- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’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 “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 POSA 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 POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about 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 POSA 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 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this 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 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Chongqing Yanmei Technology Co., Ltd. v. Terves, LLCSome claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 10,689,740 - Home Depot U.S.A., Inc. v. Lynk Labs, Inc.All claims unpatentablePTAB · May 22, 2023 · PGR2022-00009 · APJ Monica S Ullagaddi · PGR · Final written decision
Claims 1–5, 7–12, and 14–19 are unpatentable based on lack of written description, anticipation by Bruning, or obviousness over Bruning and Kabel.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“lighting device.” Accordingly, we determine that the level of ordinary skill in the art is “a bachelor’s degree in electrical engineering, or similar technical field, with two years of relevant experience in the field of design and/or development of LEDs and circuits,” as Petitioner proposes and that “the field of design and/or development” would be “in the context of lighting devices” as Patent Owner proposes, in which “[a]n increase in experience could compensate for less education.” Id.; Pet. 24 (citing Ex. 1002 ¶ 46).” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“theoretically fall under the “or greater” portion of the amended claim limitation “forward voltage of 6V or greater,” Applicant distinguished Colby on the basis that the 120V AC voltage from a wall outlet is not “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs.” See Ex. 1023, 9 (emphasis added). Applicant’s argument specifically identifies the claim language at issue––“forward voltage of 6V or greater”––and specifically states that it is not disclosed because Colby does not disclose the minimum voltage and instead, discloses something else, something larger–– 120V AC voltage. Accordingly, we conclude that Applicant disclaimed any voltage that is more than “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs” from the scope of “forward voltage.”” slip op. at 25
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“4. 35 U.S.C. § 112(a) With respect to the written description requirement, we are persuaded” slip op. at 32
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“Basis § Unpatentable Unpatentable Lack of written description, 3, 10, 17 112(a) 3, 10, 17 Lack of enablement 3, 10, 17 112(b) Indefiniteness 3, 10, 17 Lack of written description, 4, 11, 18 112(a) 4, 11, 18 Lack of enablement 4, 11, 18 112(b) indefiniteness 4, 11, 18” slip op. at 77
Patent outcomesUS 10,932,341 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 10,932,341 - PTAB · May 20, 2014 · IPR2013-00124 · APJ Lora M Green · IPR · Final written decision
The Board granted cancellation of claims 1-26 and allowed substitute claims 27-44, but denied substitute claim 45 as unpatentable over Behan.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“partes review must set forth “[t]he support in the original disclosure of the patent for each claim that is added or amended.”” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundMixed
“In order to establish a prima facie case of obviousness based on structural similarity, the prior art must provide a reason to make the claimed compound, and there must also be “„adequate support in the prior art‟ for the 7 P.E.A. Teal et al., (Z)-11-Hexadecen-1-ol: A Behavioral Modifying Chemical Present in the Pheromone Gland of Female Heliothis Zea (Lepidoptera:Noctuidae), 116 CAN. ENTOMOLOGY 777-79 (1984). Ex. 2003. 8 Yih-Shen Hwang et al., Structure-Activity Relationship of Unsaturated Fatty Acids as Mosquito Ovipositional Repellents, 10 J. OF CHEM. ECOLOGY 145-51 (1984). Ex. 2004. change in structure.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (quoting In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985)). The United States Court of Appeals for the Federal Circuit noted that the test for obviousness of a compound based on structural similarity is in accordance with the legal principles enunciated by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), specifically, that it is important to identify “„a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does‟ in an obviousness determination.” Takeda, 492 F.3d at 1356-57 (quoting KSR, 550 U.S. at 418). Thus, “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.” Takeda, 492 F.3d at 1357.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundDecided for petitioner
“We acknowledge that McMahon and the Zhang Declaration are evidence that the ordinary artisan would not have had a reasonable expectation that, because a compound is known to repel mosquitoes, such as Aedes aegypti, the compound would also repel ticks, such as Amblyomma variegatum. Claim 45, however, encompasses the use of isolongifolanone when R1 is a hydrogen atom and R2 is an oxygen atom, which is the same compound specifically taught by Behan. See Pet. 7-8 (showing the structure of isolongifolanone, and discussing how it is encompassed by the chemical formula set forth in claim 1). As discussed above, Behan teaches the use of isolongifolanone to repel mosquitoes or cockroaches. Patent Owner provides no evidence that ticks and mites would not be present on the same objects or areas where mosquitoes and cockroaches are found, which are the insects addressed by Behan. Thus, by applying the isolongifolanone taught by Behan to an object or airspace for the purpose of repelling mosquitoes or cockroaches, one would also inherently repel ticks and mites. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (noting that the realization of a new benefit of an old process does not render that process patentable); Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process that was drawn to the same use comprising the same steps of the prior art, “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). We, therefore, conclude that the preponderance of the evidence does not support the patentability of proposed claim 45.” slip op. at 17
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 7,579,016
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.