- Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision
Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17
Patent outcomesUS 11,591,393 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,591,393 - PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“To accord substantial weight to evidence of secondary considerations, it “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.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16
- Skill levelSkill level board ownDecided for petitioner
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. 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. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,036,012 - Kinderfarms LLC v. Genexa Inc.All claims unpatentablePTAB · Mar 24, 2025 · PGR2023-00051 · APJ Deborah Katz · PGR · Final written decision
Claims 1–24 are unpatentable as obvious under § 103 over FR458 with the ’4666 patent and WO133; claims 1–17 are also unpatentable over WO742 with the ’4666 patent and WO133.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The parties’ positions about the level of ordinary skill in the art are similar. (See Pet., 13–14; see PO Resp., 10–12.) In light of the parties’ arguments and evidence, we determine that the ordinarily skilled artisan would have had a bachelor of science degree in a relevant life sciences field, such as chemistry, biochemistry, or pharmacy, with at least three to four years of work or laboratory experience in pharmaceutical formulations and would have had access to team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals. (See Pet. 13–14; see PO Resp. 10–12; see Dec. 6–7.) Both of the parties’ proposals as to the level of ordinary skill in the art are consistent with the disclosure of the ’795 patent and the asserted prior art. The distinction between the parties’ proposals is minimal and would not change the outcome of this Decision. Thus, we adopt and apply Patent Owner’s proposal.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Although Petitioner puts forth constructions for terms in the claims of the ’795 patent, Patent Owner argues that we need not expressly construe any terms to resolve the controversy between the parties. (See Pet. 14–19; see PO Resp. 12.) Except as indicated below, we agree that express construction of the claim terms is not required because the parties do not materially dispute the meanings of the terms. 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))). Limitation (c) of claim 1 recites “syrup formulation” once and then “syrup” by itself twice. The parties agree that two recitations of “syrup” by itself mean and are synonymous with “syrup formulation.” (See Tr. 15:16– 19 (counsel for Petitioner: “[T]he term, syrup, by itself, means the formulation. And for that reason, we--it’s our position that it’s the syrup formulation that has the specific viscosity requirements as well as the other features that we discussed.”); 31:17–20 (counsel for Patent Owner: “But those wherein clauses, what it’s referring to, the syrup formulation and the syrup -- it was all to a complete to a final formulation, right, it’s not just the agave syrup. Everybody here recognizes and understands that from that perspective.”).) Thus, the parties agree that the “viscosity of less than 1500 centipoise at about 22 degrees” limits the final “pharmaceutical syrup formulation for oral administration,” not the “agave syrup” limitation in limitation (b) of claim 1.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues further that Dr. Crowley testifies that, “[g]enerally, suspensions having a viscosity in the range of 20 to 150 cP are considered readily pourable,” but that this range is well below the viscosity range of 200–900 cP taught in WO133 and the preferred viscosity range of 1000–3000 cP taught in the ’4666 patent. (See PO Resp. 45 (quoting Ex. 1003 ¶ 59).) Dr. Crowley testifies that “increasing the viscosity of a suspension formulation has been shown to impair the dissolution characteristics of immediate release acetaminophen” and that, “[w]ith respect to suspensions for oral administration, having a higher viscosity is generally not desirable.” (Ex. 1003 ¶ 59.) According to Patent Owner, this is a “teaching away” because Petitioner’s own expert testimony demonstrates a motivation not to combine the acetaminophen formulation of FR458- Example 1 with the 1000-3000 cP range of the ’4666 patent and the 200-900 cP range of WO133 since by his own admission doing so would yield bad results (i.e., impairing the dissolution characteristics of the acetaminophen) and generally undesirable higher viscosity. (PO Resp. 46 (citing Berkland Decl., Ex. 2009 ¶ 148).) Dr. Crowley’s cited testimony, however, is about general characteristics of suspensions for oral administration, whereas the WO133 refers specifically to sweetened analgesic formulations. (See Ex. 1006, 8:1– 3 (“The viscosity of the acetaminophen composition generally ranges from about 200–900 centipoise, preferably from about 300–700 centipoise.”); see Pet. Reply 8–9.) As Petitioner notes, Dr. Crowley also testifies that the viscosity of 29 commercially available, pediatric liquid oral antibiotic formulations were measured and determined to range from 20 to 1,780 cP” and that “[t]he viscosity of Children’s Tylenol has been reported to be less than 1,000 centipoise at shear rates between 0.05 and 0.2 reciprocal seconds.” (Ex. 1005 ¶ 58.) Thus, we are not persuaded that Dr. Crowley’s testimony contradicts the teachings regarding viscosity of analgesic formulations in the cited prior art.” slip op. at 23
Patent outcomesUS 11,617,795 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 11,617,795 - PTAB · Sep 23, 2024 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–4, 6–10, and 12–15 on all petitioned grounds, finding a reasonable likelihood of success on at least one challenge and declining Fintiv denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–4, 6–10, and 12–15 of the ’975 patent are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Obviousness is determined by looking to the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art resolved. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“pending Maryland litigation has been stayed in its entirety pending resolution of IPR2024-00240, which involves a related patent that is also involved in the litigation. Reply, 1 (citing Order in Maryland litigation, dated June 29, 2024, Ex. 1100, 1); see Sur-Reply, 1 (acknowledging “the recent stay of the parties’ co-pending litigation involving the ’975 Patent.”). In its Memorandum Opinion, the court acknowledged that inter partes reviews of additional patents involved in the litigation could be instituted. See Ex. 1101, 3. Accordingly, the first Fintiv factor weighs heavily in favor of not exercising discretion to deny institution of inter partes review. Because of the stay, the second and third Fintiv factors also weigh heavily in favor of not exercising discretion to deny institution of inter partes review. The stay indicates that the court’s trial date will not be close to the Board’s projected statutory deadline for a final written decision and that neither the court nor the parties will invest further in the parallel proceeding. See Fintiv, at 6 (“A district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts. This fact has strongly weighed against exercising the authority to deny institution under NHK.”); see also Memorandum Opinion in Maryland litigation issued June 29, 2024, Ex. 1101, 2 (noting that the” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,325,975 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentablePTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9
- Expert testimonyDecided for petitioner
“several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11
Patent outcomesUS 8,642,012 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,642,012
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.