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  • PTAB · Jul 8, 2025 · IPR2025-00155 · APJ James A Worth · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3–9, 11–17, or 19 were unpatentable on the asserted obviousness grounds.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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) (2018).1 For the reasons set forth below, we determine that Petitioner has not demonstrated that there is a reasonable likelihood that at least one of claims 1, 3–9, 11–17, and 19 of the ’187 patent is unpatentable based on the grounds set forth in the Petition, and we do not institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 19 (citing Ex. 1003 ¶ 29). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 27 (citing Ex.2001 ¶¶ 60–64). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 10

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

      “The failure to use the word “means” in a claim element creates a rebuttable presumption that § 112 ¶ 6 does not apply. Williamson v. Citrix Online, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). The presumption can be overcome and § 112 ¶ 6 will apply if the challenger demonstrates that the claim term fails to “recite[ ] sufficiently definite structure” or else recites “function without reciting sufficient structure for performing that function. “Construing a means-plus-function claim term is a two-step process.” Id. at 1351. “The [tribunal] must first identify the claimed function.” Id. “Then, the [tribunal] must determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. There may be multiple claimed functions, each with disclosed corresponding structure. See id. at 1351–52.” slip op. at 14

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

      “We are persuaded by Patent Owner that the term “automatically” in “to automatically disengage the first and second catch structures” means that it is not just the force applied by the user that disengages the first and second catch structures, but also the bias of the mouthpiece that helps to disengage the first and second catch structures. In the first instance, we agree with Patent Owner that the claim itself recites that, upon actuation, the mouthpiece assembly is “release[d]” to “move via its bias from the stowed configuration to the dispensing configuration.” See Ex. 1001, 21:59–64. This meaning is supported by the Specification which states: “In some examples, the mouthpiece assembly is biased toward the dispensing configuration and thus moves automatically under its bias upon release by the user-release mechanism.” Ex. 1001, 1:64–67. We further agree with Patent Owner that the plain and ordinary meaning of “automatic” is that the user operation alone is not responsible for the action. For example, in one dictionary cited by Petitioner, “automatic” is defined as “2: having a self-acting or self-regulating mechanism.” See Ex. 2007, 1.11 The district court construction is consistent therewith. The district court identified two functions, the first of which is the same as that of the ’028 patent, i.e., “Automatically disengaging the first and second catch structures upon actuation of the user release mechanism and thereby releasing the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.” See Section II.C.1, supra. In discussing that function, the district court states: “While a user may impart force upon user engagement portion 260 to release the mouthpiece, the bias of the mouthpiece towards the dispensing configuration causes the mouthpiece to move automatically, satisfying the requirements of Claim 1.” Ex. 2002, 16. We conclude that the term “automatically” in “adapted to” slip op. at 17

    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,684,187
  • PTAB · May 22, 2025 · IPR2025-00146 · APJ Linda E Horner · IPR · Institution

    The Board denied institution because Trove did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.

    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 and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has not shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we deny the Petition and do not institute an inter partes review of claims 1, 3, 5–8, and 10–19 of the ’879 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 10

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

      “Petitioner and Patent Owner propose constructions for the term “user release mechanism,” as recited in claim 1. Pet. 20–23; Prelim. Resp. 27–30. Patent Owner also proposes constructions for “automatically disengage the first and second catch structures,” as recited in claim 1. Prelim. Resp. 30– 32. For purposes of this particular Decision, we determine that no term requires construction to decide whether to institute inter partes review of the ’879 patent. 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.’”) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

      “First, Petitioner’s reason to modify Kiyota “to provide the advantage of a bite actuated mouthpiece” (Pet. 42) does not explain why one would use Choi’s mount 100. Petitioner has not clearly established that to use a bite-actuated mouthpiece requires mount 100. Choi describes that “cap assembly 14 may include a mount 100 to which the bite-actuated mouthpiece is removably mounted, or secured.” Ex. 1005 ¶ 46. This description suggests that mount 100 is not a required component for a bite-actuated mouthpiece. Our understanding is supported by Patent Owner’s expert, who testified that using Choi’s mount as a “rigid collar member” in Kiyota’s mouthpiece assembly does not require combining its bite-actuated valve because “the bite-actuated portion has nothing to do with the alleged rigid collar member portion.” Ex. 2001 ¶ 119 (citing Ex. 1005 ¶ 46); see also Prelim. Resp. 55. Thus, Petitioner has not adequately supported this first reason to modify Kiyota to use Choi’s mount 100.” slip op. at 22

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,165,879
  • PTAB · May 7, 2025 · IPR2024-01501 · APJ Linda E Horner · IPR · Institution

    The Board denied institution because Trove did not show a reasonable likelihood of proving claims 1, 2, 5, 6, 8, 9, 15, 16, or 21 obvious over the asserted prior art.

    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 and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has not shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we deny the Petition and do not institute an inter partes review of claims 1, 2, 5, 6, 8, 9, 15, 16, and 21 of the ’028 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner argues that a POSITA would have “a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa.” Prelim. Resp. 23 (citing Ex. 2001 ¶¶ 56–65). Patent Owner also states that it “discerns no material difference between the definitions provided by the parties for purposes the Board’s decision on whether to institute this proceeding.” Id. We agree that there appears to be no material difference in the parties’ definitions of the level of ordinary skill in the art. For the purposes of this Decision, we apply Petitioner’s definition of the level of ordinary skill in the art. We determine that this definition is consistent with the prior art of record and the skill reflected in the Specification of the ’028 patent, based on our review of the limited record. Moreover, the prior art itself may be sufficient to demonstrate the level of 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” slip op. at 11

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

      “as a means-plus-function limitation under 35 U.S.C. § 112, sixth paragraph, because “mechanism” is a nonce word for performing the claimed function without reciting structure for performing that function, and a POSITA would not have understood the term to have “a sufficiently definite meaning as the name for a structure that performs the claimed function.” Pet. 16–17 (citing Ex. 1003 ¶ 39). For claim 1, Petitioner identifies two distinct structures described in the ’028 patent that correspond to the claimed “user release mechanism” for performing the claimed functions. Id. at 34. Specifically, Petitioner asserts that the ’028 patent describes a first embodiment in which the corresponding structure includes sliding member 238, and its component parts. Id. at 34– 35 (citing Ex. 1001, 12:50–13:25, 13:29–33). In the second embodiment, the corresponding structure includes user engagement portion 260 on rigid collar 170. Id. at 35–36 (citing Ex. 1001, 13:40–54). Petitioner does not separately address the structure corresponding to the “user release mechanism” as recited in claim 21. Id. at 53‒54 (relying on the same arguments presented for unpatentability of claim 1). court issued a claim construction order in the parallel litigation construing the term “user release mechanism” as a means-plus-function limitation under § 112, sixth paragraph. Prelim. Resp. 23 (citing Ex. 2002, 12–15). The district court ruled that the corresponding structure for claim 1 includes “[s]liding member 238, including its component parts,” or “[u]ser engagement portion 260.” Ex. 2002, 15. For claim 21, the district court ruled that the corresponding structure includes “[s]liding member 238, including its component parts” or “[u]ser engagement pad 240, planar portion 242, tabs 244, collar engagement portion 254, depression 256.” Id. at 17. Patent Owner indicates that, “[f]or purposes of this proceeding only,” it does not dispute that the claimed user release mechanisms are means-plusfunction limitations, and it does not dispute the corresponding structure identified by Petitioner, even though the district court did not specifically identify engagement portion 260 as corresponding structure for claim 21. Prelim. Resp. 25 (citing Ex. 2002, 15–19). Although Patent Owner does not dispute Petitioner’s proposed interpretation of the “user release mechanism,” because claim interpretation is a matter of law and the dispositive issue in this Decision turns on the interpretation of this claim limitation, we address it in this Decision. We agree with the parties that the “user release mechanism” elements recited in claims 1 and 21 are means-plus-function limitations governed by § 112, sixth paragraph. See 35 U.S.C. § 112 ¶ 6 (“An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.”). “means,” it uses the nonce word “mechanism” without reciting structure for performing the functions recited in the claims. See Williamson v. CitrixOnline, LLC, 792 F.3d 1339, 1350 (Fed. Cir. 2015) (“Generic terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other nonce words that reflect nothing more than verbal constructs may be used in a claim in a manner that is tantamount to using the word “means” because they ‘typically do not connote sufficiently definite structure’ and therefore may invoke § 112, para. 6.”).” slip op. at 13

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

      “[U]nder § 112, ¶ 6 equivalence, functional identity is required” and “[s]tructural equivalence under § 112, ¶ 6 is met only if the differences are insubstantial, that is, if the assertedly equivalent structure performs the claimed function in substantially the same way to achieve substantially the same result as the corresponding structure described in the specification.” (citing Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., Inc., 145 F.3d 1303, 1308 (Fed. Cir. 1998)). Here, Petitioner states that Kiyota’s lock release buttons 40 “perform the claimed function in the same way to achieve the same result” as the ’028 patent’s sliding member 238, and its component parts (Pet. 37) without providing sufficient supporting explanation or evidence. Petitioner explains only that the two structures operate in “substantially the same way” by a user pressing an element that that slides towards the mouthpiece assembly to disengage the catch structures. Id. at 37–38 (citing Ex. 1003 ¶ 89). The Petition does not discuss any of the differences between Kiyota’s structure and the ’028 patent’s structure or provide an explanation of why these differences are insubstantial. Indeed, as Patent Owner persuasively explains, there are notable differences in the “way” the two structures perform the claimed function and the “result” they achieve. See Prelim. Resp. 39–40 (discussing the ’028 patent’s one-finger operation and indirect catch disengagement, versus Kiyota’s two-finger operation and direct catch disengagement). Moreover, the analysis in Dr. Vallee’s declaration substantially parallels the discussion in the Petition and does not provide any additional explanation or evidence to show that the differences between the “way” the two structures operate or the “result” they achieve are insubstantial. Compare Ex. 1003 ¶¶ 85–91, with Pet. 34–38. For these reasons, Petitioner fails to show sufficiently that Kiyota discloses an equivalent structure to the structure described in the ’028 patent corresponding to the “user release mechanism” recited in claim 1. Accordingly, Petitioner has not met its burden to show a reasonable likelihood that claim 1 is unpatentable as obvious over Kiyota. slip op. at 23

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,782,028
  • 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 · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.

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

      “Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29

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

      “To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23

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

      “We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,078,265
  • PTAB · Oct 25, 2022 · IPR2022-00803 · APJ Carl M Defranco · IPR · Institution

    The Board denied institution because Zak did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted anticipation or obviousness grounds.

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

      “Yamashita meets each of the recited claim elements. See id. at 15–42. Based on our review of Zak’s mapping, however, we find that Zak fails to show that Yamashita discloses or otherwise suggests element [1.11] of claim 1, namely, “a user release mechanism adapted to automatically disengage the first and second catch structures upon actuation of the user release mechanism and thereby release the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.”” slip op. at 10

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

      “But, although Figures 7 and 9 of Yamashita depict the catch structures engaged for stowed configuration of straw 20 and disengaged for dispensing configuration of the straw, Zak ignores intervening Figure 8 of Yamashita, which shows that merely sliding user release mechanism 33 to the left does not “automatically disengage the first and second catch structures” so as “to release of mouthpiece assembly 20 to move via its bias from the stowed configuration to the dispensing configuration,” as required by claim 1. That is because, in addition to user release mechanism 33 on the left-most end of rotating hood 35, Yamashita’s Figure 8 shows a snap-fit closure in the form of a protrusion and corresponding recess on the right-most end of hood 35 that keeps the hood in a closed state despite actuation of user release mechanism 33.6 See Ex. 1006, Fig. 8. Indeed, Yamashita explains that the straw remains in a “closed state,” i.e., a stowed configuration, despite the leftward movement of user release mechanism 33: “when the slider 33 moves to the left in the direction of the arrow X shown in FIG. 8, the hood stopper 33d separates from the hood 35 . . . [a]t this moment, [] the opening of the straw 20 is in the closed state due to the closed hood 35.” Id. at 19– 20. That hood 35 is still “closed” after actuation of user release mechanism 33 can only mean that the snap-fit closure on the right-most end of hood 35 must be actuated to automatically open the hood and release the straw from a stowed configuration to a dispensing configuration.” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not found

      “We find that Zak’s reasoning for the asserted combination lacks rational basis. In particular, we fail to comprehend why one skilled in the art would look to Dall’Agnese’s elastic tab given that Yamashita’s snap-fit closure is already pressure-actuated for conveniently popping open hood 35. Indeed, Zak’s declarant expressly admits that one skilled in the art would have known from “studying the other teachings in Yamashita and from the general context” that “the user might apply pressure to the hood with the thumb to disengage these catch structures and pop the hood open.” Ex. 1003 ¶115 (citing Ex. 1006 ¶ 59). So, given Zak’s admission that Yamashita’s snap-fit closure already has the capability of being pressure-actuated, there is no need to add Dall’Agnese’s user release mechanism for performing the same function. Thus, Zak fails to provide sufficient reasoning with evidentiary underpinning for combining Dall’Agnese’s elastic tab with Yamashita’s snap-fit closure. As such, Zak fails to demonstrate a reasonable likelihood of showing that claims 1 and 21 are unpatentable as obvious over Yamashita and Dall’Agnese. And, because Zak’s challenge of dependent claims 2 and 5–9, which are not argued separately, suffers the same deficiency of a reason to combine Yamashita and Dall’Agnese t. 83–90), we likewise determine that Zak falls short in demonstrating a reasonable likelihood that those dependent claims are unpatentable as obvious over Manganiello and Dall’Agnese.” slip op. at 15

    § 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 9,782,028
  • PTAB · Jan 7, 2022 · IPR2021-01179 · APJ Alyssa A Finamore · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving any remaining challenged claim unpatentable.

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

      “determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). We may not authorize an inter partes review to be instituted “unless . . . the information presented in the petition filed under section 311 and any response filed under section 313 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 arguments and evidence presented by both parties, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we do not institute an inter partes review of the challenged claims of the ’204 patent.” slip op. at 2

    • Adverse judgmentAdverse judgmentOther

      “D. Challenged Claims Petitioner challenges claims 1–20 of the ’204 patent. Pet. 4. Patent Owner has disclaimed claims 1, 2, 4–6, 8–12, 15, 16, and 18–20. Prelim. Resp. 3; Ex. 2009, 1. Consequently, only claims 3, 7, 13, 14, and 17 remain in this proceeding. See 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.); Gunn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 1996) (“A statutory disclaimer under 35 U.S.C. § 253 has the effect of canceling the claims from the patent and the patent is viewed as though the disclaimed claims had never existed in the patent.”).” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “amplitude and experience with cold weather could be a considered a [person of ordinary skill in the art]” (id. at 7 (citing Ex. 1004, comments)). Patent Owner contends a person of ordinary skill in the art “would have been a person who had built structures out of snow or ice, including the building of snow forts, ice castles and the like.” Prelim. Resp. 18. Based on our review of the current record, Petitioner’s proposed level of ordinary skill in the art is consistent with level of skill reflected in the ’204 patent and the cited references. Furthermore, the parties’ proposals for the level of ordinary skill in the art are similar, and we do not discern a meaningful distinction between them. Accordingly, for purposes of this Decision, we adopt Petitioner’s proposed level of ordinary art skill in the art.” slip op. at 10

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

      “would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, we expressly construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))). The parties propose constructions of the claims terms “ice log” and “sleeve.” Pet. 9; Prelim. Resp. 18–20. Nonetheless, for the reasons set forth in our analysis of the asserted grounds of unpatentability in sections III.D–H, we determine that no claim term requires an express construction for the purpose of determining whether to institute an inter partes review.” slip op. at 10

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,663,204
  • PTAB · Dec 11, 2020 · IPR2020-00853 · APJ Eric C Jeschke · IPR · Rehearing

    The Board denied rehearing, leaving institution denied because the Petition did not show a reasonable likelihood of prevailing on any asserted ground for claims 1, 2, 5–8, and 11.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “decision should be modified. See 37 C.F.R. § 42.71(d) (2019). A request on rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed” in the briefing. Id. When reconsidering a decision on institution, we review for an abuse of discretion. See 37 C.F.R. § 42.71(c).” slip op. at 2

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

      “an inter partes review of claims 1, 2, 5–8, and 11 (the “challenged claims”) of U.S. Patent No. 8,078,498 B2 (Ex. 1001, “the ’498 patent”). Paper 1 (“Pet.”). Andra Group, LP filed a Patent Owner’s Preliminary Response. Paper 10. We denied institution, determining that the Petition did not show a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims in any of the three asserted grounds of unpatentability. See Paper 12 (“Decision on Institution” or “Dec.”). Petitioner timely filed a Request on Rehearing, requesting “partial reconsideration” as to one of the three asserted grounds, in which Petitioner asserted that the challenged claims would have been obvious based on VS Webpages (Ex. 1031). Paper 13 (“Request on Rehearing” or “Req. Reh’g.”), at 1; see also Pet. 40, 51–67 (discussing this ground). For the reasons below, Petitioner’s Request on Rehearing is denied.” slip op. at 2

    • Obviousness (§103) › Analogous artNon analogous artNot reached

      “The fact that the Decision on Institution did not discuss whether VS Webpages is analogous art to the ’498 patent does not show that we “misapprehended or overlooked” an argument or evidence. See 37 C.F.R. § 42.71(d). An assessment of whether relied-upon art is analogous is a threshold inquiry in an obviousness analysis. See Johns Manville Corp. v. Knauf Insulation, Inc., IPR2018-00827, Paper 9 at 10–11 (PTAB Oct. 16, 2018) (Decision Denying Institution) (informative) (“Analogous art is merely a threshold inquiry as to whether a reference can be considered in an obviousness analysis. Demonstrating that a reference is analogous art or relevant to the field of endeavor of the challenged patent is not sufficient to establish that one of ordinary skill would have had reason to combine its teachings with other prior art in the manner set forth in the claim.”). Here, we did not address analogousness because we determined that other issues were dispositive as to the asserted ground at issue. Specifically, as discussed below, Petitioner had not shown a reasonable likelihood in prevailing with its position that human beings fall within the scope of the term “article” (or “articles”) in the challenged claims. See Dec. 13–18.” slip op. at 3

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

      “presented in the Petition. In the Decision on Institution, we expressly stated that, even in the context of Petitioner’s alternative position—involving modifying certain images displayed by VS Webpages—“Petitioner continues to rely on human beings as the ‘article[s].’” Dec. 15 n.9 (citing Pet. 58–59 (discussing the alternative reliance on Vertex as to clause D), 60 (discussing clause E)). The aspects of the Petition cited in Petitioner’s Request on Rehearing continue to support this statement.” slip op. at 5

    § 103 obviousnesscites Graham
    Patents in suitUS 8,078,498
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