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  • PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution

    The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.

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

      “In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14

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

      “Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15

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

      “As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 7,541,179
  • PTAB · Mar 23, 2023 · IPR2022-01527 · APJ David Cotta · IPR · Institution

    Institution was denied for claims 1, 2, 4, 5, 7, 8, 10, and 11 because the petition did not show a reasonable likelihood of success on any asserted anticipation or obviousness ground.

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

      “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1, 2, 4, 5, 7, 8, 10, and 11 of the ’554 patent.” slip op. at 2

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24 ,2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to provide” slip op. at 18

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable

      “a) Alleged express disclosure The evidence of record does not support Petitioner’s contention that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose what effect such treatment has on the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that “stimulation at IAF + 1 Hz triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 24. EEG power is, however, distinct from frequency. See e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses changing the frequency at which peak alpha power is observed.” slip op. at 13

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

      “1. Claim 1 Petitioner relies on the same evidence discussed in connection with Grounds 1 and 2 to establish disclosure of the intrinsic frequency limitation. Pet. 39 (“For the reasons provided above in Grounds 1 and 2, both Klimesch and Jin disclose this element [the intrinsic frequency limitation] of claim 1. In particular, the recited movement is the natural, inherent consequence of applying a magnetic field to the human brain at or near the subject’s peak frequency in the alpha band”). We have already determined that this evidence is insufficient to support that Klimesch or Jin discloses the intrinsic frequency limitation. Accordingly, we determine that Petitioner has not established a reasonable likelihood that it will prevail in showing that the combination of Klimesch and Jin renders claim 1 obvious.” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,480,554
  • PTAB · Mar 23, 2023 · IPR2022-01550 · APJ Devon Zastrow Newman · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that claim 39 was anticipated by Klimesch or Jin.

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

      “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). 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.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 39 of the ’354 patent.” slip op. at 2

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

      “Claim 39 describes a device used to treat a subject by creating an electromagnetic field to “tune” the brain and affect mood, focus, and cognition of human subjects. Ex. 1001, 62:62–63:34. Briefly, claim 39 recites a device that creates an electromagnetic field using an electromagnet. A first processor “tunes” the brain by firing the magnetic field. The first or a second processor moves one of the recited frequency characteristics in the brain to a preselected different frequency. The term “moves” in claim 39 describes a function of the first or second processor, which provides the means by which the brain frequency is shifted. See MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 1312–1315 (reviewing cases applying and distinguishing reasoning in IPXL Holdings, 430 F.3d at 1383– 84. Unlike IPXL Holdings, there is no confusion here as to when infringement of this claim would occur; infringement occurs when one makes, uses, offers to sell, or sells the claimed apparatus, which is capable of use for treatment. For this reason, we find that the recitation “wherein the first processor or a second processor moves” in claim 39 does not recite a method step, but rather describes the function of the recited structure – the first or second processor – that is capable of performing the recited (a) through (e) steps. MasterMine, 874 F.3d at 1315–16 (“the claims at issue here merely claim that the system ‘possess[es] the recited structure [which is] capable of performing the recited functions.’”) (alterations in original). As a result, we agree with Patent Owner that the recitation “wherein the first processor or a second processor moves” is limiting.7 For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order, Ex. 2001.” slip op. at 11

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “(1) Alleged express disclosure The evidence of record does not support that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose whether the treatment moves the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that stimulation at IAF + 1 Hz “triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 27. Enhancing EEG power is, however, distinct from moving frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses moving the frequency at which peak alpha power is observed. Petitioner also directs us to Klimesch’s disclosure that rTMS at IAF + 1 Hz resulted in “a significant increase in lower-2 and upper alpha desynchronization (ERD) during mental rotation.” Ex. 1005, 1132 (cited at Pet. 27–28). But ERD is also distinct from frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis showing ERD as the difference in alpha power when subjects are performing a task as compared to when subjects are in a state of alert wakefulness). Thus, an increase in ERD does not support that Klimesch discloses changing the frequency at which peak alpha power is observed. As Petitioner does not direct us to any other disclosure in Klimesch that supports moving the intrinsic frequency, Petitioner is unlikely to prevail in establishing that Klimesch expressly discloses the intrinsic frequency limitation.12” slip op. at 18

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

      “Ex. 1001, 34:56–35:5. Although this disclosure supports that the intrinsic frequency can be shifted up or down by applying a “specific magnetic field close to the head,” it does not teach that the intrinsic frequency necessarily shifts every time a magnetic field above or below the patient’s peak alpha frequency is applied. Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999) (“Inherency may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.”). In addition, Petitioner does not direct us to disclosure in the ’354 patent supporting that stimulation at IAF + 1 Hz under the circumstances disclosed in Klimesch, will necessarily shift the intrinsic frequency. See, Ex. 1003 ¶ 20 (testimony of Dr. Silvetz identifying factors that impact how the brain responds to rTMS); Ex. 1001, 40:19–32 (describing “parameters that require optimization for rTMS,” including: “[f]requency, “[i]ntensity, “[d]uration,” and “[s]ite of stimulation”).” slip op. at 21

    Claim construction§ 102 anticipationcites Phillips · Graham
    Patents in suitUS 8,475,354
  • PTAB · Mar 23, 2023 · IPR2022-01526 · APJ David Cotta · IPR · Institution

    The Board denied institution because the petition did not show a reasonable likelihood that claim 1 was anticipated by Klimesch or Jin, or obvious over their combination.

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

      “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 1 of the ’259 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends that the person of ordinary skill in the art (“POSA”) would have had “a medical degree plus at least two years of academic and/or industry experience in the field of TMS.” Pet. 10. According to Petitioner, “[a]dditional professional and/or technical experience could substitute for education, and vice versa.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA for purposes of its preliminary response. See generally, Prelim. Resp. Petitioner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’259 patent. Accordingly, for purposes of this Decision, we accept Petitioner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to prove prior knowledge or use, it must be regarded with suspicion and subjected to close scrutiny.”). peak alpha frequency moves the peak frequency to a higher frequency is not specific to the conditions under which rTMS was administered in Klimesch. This is problematic because Dr. Silvetz also testifies that the brain’s response to rTMS varies depending on the conditions under which it was administered. Ex. 1003 ¶ 20 (“The brain’s natural response varies depending on factors such as: a) the location of the electromagnet; b) the frequency of stimulation; c) the duration of stimulation; d) the number of stimulation pulses administered; e) the amplitude of the pulses administered; and f) the patient’s physiology.”). In summary, given that it not accompanied by supporting evidence, does not provide any technical reasoning, and is not specific to Klimesch, we give little weight to Dr. Silvetz’s testimony in determining whether Petitioner has established a reasonable likelihood that Klimesch inherently discloses the intrinsic frequency limitation. We do not determine here that Dr. Silvetz’s testimony is incorrect, only that it is insufficiently supported by evidence and technical reasoning to be accorded substantial weight.” slip op. at 18

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

      “Although the parties have briefed construction of the terms “preselected intrinsic frequency” and “preselected Q-factor” (Pet. 13–20; Prelim. Resp. 11–16), there does not appear to be any dispute regarding the “preselected” aspect of these claim terms. Pet. 18, 20 (proposing that “preselected intrinsic frequency” and “preselected Q-factor” be construed to require “a fixed target [intrinsic frequency/Q-factor] . . . chosen before treatment”); Prelim. Resp. 16 (proposing that the Board should adopt the district court’s claim construction: “a targeted [intrinsic frequency/Q-factor] chosen before treatment”); Reply 4 (“the parties to the IPRs have agreed that, for the purposes of these IPRs, the Board should accept the claim construction as adopted by the district court”). Accordingly, we do not find it necessary to construe any claim terms in order to resolve this proceeding. See Vivid Techs. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,446,259
  • PTAB · Jan 6, 2023 · IPR2022-01204 · APJ Donna M Praiss · IPR · Institution

    Instituted IPR on claims 1–10, 12, 13, and 15–20 because the petition showed a reasonable likelihood of prevailing on asserted anticipation and obviousness grounds.

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

      “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–10, 12, 13, and 15–20 of the ’285 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “district court trial dates are set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which a trial date has been set by the district court in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors, as there is no basis for Patent Owner’s argument for discretionary denial. Nevertheless, we address the Fintiv factors below13 and explain our reasons for not exercising discretion to deny institution based on § 314(a).” slip op. at 16

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

      “While we recognize that the plain language and grammar of the claims supports Petitioner’s proposed construction, we have also considered the District Court’s adopted construction and Patent Owner’s arguments which find support in the written description of the ’285 patent. In the end, however, we need not resolve this dispute at this time. Because the Petition provides sufficient evidence that the prior art references disclose the claimed functional groups, biomolecules, or organic dyes under either construction, it is not necessary for us to construe this claim term at this stage of the proceeding.” slip op. at 12

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

      “including Petitioner’s Reply Brief (Paper 10, “Reply Br.”) and Patent Owner’s Sur-Reply Brief (Paper 11, “Sur-Reply Br.”), we agree with Petitioner that Patent Owner’s proposed definition reads into the claim a numeric threshold for solubility from an embodiment that is nowhere apparent from the claim itself. Reply Br. 1–2. “[I]nterpreting what is meant by a word in a claim is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1348 (Fed. Cir. 2002) (internal quotation marks and citations omitted; emphasis in original). Although courts must read a patent’s claims in light of the specification, see, e.g., Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998), that obligation does not authorize “reading a limitation from the written description into the claims,” which is characterized as “one of the cardinal sins of patent law,” SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001). Confining the scope of “capable of imparting solubility” to an unexpressed minimum solubility taken from one of the Specification’s embodiments crosses that line. See, e.g., E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1432–34 (Fed. Cir. 1988) (Claims to a co-polymer improperly interpreted to include two properties). In view of the foregoing, we construe the phrase “a non-ionic side group capable of imparting solubility in water” to not require any particular numeric threshold of solubility. No further construction of the claim is necessary to resolve the dispute between the parties with respect to institution of trial.. See Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 13

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,365,285
  • PTAB · Jan 6, 2023 · IPR2022-01206 · APJ Brian D Range · IPR · Institution

    The Board instituted IPR on claims 1–10, 12–14, and 17–19, finding a reasonable likelihood of prevailing on the asserted grounds.

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

      “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–10, 12–14, and 17–19 of the ’648 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

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

      “The express language of claim 1 requires no solubility threshold, and dependent claim 10 of related U.S. Patent No. 10,288,620 B2 demonstrates that, where a solubility threshold was intended by the inventors of these patents, they knew how to expressly set forth that threshold in the claims. Compare Ex. 1004, 222:47–49 (“capable of imparting solubility in water”), with Ex. 1005, 218:12–14 (“The method according to claim 1, wherein each R is a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.”). Thus, the claim language does not support applying a particular solubility threshold in claim 1. As noted by Patent Owner, the written description of the ’648 patent explains that “each R is independently a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Ex. 1004, 2:21–22; Prelim. Resp. 17. This solubility threshold, however, is not in claim 1. Also, the ’648 patent states that this solubility applies only to some embodiments. See, e.g., Ex. 1004, 53:9–12, 55:6–20. We decline to import such a limitation from the written description into claim 1 absent reason for doing so. See SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001) (explaining that “reading a limitation from the written description into the claims” is “one of the cardinal sins of patent law”); see also Thorner v. Sony Comp. Ent’m Am., LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (“It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation. We do not read limitations from the specification into claims; we do not redefine words.”). After considering the parties’ arguments and evidence presented, we agree with Petitioner that Patent Owner’s proposed definition reads into the claim a numeric threshold for solubility from an embodiment that is nowhere apparent from the claim itself. “[I]nterpreting what is meant by a word in a claim is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1348 (Fed. Cir. 2002) (internal quotation marks and citations omitted; emphasis in original). Although we must read a patent’s claims in light of the specification, see, e.g., Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998), that obligation does not authorize “reading a limitation from the written description into the claims.” SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001). Confining the scope of “non-ionic side group capable of imparting solubility in water” to an unexpressed minimum solubility taken from only “some” embodiments encompassed by the ’648 patent crosses that line. See, e.g., E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1432–34 (Fed. Cir. 1988) (Claims to a co-polymer improperly interpreted to include two properties). In view of the foregoing, we construe the phrase “a non-ionic side group capable of imparting solubility in water” to not require any particular numeric threshold of solubility. No further construction of the claim is necessary to resolve the dispute between the parties with respect to institution of trial.15” slip op. at 13

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,17 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 17

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

      “We are not persuaded by Patent Owner’s argument. Xue expressly discloses that its glycopolymers utilizing poly(ethylene glycol)-tethered spacers (Polymers B and C) “are highly water-soluble due to their long, flexible, hydrophilic spacers.” Ex. 1010, Abstr., 2289–90. As claim 1 does not require any particular solubility threshold, on this record, Petitioner sufficiently demonstrates that Xue expressly discloses the solubility limitation of independent claim 1.” slip op. at 33

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,302,648
  • PTAB · Jan 6, 2023 · IPR2022-01205 · APJ Brian D Range · IPR · Institution

    The Board instituted review of claims 1–10, 18, and 20 based on the asserted § 102 and § 103 grounds.

    RulingsInstitution decision
    • Adverse judgmentAdverse judgmentOther

      “Here, Patent Owner filed a statutory disclaimer of claims 11–17 of the ’417 patent. Prelim. Resp. 1–2; Ex. 2019. Based on our review of Exhibit 2019, we determine that a disclaimer of claims 11–17 of the ’417 patent under 35 U.S.C. § 253(a) has been filed with the Office as of October 5, 2022. Based on the information in the public record, we find that the disclaimer complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Because claims 11–17 have been disclaimed under 35 U.S.C. § 253(a), in compliance with 37 C.F.R. § 1.321(a), we do not reach challenges to claims 11–17. As a result, the remaining challenged claims are claims 1–10, 18, and 20 (“the challenged claims”).” slip op. at 5

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the 14 Available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_ memo_20220621_.pdf. District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,15 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 16

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

      “IV. CONCLUSION For the reasons above, we determine that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail with respect to challenged claims 1–10, 18, and 20 of the ’417 patent. At this juncture in the proceeding, we have not made a final determination with respect to the patentability of the challenged claims, or with respect to claim construction. V. ORDER For the foregoing reasons, it is ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes review of claims 1–10, 18, and 20 of the ’417 patent is hereby instituted with respect to the ground of unpatentability set forth in the Petition; and FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; the trial will commence on the entry date of this Decision.” slip op. at 44

    • Skill levelOther

      “would have at least a Ph.D. degree in chemistry, or a bachelor’s or master’s degree plus experience involving the use and design of fluorescent probes or dyes.” Pet. 18 (citing Ex. 1007 ¶¶ 14–18). Patent Owner agrees that a POSITA may have a Ph.D. degree or master’s degree in chemistry, but asserts that a POSITA would also have “some experience with fluorescence” in addition to a Ph.D. degree in chemistry and that the experience of a POSITA with a master’s degree in chemistry is alternatively “industry experience in the field of biological detection systems.” Prelim. Resp. 5–6 (citing Ex. 2001 ¶ 7). For purposes of this Decision, we need not resolve these differences between the parties’ definitions, because any differences do not affect our analysis.13 If either party believes that adopting its preferred definition of the level of ordinary skill would have a material effect on the outcome of this proceeding, the party should address this issue during the instituted trial. slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,955,417
  • PTAB · Jan 6, 2023 · IPR2022-01208 · APJ Jon B Tornquist · IPR · Institution

    The Board denied institution on all challenged claims and grounds because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim.

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

      “Under 35 U.S.C. § 314(a), 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.” For the reasons stated below, we determine that Petitioner does not establish a reasonable likelihood that it would prevail with respect to at least one claim of the ’303 patent. Thus, we do not institute an inter partes review.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denialNot reached

      “1 Because we deny the Petition on the merits, we do not address the parties’ arguments related to discretionary denial.” slip op. at 2

    • Skill levelOther

      “Petitioner asserts that a person having ordinary skill in the art (POSITA) “would have at least a Ph.D. degree in chemistry, or a bachelor’s or master’s degree plus experience involving the use and design of fluorescent probes or dyes.” Pet. 17 (citing Ex. 1007 ¶¶ 14–18). Patent Owner agrees that a POSITA may have a Ph.D. degree or master’s degree in chemistry, but asserts that a POSITA would also have “some experience with fluorescence” in addition to a Ph.D. degree in chemistry and that the experience of a POSITA with a master’s degree in chemistry is alternatively “industry experience in the field of biological detection systems.” Prelim. Resp. 9–10 (citing Ex. 2001 ¶ 7). For purposes of this Decision, we need not choose between the parties’ proposed levels of one of ordinary skill in the art, which are quite similar, as neither party asserts that the anticipation or obviousness analyses in this case would turn on which definition is adopted. See, e.g., id. at 10 (noting that the arguments and conclusions reached in the Preliminary Response “would not change” if Petitioner’s definition of the ordinarily skilled artisan were applied).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

      “structure of Formula (Ia),” including specific MU, L1 and L2, G1 and G2, n, and a, b, c, and d (which define the mol % of each unit within the structure) constituents, wherein each R group must be a “[n]on-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Ex. 1006, 239:29–240:56. The ’303 patent expressly defines the phrase “[n]on-ionic side groups capable of imparting solubility in water” to refer to “side groups which are not charged and allow the resulting polymer to be soluble in water or aqueous solutions with no visible particulates.” Id. at 54:31–34. In view of structure of claim 1 and the express definition provided in the ’303 patent, we agree with Patent Owner that claim 1 requires that the non-ionic side group R must be capable of imparting solubility to the claimed conjugated polymer (having constituents that satisfy the claimed variables noted above) in excess of 10 mg/mL. Prelim. Resp. 13. On this record, it is not sufficient to show that a particular R group is capable of” slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 8,575,303
  • PTAB · Jan 6, 2023 · IPR2022-01207 · APJ Jon B Tornquist · IPR · Institution

    Instituted IPR of claims 1–14, 18, and 19 on all asserted grounds after finding a reasonable likelihood of prevailing 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 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.” For the reasons set forth below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. Thus, we hereby institute an inter partes review as to claims 1–14, 18, and 19 of the ’620 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “be lifted for each patent for which the petition is denied. As noted above, there are six related petitions at the Board involving the patents before the court. The district court stayed the litigation “pending resolution of the IPR proceedings that have been instituted on the patents at issue in this case.” Ex. 2006, 2. Regarding the length of the stay, the district court explicitly ordered the parties not to use continuance of the fact discovery to October 28, 2022 “as grounds for . . . opposing institution of any post-grant proceeding.” Ex. 2007, 2. Regarding when the stay will be lifted, the order merely gives Patent Owner the opportunity to “seek to lift the stay as to any patents that are not instituted for review.” Ex. 2006, 2 (emphasis added). But we decline to speculate whether the district court would grant such a motion directed only to one of the six patents. Among the reasons warranting a stay of the litigation, the district court found “IPR has the potential to streamline issues for trial” and “the resources the parties will need to expend for experts could be significantly impacted by the outcome of any instituted IPR proceedings.” Id. Thus, the litigation is stayed pending the outcome of the six related proceedings, not merely the outcome of this institution decision, and the district court stayed the litigation for the explicit purpose of gaining efficiency and avoiding duplication of efforts by letting this inter partes review proceed to its conclusion first.14 See Prelim. Reply. 4–5. While Patent Owner may seek to lift the stay as to any patent for which institution is denied, the grant of any such request is uncertain. Accordingly, this factor strongly weighs against discretionary denial of institution.” slip op. at 15

    • Skill levelOther

      “Petitioner asserts that a person of ordinary skill in the art (POSITA) “would have at least a Ph.D. degree in chemistry, or a bachelor’s or master’s degree plus experience involving the use and design of fluorescent probes or dyes.” Pet. 17 (citing Ex. 1007 ¶¶ 14–18). Patent Owner agrees that a POSITA may have a Ph.D. degree or master’s degree in chemistry, but asserts that a POSITA would also have “some experience with fluorescence” in addition to a degree in chemistry and that the experience of a POSITA with a master’s degree in chemistry is alternatively “industry experience in the field of biological detection systems.” Prelim. Resp. 10 (citing Ex. 2001 ¶ 7). For purposes of this Decision, we need not choose between the parties’ proposed levels of one of ordinary skill in the art, which are quite similar, as neither party asserts that the anticipation or obviousness analyses in this case would turn on which definition is adopted. See Prelim. Resp. 10 (Patent Owner stating that its arguments and conclusions “would not change” if Petitioner’s definition were applied).” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner

      “The express language of claim 1 requires no solubility threshold, and dependent claim 10 demonstrates that where a solubility threshold was intended by the inventors of the ’620 patent they knew how to expressly set forth that threshold in the claims. Compare Ex. 1005, 213:26–27 (“capable of imparting solubility in water”), with id. at 218:12–14 (“The method according to claim 1, wherein each R is a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.”). Thus, the claim language does not support applying a particular solubility threshold in claim 1. As noted by Patent Owner, the written description of the ’620 patent explains that “[i]n some embodiments, each R is independently a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Id. at 54:2–10; Prelim. Resp. 12–13. This solubility threshold, however, is not in claim 1, and we decline to import such a limitation from the written description into claim 1 absent compelling reasons for doing so. See SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001) (explaining that “reading a limitation from the written description into the claims” is “one of the cardinal sins of patent law”); see also Thorner v. Sony Comp. Entm’t Am., LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (“It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation. We do not read limitations from the specification into claims; we do not redefine words.”). In view of the foregoing, we construe the term “non-ionic side group capable of imparting solubility in water” to not include any particular numeric solubility threshold.13” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,288,620
  • PTAB · Jan 6, 2023 · IPR2022-01203 · APJ Christopher L Crumbley · IPR · Institution

    The Board instituted IPR on claims 1–10, 12–14, and 17–19 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one challenge.

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

      “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. Patent Owner has not persuaded us that we should exercise our discretion to deny institution. We hereby institute an inter partes review as to claims 1–10, 12–14, and 17–19 of the ’989 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date.”). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,14 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 18

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

      “numerical solubility limit into the claims, noting that the ’989 patent expressly defines “non-ionic side groups capable of imparting solubility in water” as simply “side groups which are not charged and allow the resulting polymer to be soluble in water or aqueous solution with no visible particulates.” Prelim. Reply 1 (citing Ex. 1001, 54:9–13). Petitioner notes that this definition contains no numerical limit, and that it is followed by a statement that in some embodiments, the R group is capable of imparting solubility in excess of 10 mg/mL. Id. at 2 (citing Ex. 1001, 54:13–16). Petitioner contends that reading a limitation from “some embodiments” into the claims would be “one of the cardinal sins of patent law.” Id. (citing Phillips, 415 F.3d at 1320; Polaris Innovations Ltd. v. Brent, 48 F.4th 1365, 1375–76 (Fed. Cir. 2022)). Petitioner also directs our attention to related patents that expressly claim a solubility in excess of 10 mg/mL, arguing that when Patent Owner sought to claim such polymers, it knew how to do so. Id. (citing Ex. 1005, 218:11–12; Ex. 1006, 239:43–45, 252:51–52, 254:39–40, 262:56–57, 269:31–35).” slip op. at 15

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

      “proposed claim construction on solubility above, which we declined to do on the present record. For this reason, we find them unpersuasive. In addition, we note that Xue expressly discloses that its glycopolymers utilizing PEG-tethered spacers (Polymers B and C) “are highly water-soluble due to their long, flexible, hydrophilic spacers.” Ex. 1010, Abstract, 2289–90. Petitioner sufficiently sets forth why a person of ordinary skill in the art would have considered the PEG side chains of Xue to impart solubility in water, which is all we have construed the claims to require.” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
    Patents in suitUS 10,458,989

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.