- CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentablePTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision
The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“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 and cancer biology, which would encompass the blood cancers recited by Patent Owner. 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))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. 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 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed
“We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16
Patent outcomesUS 10,993,942 mixedClaim construction§ 112 disclosurePatents in suitUS 10,993,942 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00044 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner
“Petitioner contends that based on Patent Owner’s implicit construction in the district court litigation “that the term ‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 15 (citing Ex. 1020 ¶¶ 41, 50, 58, 62, 74, 87).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 37
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Neither claim 1 nor claim 14 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG. Petitioner’s articulated rationale is that there was an expectation that the composition binds antibodies, including monoclonal antibodies, and therefore, would be useful in a process of for isolating antibodies. Petitioner contends that: A POSA would have also reasonably expected such a combination to achieve a process for isolating one or more target compounds using the recited affinity chromatography matrix given the well-known fact that each individual SPA domain, including the C domain, has affinity for antibodies (Ex. 1004, [1]) as well as Abrahmsén’s confirmation that a G29A mutation on SPA “would not interfere with folding [of SPA] or binding to [antibodies]” (Ex. 1005, 5:13-16). (Ex. 1002 ¶131.) Pet. 25; Reply 8 (“‘A POSA would not have been motivated only by Fab-binding ability, as even Dr. Bracewell agreed that ‘a POSA would have understood that it was desirable to purify monoclonal antibodies for therapeutic use in 2006.’(Ex. 1057, 75:17-76:4, 113:23-114:11, 157:24- 158:9; Ex. 1061 ¶29)”). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976); see In re Kemps, 97 F.3d 1427, 1430” slip op. at 44
Patent outcomesUS 10,343,142 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,343,142 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00041 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two Domain C units, or a functional fragments or variants thereof.” Ex. 1001, 7:27–30. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. 7: 44–45. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’142 patent’s express construction of the term, and because Patent Owner agrees with Petitioner’s construction, we apply it here.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 37
- Obviousness (§103) › KSR rationalesUnpatentable
“Here, the teachings of Linhult, Abrahmsén, and Hober suggest mutating the glycine at position 29 for an alanine in any one of the IgG binding domains of E, D, A, B, or C of SPA in order to avoid protein degradation. Ex. 1004, 2; Ex. 1005, 5:4–9. We, therefore, agree with Petitioner that the art expressly suggests that the glycine codon can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). Attaching any one of SPA mutated IgG binding domains E D A B or C to a matrix using “known ligand-construction methods to yield a predictable result[] (e.g., the claimed affinity chromatography matrix)” would have been obvious. Pet. 25 (citing Ex. 1002 ¶ 130). As the Federal Circuit has explained, “[w]here a skilled artisan merely pursues ‘known options’ from ‘a finite number of identified, predictable solutions,’ the resulting invention is obvious under Section 103.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). Accordingly, we agree with Petitioner that the combination of Linhult Abrahmsén, and Hober expressly suggests mutating the glycine codon for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). We also agree that the cited art teaches using these mutant SPA domains in column chromatography for the isolation of antibodies.” slip op. at 36
Patent outcomesUS 10,343,142 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,343,142 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00045 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because the art did not establish expected Fab binding.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“support, the ligand capable of binding the one or more target compound(s) and comprising at least two polypeptides.” Ex. 1001, 15:46–49; 17:28–31. Petitioner argues that “‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 19–20 (citing Ex. 1002 ¶¶ 43–45). Petitioner argues that this construction is consistent with Patent Owner’s implicit construction in the Delaware litigation between the parties. Id. Patent Owner does not challenge Petitioner’s claim construction. See generally PO Resp. According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“(c) No Teaching Away We are also not persuaded by Patent Owner’s contention that the art teaches away from the G29A substitution because it interferes with Fab binding. See PO Resp. 39–42; Sur-reply 9; Ex. 2009 at 2; Ex. 2010 at 25; Ex. 2012 at 25–26; Ex. 2029 at 7. None of claims 1, 2, or 20 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG.” slip op. at 44
Patent outcomesUS 10,875,007 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,875,007 - JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentablePTAB · May 18, 2023 · IPR2022-00042 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because Fab binding was not predictable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision. Having considered the parties’ positions and evidence of record, we determine that the express construction of any other claim term is unnecessary to resolve the disputed issues in this matter. 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))). 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 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 38
Patent outcomesUS 10,875,007 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,875,007 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCSome claims unpatentablePTAB · Apr 24, 2023 · IPR2022-00193 · APJ John G New · IPR · Final written decision
Claims 1–8, 10–18, and 20 are unpatentable as obvious over Spenser and Spenser II; claims 9 and 19 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Spenser II provides that its cloth “has a thickness ranging from about 1 to 5 mm.” Spenser and Levi both teach a valve that has a diameter of 25 mm and 26 mm respectively when fully expanded. Accordingly, even if we were to assume a POSITA used the thinnest possible cloth in Spenser II, Petitioner’s proposed combination using the smaller Spenser 25 mm diameter (12.5 mm radius) expanded valve covered by a 1 mm cloth resulting in a 27 mm diameter (13.5 mm radius) valve…. From this we can conservatively estimate how much cloth is required for a cross-section of the proposed device (Acloth) by calculating the total area of a cross-section of the cloth-covered valve (π*(13.5 mm)2) and subtracting the area of a cross-section of just the valve (π*(12.5 mm)2). Acloth = π*(13.5 mm)2 - π*(12.5 mm)2 = 81.68 mm2 Accordingly, Petitioner’s proposed combination requires 81.68 mm2 of outer cloth in a given cross-section of the device.” slip op. at 78
- Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia no nexusDecided for petitioner
“that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16
- Expert testimonyPetitioner expert creditedDecided for petitioner
“that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16
Patent outcomesUS 10,881,538 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,881,538 - Tide International (USA), Inc. v. Upl Na Inc.Some claims unpatentablePTAB · Jan 4, 2022 · IPR2020-01113 · APJ Michael A Valek · IPR · Final written decision
Claims 1–4 are unpatentable as obvious over Misselbrook, CN ’588, and JP ’902; claims 7–12 were not shown unpatentable because the grounds did not establish motivation to add a disintegrating agent.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“relevant to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may also reflect an appropriate level of skill. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner
“We also adopt the parties’ position that the preamble of claims 1 and 7 is not limiting beyond the term “granule.” Claims 1 and 7 each recite “[a] chemically stable dry flow, low compact, dust free soluble phosphoramidothioate granule consisting of” the set of ingredients recited in body of those claims. Ex. 1001, 7:44–45, 8:19–20. While the wherein clause describing the dimensions of “said granule” relies on “granule” in the preamble for antecedent basis, none of the other preamble language appears to be necessary to breathe life and meaning into the claim, and the claim body recites a structurally complete invention. See Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (explaining that a preamble is limiting if it is “necessary to give live, meaning, and vitality to the claim,” but “is not limiting where a patentee defines a structurally complete invention in the claim body”) (internal quotations omitted). Thus, we agree with the parties, and the district court in the related litigation, that the preamble language other than “granule” is not limiting.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Moreover, we agree that the transitional phrase “consisting of” in claims 1 and 7 creates a “very strong presumption that the claim element is ‘closed’ and therefore exclude[s] any elements, steps, or ingredients not specified in the claim.” Pet. 5; Resp. 12 (both quoting Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)). Neither party seeks to overcome that presumption, nor do we see any basis for doing so based on the record before us. Accordingly, we construe the challenged claims to be limited to granule compositions containing only those ingredients recited in the claims. There are no other terms that need to be construed to resolve the issues presented in this proceeding. Therefore, we do not construe any additional terms. See, e.g., Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“demonstrating that the “general conditions” regarding the use of these ingredients in such compositions was known. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (noting that any overlap between the claimed and disclosed ranges serves to disclose the “general conditions” of the claim). “Such overlap itself provides sufficient motivation to optimize the ranges.” Id. Moreover, we credit Mr. Geigle’s testimony that a POSITA would have understood because the concentration of acephate was increased the concentration of the other ingredients would necessarily decrease and that a POSITA would have been able optimize these amounts using standard techniques and testing. Ex. 1003 ¶¶ 85–113. Thus, Petitioner has demonstrated that these ingredient concentrations are result-effective variables that would have been obvious to optimize through routine experimentation.” slip op. at 24
Patent outcomesUS 7,473,685 mixedClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,473,685
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.