• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,054,758
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.

  RulingsFinal written decision

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

    “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 ¶¶ 111–250 (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 ’590 patent.” slip op. at 56

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126

  • Additional discoveryAdditional discovery, deniedDenied

    “Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3

  Patent outcomesUS 12,060,590 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,060,590
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.

  RulingsFinal written decision

  • Director reviewDirector review, deniedDenied

    “Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3

  • Additional discoveryAdditional discovery, deniedDenied

    “(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “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. 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 ’035 patent.” slip op. at 53

  Patent outcomesUS 12,123,035 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,123,035
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Jan 7, 2026 · PGR2024-00043 · APJ Ryan H Flax · PGR · Final written decision

  Claims 1–39 are unpatentable under Grounds 1–10; Petitioner did not prove lack of enablement under Ground 11, and Patent Owner’s motion to exclude was denied.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “REAL PARTIES-IN-INTEREST Petitioner identifies Avation Medical, Inc. as the real party-in-interest. Pet. x. Patent Owner identifies EMKinetics, Inc. as the real party-in-interest. Paper 5, 1; Paper 6, 1. Neither party contests the other’s assertions on this. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the claimed invention would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices. Additional work experience could substitute for a formal degree and vice versa. Ex.1003, ¶21. Pet. 20 (citing Ex. 1003). Patent Owner does not contest this proposed definition or offer an alternative. See generally Resp. We accept and use Petitioner’s uncontested definition of the ordinarily skilled artisan, which appears to comport with the level of skill in the art reflected in the prior art of record and the ’943 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may]” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.200(b). In construing claims, district courts and the Board here, by default, give claim terms 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that, “no terms require construction for purposes of this Petition.” Pet. 21. Patent Owner presents no express position on claim construction. See generally Resp. We do not expressly construe any claim terms. E.” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “question, based on factual findings. VidStream, 981 F.3d at 1063–64. Moreover, public accessibility is the touchstone in determining whether a reference is a printed publication and such depends on whether the reference was available to interested, ordinarily skilled persons exercising reasonable diligence, which is determined on a case-by-case basis. Id. at 1065. Particularly pertinent here is that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” Id. Hulu (which cites VidStream on this issue) concerned, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. Hulu, 2021 WL 487622. Hulu holds that, although testimonial evidence is one way to prove public accessibility, there are also a variety of hallmarks of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at *10–13, 21. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established, and whether the reference’s “purpose of publishing . . . was ‘dialogue with an intended audience.’” Id. at *10–21 (citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)).” slip op. at 30

  Patent outcomesUS 11,844,943 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 11,844,943
• 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
• Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentable
  PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

  Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and 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

    “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

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

    “Finally, we are reminded that “a sufficient description of the genus . . . 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.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

  Patent outcomesUS 11,278,505 unpatentable
  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,278,505
• Danxiao Information Technology Ltd. v. Shenzhen Svakom Technology Co., Ltd.All claims unpatentable
  PTAB · Jan 19, 2024 · PGR2022-00050 · APJ Jason W Melvin · PGR · Final written decision

  Claims 1–20 are unpatentable: claims 1, 2, 4–9, 11, 12, 14–17, 19, and 20 are anticipated; claims 3 and 13 are obvious. The revised motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art would “have a bachelor’s degree in electrical engineering, software engineering, computer science, or a similar field with at least two years of experience related to development of software for distributed or networked applications.” Pet. 26 (citing Ex. 1006 ¶ 51). Patent Owner does not dispute or otherwise address Petitioner’s proposed level of ordinary skill. We adopt Petitioner’s definition, as it appears to be consistent with the ’041 patent’s description and the asserted prior art.” slip op. at 9

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

    “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that no term requires construction. Pet. 13. Patent Owner agrees “that all terms in the challenged claims should be given their plain and ordinary meanings” and does not propose any constructions under that standard. PO Resp. 8. We agree that no claim term requires express construction to resolve the disputes in this proceeding. slip op. at 9

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

    “Patent Owner contends that the 2019 Lovense System does not disclose “receiving the interactive result and controlling said adult toy to actuate according to the interactive result” in each independent claim, in particular pointing to the “according to the interactive result” phrase. PO Resp. 18–20.7 In Patent Owner’s view, under its plain meaning, “‘according to’ means ‘in a manner corresponding or conforming to; in proportion or relation to; in accordance with.’” Id. at 18. Thus, Patent Owner submits, in the claim “the system needs to issue control instructions to the adult toy such that the adult toy exhibits different actuations in a manner corresponding or conforming to different interactive results.” Id. Addressing Petitioner’s evidence, Patent Owner contends that, in the 2019 Lovense System, 7 Throughout its arguments, Patent Owner cites to the Declaration of Mingshao Zhang. In resolving the parties’ disputes, we have considered the extent to which Dr. Zhang’s opinions lend a persuasive viewpoint to Patent Owner’s arguments. “regardless of the interactive result of the dice roll, all the toys always actuate by vibrating for 3 seconds.” Id. at 19. Petitioner responds that the 2019 Lovense System “discloses the toy vibrating for different lengths of time, and at differing vibration speeds, in response to different dice rolls.” Pet. Reply 15. We agree. As Petitioner shows, the configuration instructions state that, “[y]ou, the model, well also set a prize for each dice roll number” and show a configuration in which each roll corresponds to a different actuation time. Ex. 1009-2, 51, 52. Patent Owner focuses on Exhibit 1010-1, in which the narrator discusses configuring “what each dice roll will do” and states that, in the displayed configuration, “you can see all toys are going to vibrate for three seconds.” Ex. 1010-1, 5:10–5:11; accord id. at 4:28–4:44 (“And then I’ve just checked all toys to react for three seconds.”). But the screens depicted show without ambiguity that each distinct roll is associated with a setting for reaction time. Id. at 4:28–4:44. Thus, the system depicted in Exhibit 1010 (the video) is consistent with Exhibit 1009, the configuration instructions. Based on the foregoing, we find the software is configured to actuate the toy according to the interactive result in the 2019 Lovense System.8 Patent Owner does not otherwise contest Petitioner’s anticipation challenge. We have reviewed Petitioner’s assertions, agree with them, and adopt them. Pet. 28–69; Pet. Reply 14–18. Accordingly, Petitioner has shown anticipation of claims 1, 2, 4–9, 11, 12, 14–17, 19, and 20 by the 2019 Lovense System.” slip op. at 10

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “Patent Owner challenges Petitioner’s reliance on Wiltshire, arguing that it “is not an analogous prior art to Olivares or the 2019 Video.” PO Resp. 22–23. The correct inquiry is whether Wiltshire is analogous to the ’041 patent. Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1377 (Fed. Cir. 2023). Petitioner asserts that Wiltshire is “in the field of online games of chance.” Pet. Reply 21 (citing Ex. 1020 ¶¶ 8, 11, 31–36). The ’041 patent states it is “directed methods and systems for interactive online adult entertainment.” Ex. 1001, 1:7–9; see Pet. Reply 20. As Petitioner’s expert points out, the ’041 patent includes “casino style games such as a ‘dice game’ and a ‘lottery game.’” Ex. 1020 ¶ 8 (citing Ex. 1001, Fig. 4). Petitioner’s expert also identifies that Wiltshire discloses “dice games (e.g., craps) and lottery games (e.g., keno), in addition to many other casino style games.” Id. (citing Ex. 1011, 1:25–45). We conclude that Petitioner has shown Wiltshire is in the same field as the ’041 patent and, at a minimum, reasonably pertinent to problems addressed in the ’041 patent. Namely, both the ’041 patent and Wiltshire address providing online versions of casino-style games. Thus, we find that Wiltshire is analogous art to the ’041 patent.” slip op. at 13

  Patent outcomesUS 11,134,041 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 11,134,041
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Memoryweb, LLCAll claims unpatentable
  PTAB · Nov 16, 2023 · PGR2022-00034 · APJ Kevin C Trock · PGR · Final written decision

  Claims 1–34 are unpatentable: claims 1–25 and 27–34 over Pogue and Engst, and claim 26 over Pogue, Engst, and Ripps.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Cir. 1986)) for its point is also misplaced. In re Hall stands for a different proposition, one which states that “competent evidence of the general library practice may be relied upon to establish an approximate time when a thesis became accessible.” Id. at 781 F.2d at 898. Although Pogue and Engst are not doctoral theses, the principal espoused in In re Hall is still applicable here. Ms. Munford’s testimony provides competent evidence of general library practices which can be relied upon to establish an approximate time when a printed publication became publicly accessible. Accordingly, we credit Ms. Munford’s testimony on general library practices and accept her testimony as credible that Pogue was made available to the public by the Carnegie Library of Pittsburgh shortly after acquiring it on January 21, 2009, and that Engst was made available to the public by the Illinois State University Library shortly after acquiring it on May 25, 2009. Ex. 1010 ¶¶ 8–13.” slip op. at 35

  • ExcludeMotion to exclude, deniedDenied

    “determination in this case. Accordingly, Patent Owner’s motion to exclude Exhibits 1030–1033 is denied as moot.” slip op. at 100

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “d) Conclusion on Independent Claims 1 and 29 We have considered the evidence and arguments with respect to” slip op. at 86

  Patent outcomesUS 11,163,823 unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,163,823
• Ironsource Ltd. v. Digital Turbine Inc.All claims unpatentable
  PTAB · Jan 4, 2023 · PGR2021-00096 · APJ Iftikhar Ahmed · PGR · Final written decision

  Claims 1–18 are unpatentable; the contingent motion to amend proposing claims 19–36 is denied, and the parties’ motions to exclude are denied in part and granted in part.

  RulingsFinal written decision

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'IneligibleUnpatentable

    “3. Analysis On the full record developed during trial, we are persuaded by Patent Owner’s argument. Petitioner’s analysis of the independent claims described above only loosely corresponds to the actual limitations recited in the claim. The Federal Circuit has “cautioned that courts ‘must be careful to avoid oversimplifying the claims’ by looking at them generally and failing to account for the specific requirements of the claims.” McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1313 (Fed. Cir. 2016) (quoting In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016)). Petitioner’s analysis of the claim limitations appears to do. Petitioner’s argument that “the essence of all the claims” is captured by a single claim element (f3) not only ignores that that limitation recites performing two specific software tasks simultaneously—which we are not persuaded is an abstract idea—but also asks us to disregard multiple technical aspects recited in the claims, such as identifying a link, determining whether an installation client is available on the device, invoking the installation client, and redirecting to the device an app store. See, e.g., Ex. 1001, 21:6–35. That is, under Step 2A of the Guidance, we are neither persuaded that limitation f3, which Petitioner points us to, recites an abstract idea (Prong 1), nor that the other limitations recited in the independent claims fail to integrate the alleged abstract idea into a practical application (Prong 2). Petitioner characterizes the claims as directed to multitasking, which Petitioner describes as representing a basic task in organizing human activity. Pet. 30. Although the Guidance recognizes certain methods of organizing human activity, including certain activity between a person and a computer, as constituting a patent-ineligible abstract idea, we are not persuaded that the claims here fall within the scope of such activity. See Guidance, 84 Fed. Reg. at 52 (listing fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior or relationships as organizing human activity); October 2019 Update at 5 (“this grouping is limited to activity that falls within the enumerated sub-groupings . . . , and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances”). The claimed invention may result in multitasking on the device, but the claims are directed to downloading and installing an application in the background instead of directing the user to an application, and do not recite an abstract idea. And although that process does result in improving user experience, the claims recite more than that mere result; they recite specific steps—invoking, without exiting the foreground software application, the installation client for downloading and installing applications on the device to run in the background—that accomplish the desired result. See Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1305–06 (Fed. Cir. 2018) (finding a method that employs a new kind of file in a computer security system directed to a non-abstract improvement in computer functionality, rather than the abstract idea of computer security writ large). Petitioner thus fails to establish sufficiently that the claims are directed patent ineligible subject matter under Step 2A of the Guidance. We also agree with Patent Owner that the challenged claims are somewhat similar to those that the Federal Circuit held patentable in DDR Holdings. The claims there were directed to a method of generating a composite webpage that combined visual elements of a host website with content from a third-party, e.g., by combining the logo, background color, and fonts of the host website with product information from a merchant. DDR Holdings, 773 F.3d at 1248. When a user clicked on a link on the host website, the system would construct the composite web page comprising a look and feel description from the host website along with content based on product information from the merchant’s product catalog. Id. at 1250. The court held those claims were not directed at an abstract idea because they addressed the problem of retaining website visitors that, absent the claimed invention, would be instantly transported away from a host’s website after clicking on an advertisement and activating a hyperlink. Id. at 1257.” slip op. at 29

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “1. Independent Claim 1 a) “A mobile device configured for running software applications, comprising:” Petitioner contends that Pasha discloses computer system 600, which” slip op. at 38

  • 112 supportMotion to amend, deniedDenied

    “4. Support in the Original Disclosure A motion to amend may not present substitute claims that introduce new subject matter. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii) (“A motion to amend may be denied where . . . [t]he amendment seeks . . . introduce new subject matter.”). “Normally, a claim element without support in the original disclosure (i.e., the application as originally filed) merits a rejection under 35 U.S.C. § 112 for lack of written description support.” Lectrosonics, Paper 15, 7. Accordingly, a motion to amend must set forth written description support in the originally filed disclosure of the subject patent for each proposed substitute claim.” Id.” slip op. at 74

  • ExcludeMotion to exclude, grantedGranted in part

    “CTPG at 73–74. Accordingly, Rule 42.23(b) prohibits filing of new evidence other than deposition transcripts of the cross-examination of any reply witness with a sur-reply. Patent Owner does not argue that the opinions presented in paragraphs 4–13 of Dr. Mao’s declaration are within the scope of §42.23(b). See generally PO MTE Opp. Nor do we find it in the interests of justice to allow this evidence in the case file. Accordingly, we grant in part Petitioner’s Motion to Exclude paragraphs 4–13 of Exhibit 2013 pursuant to 37 C.F.R. § 42.23(b).22” slip op. at 90

  Patent outcomesUS 10,782,951 unpatentable
  § 101 eligibility§ 102 anticipationcites Alice · Enfish · Phillips · KSR · Graham
  Patents in suitUS 10,782,951

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.