• 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
• Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentable
  PTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7

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

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

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

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

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

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

  Patent outcomesUS 10,307,384 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,307,384
• 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
• Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentable
  PTAB · Apr 4, 2023 · IPR2021-01478 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–16 are unpatentable: claims 1–14 and 16 as anticipated by Kaiser, and claims 1–16 as obvious under the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided 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 qualifies 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 also an Engineering POSA, or is 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” slip op. at 33

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “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 qualifies 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 also an Engineering POSA, or is 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” slip op. at 34

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

    “Accordingly, we agree with Petitioner that the ’871 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 page 11 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 30–31 (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 46

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

    “It is Patent Owner’s burden in this proceeding to overcome the presumption that Kaiser 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 Kaiser for the reasons set forth on pages 16–19 of Petitioner’s Reply, which we adopt in full and briefly address below. With respect to enablement of Kaiser’s device, we find persuasive Dr. Day’s testimony that no substantial modification of Kaiser’s IVC embodiment would be necessary to deploy it in the SVC. See Ex. 2006, 218:6–220:13; Ex. 1002 ¶ 109 (annotated version of Kaiser’s Fig. 2 showing that the lead/catheter passes through the SVC to reach the IVC). With respect to enablement of Kaiser’s method in the SVC, Dr. Brecker’s analysis also falls short of overcoming the presumption that Kaiser is enabling. Dr. Brecker asserts, for example, that Kaiser also does not describe what pressure differential would need to be created through the use of a flow impedance device in the SVC in order to successfully perform its method using such a device in the SVC, and does not provide any exemplary pressure recordings demonstrating that its method can be successfully performed using a device in the SVC. Ex. 2005 ¶ 110. We find persuasive, however, Petitioner’s argument that Kaiser discloses representative pressure differentials, including an effective pressure differential for occluding the IVC (3 mmHg), which Dr. Brecker could not say would be ineffective for the SVC— but which a Clinician POSA could test, along with other pressure differentials to see what results they produced if the SVC were occluded. Reply 16–17 (citing Ex. 1007, 14:22, Fig. 4 (table showing exemplary hemodynamic data obtained by creating a pressure differential in the inferior vena cava); Ex. 1032, 190:23– 192:3 (Dr. Brecker’s testimony that a Clinician POSA would know how to measure the pressures such as those disclosed in Figure 4), 193:14–194:17 (at least some information could be derived from animal testing)). At least because Patent Owner has not argued (let alone demonstrated) that such testing would be undue, Patent Owner has not satisfied its burden to show non-enablement.” slip op. at 50

  Patent outcomesUS 10,653,871 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,653,871
• Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentable
  PTAB · Apr 4, 2023 · IPR2021-01477 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–16 are unpatentable: claims 1 and 3–16 are anticipated by Gelfand, and claims 1–16 are also obvious over the listed combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s contention that the hypothetical person of ordinary skill in the art may not comprise a multidisciplinary team, but may be “a member” of that same multidisciplinary team, strikes us as a distinction without a difference. See id. Thus, although we disagree with Patent Owner’s analysis, we rephrase part one of our provisionally adopted definition to reference “a member of a multidisciplinary team.”” slip op. at 31

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “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 34

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

    “Accordingly, we agree with Petitioner that the ’871 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 30–31 (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 46

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

    “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 12–24 of Petitioner’s Reply, which we adopt in full and briefly summarize below.” slip op. at 51

  Patent outcomesUS 10,653,871 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,653,871
• 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
• Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution denied
  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

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.