- PTAB · Oct 6, 2025 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of unpatentability based on the asserted obviousness and anticipation challenges.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8).” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“In sum, Petitioners bear the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioners’ assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioners’ decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem-Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11–12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,668,430 - PTAB · Oct 6, 2025 · IPR2025-00422 · APJ Zhenyu Yang · IPR · Institution
Instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of prevailing on the asserted anticipation and obviousness challenges.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot time barredDecided for petitioner
“Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 8–9).” slip op. at 12
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. See 35 U.S.C. § 316(e); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that a patent challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). Here, because Petitioners initially show Downs-Boiler qualifies as prior art on its face, Patent Owner bears the subsequent procedural burden to produce evidence antedating the reference. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015); Magnum Oil, 829 F.3d at 1375. Although the burden of production can be a shifting burden, the burden of persuasion is on Petitioners to ultimately prove “unpatentability by a preponderance of the evidence,” and that this burden never shifts to Patent Owner. Dynamic Drinkware, 800 F.3d at 1378.” slip op. at 37
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioners assert that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,668,430 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,926,859 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · Sep 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSA at the time of the alleged invention would have 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; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner
“The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 9,358,286 - PTAB · Sep 9, 2025 · PGR2025-00023 · APJ Michael J Fitzpatrick · PGR · Institution
Instituted PGR on claims 1–9 because the Board found it more likely than not that at least one challenged claim is unpatentable over the ’629 publication.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of a post-grant review requires that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable” or that “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” 35 U.S.C. § 324(a)–(b). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Accordingly, we grant the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“III. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends a person of ordinary skill in the art (“POSITA”) would have a Ph.D. degree in biological, chemical or biochemical engineering, molecular biology, or biochemistry and at least two years of experience in the field of utilizing or assessing horseshoe crab zymogen proteins (lysate, purified native and/or recombinantly produced) for endotoxin detection and quantitation. More education could substitute for experience to a certain extent, and vice versa. Pet. 22 (citing Ex. 1003 ¶¶48–49). Patent Owner does not dispute Petitioner’s description of a POSITA in its Preliminary Response. Prelim. Resp. 10. 1 In addition to other changes to Title 35, the AIA introduced amendments to 35 U.S.C. § 102. Because Patent Owner concedes that the ’725 application “contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013” (Ex. 1022), the AIA version of § 102 applies to the ’109 patent. AIA § 3(n)(1)(B); Ex. 1001, 1:11–14 (claiming priority to the ’725 application). 2 US 2019/0241629 A1, published August 8, 2019 (“the ’629 publication” (Ex. 1015)). At this stage, we find Petitioner’s description of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23; Prelim. Resp. 10. We determine that no express claim construction is necessary based on the present record.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“To show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23– 24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in which a POSA would have understood the prior art, or what a POSA would have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [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.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description.” slip op. at 12
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - PTAB · Sep 9, 2025 · IPR2025-00440 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claim 21 on both asserted § 103 grounds, finding a reasonable likelihood that claim 21 is obvious over Mizumura with the ’498 PCT and over Mizumura with McClymont.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claim of the ’318 patent is unpatentable. Accordingly, we institute an inter partes review of the challenged claim on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Nevertheless, we determine that the contrary evidence Petitioner has cited suffices to establish a reasonable likelihood of success at this preliminary stage of the proceeding. In this regard, we also note Dr. Jain’s testimony — currently unrebutted — that an ordinarily skilled artisan would have known, based on Tokunaga’s sequence comparisons of Factor C proteins, that “certain sequence differences between [Limulus polyphemus] and Tachypleus tridentatus were non-conservative (i.e., potentially giving rise to changes in function in terms of enzymatic activity of Factor C).” Ex. 1002 ¶ 94 (citing Ex. 1022, 157). We likewise note Dr. Jain’s testimony that such artisan would have recognized Tokunaga’s conclusion, regarding “immunological and biochemical properties” of Factor C proteins of the two different horseshoe crab species, to be “based on only gross biophysical-biochemical properties” that are not “granular enough” to predict functional properties such as residual activity in presence of specific ions. Ex. 1002 ¶ 100.” slip op. at 22
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledOther
“submitted in a different proceeding and in a different forum, and our rules contemplate objections to admissibility only after institution. See 37 C.F.R. § 42.64(b)(1) (“Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial.”); also compare Fed. R. Evid. 801(c) (defining hearsay as a statement, not made at the current trial or hearing, “offer[ed] in evidence to prove the truth of the matter asserted”), with Fed. R. Evid. 801(d)(2) (excluding from hearsay statement offered against an opposing party where statement was made by “a person whom the party authorized to make a statement on the subject” or by a “party’s agent or employee on a matter within the scope of that relationship and while it existed”). Nevertheless, as discussed above, Petitioner has provided contrary evidence, including statements from Patent Owner’s patent application, suggesting that, “due to the various differences and diversity of biomolecules depending on the genus and species of the horseshoe crab,” it had not been possible “to accurately determine the full-length sequence structure, expression, and function of [Limulus] proteins and genes using conventional methods” more than 20 years after complete gene and amino sequences from two Tachypleus horseshoe crab species had been reported. Pet. 35 (citing, e.g., Ex. 1005 ¶¶ 12–17). Thus, even if we were to take the Frohman Declaration into account, we find that Petitioner has established a reasonable likelihood 28 of success that the ’767 application disclosures did not enable an ordinarily skilled artisan to make and use the invention of the challenged claim without undue experimentation. Furthermore, assuming that the disclosures in ’767 application would have enabled an ordinarily skilled artisan to express recombinant Limulus polyphemus Factor C protein in HEK293, we find Petitioner has established, sufficient for purposes of institution, that the disclosures do not enable an ordinarily skilled artisan to make such a protein exhibiting the “full scope” of the claimed residual activity, without undue experimentation. Patent Owner cites to disclosures in the ’767 application that (1) describe how to produce recombinant Factor C in HEK293 cells and measure residual activity, (2) suggest “Factor C expressed in mammalian cells can have low susceptibility to activity inhibition by ions,” and (3) provide examples where residual activity met the required minimum. Prelim. Resp. 26–27, 32–34. Nevertheless, whether an ordinarily skilled artisan would have been able to make, based on these disclosures and without undue experimentation, a recombinant Factor C protein having residual activity encompassed by claim 21 but higher — even significantly higher — than that achieved in the example, is a fact intensive issue that would benefit from further development during trial.15 See, e.g., In re” slip op. at 28
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’767 application does not provide adequate written description support for claim 21 of the ’318 patent and that, accordingly, Mizumura, the ’498 PCT, and McClymont qualify as prior art to the challenged claim.” slip op. at 19
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,236,318 - Lifevac, LLC v. Dcstar Inc.Institution deniedPTAB · Sep 8, 2025 · IPR2025-00454 · APJ Cynthia M Hardman · IPR · Institution
The Board denied institution on claims 1–17 because Petitioner did not show a reasonable likelihood that Zhongnan qualifies as prior art under the § 102(b)(1)(B) exception.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 8
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner
“provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) (patent, printed publication, public use, sale, or other means of public availability) is excepted as prior art if: (1) the disclosure was made one year or less before the effective filing date of the claimed invention; and (2) the subject matter disclosed had been previously publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor. MPEP § 2153.02 (9th ed. rev. 01.2024 Nov. 2024); see also Sanho, 108 F.4th at 1381. As to point (1), there is no dispute that Zhongnan was published one year or less before the effective filing date of the challenged claims. See, e.g., Ex. 1005, code (43); Pet. 11, 20; Prelim. Resp. 9–10. Thus, we focus on point (2), which requires that IDEAR be previously publicly disclosed by the inventor, and that Zhongnan and IDEAR disclose the same subject matter.” slip op. at 10
- BurdenDecided for patent owner
“Our rules require that in determining whether to institute inter partes review, we “take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence.” 37 C.F.R. § 42.108(c) (emphasis added); Prelim. Sur-reply 3. As Patent Owner correctly notes, “the Board routinely weighs declaratory testimony at the institution[] stage and virtually always makes institution decisions without the benefit of cross-examination.” Prelim. Resp. 19–20 (emphasis omitted) (citing LG Elecs. Inc. v. Wi-LAN Inc., IPR2018-00704, Paper 14 at 13–14 (PTAB 2018); Freebit AS v. Bose Corp., IPR2017-01308, Paper 8 at 28 (PTAB 2017)). For example, in LG Electronics and Freebit, the Board denied institution, finding that the patent owner had provided sufficient evidence to antedate the petitioners’ proffered prior art references. See LG Elecs., IPR2018-00704, Paper 14 at 7; Freebit, IPR2017-01308, Paper 8 at 25, 34.10” slip op. at 23
§ 102 anticipationPatents in suitUS 11,478,575 - 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 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.InstitutedPTAB · Aug 14, 2025 · IPR2025-00505 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–15 on all grounds, finding a reasonable likelihood that the claims would have been shown obvious over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“However, Patent Owner has not shown that circumstances exist that would require dismissal of the proceeding as barred under § 315(b) if the unnamed party were added as a real party in interest. Patent Owner has also not alleged any discovery abuse at this time. We determine that we need not address whether Cipla is an unnamed RPI at this stage. The parties may further address this issue during the trial portion of the proceedings. As the Board explained in SharkNinja, it “better serves the interest of cost and efficiency” when the Board does not engage in the “extensive analysis” required to determine whether a party is an unnamed RPI if the result of that analysis has no material impact on the proceeding. SharkNinja v. iRobot Corp., IPR2020-00734, Paper 11 at 19–20 (PTAB Oct. 6, 2020) (precedential). Here, it is undisputed that Petitioner could have named Cipla as an RPI in its Petition without triggering a statutory bar or estoppel under 35 U.S.C. § 315.” slip op. at 5
- Skill levelSkill level petitioner adoptedOther
“Patent Owner states it disagrees with Petitioner’s “definition of a POSA but assumes their definition for purposes of the arguments presented herein.” Prelim. Resp. 6. At this stage in the proceeding, we find that Petitioner’s analysis reasonably establishes a level of ordinary skill in the art as it directly relates to those deciding treatments based on the prior art references. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See, e.g., Ex. 1003, 1817, author list. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“Thus, the ’552 patent teaches that patients may or may not receive some therapeutic benefit from the treatment and also recognizes that any therapeutic benefit may result in prolonging life, but not necessarily result in complete remission of the pancreatic tumor. This understanding is consistent with Dr. Ratain’s testimony that “[t]reating a patient is always with the attempt or intent to cause a therapeutic improvement of the patient, which, in the case of metastatic pancreatic cancer, could be reduced tumor growth or increased overall survival in the patient.” Ex. 1002 ¶ 50. We are unpersuaded, however, by Dr. Ratain’s statement equating “treatment with a saline control” with the claimed “treating metastatic adenocarcinoma,” because the claim is addressing a disease condition whereas the example in Figure 6A is clearly providing a control, without any expectation of therapeutic benefit. See id. ¶ 55. We are not persuaded, on this record, that because Patent Owner did not include the phrase “therapeutically effective amount” in the claims, the claims solely relate to “administering” the antineoplastic therapies without any resulting therapeutic benefit. Rather, on this record, we agree with Patent Owner 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. To the extent that Patent Owner’s position would require some” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“While we are aware that hindsight bias may plague determinations of obviousness, Graham, 383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. The evidence of record shows the prior art provides specific reasons to replace irinotecan with liposomal irinotecan in the treatment of pancreatic cancer, including improved sustained release, local bioactivation, increased efficacy, and reduced side effects. Ex. 1006, 9; Ex. 1008, 921; Ex. 1002 ¶¶ 91, 238, 239. These specific reasons, as supported by Dr. Ratain, provide specific support for the obviousness of modifying the Conroy Protocol for patients with toxicity to substitute a 60 mg/m2 dose of liposomal irinotecan for irinotecan, particularly in patients with the particular UGT1A1 allele identified by Bayever. Ex. 1006, 3.” slip op. at 37
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,344,552 - Qiagen Sciences, LLC v. Tecan Genomics, Inc.Adverse judgmentPTAB · Aug 12, 2025 · IPR2025-00027 · APJ Deborah Katz · IPR · Adverse judgment
The Board granted the parties’ joint motion for adverse judgment against Patent Owner after it disclaimed the entire patent term, and terminated the instituted inter partes review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“17.) Previously, on July 11, 2025, Patent Owner filed a disclaimer disclaiming the entire term of the ’241 patent. (See Ex. 2020.) Because there is no term left for any claim of the ’241 patent, we determine it is appropriate to terminate the inter partes review and enter judgment against Patent Owner. ORDER Accordingly, it is: ORDERED that the parties’ joint motion for adverse judgment is granted; and” slip op. at 2
NonePatents in suitUS 11,725,241
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.