- 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 - PTAB · Mar 27, 2025 · IPR2024-01451 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1–19 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Larson alone.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“of whether we exercise our discretion to deny institution under 35 U.S.C. § 314(a). Rather, when considering the Fintiv factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv at 6. Here, factors one and six are neutral, factors two and three weigh against discretionary denial, and factors four and five favor denial. We assign less weight to the existence of an overlap in asserted claims and prior art, in view of there being no trial date scheduled in the District Court case and no persuasive evidence that the court’s trial date would be expected to be significantly before the due date of our Final Written Decision. Therefore, after weighing all of the factors, we determine that the facts in this case that weigh against exercising discretion outweigh the facts that favor exercising discretion. Accordingly, we decline to exercise our discretion to deny institution under § 314(a).” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the person of ordinary skill in the art. Prelim. Resp. 27. In view of this, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition for purposes of this Decision. We note, however, that the open-ended language “at least” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We determine that there is no need to expressly construe any claim term to determine whether to institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 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 that any discussion regarding the scope of a claim term is relevant to our decision, we address that issue in our analysis of the asserted grounds of unpatentability.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Owner that Petitioner has not demonstrated sufficiently in the Petition, for purposes of institution, that all of the portions of Saxonov relied upon in the Petition are prior art. In particular, we determine that Petitioner has not established that the disputed portions of Saxonov are entitled to claim the benefit of the ’013 provisional filing date because Petitioner has failed to satisfy the second condition for this benefit, i.e., by showing that the provisional application provides sufficient support for certain subject matter in Saxonov relied upon for prior art purposes in the Petition.” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,827,921 - PTAB · Mar 7, 2025 · IPR2024-01353 · APJ Tawen Chang · IPR · Institution
Instituted IPR of claims 1–20 on all asserted grounds; the Board found a reasonable likelihood of unpatentability over Kanan and Neri, with Famulok for claim 16.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an 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
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On the current record, for purposes of this Decision, we apply Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’848 patent. 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)). We note, 8 “POSA” refers to “person of ordinary skill in the art.” Pet., cover page. experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s definition. C. Claim Construction” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“As an initial matter, two criteria determine whether prior art is analogous: “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). We find that, at this stage of the proceeding, Petitioner has sufficiently shown that Kanan and Neri are and/or are reasonably pertinent to the problem which the inventor is involved, in particular “encoding individual members of a library of chemicals with unique nucleotide sequences that can later be detected and analyzed to determine the identification of the members involved in the interaction.” Pet. 17.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“argument does not undermine Petitioner’s challenge at this stage. In particular, Petitioner has explained that the modification of Kanan with Neri’s self-assembly sequence would “reduce the time to synthesize a library where all members can interact.” Pet. 18 (citing Ex. 1005 ¶¶ 97–101). Similarly, Petitioner has explained the reason for including a “coding region” for each library member, i.e., to “provide a unique nucleic acid identification sequence for each conjugate that can be identified downstream,” as for instance taught by Neri. Id. at 30 (citing Ex. 1005 ¶ 97). Finally, Petitioner has explained “a POSA . . . would . . . add the d-spacer taught in Neri, as this prevents the identification sequence element of pool B members from interacting with the identification sequence element of supports Petitioner’s contentions and that testimony is, at present, substantively unrebutted. On the record before us, and at this preliminary stage of the proceeding, we do not find Petitioner’s asserted motivations to be improperly disparate or based on hindsight. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (explaining that reconstruction of prior art is not improper “so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”). To the extent Patent Owner is also arguing that Petitioner’s assertions regarding reasonable expectation of success are unsupported, Prelim. Resp. 24, the argument is similarly unavailing. Petitioner has pointed to teachings in Neri and the knowledge of an ordinarily skilled artisan to support its assertions. Pet. 21–23 (citing, e.g., Ex. 1005 ¶¶ 104–105, 149, 171, 183 and Ex. 1011 ¶¶ 10, 82 to explain why an ordinarily skilled artisan would have reasonably expected success in applying, to Kanan’s small molecules, Neri’s “method of preparing organic molecules, peptides, and oligomeric proteins linked to an oligonucleotide that results in stable self-assembled associated oligonucleotides”). In this regard, we note that “the expectation of success need only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).” slip op. at 25
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,883,848 - PTAB · Jan 27, 2025 · IPR2024-01197 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims, 1–40, and all petitioned grounds after finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not proposed a definition of a person of ordinary skill in the art in its Preliminary Response. On the current record, for purposes of this Decision, we apply Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’729 Patent. 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)). We note, however, that the open-ended language “at least” and “or more” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner bears the burden of stating “[h]ow the challenged claim is to be construed.” 37 C.F.R. § 42.104(b)(3). However, only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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))). Based on the preliminary record, we find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. Any final written decision entered in this case may include express” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Conclusion as to Ground 1 Based on the foregoing discussion, and having considered the arguments and evidence presented by Petitioner, including the presently unrebutted testimony of Dr. Parr, we are persuaded Petitioner has shown a reasonable likelihood of prevailing with respect to Ground 1 sufficient for purposes of institution. E. Other Asserted Grounds of Unpatentability Having determined that Petitioner meets the threshold showing necessary to support institution of review based on the ground that asserts obviousness over Dohil in view of the knowledge of a POSA, we decline to address whether any other ground asserted in the Petition also supports institution. See Pet. 15–16 (grounds chart); see also SAS, 138 S. Ct. at 1359–60 (requiring the Board’s final written decision to address every claim the petitioner presents for review); Patent Trial and Appeal Board Consolidated Trial Practice Guide7 (“Trial Practice Guide”) (Nov. 2019) 11 (“The Board will not institute on fewer than all claims or all challenges in a petition.”); PGS Geophysical, 891 F.3d at 1359–1360. We emphasize our determination in this Decision is not a final determination on the construction of any claim term or the patentability of any challenged claim and, thus, leaves undecided any factual issues necessary to determine whether sufficient evidence supports Petitioner’s contentions by a preponderance of the evidence in the final written decision.” slip op. at 23
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“additional evidence and facts presented in the Petition warrant reconsideration of prior art or arguments,” we agree with Petitioner that the Examiner materially erred because the Examiner did not have the benefit of the teachings of the FDA Guidance, which Petitioner relies on in Grounds 1 (Dohil) and 3 (Dohil and Venkatesh) as representative of the knowledge of a POSA with regard to orally disintegrating tablets. See, e.g., Pet. 23.” slip op. at 36
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,771,729 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an 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 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - PTAB · Aug 23, 2024 · IPR2024-00526 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claims 36–70 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on the challenged claims.
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 claims of the ’554 patent are unpatentable. Accordingly, we institute an inter partes review of all challenged claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 3
- BurdenDecided for petitioner
“We are not persuaded by Patent Owner’s arguments. Even if Chen does not explicitly determine three-dimensional positional information of nucleic acid molecules in its paper, Petitioner has provided sufficient evidence, for purposes of institution, that the combination of asserted prior art would have given a skilled artisan reason to use MERFISH to “determin[e] three-dimensional positional information of . . . nucleic acid molecules,” as recited in claim 36, with a reasonable expectation of success.29 Petitioner does not rely on the bare disclosure of optical sectioning and/or z-scanning to argue that the combination of asserted art suggests the limitation at issue. Rather, Dr. Cyzmmek testifies that, because Chen “had the goal of identifying ‘distinct spatial distribution pattern of RNAs,” a skilled artisan “would have been motivated to use the MERFISH 29 In this regard, we also make clear that claim 36, a system claim, does not require a step of determining three-dimensional positional information of nucleic acid molecules. Rather, it only requires program instructions that are executable by a processor to cause the processor to perform the step. 39 method for 3D investigation.” Ex. 1002 ¶ 207. Citing to Larsson30 and Parillo,31 Dr. Cyzmmek further testifies that “[t]hree-dimensional FISH was routine and well-known long before the 2015 priority date.” Id. ¶ 208. Dr. Cyzmmek opines that, because “MERFISH was an extension of existing FISH technologies,” a skilled artisan would have reasonably expected it to also be capable of similar three-dimensional imaging.” slip op. at 39
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“36 Petitioner also asserts that the Board should not exercise our discretion to deny institution under 35 U.S.C. § 325(d). Pet. 66–68. Patent Owner did not address issues relating to 35 U.S.C. § 325(d) in the Preliminary Response. Under these circumstances, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 48
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“At this point, it appears, based on the parties’ submissions that, as of the institution decision date, fact discovery will still be ongoing, expert discovery will not have begun, and the deadline for filing dispositive motions will still be some time away. Furthermore, we note that, although the Court has issued a claim construction order, none of the construed terms were of the ’554 patent claims. See generally Ex. 2020.” slip op. at 54
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,542,554 - PTAB · Jun 24, 2024 · IPR2024-00313 · APJ Tawen Chang · IPR · Institution
The Board instituted review of claims 1–54 on all three obviousness grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot reached
“Under our precedent, where there is no time bar or estoppel implication with respect to alleged unnamed real parties-in-interest, the Board need not address, for the purposes of institution, whether such parties should be so named. SharkNinja Operating LLC v. iRobot Corp., IPR2020- 00734, Paper 11, 18–20 (PTAB Oct. 6, 2020) (precedential) (“SharkNinja”). In this case, Patent Owner has not alleged that either Lin BioScience or Belite Bio is barred or estopped from this proceeding. Patent Owner suggests that “Belite Bio’s status as a publicly traded company with a vested interest in the outcome of this Petition, and the Petition’s failure to disclose Belite Bio as a [real party-in-interest,] raise concerns about its motivations.” Prelim. Resp. 75. However, Patent Owner has not pointed to any evidence tending to show beyond speculation that Petitioner purposefully omitted these parties to gain an unfair advantage. SharkNinja at 19. Accordingly, on this record, we will not consider whether Lin BioScience and Belite Bio must be named as real parties-in-interest and” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had an advanced degree (e.g., Ph.D., M.D., M.S., or equivalent), in chemistry, biochemistry, pharmaceutical science, medicine, or a related field. This individual may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration. Moreover, skilled artisans would have had practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect, including the patents and publications discussed herein.” slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“First, the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a compound for a specific purpose (i.e., treating a macular degeneration), and the method comprises a single step of administering that compound in an 30 effective amount, the Federal Circuit “[has] generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. Moreover, “[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003); see also Eli Lilly & Co., 8 F.4th at 1341. In this case, claim 28 recites “[a] method of treating a macular degeneration, comprising administering an effective amount of a substituted C20-D1-3-retionoid to a patient in need thereof.” The preamble of “treating a macular degeneration” is necessary to understand the patients to whom the substituted C20-D1-3-retionoid should be administered; thus, it limits the claim. See Eli Lilly & Co., 8 F.4th at 1341–42 (citing Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1332–33 (Fed. Cir. 2003)); Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (holding the preamble to be limiting in a claim directed to “[a] method for treatment of sleep apneas comprising administration of a therapeutically effective amount of a [recited] compound . . . to a patient in need of such treatment,” because otherwise “the phrase ‘to a patient in need of such treatment’ would not have a proper antecedent basis”). Thus, we construe the preamble of claim 28 as limiting and give patentable weight to the phrase “method of treating a macular degeneration.” To the extent either party disagrees with our construction, the parties are welcome to further address this issue at trial.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The Petition points to Mata’s express suggestion of “‘[p]harmacologic inhibition of one or more steps in the A2E synthetic pathway’ as ‘an effective treatment strategy for other macular degenerations associated with lipofuscin accumulation.’” Pet. 31 (quoting Ex. 1010, 7159) (alteration in original). The Petition, again relying on Dr. Guengerich’s testimony, further explains Mata taught that deprotonation at C-20 of retinal — involving cleavage of a carbon-hydrogen bond — was “a pre-requisite for undesirable A2E formation,” and that a skilled artisan “would have recognized that this deprotonation likely was a rate-limiting step in A2E formation” such that slowing the deprotonation “would slow A2E formation,” i.e., lower the production of a toxic reaction product. Id. at 41 (citing Ex. 1002 ¶¶ 259– 260). Moreover, although the evidence of record may suggest that, at least as of 1999, “there are no drugs on the market that contain deuterium in the molecule,” Ex. 1046, 85, left col., Petitioner has also provided evidence, for instance in the form of Dr. Calman’s testimony, that “there was significant interest in making deuterated versions of known therapeutics in order to slow rates of undesirable reactions.” Ex. 1004 ¶ 96; see also Pet. 15 (stating that “it was known before 2007 to . . . use deuterium to slow undesirable reaction”) (citing Ex. 1002 ¶ 123; Ex. 1004 ¶¶ 96–102). 18 Kushner et al., Pharmacological Uses and Perspectives of Heavy Water and Deuterated Compounds, 77 CANADIAN J. PHYSIOLOGY & PHARMACOLOGY 79 (1999) (Ex. 1046, “Kushner”). 37 Finally, we note that claim 1, at least, is not directed to a method of treating any particular disease, but only a method of retarding the accumulation of particular compounds (i.e., lipofuscin pigments). We are persuaded, at least at this stage of the proceeding and based on the present record, that Petitioner has shown sufficiently that a skilled artisan would have had a reason to use C20-deuterated vitamin-A in the manner suggested in the Petition, with a reasonable expectation of success, based on alleged similarities between the use of deuterated compounds in the claimed method and use of such compounds to, e.g., lower production of toxic metabolites.” slip op. at 37
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
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.