ground alleged by Petitioner.” Marvell Semiconductor, Inc. v. Uniloc 2017 LLC, IPR2019-01349, Paper 9 at 14 (PTAB Feb. 4, 2020) (instituting review); Paper 2, 2.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION Petitioner has, at this stage, established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. See In re NuVasive, 842 F.3d 1376, 1380–81(Fed. Cir. 2016) (noting in the context of an inter partes review that “there is a significant difference between a petitioner’s burden to establish a ‘reasonable likelihood of success’ at institution, and actually proving invalidity by a preponderance of the evidence at trial”) (quoting 35 U.S.C. § 314(a) and comparing § 316(e)).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed at least a B.S. in biology, chemistry, chemical engineering, biochemistry, biophysics, pharmaceutical science, or a related discipline, with two or more years of industry, laboratory, and/or clinical experience in analyzing or characterizing biomolecules, including viruses or viral vectors. Such a person may be familiar with, or consult with someone familiar with, the development, formulation, and/or administration of viral vectors for gene therapy and quality Pet. 17 (citing Ex. 1020 ¶ 58). We do not find a proposal by Patent Owner for a different level of skill in the preliminary response. See PO Resp. generally. For this Decision, we adopt and apply Petitioner’s proposal for the person of ordinary skill in the art level, which appears to be consistent with the level of skill reflected in the’288 patent and the asserted prior art.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In particular, we are persuaded on the current record by the testimony of Dr. Berkowitz that “Le Bec teaches a method for characterizing a viral preparation of rAAV particles that can analytically separate, detect, and quantify the presence of empty capsids, full capsids, and aggregates based on sedimentation coefficients.” Ex. 1020 ¶ 72 (citing Ex. 1003, 16:25–29; 15:17–23; 18:1–6). Here, we note that Le Bec teaches that the “distribution profile of the species allows the identification of two categories of populations,” which include species identified as 60S, 90S, and 105S, for example. Ex. 1003, 18:11–27; see also Figs. 2 and 3. We have considered Patent Owner’s arguments and the testimony of Dr. Hansen, and are not persuaded on the current record to deny institution. Prelim. Resp. 31–45; Ex. 2001 ¶¶ 96–113. For example, we recognize Patent Owner’s contention that Petitioner “fails to identify where Le Bec discloses integrating and determining the area of specific peaks in its species, for example at 77S and 90S.” Prelim Resp. 33 (citing Ex. 2001 ¶ 104; see also id. at 33 (The “Petition is understandably silent on Le Bec’s lack of disclosure of concentrations for each peak in its C(s) distributions that correlate to, for example, partial or fragmented genomes.”). We recognize also Dr. Hansen’s testimony that, even accepting Petitioner’s argument that the SEDFIT software was available and could have been used to “calculate[] relative concentrations by integrating the area under the peaks of a sedimentation coefficient distribution profile,” “the POSA would not have considered Le Bec to have provided any indication that the area under each peak was determined nor that the area under each peak was converted to concentrations by applying the extinction coefficients for the rAAV species corresponding to each peak.” Ex. 2001 ¶ 97 (citing Ex. 1020 ¶ 83; Pet. 27); see also id. at ¶ 100 (“Neither the Petition nor the Berkowitz Declaration address Le Bec’s omissions of concentration values for each peak in its C(s) distributions in Figures 2 and 3”). Having considered that information presented by Patent Owner, however, we determine that the information presented by Patent Owner creates genuine issues of material fact about whether a person of ordinary skill in the art would have interpreted Le Bec to disclose “integrating the area under each peak in the C(s) distribution to determine the relative concentration of each peak, wherein each peak represents a species of recombinant AAV particle.”5 See 5 We note also that, while the parties’ dispute centers on whether Le Bec discloses “integrating the area under each peak,” as required by the claims, neither party has offered a claim construction of that phrase. We understand that phrase to refer to a known standard technique for determining relative concentrations in a sample by calculating the area under the curve. Here, we credit the testimony of Dr. Berkowitz that “the SEDFIT software referenced [Patent Owner’s] testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.”). Those issues may be further briefed and developed during trial, and the parties are encouraged to do so.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,429,288 - Daiichi Sankyo, Inc. / Astrazeneca Pharmaceuticals, LP v. Seagen Inc.All claims unpatentablePTAB · Jan 16, 2024 · PGR2021-00030 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–5, 9, and 10 are unpatentable for lack of written description, lack of enablement, indefiniteness, and anticipation by Ogitani.
RulingsFinal written decision- Skill levelSkill level board ownOther
“respective definitions for the level of ordinary skill in the art. While there seems to be a slight difference in whether the ordinary artisan has ADC design experience obtained after a master’s degree or postdoctoral, neither party provides clear basis to explain how this will impact the analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“III. CLAIM CONSTRUCTION We interpret claim terms using “the same claim construction standard” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“4. Analysis We note that “[i]t is not sufficient for purposes of the written” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“4. Analysis The facts here are consistent with the situation in Amgen, which” slip op. at 76
Patent outcomesUS 10,808,039 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites Phillips · NautilusPatents in suitUS 10,808,039
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.