- 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 · Feb 20, 2025 · IPR2024-00996 · APJ Ken B Barrett · IPR · Institution
The Board instituted review of claims 13–18 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“inter partes review, “the 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 uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8. The art or arguments presented in the Petition are not “substantially the same” as those previously presented to the Office when there are differences between them that are material to the Office’s prior consideration of the art and arguments. Wolfspeed, Inc. v. Trs. of Purdue Univ., IPR2022-00761, Paper 13 at 7–8 (Vidal Mar. 30, 2023).” slip op. at 9
- Skill levelSkill level petitioner adoptedOther
“Petitioner contends that: [A] person of ordinary skill in the art at the time of the alleged invention (“POSITA”) would have had a bachelor’s degree or higher in electrical engineering, at least 3 years of experience designing or researching electronic circuits, and familiarity with power electronics and inductive power transfer circuits. Pet. 8 (citing Ex. 1003 ¶ 20). Patent Owner states that, “[f]or purposes of this preliminary response, Patent Owner adopts the Petitioner’s proposal.” Prelim. Resp. 17. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[a]ll claim terms should be construed according to the Phillips standard,” and “[h]ere, given the remarkable overlap between the preferred embodiment of the ’461 patent and the prior art/predictable combinations articulated in Grounds 1A–3, Petitioners submit that no claim elements need a formal construction for purposes of resolving the controversy in this proceeding.” Pet. 8. Patent Owner states that, “[t]o simplify the issues before the Board, Patent Owner has not asserted any claim constructions in this preliminary response and adopts the Petitioner’s position that ‘[a]ll claim terms should be construed according to the Phillips standard.’” Prelim. Resp. 17 (quoting Pet. 8). On this record and for purposes of this decision, we determine that no” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“At this preliminary stage of the proceeding, we do not agree with Patent Owner’s arguments. Patent Owner does not cite to evidence, such as expert testimony, to support its implied argument that Olson’s measured current is “fundamentally different” from the current received by the primary coil. See Prelim. Resp. 31–32. Petitioner’s declarant, Dr. Woods, on the other hand, testifies, inter alia, that “[t]he ‘[c]urrent measured by current measure block 226 is used in the calculation of power, which as depicted in FIG. 14, measures the ‘power in’ provided to transmit block 214/primary coil 54.” Ex. 1003 ¶ 37 (citing Ex. 1004 ¶¶ 74–75, Fig. 14) (first alteration added); see also, e.g., id. ¶ 42 (Dr. Woods testifying that the measured current to the power supply “is the current driving the external antenna 52, via the transmit block 214 and to the primary coil 54.” (citing Ex. 1004 ¶¶ 74–75, 112, Fig. 14)). Paragraph 75 of Olson, cited in support of that testimony, provides: “The power in is gauged by the power generated by charging unit 50 and is determined by multiplying the voltage of the internal voltage of charging unit 50, e.g., the voltage of a battery or batteries internal to charging unit 50, by the current driving external antenna 52.” Ex. 1004 ¶ 75 (emphasis added). We note that external antenna 52 includes primary coil 54. See, e.g., Fig. 14. Dr. Woods’ testimony is, at this stage, unrebutted. Patent Owner also argues that “Petitioner fails to provide any evidence regarding the function of Olson’s microprocessor 212 in relation to measuring input power,” and that, “[w]hile Olson describes a power calculation in paragraph [0075], Olson does not describe this power calculation as performed by microprocessor 212.” Prelim. Resp. 32 (citing Pet. 16; Ex. 1004 ¶ 72) (first alteration added). At this preliminary stage of the proceeding, we do not agree with Patent Owner’s arguments regarding the microprocessor. Although Patent Owner does not bear the burden to show patentability, we observe that Patent Owner does not suggest that there is another component in Olson’s external charging device that might perform the admittedly-disclosed power calculation. See Prelim. Resp. 32–33. Dr. Woods testifies that microprocessor 212 receives the measured current and the input voltage of the charging device, and, from those values, calculates power in. See Ex. 1003 ¶¶ 43–44 (citing, inter alia, Ex. 1004 ¶¶ 71–78, Fig. 14); see also Ex. 1004 ¶ 74, Fig. 14 (Olson stating that “[c]urrent measured by current measure block 226 is used in the calculation of power in along with the voltage of batteries 160,” and Figure 14 depicting the signal from measure block 226 as an input to microprocessor 212). Dr. Woods’ testimony is, at this stage, unrebutted.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,626,461 - PTAB · Feb 20, 2025 · IPR2024-00995 · APJ Ken B Barrett · IPR · Institution
The Board instituted IPR on claims 1–6, 8, and 10–13 on all asserted grounds, finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“inter partes review, “the 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 uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8. The art or arguments presented in the Petition are not “substantially the same” as those previously presented to the Office when there are differences between them that are material to the Office’s prior consideration of the art and arguments. Wolfspeed, Inc. v. Trs. of Purdue Univ., IPR2022-00761, Paper 13 at 7–8 (Vidal Mar. 30, 2023).” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“information presented in the petition . . . 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). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’204 patent. Accordingly, we institute an inter partes review as to all the challenged claims of the ’204 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quoting Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)).” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“different from the resonant frequency of the inductive couple.” Ex. 1001, 21:16–20. The Specification then states the following: “Preferably the transmission frequency is selected to lie within one of the near-linear regions 6, 8 [of Figure 6b] where the slope of the frequency-amplitude graph is less steep.” Id. at 21:20–23; see also id. at 21:56–59 (“Referring back to FIG. 6b, the frequency of transmission is selected to be in the approximately linear region 8 of the curve between a lower frequency value of fL and an upper frequency value of fU.”9); Pet. 8 (citing the same).” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,083,204 - PTAB · Dec 10, 2024 · IPR2024-00994 · APJ Ken B Barrett · IPR · Institution
The Board instituted IPR on claims 1–7 and 9–14 on all asserted grounds, finding a reasonable likelihood of success on the Onishi-based obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“inter partes review, “the 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 uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially 4 For purposes of this Decision, we assume the challenged claims have an effective filing date prior to March 16, 2013, the effective date of the relevant aspects of the Leahy-Smith America Invents Act, Pub. L. No. 112- 29, 125 Stat. 284 (2011) (“AIA”), and we apply the pre-AIA version of 35 U.S.C. § 103. the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8. The art or arguments presented in the Petition are not “substantially the same” as those previously presented to the Office when there are differences between them that are material to the Office’s prior consideration of the art and arguments. Wolfspeed, Inc. v. Trs. of Purdue Univ., IPR2022-00761, Paper 13 at 7–8 (Vidal Mar. 30, 2023).” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’696 patent. Further, we decline to discretionarily deny inter partes review. Accordingly, we institute an inter partes review as to all the challenged claims of the ’696 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner, at this stage, does not disagree or propose a different definition of the person of ordinary skill in the art. However, Patent Owner’s declarant, Dr. Mercier, opines that [A]t the time of the ’696 Patent, a POSITA would have a working knowledge of wireless charging and inductive charging. The person would have gained this knowledge through an undergraduate Bachelor of Science degree in electrical engineering, computer engineering, computer science, or a related field, with at least two years of experience working in the field of wireless or inductive charging device design, or testing of such wireless or inductive charging device testing, or 5 The parties have not directed our attention to any objective evidence of obviousness or non-obviousness. an equivalent combination of academic study and work experience. More education (e.g., a Master’s degree) or work experience any relevant field may compensate for a deficit in one of the relevant qualifications stated above. Ex. 2001 ¶ 26. We observe that, in Dr. Mercier’s definition, the undergraduate degree categories are a bit broader and the experience possibly a bit more specific than in Petitioner’s definition. However, at this stage and absent argument to the contrary by the parties, we discern no material difference between the parties’ definitions. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art. We note, however, that were we to adopt Dr. Mercier’s assessment, the outcome of this Decision would be the same.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“near-linear region—consistent with the quoted applicant’s use of the term “near-linear”—rather than a linear or non-linear region, which seemingly would encompass the entire curve. As to the second part, we understand Patent Owner to be referring to the purported benefit of linear control, and we determine that Patent Owner has not explained adequately why such a benefit should be read into the claim term “substantially different,” particularly where the quoted Specification support does not explicitly mention linear regulation.7 See Ex. 1001, 21:61–63 (“The induced voltage 7 To the extent that Patent Owner relies on its declarant’s testimony as an explanation of Patent Owner’s claim construction position, we remind Patent Owner about the prohibition on incorporation by reference. See 37 C.F.R. § 42.6(a)(3); Consolidated Trial Practice Guide, November 2019, 35–36 can be increased by reducing the transmission frequency and can be reduced by increasing the transmission frequency.”). On this record and for purposes of this decision, we determine that— consistent with the Specification’s description of the frequency that is “[p]referably . . . selected” and applicant’s argument regarding the same during prosecution—“a transmission frequency substantially different from said characteristic resonant frequency of said inductive couple” encompasses frequencies that lie within one of the near-linear regions of a frequency-amplitude graph associated with the inductive couple. See Ex. 1001, 21:20– 24; Ex. 1002, 70. At this time and for purposes of this Decision, we need not and do not reach the issue of the outer bounds of the scope of “substantially different.” We also note that independent claim 1 is an apparatus claim and the subject limitation 1.7 further defines the “driving circuit” recited in limitations 1.5 and 1.6. Specifically, limitation 1.7 requires a driving circuit that is “configured and operable to produce said oscillating driving voltage at a transmission frequency” that is “substantially different” from the inductive couple’s resonant frequency. Ex. 1001, 28:43–46. In future briefing, the parties’ arguments regarding the prior art references should focus on that recited structure, i.e., a circuit that is configured and operable to produce the recited frequency.” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,048,696 - PTAB · Nov 22, 2024 · PGR2024-00034 · APJ Patrick R Scanlon · PGR · Institution
Instituted PGR on claims 1–19 and all asserted grounds after finding at least one claim more likely than not unpatentable.
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. See 35 U.S.C. § 324 (2018); 37 C.F.R. § 42.4(a) (2022). To institute a post-grant review, we must determine that “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). For the reasons set forth below, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of at least one challenged claim. Accordingly, we institute a post-grant review of the challenged claims on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“We note that the identification of a Ph.D. as an example of “more formal education” creates a vast range of education relative to a bachelor’s degree. Thus, we treat the identification of a Ph.D. just as it is—an example—and not a requirement. In this case, “more formal education” can be satisfied by a level of education less than a Ph.D (but greater than a bachelor’s degree). Based on our review of the record before us, we determine that Petitioner’s stated level of ordinary skill in the art is reasonable because it appears consistent with the evidence of record, definition, limited as discussed above, for the purposes of this Decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the present record, we do not discern a need to construe explicitly any claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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)).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“would have understood Unger’s disclosure to “suggest the use of a torsion spring to facilitate attachment and detachment, because torsion springs are designed to impart this functionality.” Id. (citing Ex. 1002 ¶ 118). Petitioner also asserts that one of ordinary skill in the art would have “understood that there were a limited number of ways to impart the referenced resilient or flexible ‘manipulation,’” and “would have been motivated to look to various known solutions to impart the suggested functionality, including the torsional spring mechanism of Smith that is used in a similar hearing protection device application for a similar purpose as Unger’s mounting arms (to apply a clamping force).” Id. at 32 (citing Ex. 1002 ¶¶ 120–121).” slip op. at 17
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,736,855
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.