- 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 · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution
Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 of the ’201 patent.” slip op. at 2
- Skill levelSkill level board ownOther
“At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,938,201 - PTAB · Jun 6, 2025 · IPR2025-00140 · APJ James A Worth · IPR · Institution
The Board instituted IPR of claims 1–18 on all petitioned challenges, finding a reasonable likelihood that at least claim 1 is obvious over Nakajima and the knowledge of a person of ordinary skill.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 shows that 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) (2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 1–18 of the ’250 patent is unpatentable, and we institute an inter partes review of claims 1–18 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 15 (citing Ex. 1002 ¶ 25). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 28 (citing Ex. 2001 ¶ 50). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“For purposes of this decision on institution, we adopt the proffered dictionary definition of “mouthpiece” as “a part (as of an instrument) that goes in the mouth or to which the mouth is applied” (see Ex. 2005), and we construe this as an intended use of this component of the apparatus, because this definition is consistent with the plain and ordinary meaning of the term which is a compound of “mouth” and “piece” and also because this definition is consistent with the Specification. For example, the Specification describes the use of the mouthpiece as follows: “In use, the mouthpiece is adapted to be configured to the dispensing configuration by a user placing the mouthpiece in the user’s mouth and biting upon or otherwise compressing the appropriate portions of sidewalls 92 of the mouthpiece.” Ex. 1001, 8:45–49. We note that, although the Specification refers to bite-actuation of the mouthpiece, for example in the field of the disclosure and certain embodiments (e.g., Ex. 1001, 1:25–27), the independent claims do not require bite-actuation. The Specification identifies the mouthpiece as item 72 (which is depicted, for example, in Figure 25, reproduced supra). Ex. 1001, 3:7‒8. 7 Exhibit 2005 appears to be from an online Merriam-Webster dictionary accessed March 13, 2025. Ex. 2005, 4. At this time, there is no argument in the preliminary record that this definition would have been different before the critical date of the patent.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although the construction of this limitation may be helpful in deciding the issues of unpatentability, we determine that the construction of this term would benefit from further briefing during the trial phase of this proceeding, and we invite the parties to continue to brief this issue. Therefore, we do not provide a preliminary construction of the term at this time.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,851,250 - PTAB · Apr 21, 2025 · IPR2024-01504 · APJ James A Worth · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 7, 9, and 10 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Iafrate and Kivioja.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 21–22. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. Instead, for purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“1. “indexing site” Petitioner argues that the ’357 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 23 (citing Ex. 1004, 4:40–44). Patent Owner does not disagree other than to argue that no claim requires construction. The ’357 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. provide a definition for “indexing site,” and we construe the term in accordance therewith.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. “identifying sequence reads with identical identifier and target sequences as duplicates” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary the term “duplicates” means that the sequences are identical. We observe that the ’357 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1004, 4:12–15. The claim does not use the exact wording as the Specification.4” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“4. “comprising” The parties may address the meaning of the transitional phrase “comprising” and whether the prior art meets the claim if the prior art discloses a method of identifying as duplicates those sequence reads with identical labels and target fragments and, in addition also identifies other sequence reads as duplicates, including sequence reads with some mutations resulting from PCR or SBS error. See Ex. 1079 ¶ 117. On this preliminary record, we construe “comprising” as an open-ended transition that is not limited to the listed steps. See Vivid Techs., Inc., 200 F.3d at 811.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,098,357 - PTAB · Apr 21, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Institution
Instituted IPR of claims 1–3, 5–11, and 14–17 on all petitioned grounds; the Board found a reasonable likelihood that at least claim 1 was obvious over Iafrate and Kivioja.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the record at this stage of the proceeding, we determine that Petitioner has made an adequate showing on claim 1’s preamble language.9 Kivioja discloses that “with the UMI method one can reproducibly detect the number of molecules after different numbers of PCR cycles without normalization.” Ex. 1012, 2–3. Dr. Sims opines that a person of ordinary skill would have understood that Kivioja’s method teaches a method of detecting and removing duplicate sequencing reads, i.e., that Kivioja’s method of counting unique sequences necessarily identifies duplicate reads. See Ex. 1079 ¶ 260. 8 We recognize that the burden remains with Petitioner to prove unpatentability of the challenged claims. See 35 U.S.C. § 316(e). 9 We do not need to decide for purpose of institution whether the preamble is limiting.” slip op. at 20
- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 23. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’399 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“1. “indexing site” Petitioner argues that the ’399 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 24 (citing Ex. 1003, 4:34–38). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. Ex. 1003, 4:34–38. We understand this passage of the ’399 patent to provide a definition for “indexing site,” and we construe the term in accordance therewith. 2. “indexing primer binding site” Petitioner argues that the ’399 patent defines “indexing primer binding site” as the binding site for a primer used to read the indexing site/sample index, specifically, “a nucleotide sequence for binding a primer for an indexing site.” Pet. 24 (citing Ex. 1003, 4:33–34). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An indexing primer binding site is a nucleotide sequence for binding a primer for an indexing site.” Ex. 1003, definition for “indexing primer binding site,” and we construe the term in accordance therewith. 3. “identifier site” Petitioner argues that the ’399 patent defines “identifier site” as a molecular tag attached to fragments prior to amplification, specifically, “a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Pet. 25 (citing Ex. 1003, 4:43-45). Petitioner argues that an “identifier site” “can be designed as a set of sequences, or it can be semi-random, or it can be completely random.” Id. (citing Ex. 1003, 4:49–51). Petitioner argues that an “identifier site” can also “be a fixed length, or it can be a variable length.” Id. (citing Ex. 1003, 4:51–54). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An identifier site is a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Ex. 1003, 4:43–45. We understand this passage of the ’399 patent to provide a definition for “identifier site,” and we construe the term in accordance therewith. 4. “target sequence primer binding site” Petitioner argues that the ’399 patent defines “target sequence primer binding site” as a binding site for a primer used to read the fragment sequence, specifically, a “nucleotide sequence for binding a primer for a target sequence.” Pet. 25 (citing Ex. 1003, 4:62–65). Petitioner also argues that the ’399 patent expressly discloses that this site can be a standard Illumina sequence compatible with an Illumina primer for an SBS reaction to read the DNA fragment. Id. (citing Ex. 1003, 16:48–51 & SEQ ID No. 3). requires construction. The ’399 patent states: “A target sequence primer binding site nucleotide sequence for binding a primer for a target sequence.” Ex. 1003, 4:62–63. The ’399 patent appears to have a typographical error at this juncture in the Specification because the quoted text is missing a verb (e.g., “is”) and is therefore an incomplete sentence. Based on the context of the surrounding parts of the Specification, we infer that the ’399 patent intended to define “target sequence primer binding site” as a “nucleotide sequence for binding a primer for a target sequence.”” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“5. “identifying a duplicate sequencing read as the sequencing read comprising the same identifier site and nucleic acid fragment as another sequencing read in the population of sequencing reads” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary to resolve a dispute). For example, the parties may wish to address whether the “same identifier and nucleic acid fragment” means that the sequences are identical. We observe that the ’399 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1003, 4:8–11. The claim does not use the exact wording as the Specification.5” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 9,546,399 - PTAB · Jan 29, 2025 · IPR2024-00842 · APJ Michael L Woods · IPR · Institution
The Board instituted review of claims 1–29 based on a reasonable likelihood of prevailing and granted EndyMed’s motion to join the ’386 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the foregoing reasons, the underlying premise of Serendia’s arguments here and in the ’386 IPR remains substantially the same. Thus, for the same reasons discussed in our decision instituting the ’386 IPR, we find that EndyMed demonstrates a reasonable likelihood of prevailing with respect to at least one of challenged claims 1–29 of the ’836 patent. See ’386 IPR, Paper 18. That is not to say, however, that Serendia may not ultimately persuade us at trial of the deficiency of EndyMed’s showing based on a preponderance of the evidence.” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“evidences nonobviousness for four different patents. In this situation, a presumption of nexus is appropriate only if patent owner demonstrates that the claims of all four patents “generally cover the same invention.” See Fox Factory, 944 F.3d at 1377 (“Where a product embodies claims from two patents, a presumption of nexus can be appropriate only if the claims of both patents generally cover the same invention.”). “The same evidence of secondary considerations cannot be presumed to be attributable to two different combinations of features.” Id. at 1378 (citation omitted). “In such situations, the patentee retains the burden of proving the degree to which evidence of secondary considerations tied to a product is attributable to a particular claimed invention.” Id. (citation omitted). Here, Serendia does not demonstrate that the four different patents cover the same invention. See Prelim. Resp. 59–74. Indeed, Serendia does not address U.S. Patents 9,775,774, 9,320,536, and 10,869,812 at all. See id. That Serendia separately sought patent protection for each of these four patents suggests that these patents do not generally cover the same invention. Cf Fox Factory, 944 F.3d at 1378 (“The same evidence of secondary considerations cannot be presumed to be attributable to two different combinations of features.”). We made a similar determination in the ’386 IPR. See, e.g., ’386 IPR, Paper 18 at 38 (“Patent Owner fails to set forth which patents ‘generally cover’ the Sylfirm X device.” (citations omitted)).” slip op. at 12
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“We disagree with Serendia. EndyMed need not justify its delay where, as here, EndyMed satisfies the joinder requirement of filing the petition within one month of our institution of trial in the ’386 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, by rule, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.”) (emphasis added). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’836 patent, EndyMed’s petition and motion are nonetheless timely. Serendia also argues that joinder should be denied due to duplicative efforts with the parallel Delaware litigation, which involves the same parties and patent as here. See PO Opp. 3–4. That argument fails for the simple reason that EndyMed submits a Sotera stipulation, agreeing not to pursue in the Delaware litigation the same grounds that are asserted in the petition here or any grounds that reasonably could have been raised here. See Pet. Reply 1–2. A Sotera stipulation mitigates concerns of duplicative efforts, and we decline to discretionarily decline institution where a petitioner makes such a stipulation. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022) (“Director Memo”), at 3, 7–8. Thus, we will not discretionarily deny the petition or motion for joinder on the basis of the parallel Delaware litigation.8” slip op. at 14
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“the joinder requirement of filing the petition within one month of our institution of trial in the ’386 IPR. See 37 C.F.R. § 42.122(b); see also 37 C.F.R. §§ 1.7(a), 42.1(a). Indeed, by rule, EndyMed could not have filed the instant petition prior to institution of the IPR it was seeking to join. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.”) (emphasis added). And, although there is a one-year statutory bar from the date of service of a complaint alleging infringement for requesting inter partes review, that bar does not apply to a request for joinder. See 35 U.S.C. § 315(b). Thus, despite being filed more than one year from the service date of Serendia’s complaint alleging infringement of the ’836 patent, EndyMed’s petition and motion are nonetheless timely.” slip op. at 14
§ 103 obviousnessDiscretionary denialPatents in suitUS 9,480,836 - PTAB · Jan 15, 2025 · IPR2024-01108 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 10–15, 17, 18, 20, and 21 under § 103 and granted BRP’s motion to join the Foil Boarding IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this stage of the proceeding and based on our preliminary review, we find Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims for the same reasons discussed in our Decision on Institution in the Foil Boarding IPR. Granting the Petition and joining Petitioner to the Foil Boarding IPR will provide us with the opportunity to more fully consider Patent Owner’s arguments—first raised in response to the petition in the Foil Boarding IPR—in the context in which they were first raised. Those common arguments will be fully considered in the Foil Boarding IPR, with the benefit of a complete record.8 Accordingly, for the reasons discussed above, we are persuaded Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims of the ’044 patent. We therefore grant the Petition, and institute inter partes review of the Challenged Claims.” slip op. at 6
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“challenges the same claims on the same grounds using the same prior art, Kyocera factor (2) favors joinder. See Kyocera, IPR2013-00004, Paper 15 at 4. Indeed, the Board “routinely grants motions for joinder where the party seeking joinder introduces identical arguments and the same grounds raised in the existing proceeding.” Samsung Elecs. Co. v. Raytheon Co., IPR2016- 00962, Paper 12 at 9 (PTAB Aug. 24, 2016). Moreover, because the issues to be decided are the same and Petitioner avers that it will take an “understudy” role to Foil Boarding in the Foil Boarding IPR by consolidating all filings, refraining from advancing new arguments, binding itself to any discovery agreements, and limiting its deposition time to the time already allotted, Kyocera factors (3) and (4) also favor joinder. See Mot. 4–6; Kyocera, IPR2013-00004, Paper 15 at 4. For the reasons explained above, we find that joining Petitioner to the Foil Boarding IPR is appropriate under the present circumstances. We, therefore, grant Petitioner’s Motion.” slip op. at 8
NonePatents in suitUS 9,359,044 - PTAB · Jan 15, 2025 · IPR2024-01107 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7–11, 13, and 15 under § 103 and granted BRP’s motion to join IPR2024-00085.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this stage of the proceeding and based on our preliminary review, we find Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims for the same reasons discussed in our Decision on Institution in the Foil Boarding IPR. Granting the Petition and joining Petitioner to the Foil Boarding IPR will provide us with the opportunity to more fully consider Patent Owner’s arguments—first raised in response to the petition in the Foil Boarding IPR—in the context in which they were first raised. Those common arguments will be fully considered in the Foil Boarding IPR, with the benefit of a complete record.8 Accordingly, for the reasons discussed above, we are persuaded Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims of the ’659 patent. We therefore grant the Petition, and institute inter partes review of the Challenged Claims.” slip op. at 6
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Patent Owner does not oppose Petitioner’s Motion. We are persuaded by Petitioner’s arguments. Because the Petition challenges the same claims on the same grounds using the same prior art, Kyocera factor (2) favors joinder. See Kyocera, IPR2013-00004, Paper 15 at 4. Indeed, the Board “routinely grants motions for joinder where the party seeking joinder introduces identical arguments and the same grounds raised in the existing proceeding.” Samsung Elecs. Co. v. Raytheon Co., IPR2016- 00962, Paper 12 at 9 (PTAB Aug. 24, 2016). Moreover, because the issues to be decided are the same and Petitioner avers that it will take an “understudy” role to Foil Boarding in the Foil Boarding IPR by consolidating all filings, refraining from advancing new arguments, binding itself to any discovery agreements, and limiting its deposition time to the time already allotted, Kyocera factors (3) and (4) also favor joinder. See Mot. 4–6; Kyocera, IPR2013-00004, Paper 15 at 4. For the reasons explained above, we find that joining Petitioner to the Foil Boarding IPR is appropriate under the present circumstances. We, therefore, grant Petitioner’s Motion.” slip op. at 8
NonePatents in suitUS 9,586,659 - PTAB · Aug 9, 2024 · IPR2024-00385 · APJ Michael L Woods · IPR · Institution
The Board instituted inter partes review of claims 1–4, 6, and 7 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). The Board evaluates discretionary denial under § 325(d) using a two-part framework: first, the Board considers whether the same or substantially the same art or arguments were previously presented to the Office; and if so, second, the Board considers whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In determining whether the same or substantially the same art or arguments were previously presented to the Office, the Board considers the following nonexclusive factors: (1) the similarities and material differences between the asserted art and the prior art involved during examination; (2) the cumulative nature of the asserted art and the prior art evaluated during examination; and (3) the extent of the overlap between the arguments” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that 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). After considering the Petition, the Preliminary Response, the Reply, the PO Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’332 patent. Accordingly, we institute an inter partes review of claims 1–4, 6, and 7 of the ’332 patent on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“A person of ordinary skill in the art (POSITA) would have had: (i) a B.S. degree in Chemical Engineering, Petroleum Engineering, or an equivalent field and (ii) two or three years of academic or industry experience in chemical processing systems, oil and gas production and/or refining; or comparable experience. Additional work experience can substitute for educational or research experience, and vice versa. Pet. 8 (citing Ex. 1002 ¶¶ 26–29); see also Prelim. Resp. 16 (agreeing with Petitioner’s proposed definition of a POSITA). For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this stage of the proceeding, we decline to adopt Patent Owner’s interpretation that cryogenic conditions occur only below 50°F. See Prelim. Resp. 19 (citing Ex. 2001 ¶ 55). For purposes of this Decision, we need not and do not formally determine the temperature at which cryogenic conditions occur, as our construction would not affect our decision to institute. 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)). We agree with Petitioner that “[e]xplicit construction of terms is unnecessary because it is not dispositive—the art teaches the claims under any reasonable construction.” Pet. 8 (citing Vivid Techs., 200 F.3d at 803). As explained below, for purposes of institution, Petitioner has shown a reasonable likelihood that Aycaguer does not disclose subjecting the recited streams to “cryogenic conditions” at any temperature, as recited in Limitation 1.6. See Pet. 34–36; see also infra § IV.D.2.g.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,505,332
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.