- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.
RulingsFinal written decision- Additional discoveryAdditional discovery, deniedDenied
“Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56
Patent outcomesUS 12,054,758 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and 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 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). 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 the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and 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 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Resmed Corp. v. Cleveland Medical Devices, Inc.All claims unpatentablePTAB · Jun 29, 2026 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 15–29 are unpatentable as obvious over the asserted combinations; the contingent motion to amend claims 30–41 is denied for lack of written-description support.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, ResMed Inc., as a real party in interest. Paper 39. Petitioner filed an opposition. Paper 42. Patent Owner filed a reply. Paper 43. We denied the Motion to Terminate. Paper 51.” slip op. at 3
- Skill levelSkill level board ownOther
“understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44); PO Resp. 4. 9 Patent Owner does not assert any objective indicia of nonobviousness. See generally PO Resp. 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.4. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner does not persuade us to construe the term as “a value [or calculated value] that indicates how dire a patient’s symptoms are.” Patent Owner points to nothing in the intrinsic record that purportedly supports this construction, and we agree with Petitioner that “the patent specification’s disclosures regarding determining a level of symptom severity are broad, establishing that it can generally be derived from any sensor data and/or breathing events.” Pet. Reply 3–4; see also Ex. 1001, 3:44–46 (“Signals from the[] sensors are then analyzed to determine the level of severity of the symptoms of the subject’s sleep disorder.”). Patent Owner relies only on expert declarations to support its construction. But as indicated by the Federal Circuit, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable here, where neither Dr. D’Ambrosio’s nor Dr. Schwartz’s declaration was prepared for this proceeding, and neither declarant was subject to cross examination on their opinions. Moreover, neither of the declarants was opining on claim construction; rather, they were addressing indefiniteness and/or written description issues. See Ex. 1058 at 7 (heading addressing definiteness); Ex. 2026 at 18 (heading addressing written description). Further, Dr. Schwartz appears to have been making an argument about certain patent claims (not the challenged ’333 patent) based on Patent Owner’s own statements made during prosecution of a separate patent application. See Ex. 2026 ¶ 47 (“[T]he similar term used in the ’284 patent claims (‘data of severity of sleep disorder symptoms’) does not find written description support in the specification by a disclosure of the same statistics disclosed in Wright, because CleveMed argued those statistics are not related to severity of sleep disorder symptoms.” (emphasis added)). Patent Owner has not persuaded us that Dr. Schwartz’s testimony has direct applicability to the claim term at issue here. Dr. Borkholder’s testimony is likewise unpersuasive. Aside from citing Dr. D’Ambrosio’s and Dr. Schwartz’s declarations, Dr. Borkholder cites Exhibits 2027 and 2016. These exhibits discuss indices such as AHI and RDI that are used to assess the severity of a patient’s symptoms, but Patent Owner has not adequately explained how they bear on construction of the claim term at issue here, which is not addressed in these exhibits. Ex. 2022 ¶¶ 32–33. Accordingly, we accord Dr. Borkholder’s claim construction opinions little weight, because they are unsupported by reference to objective, corroborating evidence of record. See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”).” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We find that Petitioner has the better argument. Tidal volume refers to “the volume of air that is inspired or expired during a respiratory cycle.” Ex. 2028, 13–14; PO Resp. 10. “[H]ypopnea events are defined as a reduction of ≥50 % or 74 % in tidal volume from baseline and apnea events as absence of tidal volume for at least 10s.” Ex. 2028, 13–14 (emphasis omitted). Toge teaches that a control unit analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. The calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. As Dr. Chatterjee explains: Toge discloses that tidal volume Fp is a quantified level of data because Toge discloses that Fp is monitored with respect to threshold values (id., [0051]) and because Fp is a function of Ft, Fa, and Fb, which are quantitative values. Toge discloses that tidal volume Fp is severity data because Toge discloses that tidal volume is indicative of whether the patient’s breathing warrants “emergency measures” (id., [0039]) and whether to “send an alert” in “an emergency where the patient’s breathing has drastically weakened” (id., [0055]). . . . . Because Toge discloses determining tidal volume (determine a quantified level of severity data) based on Ft, Fa, and Fb (id., [0035]), which corresponds to the subject’s condition (subject’s sleep apnea symptoms) while using the device (during the therapy) (id., [0036], [0037]), Toge discloses determin[ing] a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy. Ex. 1005 (Chatterjee Decl.) ¶¶ 122–125. Patent Owner’s attempt to dismiss tidal volume as a mere “breathing metric” is unavailing. First, Petitioner correctly “notes that in the paragraph PO cites to in Dr. Schwartz’s declaration, he indicates that breathing metrics are a level of severity data.” Pet. Reply 8 (citing Ex. 2026 ¶ 46 (“standard sleep disordered breathing metrics” [ ] were well validated indicators of the type and severity of sleep disordered breathing”)). Second, Dr. Kirkness explains that tidal volume represents the level of airway obstruction, e.g., apnea “is the most severe form of reduction in airflow [and] the absence of airflow results in quantified tidal volume of zero milliliters per breath.” Ex. 1003 (Kirkness Decl.) ¶¶ 157, 159; see also PO Resp. 10–11 (Patent Owner recognizing that an apnea is defined as absence of tidal volume for at least 10 seconds). The calculated tidal volume thus indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158; Pet. 15–16; Ex. 1044 (Toge) ¶ 39.” slip op. at 26
Patent outcomesUS 11,857,333 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,857,333 - Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentablePTAB · May 13, 2026 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–12 and 14–19 are unpatentable as obvious over the listed combinations; Petitioner’s motion to strike is denied.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“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.” slip op. at 7
- 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 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
Patent outcomesUS 10,876,108 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,876,108 - Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentablePTAB · May 12, 2026 · IPR2025-00026 · APJ Georgianna W Braden · IPR · Final written decision
Claims 1–10 are unpatentable: claims 1–3 and 5–10 are anticipated by Porreca and obvious over Schmitt and McCloskey; claims 4 and 7 are also obvious over the listed Illumina combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“On the initial trial record, we agreed with Patent Owner that one of ordinary skill in the art would have had experience with next generation sequencing, but were not persuaded that this would only be possible in the field of molecular biology. Instead, we found that a person of ordinary skill would have had either (1) a Ph.D. in the field of chemistry, molecular biology, or biochemistry or (2) a B.S. or M.S. degree with three to five years of experience working in any of those fields. Inst. Dec. 8. We specifically found that “[t]he person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned.” Id. at 8–9. Patent Owner now submits that it does not dispute the definition of a person of ordinary skill in the art as laid out in the Institution Decision. PO Resp. 13. Reviewing the entire trial record, we maintain the same definition of a person of ordinary skill in the art and note that it is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that the skill level does not affect our analysis or our final decision.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In the Institution Decision, the Board adopted Petitioner’s construction of the term “adaptor.” Inst. Dec. 9. Patent Owner does not dispute this construction. PO Resp. 13–14. During oral argument, Petitioner argued that claim 1 requires “an adapter to be ligated onto a target DNA, and that adapter needs to have two different sequences of DNA that are used for identification” including a “socalled identifier that's one to eight nucleotides in an indexing site.” Tr. 6:19–7:2. Patent Owner, again, did not dispute this characterization of “adaptor.” See generally Tr. Based on the entirety of the trial record, we continue to apply Petitioner’s construction of the term “adaptor,” although we note that it does not affect our analysis.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Based on the entirety of the trial record, we do not agree with Patent Owner’s reading of either the claims or the prior art because Patent Owner takes too narrow a view of both. First, based on the plain language of Porreca, we find it uses a combination of the sequence reads of the target sequence and differentiator tag sequences to determine whether there is duplication. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. All that the claim requires is that the method identifies sequence reads with identical identifier and target sequences as duplicates. Because claim 1 contains the transition “comprising,” the claim is still satisfied if the category of identified duplicate reads contains identical labels and also contains more. Patent Owner admits that the identifier and target sequence do not have to be used simultaneously. Tr. 46:16–48:4. Instead, Patent Owner challenges whether Porreca uses the required elements in combination as recited in the challenged claims. Based on the record before us, we agree with Petitioner’s position especially in view of the open-ended nature of the claims and Patent Owner’s own admission that there is no temporal requirement for the use of target sequences and differentiator tag sequences. Specifically, we find that Porreca teaches using the combination of the target sequences and the differentiator tag sequence to determine whether particular sequence reads are unique or PCR duplicates. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. The use of both such sequences meet the claim limitations. This finding is consistent with the prosecution history of the ’357 patent and how the applicant and examiner interpreted the claims. See Ex. 1013, 69–70, 78–79. Second, we find the disclosure of Porreca sufficient to demonstrate to an ordinarily skilled artisan that “collapsing” is done by comparing target sequences and differentiator tag sequences. Porreca specifically explains that: after multiple reads have been collected for a given locus, it is possible that due to bias (e.g., caused by PCR amplification steps), a large fraction of the reads are derived from a single originating molecule. This would skew the population of target sequences observed, and would affect the outcome of the genotype call.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We do not agree with Patent Owner for at least two reasons. First, Patent Owner fails to address the fact that Schmitt cites to McCloskey 2007. We find that the citation of McCloskey 2007 in Schmitt indicates that the ordinarily skilled artisan would have considered the teachings of McCloskey to be highly relevant to the teachings of Schmitt and would have considered them to be both useful in the field of sequencing. See Ex. 1005 ¶ 6. Second, Patent Owner fails to explain or even identify the purported structural differences between Schmitt and McCloskey that would prevent the teachings of McCloskey from being relevant to Schmitt. In addition, we credit the testimony of Dr. Metzker that one of ordinary skill in the art would have understood the benefits of adding a barcode to target sequences and would have looked to McCloskey and the batch-stamps it teaches because both Schmitt and McCloskey are in the same field and address the same problems. See Ex. 1003 ¶¶ 110, 114. Accordingly, we find that Petitioner has demonstrated by a preponderance of the evidence that a person of ordinary skill in the art at the critical time would have had sufficient reason to combine the teachings of Schmitt and McCloskey to arrive at challenged claim 1.” slip op. at 48
Patent outcomesUS 11,098,357 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,098,357 - Ascentcare Dental Product, Inc. v. Solmetex, LLCInstitution deniedPTAB · Dec 12, 2025 · IPR2025-01175 · APJ James A Tartal · IPR · Institution
The Board denied institution because Petitioner did not sufficiently show the patent was eligible for IPR when it filed the petition less than two months after issuance.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“We determine that Petitioner cannot credibly certify that the ’418 patent is available for inter partes review, based on a claim of priority on the face of the ’418 patent to the ’939 provisional application filed prior to the effective date of the AIA, where, as here, Petitioner contradictorily contends in the Petition that the ’939 provisional application “does not support all claim limitations” of the ’418 patent.4 Id. If Petitioner’s allegation that claims of the ’418 patent are not supported by the ’939 provisional application is correct, then the ’418 patent would be a post- AIA patent for which a petition may not be filed earlier than 9 months after the ’418 patent issued. See 35 U.S.C. § 311(c). Thus, based on the arguments and evidence presented by Petitioner, Petitioner fails to show that the ’418 patent is eligible for inter partes review when Petitioner filed the Petition less than two months after the ’418 patent issued. 35 U.S.C. § 311(c), 37 C.F.R. § 42.102(a)(1). We, therefore, deny the Petition. IV. CONCLUSION For the foregoing reasons, we find that Petitioner has not shown sufficiently that the Petition complies with 35 U.S.C. § 311(c) and, therefore, deny the Petition.” slip op. at 10
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportNot reached
“review when the Petition was filed “because the ’418 Patent claims priority to December 7, 2012 and is therefore,” not a post-AIA patent. Pet. 17 (emphasis added). Contrary to Petitioner’s assertion, the ’418 patent is a post-AIA patent if any claim of the ’418 patent does not have priority to the ’939 provisional application, regardless of whether, on its face, the ’418 patent “claims priority” to an application filed prior to the effective date of the AIA. See In re NTP, Inc., 654 F.3d 1268, 1276–77 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.”).” slip op. at 9
§ 102 anticipationPatents in suitUS 12,290,418 - Clearcorrect Operating, LLC v. Align Technology Inc.Institution deniedPTAB · Oct 23, 2025 · IPR2025-00815 · APJ Cynthia M Hardman · IPR · Institution
The Board denied institution because ClearCorrect did not show a reasonable likelihood that claims 1–24 would have been obvious over Chishti-511, Chishti-876, Sachdeva, and Becker.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“3. Analysis In view of the arguments and cited evidence, we find on this record that Petitioner has not demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine Becker’s round-tripping with the teachings of the Chishti patents and Sachdeva.” slip op. at 20
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Neither party indicates that any other claim term requires express construction. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no other claim term requires construction.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITA
“Court for the Western District of Texas (see supra Section I.B), they jointly adopted the definition of “round-tripping” set forth in the ’879 patent Specification. Pet. 9; Prelim. Resp. 8; Ex. 1013, 8. The ’879 patent Specification defines “round-tripping” as moving a first tooth out of the path of a second tooth, and once the second tooth has moved sufficiently, moving the first tooth back to its previous position before proceeding to a desired final position of that first tooth. See Ex. 1001, 13:9–13. We adopt this agreed-upon construction for purposes of this Decision.” slip op. at 9
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,524,879 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Jun 13, 2025 · IPR2025-00160 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–5, 7, 8, 10–13, 15–18, and 20–31 because ResMed showed a reasonable likelihood of proving at least one challenged claim obvious.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherDenied
“We are not persuaded by these arguments. We are aware of no regulation, rule, case law, or Office guidance that prohibits a party from filing both an ex parte reexamination and an inter partes review, or deems doing so “an abuse of the patent system” or a due process violation. Prelim. Resp. 7–8. Indeed, the Office has previously permitted parallel reexaminations and inter partes reviews, even when filed by the same party. See, e.g., CBS Interactive et al. v. Helferich Patent Licensing, IPR2013- 00033, Paper 15, 2 (PTAB Nov. 6, 2012) (“four of the five Petitioners [in the inter partes] are also the third-party requesters who filed the request for reexamination”); Arctic Cat, Inc. v. Polaris Indus. Inc., IPR2015-01781, Paper 78, 2 (PTAB Sept. 25, 2018) (denying patent owner’s motion to stay or terminate ex parte reexamination 90/013,999, which was filed by same petitioner in the related inter partes review); Emerson Electric Co. v. Sipco, LLC, IPR2017-00359, Paper 62, 5, 19 (PTAB Mar. 21, 2019) (declining to terminate two ex parte reexaminations filed by a party who previously filed an inter partes review on the same patent). The Office’s April 2019 Notice Regarding Options for Amendments by Patent Owner Through Reissue or Reexamination During a Pending AIA Trial Proceeding provides information as to how the Office may handle parallel reexamination and AIA proceedings involving the same patent. See 84 Fed. Reg. 16,654, 16656–58 (Apr. 22, 2019). The existence of this Notice indicates that there is nothing per se improper about parallel ex parte reexaminations and inter partes reviews. Accordingly, on this record, we are not persuaded to discretionarily deny this Petition based on” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“We find that although the parties engaged in some discovery and briefing in the Ohio case, the bulk of the work remains, including the completion of fact discovery, expert discovery, motion practice, trial preparation, and trial. Additionally, prior to the stay, the district court had not issued orders related to claim construction or the validity of the ’680 patent. Accordingly, the relatively minimal investment in the Ohio case weighs against exercising discretion to deny institution. Fintiv, Paper 11, 10.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A patent claim is unpatentable for obviousness if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). In Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966), the Supreme Court set out a framework for assessing obviousness that requires consideration of four factors: (1) the “level of ordinary skill in the pertinent art,” (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of nonobviousness such as “commercial success, long felt but unsolved needs, determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20. 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 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“On this record, these arguments are unavailing. “[A] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate a motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Thus, even if Patent Owner is correct that the proposed combination would no longer have the ability to push information directly to physician-side client devices, or would have duplicative storage, this does not necessarily obviate Petitioner’s proffered motivations to combine, which we find sufficient for purposes of institution.” slip op. at 36
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,786,680
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.