• Signify North America Corp. v. Cao Lighting, Inc.Instituted
  PTAB · Jun 15, 2023 · IPR2023-00213 · APJ Brian D Range · IPR · Institution

  The Board instituted IPR on claims 21, 25–29, 36, 40–43, 47–49, and 52–57 on all asserted grounds, finding a reasonable likelihood of success on the §103 obviousness challenges.

  RulingsInstitution decision

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

    “Conclusion as to claim 21 Based on the evidence in the present record, we determine that Petitioner has shown sufficiently for purposes of this Decision that the combination of Begemann, Bogner, and Sugiura teaches or suggests all elements of claim 21 and that Petitioner sufficiently shows that a person of ordinary skill in the art would have had reason to combine the references’ teachings with rational underpinning and reasonable expectation of success. Thus, we determine Petitioner has established a reasonable likelihood of prevailing in showing that claim 21 is unpatentable over the combination of Begemann, Bogner, and Sugiura. b. Dependent Claims 25–29, 36, 40, 42, 43, 47–49, and 52–57 Petitioner accounts for the limitations recited in claims 25–29, 36, 40, 42, 43, 47–49, and 52–57 (which depend from claim 21). Pet. 6, 51–71. Petitioner shows sufficiently for purposes of this Decision that each element of claims 25–29, 36, 40, 42, 43, 47–49, and 52–57 is taught or suggested by the combined teachings of Begemann, Bogner, and Sugiura and shows reason to combine the references’ teachings with rational underpinning and reasonable expectation of success. Thus, we determine that Petitioner has sufficiently established a reasonable likelihood of establishing claims 25–29, 36, 40, 42, 43, 47–49, and 52–57 are obvious in view of Begemann, Bogner, and Sugiura.” slip op. at 45

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

    “We do not agree, however, that Petitioner fails to show material error. Rather, Petitioner shows sufficiently that the outcome of the reexamination hinged on Patent Owner’s representation that the prior art did not teach LED chips “configured to output light at greater than about 40 milliwatts.” Pet. 19 (quoting Ex. 1014, 238–239 (Patent Owner’s statement in file history); see also Ex. 1014, 159 (examiner explaining that claims are found patentable based on Patent Owner’s argument that the “greater than about 40 milliwatts” recitation is not “taught or suggested by any reference currently relied on”). Petitioner then explains in detail why Patent Owner’s representation, and the Examiner’s resulting conclusion, was in error. Pet. 20–24. Petitioner’s explanation as to why Begemann, the cited art, actually taught the “greater than about 40 milliwatts” recitation is supported by the evidence of record sufficiently to demonstrate a reasonable likelihood of success at trial. See, e.g., Ex. 1002 ¶¶ 85–93, 141–144 (Petitioner’s witness, Dr. Jokerst, explaining why the references suggest the “greater than about 40 milliwatts” recitation when a correct calculation is applied).” slip op. at 20

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner

    “the presently cited art at the time a different petitioner filed the Cree IPR. Prelim. Resp. 27. We note, however, that this factor also includes considering whether the prior art relied on in the later petition “could have been found with reasonable diligence.” General Plastic, slip op. at 20. Although the cited references easily could have been found by reviewing the ’961 patent’s file history, it is less clear that the key alleged error in Patent Owner’s representations concerning the teachings of those references would have been readily apparent. As such, this factor is neutral. 3. whether at the time of filing of the second petition the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition; Patent Owner argues that Petitioner used the Board’s institution decision (instituting trial) in the Cree IPR as a roadmap for its petitions. Prelim. Resp. 27–28. Patent Owner, however, presents no factual evidence merely result from the strength of references raised in prior reexamination rather than copying from one petition to another. The record lacks evidence directly establishing how or why Petitioner came to select the evidence the Petition relies upon, and we decline to speculate. to support this point, for example, instances in the Petition that facially support a finding that the arguments presented in the Petition track the analysis in the Board’s prior institution decision. Moreover, we agree with Petitioner that the road-mapping concern is either not relevant or is less relevant when the earlier IPR was instituted. Reply 1–2; see also General Plastic, slip op. at 17–18 (explaining that factor 3 is directed to road-mapping concerns). This is not a multiple-bites-of-an-apple situation where the second bite is modified after the first bite fails. This factor weighs against discretionary denial or is neutral.” slip op. at 24

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

    “The facts here are analogous to those of Hulu, LLC. The Bogner reference provides the indicia at bottom left corner of its first page. Ex. 1007, 143. The indicia states: “Part of the SPIE Conference on Light- Emitting Diodes Research, Manufacturing and Applications III • San Jose, California • January 1999 SPIE Vol 3621 • 0277-786X/99/$10.00.” Id. The January 1999 date being printed adjacent to the name of a particular conference and San Jose, California suggests that the paper was presented at the 1999 conference. The “99” within 0277-786X/99/$10,00 indicates a 1999 publication, and the “$10.00” suggests public availability at the price of ten dollars in 1999. The indicia also suggest that the paper was published by an established publisher—SPIE (the international society for optics and photonics). As further evidence, Petitioner includes in the record a page from the SPIE website that appears to be from October 12, 2022. Ex. 1007, 1. The page indicates Bogner was published “14 April 1999” in “SPIE Proceedings Vol. 3621.” Id.10 This information is consistent with the indicia on the first page of the paper itself. The evidence, in total, supports Petitioner’s contention that the paper was presented at a conference in January 1999 and then published within SPIE Proceedings Volume 3621 in April 1999–– absent contrary evidence, which Patent Owner does not advance at this stage of the proceeding. As in Hulu, LLC, the Bogner reference’s indicia provide some evidence of printed publication status. The page from the SPIE website provides further evidence. Thus, given the record as a whole, which contains some evidence that Bogner was a printed publication as of 1999 and no evidence to the contrary, and in view of the Hulu LLC precedent, we determine that Petitioner has established at this stage of the proceeding a reasonable likelihood that the Bogner reference is a printed publication that was publicly accessible before the critical date11 of the challenged patent.” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 6,465,961
• Infineon Technologies AG v. Feinics Amatech TeorantaAll claims unpatentable
  PTAB · Jun 12, 2023 · IPR2022-00235 · APJ Stacey G White · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–7 over Takeda-322 under §§ 102 and 103, claims 1–6 over Murayama under § 102, and claim 7 over Murayama under §§ 102 and 103.

  RulingsFinal written decision

  • Adverse judgmentDecided for patent owner

    “Under the circumstances of this case, we do not agree that adverse judgment with respect to the disclaimed claims is appropriate. Our Rules, provide that a party may request judgment against itself. 37 C.F.R. § 42.73(b). Here, Patent Owner is not requesting adverse judgment against itself. While it is true that 37 C.F.R. § 42.73(b) provides that “[a]ctions construed to be a request for adverse judgment include . . . (2) [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial” (emphasis added), we decline to construe Patent Owner’s statutory disclaimer as a request for adverse judgment in this proceeding because Patent Owner does not disclaim all challenged claims and the majority of the challenged claims remain in this trial.” slip op. at 4

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties are in general agreement as to the level of education (undergraduate degree in electrical engineering or equivalent) and the number of years of experience working with RFID devices (1–2 years), but differ as to the exact nature of that experience (developing antennae used in RFID devices versus developing antennae used in RFID devices for inductive coupling). Petitioner points out that “the claims are not limited to a [Booster Antenna (BA)] operating at any particular frequency range.” Reply 25. In addition, Patent Owner submitted into the record a text titled RFID Handbook, which details different frequencies and types of coupling that may be at use by various RFID systems. See Ex. 2005, 22–23. Although this text differentiates between “inductively or capacitively coupled system[s] and microwave system[s] or backscatter system[s]” (id. at 23 (emphasis omitted)), its description of each of these types of RFID devices indicates that an ordinary artisan would have had experience with RFID devices generally. Thus, we are not persuaded that the level of ordinary skill should be narrowly confined to developing antenna for RFID devices that are used for inductive coupling. For the purposes of this Decision, we adopt Petitioner’s definition of the level of ordinary skill in the art as “a Bachelor’s degree in electrical engineering or a similar field, and 1– 2 years of experience researching and developing antennas used in RFID applications.” Pet. 87.” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “testimony of Petitioner’s declarant, Dr. van der Weide, because he “he lacks relevant experience, his testimony runs counter to fundamental principles of the RFID technology disclosed in the ’932 patent, and his testimony evidences a lack of candor.” PO Resp. 46. According to Patent Owner, Dr. van der Weide “has experience with RFID that operates at microwave frequencies,” but “identifies no experience with inductive RFID systems at lower frequencies (e.g., frequencies such as 13.56MHz and 8.2MHz).” Id. This argument is based on Patent Owner’s articulation of the level of ordinary skill in the art, which we have not adopted. Moreover, Petitioner presents evidence that Dr. Van der Weide’s experience exceeds even Patent 7 We further note that our final determination, on the merits, would be the same even under Patent Owner’s definition of the level of ordinary skill in the art. Owner’s articulation of the level of ordinary skill in the art. Reply 25–27. Dr. van der Weide’s education and experience are sufficient to allow us to grant his testimony our full consideration. See Ex. 1003 ¶¶ 2–7; Ex. 1004 (van der Weide curriculum vitae).” slip op. at 11

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

    “Petitioner asserts that “[n]o claim term requires an exact outer boundary construction, because the prior art relied upon herein meets the claim terms under any reasonable interpretation.” Pet. 9. Patent Owner proposes constructions for the claim terms “booster antenna,” “card antenna component,” “coupler coil component,” and “extension antenna component.” PO Resp. 25–45. According to Patent Owner, Petitioner also has proposed its own constructions for these terms, despite stating that no claim term requires construction. Id. at 25–26. We address “booster antenna” and “extension antenna” below.8 It is unnecessary to construe “card antenna component” or “coupler coil component” in this Decision 8 Patent Owner also argues that Petitioner belated construes “card body” in Petitioner’s Reply. Sur-Reply 16–18. We do not construe “card body” because this construction is not necessary to resolve this matter. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). because none of the parties’ disputes turn on the meaning of either term. See, e.g., Nidec Motor Corp., 868 F.3d at 1017.” slip op. at 13

  Patent outcomesUS 9,195,932 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,195,932
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9

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

    “Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 10

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

    “established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24

  Patent outcomesUS 10,900,034 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,900,034
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00402 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–7, 9, 10, 12–15, 17, 18, 20–25, and 27–30 are anticipated; the remaining challenged claims are obvious.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Petitioner further asserts that “[a] POSA would have understood the chemical structure of nucleic acids, such as DNA and RNA, and would have understood the role of such nucleic acids in cellular biology” and been aware of various prior art “methods to chemically modify RNA, including gRNAs for use in gene regulation.” Id. at 12–13 (citing Ex. 1003 ¶¶ 61–72, 80). Patent Owner agrees that a POSA would have this educational level. Resp. 24. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties may disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “Independent claims 1 and 12 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to a target polynucleotide.” Ex. 1001, 243:20–22, 244:28–31. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 17 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 17. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:36–40. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 12. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24–25. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 9

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

    “We find Petitioner’s arguments and evidence persuasive. It is well established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 24–26. There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. Smithkline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 21

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional. Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 79 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 79, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 23

  Patent outcomesUS 10,337,001 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,337,001
• Streck, Inc. / Streck LLC v. Ravgen, Inc.No claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01577 · APJ Timothy G Majors · IPR · Final written decision

  Claims 55–61, 68, 69, 80–86, 89–92, 94, 126–130, 132, and 133 were not shown unpatentable under the asserted anticipation and obviousness grounds.

  RulingsFinal written decision

  • Strike new argumentNew argument consideredDenied

    “III. MOTIONS Motion to Strike (Paper 50) Petitioner filed a motion to strike portions of Patent Owner’s Sur- Reply. Paper 50. Patent Owner opposes the motion. Paper 53. Petitioner contends Patent Owner raised new argument about Exhibit 1014 (a paper authored by Dr. Patterson), which was submitted with the filing of the Petition but only cited by Patent Owner for the first time in its Sur-Reply. Paper 50, 1–3; PO Sur-Reply 14 (citing Ex. 1014). According to Petitioner, Patent Owner presents new argument about the reversibility of certain crosslinks caused by formaldehyde, cites new experimental data (in Ex. 1014, Fig. 2.1), and argues such matters would have been known before any possible priority date of the ’277 patent. Paper 50, 1–3. Moreover, Petitioner argues, the untimeliness of Patent Owner’s arguments about Exhibit 1014 prevented the exhibit’s author, Dr. Patterson, from addressing them to provide explanation or context. Id. at 2–3. For the reasons given below, we deny Petitioner’s motion to strike. First, we find that Patent Owner’s arguments on Exhibit 1014 are, on balance, responsive to issues raised by Petitioner in its Reply. It is true that Petitioner submitted Exhibit 1014 with its Petition and that Patent Owner did not cite it until its Sur-Reply. However, the points raised by Patent Owner about Exhibit 1014 respond to certain of Petitioner’s arguments raised for the first time in its Reply. For example, Petitioner argued a POSA would not have been concerned about formaldehyde’s use (such as cross-linking disclosed in Heinmoller that Patent Owner cited in its Response) and that those concerns arose only after the supposed priority date of the ’277 patent. 88 Pet. Reply 8–9. Patent Owner’s citation of Exhibit 1014 is responsive on such points (e.g., it discusses cross-linking with formaldehyde’s use), it published in 2000 and is thus earlier than some references Petitioner argued were too late to evidence a POSA’s knowledge, and, lastly, it was authored by Dr. Patterson and arguably called into question the credibility of rebuttal opinions he offered about the state of a POSA’s knowledge on such issues. Second, Exhibit 1014 does not, ultimately, help Patent Owner as we do not rely on the portions of Exhibit 1014 cited by Patent Owner or Patent Owner’s argument about them. As discussed in our analysis, if cross-linking (as reported in Heinmoller or, for that matter, Exhibit 1014) was a perceived problem, Dr. Patterson provides a credible explanation how it could be and likely was addressed by Pertl.54 Supra Section II(G)(3) (citing Ex. 1047).” slip op. at 88

  • ExcludeDenied

    “by the non-designating party. See generally Paper 60. We nevertheless reviewed the designated testimony. The objections are overruled, but were also considered during review.” slip op. at 90

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

    “evidence that any of the challenged claims are unpatentable based on grounds advanced in the Petition.” slip op. at 93

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “3. Conclusion For the reasons above, we find Petitioner has not established by a preponderance of the evidence that the combination of Chiu/Lee discloses “an agent that inhibits cell lysis, if cells are present” as recited in independent claims 55 and 81, and the claims depending therefrom. Accordingly, Petitioner has not established that claims 55–59, 61, 68, 69, 80–86, 89, 94, and 126–130 would have been obvious over Chiu and Lee.” slip op. at 52

  Patent outcomesUS 7,332,277 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,332,277
• Hope Medical Enterprises, Inc. v. Oregon Health & Science UniversityOther
  PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision

  The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20

  • 112 supportMotion to amend, deniedDenied

    “In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached

    “F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26

  § 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,596,190
• Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentable
  PTAB · Apr 4, 2023 · IPR2021-01565 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–24 are unpatentable: claims 1–10, 12–22, and 24 as anticipated by Kaiser, and claims 1–24 as obvious under the listed grounds.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

    “demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

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

    “activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 44

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

    “Although Kaiser exemplifies in detail a method involving IVC occlusion, its disclosure makes clear that the method is also applicable to the SVC. See, e.g., Ex. 1007, 6:60–64 (“the adjustable component may create a pressure gradient by . . . adjusting blood flow impedance through the superior vena cava”), 5:64–6:2 (disclosing “systems and methods may be provided to create a pressure differential” using “balloons . . . to increase a pressure drop through the . . . superior vena cava”), Claim 5 (reciting a “flow impedance device implantable within a patient’s inferior vena cava”), Claim 17 (“The method of claim 10, wherein the body lumen within which the adjustable component is positioned is . . . a superior vena cava.”), 6:31–36 (positioning pressure sensor in the superior vena cava); see also Ex. 1010, 19–22 (claims of provisional application directed to reducing blood flow through the superior vena cava); see also Pet. 29–34, 36–39; Reply 14–16; Ex. 1002 ¶¶ 152–153, 156–159, 165, 167–176 (Dr. Day’s testimony regarding the SVC positioning elements). Considering the arguments and evidence of record, including our own reading of Kaiser (see supra Section I.I.1), we find that Kaiser expressly discloses the contested element of Ground 1 relating to use of the restrictor in the SVC.” slip op. at 47

  Patent outcomesUS 10,639,460 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,639,460
• Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentable
  PTAB · Apr 4, 2023 · IPR2021-01564 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–24 are unpatentable: claims 1, 3–13, and 15–24 are anticipated by Gelfand, and claims 1–24 are also obvious under Grounds 2–8.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedPetitioner expert creditedDecided for petitioner

    “Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art”).” slip op. at 31

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

    “normal intravascular pressure at or near the region of intervention. To the contrary, the Specification repeatedly discloses the creation and maintenance of low-pressure zones at or near the catheter apparatus restrictors during the course of treatment. See, e.g., Ex. 1001, 15:33–36 (“control module 200 can include multiple feedback loops to adjust performance of the system 10 to create and maintain a low pressure zone while the lymphatic fluid is cleared”) (emphasis added), 13:2–7 (“A pressure sensing lumen, which is positioned proximately to the catheter suction port within the isolated area, can be used to control the rate of suction by maintaining the pressure of the isolated area between about 2–5 mmHg and thus prevent collapse of the thoracic duct due to excessive suction and ensure optimized lymph drainage.”) (emphasis added), 17:52–63 (“[T]he pressure gradient across the proximal restriction is achieved by the pressure reduction within the area between the two restrictions. Actuation of the pump helps to create a low pressure zone in the vicinity of the junction of the jugular vein and the subclavian vein by withdrawing fluid in this region, recirculating it through the pump, and discharging the fluid downstream of this region. Because the outflow of the thoracic and lymphatic ducts is located in this region, the lower pressure will facilitate drainage of lymphatic fluid.”) (emphases added). Accordingly, we agree with Petitioner that the ’460 Patent “teaches activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 43

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

    “Considering the posture of this case, it is Patent Owner’s burden to overcome the presumption that Gelfand is enabled. See, e.g., Amgen, 314 F.3d at 1354–55. This requirement is not excused in IPR proceedings. See Apple Inc. v. Corephotonics, Ltd., 861 F. App’x 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). Considering all the argument and evidence of record, we find that Patent Owner has not overcome the presumption with respect to Gelfand for at least the reasons set forth on pages 13–25 of Petitioner’s Reply, which we adopt in full and briefly summarize below.” slip op. at 48

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “On this record, we find persuasive Dr. Day’s testimony that, “there is no functional difference between the SVC and the IVC that would preclude a catheter from functioning once in the SVC.” Ex. 2006, 73:21–74:5; see also Ex. 1002 ¶ 134 (the “methods of balloon activation and operation are the same regardless of whether the occlusion balloon is placed in the SVC or the IVC”). We likewise find persuasive Dr. Day’s testimony that, “Gelfand’s methods, systems and devices . . . could be used in the SVC without any substantial modification other than the catheter potentially being inserted into a vein upstream of the SVC.” Ex. 1002 ¶¶ 122–126; see also id. ¶¶ 130– 134 (similar testimony specific to element [1e]); Ex. 2006, 93:11–99:16, 71:7–78:15, 86:13–87:19, 88:14–90:9, 97:10–13. But to the extent Gelfand’s device needed to be modified, we find persuasive Dr. Day’s testimony that an Engineer POSA would have found such modifications “routine.” Ex. 2006, 205:8–212:21 (“they’re just different variants or dimensions of the invention”). We, likewise, find persuasive Dr. Garcia’s testimony that “Gelfand discloses occluding the SVC or IVC with a balloon catheter device to reduce blood flow to the heart. Gelfand’s catheter is a type of Swan-Ganz catheter, a commonly used catheter with which I and other clinicians are very familiar, and Gelfand discloses that its catheter can be inserted and placed using conventional techniques.” Ex. 1004 ¶ 60; see also Ex. 1006 ¶¶ 27–31 (Dr. Day’s overview of therapeutic balloon catheters). Referencing Dr. Day’s testimony, Dr. Garcia further states that [f]rom a clinician’s perspective, there would have been no difference in using Gelfand’s device to partially occlude the SVC and in using it to fully occlude the SVC. The device would simply have been inserted percutaneously, advanced so that the balloon is in the SVC, and then operated to inflate the balloon to the inner diameter of the SVC. Id. ¶ 127; see also id. ¶¶ 81–83, 127 (detailed explanation of why one of ordinary skill in the art would know how “to place the occlusion balloon in the SVC as taught by Gelfand”). As further noted by Petitioner, “Garcia explained that Gelfand discloses, and a POSA would know, that a modified Swan-Ganz catheter like Gelfand’s could be inserted via the right internal jugular vein so as to place the occlusion balloon in the SVC.” Reply 17 (citing Ex. 1004 ¶¶ 73–83 (showing modified version of Gelfand’s Figure 1), 136, 145–159; Ex. 2006, 101:8–103:10); see also id. at 18–19 (citing Ex. 1032, 51:19–53:23, 204:4–205:22, 206:10–208:24) (Dr. Brecker’s admissions that diameters of Gelfand’s catheter would allow SVC placement via jugular vein and that placement of Swan-Ganz catheters through the SVC via the right internal jugular vein was known).” slip op. at 50

  Patent outcomesUS 10,639,460 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,639,460
• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  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
• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  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

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.