• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,672,803
• Innoscience (Zhuhai) Technology Company, Ltd / Innoscience America, Inc. v. Efficient Power Conversion CorporationAll claims unpatentable
  PTAB · Mar 18, 2025 · IPR2023-01381 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 1–3 and 7–9 are unpatentable as obvious over Uemoto and Smith; the motion to amend is granted, and proposed substitute claims 13 and 14 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In order to determine whether an invention would have been obvious at the time the application was filed, we consider the level of ordinary skill in the pertinent art. Graham, 383 U.S. at 17. In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quotation omitted). Petitioner contends a person of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering, chemical engineering, physics, or material science, or a closely related field, and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies.” Pet. 5–6. Petitioner contends “[a]dditional education could substitute for professional experience and vice versa.” Id. at 6. Patent Owner contends that a person of ordinary skill in the art would have had “at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” PO Resp. 7 (citing Ex. 2009 ¶ 82). Upon review of the evidence of record and the parties’ arguments, we adopt Petitioner’s definition of the person of ordinary skill in the art as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). We note, however, that the conclusions reached in this Decision would be the same under either proposed definition of the ordinarily skilled artisan. See Ex. 2009 ¶ 83 (Dr. Schubert testifying that his opinions would be the same under either proposed definition); Ex. 1033 ¶ 9 (Dr. Shealy testifying that the differences in proposed definitions of the ordinarily skilled artisan “would not change the outcome of the invalidity analysis in any material manner”); PO Resp. 7; Pet. Reply 1.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “compensated GaN layer above the barrier layer, and a gate contact above the compensated GaN layer.” Ex. 1001, 5:12–18. Petitioner contends the term “compensated” indicates that the step of compensating the GaN layer has already occurred, such that the term “compensated GaN layer” should be construed as a “‘[d]oped GaN layer formed with a step to passivate its impurities’ which is a ‘product-by-process’ limitation.”5 Pet. 12–14. And, because compensation with hydrogen was the “critical step” distinguishing the claims from the prior art, and because hydrogenation in as-grown III-nitride materials had been well known for over a decade by 2009, Petitioner contends “compensated” “cannot be interpreted as mere hydrogen presence in as-grown material, a well-known property of doped GaN.” Id. at 15. Patent Owner contends “compensated GaN material” should be construed as “a semiconductor GaN gate material in which one type of impurity (for example, donor) cancels the electrical effects of the other type of impurity (for example, acceptor).” PO Resp. 11 (citing Ex. 2009 ¶ 92) (emphasis added). Patent Owner contends this construction is consistent with the IEEE dictionary, which defines “compensated semiconductor” as 5 Given that product-by-process steps in a device claim are not entitled to patentable weight, Petitioner contends “the prior art only need show a material with passivated impurities to show unpatentability, not the step to achieve it.” Pet. 15–16. “[a] semiconductor in which one type of impurity or imperfection (for example, donor) partially cancels the electric effects of the other type of impurity or imperfection (for example, acceptor).” PO Resp. 14 (quoting Ex. 2004). Patent Owner contends its construction is also consistent with the written description of the ’294 patent, which explains that a compensated GaN material is part of the gate and includes a p-type impurity that imparts an electrical effect (i.e., conductivity), as well as a second impurity, e.g., hydrogen, that partially cancels the electrical effect of the p-type impurity, rendering the layer semi-insulating. Id. at 14–15 (citing Ex. 1001, 3:10–13, 3:43–45). On this record, we construe “compensated GaN layer” as “a GaN layer in which one type of impurity (for example, donor) partially cancels the electric effects of the other type of impurity (for example, acceptor).” This is consistent with the disclosures of the ’294 patent, the IEEE dictionary definition, and the construction ultimately adopted by the ITC. Ex. 2004, 3; Ex. 1049, 16–17 (ITC construing “compensated GaN layer” to mean “a GaN layer in which one type of impurity partially cancels the electrical effects of another type of impurity”); Ex. 1001, 3:43–45 (explaining that the compensated GaN layer of the ’294 patent is formed through the “passivation of a p-type impurity using hydrogen”). For the reasons set forth below, however, we decline to construe “compensated GaN layer” as a product-by-process claim term (as asserted by Petitioner), or to limit the compensated GaN layer to a gate material (as asserted by Patent Owner).” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

    “There are two exceptions to the general rule that we apply the ordinary and customary meaning of a claim term: (1) when a patentee sets out a definition and acts as his own lexicographer, or (2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution. See Thorner, 669 F.3d at 1365. The standards for lexicography and disclaimer, however, are “exacting.” Id. at 1366. There is no argument that the patentees acted as their own lexicographer to redefine the term “compensated GaN layer.” With respect to disavowal, a “patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Thorner, 669 F.3d at 1366 (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002)). As noted by Patent Owner, the title of the ’294 patent is, in part, “Compensated Gate MISFET” and much of the discussion of the ’294 patent is of a compensated GaN layer that is directly below the gate contact and above a barrier layer and operates in conjunction with the gate contact to control the on/off state of the transistor. PO Resp. 12–14. We are presented with insufficient argument or evidence to conclude, however, that these disclosures rise to the level of a disclaimer. For example, although the title of the ’294 patent is directed to a “Compensated Gate MISFET,” claim 1 is more broadly directed to “[a] column III Nitride transistor.” Ex. 1001, 5:12, code (54). Nor are we directed to an expression or statement of manifest exclusion in the ’294 patent that would serve to disclaim any “compensated GaN layer” that is not directly below the gate and/or that does not function in concert with the gate electrode to control the on/off state of the transistor. See Thorner, 669 F.3d at 1366. With respect to the stated goals of the invention, as noted by Patent Owner, one of the primary purposes of the compensated GaN layer of the ’294 patent is to reduce gate leakage and gate capacitance. Ex. 1001, 2:13– 19, 3:18–21 (“[U]sing a compensated semiconductor layer 38 leads to low gate leakage during device operation.”). We cannot use the goals of the invention, however, to rewrite the claims or insert terms that are not present. See Thorner, 669 F.3d at 1366. Moreover, the prior art of record indicates that a compensated GaN layer that is below the gate contact and above a barrier layer, but not part of the active gate structure, may also “decrease the leakage current between the gate and the drain.” Ex. 1006 ¶¶ 44 (“Even when a positive bias of 5 V or higher is applied to the gate electrode, no significant gate-leakage current is observed.”), 61. As such, evidence of record suggests that a person of ordinary skill in the art would have understood that one of the primary goals disclosed in the ’294 patent is achieved regardless of whether the compensated GaN layer is part of the gate, or simply in close vicinity to the gate. In view of the foregoing, we are not persuaded that the written description of the ’294 patent indicates that the “compensated GaN layer” must be part of the gate structure.” slip op. at 17

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “To be probative, Patent Owner must prove there is a nexus between the presented evidence and the merits of the claimed invention. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A rebuttable presumption of nexus applies when the “patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco, 851 F.2d at 1392). “That is, presuming nexus is appropriate ‘when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.’” Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). If the praise is not limited to the features of the claimed invention, the patent owner may still prove nexus “by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Patent Owner contends that the compensated gate of the ’294 patent “was a breakthrough invention and resulted in the first commercially viable enhancement-mode GaN transistor.” PO Resp. 60 (citing Ex. 2009 ¶¶ 192– 193, 197; Ex. 2021). Patent Owner further contends that this achievement required the counter-intuitive use of a compensated gate material in the gate structure, and represented “a technological leap that laid the foundation for viable enhancement-mode GaN transistors.” Id. at 61–62. For this achievement, Patent Owner contends the inventor, Dr. Alex Lidow, received the 2015 SEMI Award. Id. at 60 (citing Ex. 2021). Upon review of Patent Owner’s evidence and the parties’ arguments, we find that Patent Owner’s objective indicia evidence is entitled to little, if any, weight. The evidence of praise relied upon by Patent Owner is not clearly linked to the claimed invention or any particular product having each of the claimed features of the ’294 patent. Ex. 2021. For example, the 2015 SEMI award was provided to Dr. Lidow “for commercialization of GaN power devices.” Id. An article explaining the award indicates that “high cost” previously “limited [the] commercial success” of GaN technologies, but Dr. Lidow was able to overcome these issues, “from resolving packaging limitations to establishing a low-cost supply chain,” “through persistence.” Id. This praise is not demonstrably linked to the claimed invention or any particular device, and does not mention the use of a compensated gate, or any other relevant feature recited in the claims. In view of the foregoing, we determine that Patent Owner’s objective evidence of non-obviousness is entitled to little, if any, weight.” slip op. at 20

  Patent outcomesUS 8,350,294 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,350,294
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54

  • ExcludeMotion to exclude, deniedMixed

    “with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11

  Patent outcomesUS 11,007,201 unpatentable
  § 112 disclosurecites Phillips
  Patents in suitUS 11,007,201
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision

  Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10

  • Strike new argumentOther

    “Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56

  Patent outcomesUS 10,849,908 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,849,908
• Nespresso USA, Inc. v. K-Fee System GmbHAll claims unpatentable
  PTAB · Sep 10, 2024 · IPR2023-00485 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 1–10 are unpatentable as obvious over the combined disclosures of Yoakim, Jarisch, Rossi, and Castellani.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

    “have a bachelor’s degree in engineering plus five years of experience in design of mechanical beverage systems, or similar products.” Pet. 31 (citing Ex. 1003 ¶ 40). In the Institution Decision, we preliminarily determined that a person of ordinary skill in the art “would have a bachelor’s degree in engineering plus five years of experience in design of mechanical beverage systems, or similar products, as well as experience with sensors for recognizing an identifier.” Inst. Dec. 8 (emphasis added). Neither party disputes this conclusion. PO Resp. 9; see generally Pet. Reply. As such, we adopt our preliminary definition of the ordinarily skilled artisan for purposes of this Final Written Decision.” slip op. at 8

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “designing medical devices and components, and that those experiences represent work designing products similar to mechanical beverage systems, Patent Owner fails to direct the Board to evidence sufficient to establish that this experience, in the aggregate, amounts to at least “five years” or involved “experience with sensors for recognizing an identifier.” Inst. Dec. 8 (adopting Patent Owner’s own proposed definition of one of ordinary skill in the art); see Sur-reply 3–4 (citing Ex. 1066, 34:16–35:9; Ex. 1067, 101:3– 12, 102:20–104:9; Ex. 2017 ¶¶ 3–4, 8–10) (failing to establish adequately, if at all, how Dr. Howle’s qualifications include the requisite minimum five-year period of relevant design experience). Accordingly, we determine that Dr. Howle is not qualified to offer expert testimony from the perspective of a person having ordinary skill in the art in this proceeding.10 See Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). The Federal Circuit has explained that “[t]o offer expert testimony from the perspective of a skilled artisan in a patent case,” including the issue of patent “validity,” the “witness must at least have ordinary skill in the art.” Id. (Board’s emphasis). “Without that skill, the witness’[s] opinions are neither relevant nor reliable.” Id. at 1377.” slip op. at 13

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “Second, Patent Owner and Dr. Howell assert that a person of ordinary skill in the art “would have understood upon reading the second German application that the capsule features described would be intended to be combinable with each of the described embodiments.” PO Resp. 40; Ex. 2017 ¶ 61. But Patent Owner and Dr. Howell do not explain how a barcode could be used in the devices depicted in Figures 16–18, which place the detection means 2.4.2 on the outer circumference of the flange (not its underside) and rely on toothed-rings physically interacting with either the chamber, retaining arms, or a pinion. Ex. 1047, 12:22–31, 13:8–18. Indeed, the second German priority application explains that means 2.4.2 physically interacts with retaining arms 30 (embodiments of Figures 16 and 17) or a pinon (embodiment of Figure 18), and if means 2.4.2 were not present in these embodiments the capsule would either “drop through into a waste container” or could not be inserted through the insertion shaft. Id. at 12:22– 27, 13:9–12, 13:16–35 (noting that in the embodiment disclosed in Figure 18 a pinon interacts with means 2.4.2 and only when means 2.4.2 “is formed complementary to the teeth of the means” can the capsule be inserted). At no point does the second German application identify means 2.4.2 as a barcode or suggest a barcode could be used as the detection means. The second German application also states that A person skilled in the art is also aware that for example the insertion shaft may also contain a sensor, for example a camera, clear, however, that element 27 is part of the brewing chamber, and not the capsule. Ex. 1047, 12:27–31, 13:5–8, 13:21–26, 15:36. Thus, we are not persuaded that the toothed ring is in fact on the bottom side of the flange. which senses the shape of the means 2.4.2. For example, it would be possible, in the present case, for the shape of the teeth and/or the spacing between the same to be sensed. This signal, in turn, is passed to a control means, which frees, for example, the brewing chamber if the capsule is the correct one. Ex. 1047, 14:11–19. Again, despite using a camera to determine if a capsule is “the correct one,” the second German application does not suggest using a barcode in place of the toothed-ring structure, or suggest moving the location of the detection means 2.4.2 from the outer surface to the underside of the flange. This reinforces that the inventors did not contemplate using a barcode in the embodiments depicted in Figures 16–18.” slip op. at 23

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “As asserted by Petitioner, Jarisch teaches how to move a code in a centrifugal brewing system to the bottom of the flange and how to configure a light-conductive material so that the detector’s light source will reach the bottom of the flange. Pet. 48–49; Pet. Reply 23–24 (Ex. 1003 ¶¶ 184–185; Ex. 1005 ¶¶ 82–84, Fig. 5). And, although Figure 61 of Yoakim discloses a flare in its brewing chamber, bodily incorporation is not required, and we are directed to no persuasive argument or evidence that Yoakim could not be configured with a straight chamber, as generally depicted in Figure 5 of Jarisch. Pet. Reply 24 (noting that Dr. Howle’s testimony on this subject is “conclusory” and depends on “bodily incorporation”). As such, we credit the testimony of Mr. Jobin that a person of ordinary skill in the art would have sought to place the code at the bottom of the flange and would have had a reasonable expectation of success in so doing.17 Ex. 1003 ¶ 184. Patent Owner further contends that Yoakim requires that the capsule holder be capable of receiving a set of multiple volume capsules and that 17 As discussed above, Mr. Jobin has extensive experience in the design of brewing devices. Conversely, Dr. Howle has limited experience in this field and is not one of ordinary skill in the art. Although Mr. Jobin’s testimony is more persuasive regardless of the discrepancy in experience between the two declarants, when this difference in design experience is considered, it only serves to increase the weight we give to Mr. Jobin’s testimony. there is a “snug fit” to avoid “unbalances.” PO Sur-reply 8 (citing Ex. 1004 ¶¶ 205, 479, 484, 507, 512). According to Patent Owner, Petitioner does not explain adequately how the use of Jarisch’s “straight chamber” with a capsule holder that does not engage with the side wall of the capsule would allow insertion of the multiple volume capsules or permit a “snug fit.” Id.; PO Resp. 28. Patent Owner’s assertion that Yoakim discloses the use of certain capsules that might not fit into a device with Jarisch’s non-flared structure is ineffective to undercut the sufficiency of Petitioner’s showing on this point. As noted by Patent Owner, Yoakim discloses the use of certain capsules which might not fit into a device with Jarisch’s non-flared structure. But Petitioner is not seeking a bodily incorporation of Yoakim and Jarisch, and other embodiments of Yoakim do not require the type of flared capsule identified by Patent Owner. Ex. 1004, Fig. 63. Moreover, we are directed to no persuasive evidence that Jarisch’s lack of contact between the capsule side wall and the holder would render the device inoperable or even less effective. Id. (citing Ex. 2019, 36:18–37:6; Ex. 1005 ¶ 23 (Jarisch explaining that its device includes a capsule holding means and that the capsule may be successfully driven in rotation). As such, we credit the testimony of Mr. Jobin that one of ordinary skill in the art would have understood how to design the chamber of Yoakim to allow reading of a barcode on the underside of the flange and that this design would allow for successfully receiving single-serve capsules and driving them in rotation. Ex. 1003 ¶¶ 182–184; Ex. 1005 ¶ 23.” slip op. at 39

  Patent outcomesUS 11,230,430 unpatentable
  § 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,230,430
• Chongqing Yanmei Technology Co., Ltd. v. Terves, LLCSome claims unpatentable
  PTAB · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with the prior art of record.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written Decision. 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 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

    “The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22

  Patent outcomesUS 10,689,740 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · Nautilus
  Patents in suitUS 10,689,740
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. 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 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28

  Patent outcomesUS 9,956,087 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,956,087
• Beigene USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCInstituted
  PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution

  The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,672,803
• Guardant Health, Inc. v. University Of WashingtonAll claims unpatentable
  PTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition 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.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18

  Patent outcomesUS 10,752,951 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,752,951

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.