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  • 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
  • PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23

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

      “C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,149,283
  • PTAB · Dec 19, 2023 · IPR2023-01036 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–34 and all petitioned grounds, finding a reasonable likelihood of success on at least one challenged claim.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’555 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 17–18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22

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

      “We agree with Petitioner that the priority applications do not disclose sufficient representative species compared to the breadth of the claims. As Petitioner contends, SEQ ID NO: 9 and the two AAD-1 variants that differ from SEQ ID NO: 9 by just one or two amino acids do not fairly represent the diversity of proteins within genus of at least 2044 variants. Pet. 30–31; Ex. 1054 ¶¶ 81–82 (showing the minimal sequence differences in AAD-1 v2 (alanine substituted for histidine at position 2, and cysteine substituted for arginine at position 212), and v3 (alanine insertion at position 2)); Ex. 1001, Dr. Hausinger testifies persuasively that the > 99% identity shared by these three AAD-1 variants “are simply not representative of proteins having as little as 85% sequence identity to AAD-1 v1 (SEQ ID NO: 9).” Ex. 1054 ¶¶ 83–86 (testifying, e.g., that the specification “does not provide any structural information that might have allowed the POSA to make inferences about the effect of a given change” and that nothing in the disclosure “would have suggested to the POSA that changes at [the positions in which v2 and v3 differ] would be particularly informative.”). Patent Owner provides no argument or evidence to the contrary on the question whether sufficient representative species are disclosed.27” slip op. at 43

    § 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,947,555
  • PTAB · Sep 13, 2023 · IPR2023-00485 · APJ Jon B Tornquist · IPR · Institution

    Instituted IPR of claims 1–10 on all petition grounds; Petitioner showed a reasonable likelihood that the claims would have been obvious over Yoakim, Jarisch, Rossi, and Castellani.

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

      “second German priority application do not disclose every limitation of independent claims 1 and 7 of the ’430 patent. Figure 1 does not depict a barcode under the flange, but rather the use of raised areas on the side of the capsule that act as an identifier. Ex. 1047, Fig. 1. Figure 2, coupled with its associated description, might suggest that the barcode could be on the portion of the base element facing away from the membrane,9 but this figure does not disclose many of the other elements of the claim, including holding arms, a drop box, annular convexity and concavity, and a pump to supply water to the single-serve capsule. Pet. 41; Ex. 1047, 9:21–24, Fig. 2. We also determine that Patent Owner does not sufficiently demonstrate that Figures 16–18 of the second German priority application provide adequate disclosures showing that the inventors were in possession 9 We question whether the second German priority application supports placing a barcode under the flange. The application states that the barcode could “be provided on that side of the peripheral region of the basic element which is directed away from the membrane.” Ex. 1047, 9:21–24. This statement is rather ambiguous as to where the “peripheral region” is that is “directed away from the membrane.” The text goes on to explain, however, that “[t]his barcode,” i.e., the barcode that is “directed away from the membrane,” “is read by a detector 13,” which in Figure 2 is oriented to read a barcode on the top surface of the flange. Id. at 9:25–26, Fig. 2. This suggests that the barcode is not on the bottom side of the flange and that arrow 15 is pointing to the outer portion of the peripheral region that is not covered by the membrane, and not necessarily the bottom of the flange. First, the second German priority application describes the use of “an identifier” that is read by a “sensor/detection means” and then compared to a stored identifier. Ex. 1047, 2:29–31. In Figure 2 the identifier may be a barcode and the detection means is detector 13. Id. at 9:11–26. In Figures 16–18, however, element 2.4.2 is not an identifier, but rather a “a form-fitting and/or friction-fitting means and/or a detection means.” Id. at 12:22– 24 (emphasis added). As such, it is unclear how this disclosure would demonstrate possession of the disputed claim limitation, when combined with the other limitations of claims 1 and 7 as a whole. Second, it is not evident that the toothed rings of Figures 16–18 are on the underside of the flange, as asserted by Patent Owner. Prelim. Resp. 42 (asserting that a barcode “could be located on the bottom side of the flange instead of the toothed ring”); Prelim. Sur-reply 4. The second German priority application states that the “form-fitting and/or friction-fitting means and/or detection means 2.4.2” is located in the “outer region” of the peripheral region 2.4. Ex. 1047, 12:22–24. We are directed to no evidence that this “outer region” is on the bottom of the flange, and Figures 16–18 each appear to depict means 2.4.2 on, or forming, the outer circumference of the flange.11 Id. at Figs. 16–18, 6:8–11 (noting that the toothed ring is provided “on the outer circumference of the periphery”). 10 The parties dispute whether Figure 16 of the second German priority application discloses annular convexity and concavity. Pet. 42–43; Prelim. Resp. 45–46; Prelim. Reply 4–5; Prelim. Sur-reply 4. At most, the parties identify a material issue of fact with respect to these two claim elements that is best resolved on a full trial record. 11 At first blush, Figure 17A appears to show means 2.4.2 under a portion of element 27 of the capsule. Ex. 1047, Fig. 17A; Prelim. Sur-reply 4 depicted in Figures 16–18, which rely on toothed rings physically interacting with either the chamber, retaining arms, or a pinion. Ex. 1047, 12:22–31, 13:8–18. 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). Patent Owner does not sufficiently explain how a barcode could replace means 2.4.2 in these embodiments and still retain the capsule within the device or allow the capsule to enter the insertion shaft.” slip op. at 14

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “First, Yoakim expressly states that the capsule may use a “barcode,” and the plain and ordinary meaning of this term is a code that satisfies the construction adopted by the district court. To the extent Patent Owner has reason to believe that Yoakim does not apply the plain and ordinary meaning of the term “barcode,” and that one of ordinary skill in the art would have understood this fact, it is encouraged to present such evidence during trial. Second, in this obviousness inquiry the question is not whether a person of ordinary skill in the art is more likely to adopt a barcode or a bitcode, but whether one of ordinary skill in the art would have seen a benefit to applying the “barcode” of Yoakim under the flange of the capsule. See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021) (“Our case law is clear. It’s not necessary to show that a combination is ‘the best option, only that it is a suitable option.’”). On that point, Jarisch expressly discloses the benefits of doing so. Ex. 1005 ¶ 22 (noting that applying the code at the bottom of the rim lowers the risk of the code becoming unreadable). As such, we determine that Petitioner sufficiently identifies where Yoakim discloses a barcode and explains why one of ordinary skill in the art would have placed such a “barcode” on the bottom of the capsule’s flange.” slip op. at 27

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Information Disclosure Statement (IDS) during prosecution of the ’430 patent and that Rossi and Castellani were mentioned in the inter partes reviews that were cited on the IDS. Pet. 19; Prelim. Resp. 23. We need not determine whether Part 1 of the Advanced Bionics framework is satisfied based on these disclosures, however, as Part 2 of the analysis, which we address below, is dispositive. a) Factor (c)—the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for a rejection The Examiner did not issue any rejections during prosecution of the ’430 patent. Ex. 1002, 232–234. As the reasons for allowance, the Examiner stated: [A]llowance of claims 1 and 21–29 is indicated as none of the cited prior art discloses or suggests the flange comprising a top side and an opposing bottom side; a cover that is fastened to the top side of the flange to close the cavity; and an identifier provided on the bottom side of the flange, the identifier being a barcode, wherein the beverage machine, by reading or detecting the identifier with the sensor/detector, is configured to determine if the single-serve capsule belongs to a group of single serve capsules operable for use with the beverage machine, and only if the beverage machine determines that the single-serve capsule belongs to the group of single serve capsules operable for use with the beverage machine is the pump controlled to push the water into the single-serve capsule. Id. at 233. In arriving at this conclusion, the Examiner did not cite or discuss the disclosures of Yoakim, Jarisch, Rossi, or Castellani. Id. at 232–234. Yet, these references appear, based on the current record, to expressly teach or allowance, including a “flange comprising a top side and an opposing bottom side” (Ex. 1004 ¶ 197, Fig. 6); “a cover that is fastened to the top side of the flange to close the cavity” (Ex. 1004 ¶¶ 128–129, 197, 414); “an identifier provided on the bottom side of the flange” (Ex. 1005 ¶ 22) that is “a barcode” (Ex. 1004 ¶¶ 496, 525); and “reading or detecting the identifier with the sensor/detector . . . to determine if the single-serve capsule belongs to a group of single serve capsules operable for use with the beverage machine” (Ex. 1004 ¶¶ 25, 192, 477, 494–496, 525; Ex. 1005 ¶ 82; Ex. 1041, 3, 11). As such, to the extent the asserted combination of prior art references was evaluated during prosecution of the application that matured into the ’430 patent, we determine that such evaluation was minimal.” slip op. at 37

    • Other 314aDecided for petitioner

      “B. 35 U.S.C. § 314(a) Patent Owner contends that “[t]he parties have been embroiled in disputes involving substantive claims for infringement for both the ’430 Patent and the Jarisch 929 reference,” and “it is unnecessary to open up yet another front in this dispute.” Prelim. Resp. 68–69. As such, Patent Owner requests that we deny institution under 35 U.S.C. § 314(a). Id. Patent Owner directs our attention to no case in which the Director has exercised discretion to deny a petition merely because the same patent was the subject of a co-pending district court infringement action. Indeed, 35 U.S.C. § 315(b) specifically contemplates such a scenario. Accordingly, we decline to exercise discretion to deny the Petition under 35 U.S.C. § 314(a).” slip op. at 40

    § 103 obviousness§ 112 disclosureDiscretionary denial
    Patents in suitUS 11,230,430
  • PTAB · Sep 13, 2023 · IPR2023-00502 · APJ Grace Karaffa Obermann · IPR · Institution

    Instituted IPR on claims 1–16 because Petitioner showed a reasonable likelihood that the claims would have been obvious over Yoakim, Jarisch, and Rapparini.

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

      “review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, Petitioner demonstrates a reasonable likelihood of prevailing with respect to claims 1–16 of the ’923 patent. Accordingly, we institute an inter partes review.” slip op. at 2

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

      “benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). One may show support for the claims of a later application by showing that a single, earlier application provides written description support for the claims. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); Studiengesellschaft Kohle, MBH v. Shell Oil Co., 112 F.3d 1561, 1564 (Fed. Cir. 1997) (noting that a patentee “cannot distinct previous applications”). Once Petitioner identifies a prior art reference with an effective filing date prior to that of the challenged patent, the burden of production to show entitlement to the benefit of the filing date of an earlier filed application shifts to Patent Owner. See In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (“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”). Patent Owner may show possession of the invention through “such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Although the exact terms need not be used in haec verba, . . . the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Id.” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artPriority date, deniedDecided for petitioner

      “Once Petitioner identifies a prior art reference with an effective filing date prior to that of the challenged patent, the burden of production to show entitlement to the benefit of the filing date of an earlier filed application shifts to Patent Owner. See In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (“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”). Patent Owner may show possession of the invention through “such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Although the exact terms need not be used in haec verba, . . . the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Id.” slip op. at 10

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

      “7. Analysis: Reasons to Combine the References Petitioner shows sufficiently that Yoakim, Jarisch and Rapparini are “analogous art in the field of portion capsule beverage extraction, each disclosing an invention that may be applied in automatic coffee/espresso machines.” Pet. 43. “Yoakim and Jarisch both improve the optimization of beverage parameters in a single-serve brewing system, and use optical codes read by the machine to achieve this.” Id. “Rapparini further improves the the wall of the capsule body like those used in Yoakim and Jarisch.” Id. at 43–44; see id. at 50–51, 53–54 (Petitioner’s further argument that Rapparini discloses “an optimized capsule structure that is stiffer and more stable” by virtue of radially spaced and vertically oriented ribs and grooves, where the vertically oriented grooves are free from extending entirely to the bottom region of the capsule). Petitioner directs us to additional evidence tending to establish that an ordinarily skilled artisan would have been prompted to modify Yoakim’s device, to include the code placement of Jarisch and the grooves and ribs of Rapparini, to arrive at the claimed invention with an expectation of success. Id. at 44–48.” slip op. at 27

    § 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,994,923
  • PTAB · Aug 30, 2023 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Institution

    The Board instituted IPR on claims 19–61 and 63–81 on all petitioned grounds, finding a reasonable likelihood that Doud anticipates claims 19–61 and 63–75.

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

      “review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we determine that Petitioner demonstrates a reasonable likelihood of prevailing with respect to at least one claim of the ’740 patent. Accordingly, we grant institution of an inter partes review.” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

      “the application describe the claim limitations exactly,” the application must demonstrate to persons of ordinary skill in the art that the applicants invented a composition including those limitations. Wertheim, 541 F.2d at 262. On its face, the range of “at least 0.01 wt. %” encompasses a range that is broader than 0.01–35 wt. %, and Patent Owner does not sufficiently explain why a person of ordinary skill in the art would understand from merely a disclosure of 35 wt.% that the inventors were in possession of the entire claimed range for copper, cobalt, or nickel in the magnesium composition.” slip op. at 11

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther

      “On this record, the term “at least 0.01 wt. %” in the ’740 patent encompasses values for nickel, copper, and cobalt that are higher than the 35 wt. % (nickel and copper) and 20 wt. % (cobalt) limits outlined in the parent and grandparent applications. Accordingly, we determine that there is a reasonable likelihood that claim 19 of the ’740 patent is not entitled to the benefit of the filing dates of its priority applications. Challenged claims 20–61 and 63–75 depend from claim 19 and there is no argument presented that these claims have independent written description support in Doud. For example, there is no evidence presented that any of these dependent claims narrow the ranges for each of copper, nickel, and cobalt recited in in the ’295 application for these claims.7 Accordingly, for purposes of this Decision, we apply Doud as prior art to challenged claims 19–61 and 63–75.” slip op. at 12

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

      “as the ’740 patent. For example, Doud and the ’740 patent both disclose a method of forming a novel magnesium composite that includes melting an AZ91D magnesium alloy containing 90 wt. % magnesium, 9 wt. % aluminum, and 1 wt. % zinc. Ex. 1005 ¶¶ 45, 47; Ex. 1001, 21:43–51, 22:48–53, 33:32–43, 34:9–12. To this alloy is added either 7 wt. % nickel or 10 wt. % copper. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:48–51, 22:53–56, 33:35–36, 34:12–13. These additives are mixed in the magnesium alloy at a temperature that is less than the melting point of copper or nickel, and the casting is then cooled. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:51–54, 22:56–58, 33:35, 34:12-13. Doud reports that nickel and copper, when added to molten magnesium, will form Mg2Ni and CuMg2 intermetallic, galvanically-active, in situ precipitates. Ex. 1005 ¶¶ 12–13. Doud discloses that the dissolution rate of the resulting casting material is either 325 mg/cm2-hr (nickel) or 50 mg/cm2-hr (copper) in a 3% KCl solution at 90° C. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:60–62, 22:61–63, 33:41–43, 34:15–17. Doud also discloses that the average particle diameter of the additives used in the invention is generally “at least about 0.1 microns” and “typically no more than about 500 microns.” Ex. 1005 ¶ 6. Petitioner explains how the identified disclosures of Doud anticipate independent claim 19. Pet. 39–40. Petitioner also identifies where the limitations of dependent claims 20–61 and 63–75 are disclosed in Doud. Id. at 41–45. Patent Owner does not address Petitioner’s anticipation arguments with respect to claims 19–61 and 63–75, apart from arguing that Doud is not prior art to these claims. Prelim. Resp. 27–39. demonstrates a reasonable likelihood that claims 19–61 and 63–75 are anticipated by Doud.” slip op. at 16

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denial
    Patents in suitUS 10,689,740
  • PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

    The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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 itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

      “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

      “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

    Patent outcomesUS 10,993,942 mixed
    Claim construction§ 112 disclosure
    Patents in suitUS 10,993,942
  • PTAB · 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 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 10,932,341
  • PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution

    The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denialInstitutedDenied

      “This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10

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

      “We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed

      “reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22

    § 102 anticipation§ 112 disclosureDiscretionary denial
    Patents in suitUS 11,110,087
  • PTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision

    Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as 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 itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7

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

      “Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10

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

      “stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

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

      “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13

    Patent outcomesUS 10,307,384 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,307,384
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