- Illumina Inc. v. Molecular Loop Innovations LLCAll claims unpatentablePTAB · Jan 16, 2026 · IPR2024-00965 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–6 are unpatentable: Gloor anticipates them, Parameswaran and Gloor render them obvious, and Parameswaran, Binladen, and Bentley render claim 6 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 18 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 20–23). After reviewing the record, we adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We acknowledge the ambiguous nature of the disputed claim language. On its face, it could require two or more identifier sequences together be uniquely associated with the nucleic acid of interest, as Petitioner argues; or it could require two or more identifier sequences, each individual identifier sequence must be uniquely associated with the nucleic acid of interest, as Patent Owner asserts. See Reply 2–3; Sur-reply 1–6. We, therefore, must examine the words of the claim and the specification to ascertain the scope of this limitation. The specification states that “[w]hile the pair of barcodes associated with any given template is unique, individual barcode sequences can be used with multiple templates as long as no pair is used across two different samples.” Ex. 1001, 2:50–53 (emphasis added). Elsewhere, it states that [t]he first and second identifiers are designed such that each set of identifiers is correlated to a particular sample (e.g., material obtained from a particular patient or group of patients), allowing samples to be distinguished and/or validated. The first and second identifiers may be the same or different, so long as the combination is unique with respect to the sample or sub-sample that one seeks to distinguish and/or validate. Id. at 3:15–22 (emphases added). We agree with Petitioner that the specification supports its proposed construction. See Reply 2.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Claim 5 recites “homopolymer region.” The ’200 patent specification provides an express definition for the term, stating that “the barcode sequences can be designed to have minimal or no homopolymer regions, i.e., 2 or more of the same base in a row such as AA or CCC, within the barcode sequence.” Ex. 1001, 9:6–10. Thus, we agree with Patent Owner that the term “homopolymer region” should be construed as “two or more of the same base in a row.” See PO Resp. 13 (citing Ex. 2001 ¶ 24). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any other claim term.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“A reference is considered publicly accessible if it is “made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1355 (Fed. Cir. 2018). To “determine whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents,” we “must consider all of the facts and circumstances surrounding the disclosure.” In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009); see also In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004) (explaining that a determination of whether a reference qualifies as a printed publication “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public”).” slip op. at 15
Patent outcomesUS 11,768,200 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,768,200 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - PTAB · Oct 9, 2025 · IPR2025-00847 · APJ Brian D Range · IPR · Institution
Instituted IPR on claims 1–11 because Petitioners showed a reasonable likelihood of proving at least one challenged claim unpatentable across the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioners meet the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–11 of the ’847 patent based upon Petitioners’ asserted grounds of unpatentability.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a master’s degree in electrical engineering, physics, chemistry, materials science, or a related field and three years of work experience in semiconductor manufacturing, such as, for example, in integrated circuit device (or transistor) design and/or manufacturing,” and “[a]dditional relevant education could substitute for professional experience, and significant work experience or training could substitute for formal education.” Pet. 11 (citing Ex. 1003 ¶ 38). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’847 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner does not propose any claim constructions, except to explain that the claim 7 limitation “the spacer further comprises an offset spacer, positioned between the gate and the spacer,” is “satisfied if one layer (an ‘offset spacer’) of the claimed ‘spacer’ lies between another layer of the ‘spacer’ and the gate.” Pet. 11. Patent Owner does not dispute Petitioner’s assertions or offer any claim constructions. See generally Prelim. Resp. Because resolution of Petitioner’s proposed construction is unnecessary to our analyses for purposes of this decision, we do not address the proposal here. 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 do not discern a need to construe any other claim language at this juncture 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, 912 F.3d at 1375.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“a. Claim 1 Petitioner contends that claim 1 is anticipated by Lan or, alternatively, obvious in view of Lan. Pet. 18–26. Petitioner explains how Lan teaches or suggests each recitation of claim 1, and Petitioner’s position is supported by adequate evidence for institution. Id. (citing, e.g., Ex. 1003 ¶¶ 100–125). Petitioner, for example, persuasively compares the structure of Figure 12 of Lan to each limitation of claim 1. Id. Patent Owner does not dispute Petitioner’s contentions except to argue that Lan (and the Petition’s other asserted references) “Do Not Mention, Describe, or Concern ‘Raised Epitaxial Layers.’” Prelim. Resp. 22–24. Patent Owner does not persuasively undermine Petitioner’s position.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,745,847 - PTAB · Oct 6, 2025 · IPR2025-00611 · APJ Christopher L Ogden · IPR · Institution
The Board instituted IPR of claims 1–10, 12, 13, 19, and 20 on all petition grounds after finding a reasonable likelihood that claim 1 was obvious over Douglas and Mark.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A claim is unpatentable under § 103 “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103; see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). When a ground in a petition is based on a combination of references, we consider “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties agree that experience could substitute for a degree, and vice versa. Pet. 3 (citing Ex. 1003 ¶¶ 19–21); Prelim. Resp. 9. The parties’ proposed levels of ordinary skill are substantially similar. Although we discern no difference in the outcome of this decision from choosing one over the other, we adopt Petitioner’s proposal for this decision. Only Petitioner’s proposed level is supported by testimonial evidence on the preliminary record, and it appears to be consistent with the problems addressed in the ’774 patent. See Ex. 1001, 1:16–52. Therefore, we adopt Petitioner’s proposal for this decision.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“CLAIM CONSTRUCTION B. In an IPR, we construe a patent claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). This generally includes “construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. The ordinary and customary meaning of a claim term “is its meaning to the ordinary artisan after reading the entire patent,” and “as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1313, 1321. Neither Petitioner nor Patent Owner argues that we need to construe any claim terms explicitly. See Pet. 2–3; Prelim. Resp. 9. However, the parties’ positions depend on interpreting the claim language in a particular way, and we discuss the relevant claim language below in the context of the parties’ arguments regarding the prior art. 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 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“At this stage, we find Petitioner’s arguments persuasive and disagree with Patent Owner. Patent Owner appears to equate a “fabrication profile” with a toolpath description, but nothing in the plain language of claim 1 supports that narrow interpretation. The ’774 patent describes a “fabrication profile” broadly and states that the profile can simply “include the dictionary [of configuration information],” or be “used to determine which machineready representation is available or suitable for a target printer.” Ex. 1001, 23:49–52. The preliminary evidence suggests that Douglas’s “operational parameters” would count as a “fabrication profile” because it is “the basis for generation of a machine-ready representation of the three-dimensional model that is executable on the target printer.” Id. at 23:37–39; see infra Section III.C.8. We also disagree that Petitioner’s argument is impermissible hindsight, because it is based on the disclosures in Douglas and Mark, and Petitioner has articulated a sufficiently persuasive reason to combine those references without referring to the ’774 patent itself. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (an obvious rationale is not improper hindsight if it “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”). Finally, Petitioner appears to rely on Mark for providing a particular example of a fabrication profile, not to replace Douglas’s overall system in which the 3D printer can receive “operational parameters” rather than just G-code. See Pet. 8–10, 17–23; see also Ex. 1005 ¶ 41 (the print queue, which stores tool instructions, may be maintained locally on printers 204 or on print servers 208); see In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“[A] determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” (citing In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc))).” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,886,774 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).) According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. (See PO Resp. 18–20.) Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. (See id. at 19–20.) Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” (Id. at 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219 - Apple Inc. v. Geoscope Technologies Pte. Ltd.All claims unpatentablePTAB · May 7, 2025 · IPR2024-00031 · APJ Annette R Reimers · IPR · Final written decision
Claims 16–20, 24, 26, and 27 are unpatentable: claims 16, 19, 20, 24, and 27 are anticipated by Bhattacharya, and all challenged claims are obvious over Bhattacharya and Spain.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner for the following reasons. First, Patent Owner’s definition is consistent with our determination in IPR2023-01210, which involved the same ’358 patent, and Petitioner does not explain sufficiently why we should adopt a different definition. See generally Pet. Reply.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Sundaresan Declaration, Dr. Sundaresan implied agreement with the POSITA definition based on its inclusion in a signed declaration.” Pet. Reply 15. We agree with Petitioner. Although Dr. Sundaresan does not state explicitly that the proposed definition of the ordinary skill in the art is his opinion, we are persuaded that the manner in which the definition is set forth in his declaration indicates that he agrees with the definition. In this case, Patent Owner attempts to make much of Dr. Sundaresan’s statement that he had been informed of the qualifications of a person of ordinary skill in the art. See PO Resp. 42–44. Dr. Sundaresan’s testimony, however, set forth this understanding of the requisite level of skill in the art (Ex. 1003 ¶ 8). In his supplemental declaration, Dr. Sundaresan further testifies that: I agreed with this POSITA definition when preparing the Declaration, and I continue to hold the opinion that the POSITA definition is both correct and appropriate based on the disclosures of the ’358 patent and the prior art analyzed in the Declaration. Ex. 1055 ¶ 17. Dr. Sundaresan further testifies that “[i]f I did not agree with the POSITA definition, then it would not have been included [] in paragraph 8 of the Declaration.” Id. ¶ 18. Dr. Sundaresan’s inclusion of the definition of the level of ordinary skill in his original declaration indicates that he” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“explained below, we agree with Petitioner that Patent Owner’s additional requirement of evaluating the calibration data to determine the boundaries of the area represented by a grid point should not be included in the construction of either “grid point” or “non-uniform grid point.” Instead, based on the full record, we discern no reason to alter our prior construction of “grid point” as “a point associated with representative calibration data for an area” and maintain that construction for this Final Written Decision. The construction of “grid point” we adopt is supported by the Specification of the ’358 patent. Namely, the ’358 patent discloses that “[i]n general, a non-uniform grid point (NUG) may represent the signal characteristics and/or calibration data over a given region,” and “NUGs district court identified the second quoted passage, which is identically recited in the ’104 patent (see Ex. 2018, 3:50–60) as “provid[ing] a clear indication of the meaning of ‘grid point.’” Ex. 2012, 19 (emphasis added). We agree with the district court’s analysis. Although the ’358 patent does not explain how a generic “grid point” might differ from the described “nonuniform grid point,” we do not find this distinction pertinent to construing “grid point” in this case because neither party raises this issue. Also, based on the claim wording “non-uniform grid point,” a “non-uniform grid point” is a type of grid point. See Pet. Reply 4 (explaining why that plain meaning supports Petitioner’s proposed construction). Furthermore, the district court construed “grid point” only, not “non-uniform grid point.” Ex. 2012, 18–20.” slip op. at 26
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Based on the entire trial record, we agree with Petitioner’s analysis with supporting evidence and credit Dr. Sundaresan’s testimony supporting Petitioner’s position. See Pet. 20–37. Thus, we determine that Bhattacharya discloses the recitations of claim 15. b. Remaining Claims 16, 19, 20, 24, and 27 Claims 16, 19, 20, 24, and 27 depend from claim 15. Ex. 1001, 13:19–21, 12:30–36, 12:52–55; 12:63–67. Petitioner accounts for the limitations recited in each of claims 16, 19, 20, 24, and 27. Pet. 37–42. Patent Owner does not offer any arguments specifically addressing the limitations of claims 16, 19, 20, 24, and 27. See PO Resp. passim. Petitioner shows, by a preponderance of the evidence, that each element of claims 16, 19, 20, 24, and 27 is disclosed by Bhattacharya.” slip op. at 41
Patent outcomesUS 8,400,358 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,400,358 - Apple Inc. v. Geoscope Technologies Pte. Ltd.All claims unpatentablePTAB · May 7, 2025 · IPR2024-00032 · APJ Brian D Range · IPR · Final written decision
Claims 2–5, 9, 11, 12, 14–16, 18–22, 27, 29, 31, and 32 are unpatentable over the asserted anticipation and obviousness grounds; claims 1, 25, and 35 were disclaimed.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The ’494 patent is directed to locating a wireless mobile device in a geographic region. Ex. 1001, 1:20–27; PO Resp. 45. Bhattacharya is directed to estimating the geographic location of a wireless terminal. Ex. 1005, code (57), ¶¶ 1, 13; PO Resp. 44–45. Spain is directed to a method for locating the concentration of mobile radio traffic in a coverage area. Ex. 1006, code (54), ¶¶ 1, 11; PO Resp. 45. We find that there is support in the ’494 patent and prior art consistent with Patent Owner’s assertion that the qualifications of a person of skill would include knowledge of radio navigation and mobile communications technology. Accordingly, we adopt Patent Owner’s proposed qualifications for a person of ordinary skill.” slip op. at 9
- BurdenDecided for petitioner
“Patent Owner, however, has not identified any language in the Petition that explicitly incorporates by reference Dr. Sundaresan’s testimony. See generally PO Resp.; PO Sur-Reply. Nevertheless, to the extent that the Petition purportedly incorporates by reference Dr. Sundaresan’s testimony, we do not find such incorporation sufficiently extensive to merit disregarding the testimony. Typically, an incorporation by reference is deemed improper in instances in which large portions of a declaration are incorporated—particularly where the incorporation serves to circumvent a word-count limit. See, e.g., Cisco Systems, Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 at 10 (PTAB Aug. 29, 2014) (informative). In this case, however, Dr. Sundaresan’s testimony describing the level of ordinary skill in the art is short. Ex. 1003 ¶ 8. The amount of testimony is not extensive and, thus, its purported incorporation into the Petition presents little or no imposition on Patent Owner or the Board.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In reply, Petitioner argues that “under any reasonable read of the Sundaresan Declaration, Dr. Sundaresan implied agreement with the POSITA definition based on its inclusion in a signed declaration.” Pet. Reply 15. We agree with Petitioner. Although Dr. Sundaresan does not state explicitly that the proposed definition of the ordinary skill in the art is his opinion, we are persuaded that the manner in which the definition is set forth in his declaration indicates that he agrees with the definition. Patent Owner attempts to make much of Dr. Sundaresan’s statement that he had been informed of the qualifications of a person of ordinary skill in the art. See PO Resp. 41–43. Dr. Sundaresan’s testimony, however, set forth this understanding of the requisite level of skill in the art (Ex. 1003 9 Dr. Sundaresan has a doctoral degree in electrical and computer engineering and has extensive experience in wireless communications. Ex. 1003 ¶¶ 75–78. Dr. Sundaresan also has experience with navigation and geolocation systems such as development of wireless tracking systems, as evidenced by his experience in companies such as NavigateIO Inc. Id. at ¶¶ 77–78. Patent Owner does not argue that Dr. Sundaresan fails to meet requirements for the level of qualifications of one of ordinary skill in the art under its proposed qualifications, which we adopt here. See generally PO Resp.; PO Sur-reply. Based on a review of his qualifications, we determine that Dr. Sundaresan qualifies as a person of ordinary skill at the time of the invention. ¶ 8). In his supplemental declaration, Dr. Sundaresan testifies: I agreed with this POSITA definition when preparing the Declaration, and I continue to hold the opinion that the POSITA definition is both correct and appropriate based on the disclosures of the ’358 patent and the prior art analyzed in the Declaration. Ex. 1055 ¶ 17. Dr. Sundaresan further testifies that “[i]f I did not agree with the POSITA definition, then it would not have been included [] in paragraph 8 of the Declaration.” Id. ¶ 18. Dr. Sundaresan’s inclusion of the definition of the level of ordinary skill in his original declaration indicates that he agrees with the definition, as confirmed by his cited subsequent testimony. We note that, even with Patent Owner’s arguments, the record is clear that Patent Owner was on notice of Petitioner’s proposed definition of the level of ordinary skill at the time of the Petition. Pet. 6; cf. Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1006 (Fed. Cir. 2023) (holding that Petitioner is not required to anticipate all arguments in its Petition and allowing consideration of reply where patent owner had sufficient notice of petitioner’s position and adequate opportunity to respond).” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“explained below, we agree with Petitioner that Patent Owner’s additional requirement of evaluating the calibration data to determine the boundaries of the area represented by a grid point should not be included in the construction of either “grid point” or “non-uniform grid point.” Instead, based on the full record, we discern no reason to alter our prior construction of “grid point” as “a point associated with representative calibration data for an area” and maintain that construction for this Final Written Decision.” slip op. at 27
Patent outcomesUS 8,786,494 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,786,494 - Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentablePTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30
Patent outcomesUS 11,672,803 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,672,803 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13
- BurdenDecided for petitioner
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730
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.