• Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentable
  PTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. 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))).” slip op. at 8

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

    “specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14

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

    “2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. 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 16

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

    “We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27

  Patent outcomesUS 11,406,402 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,406,402
• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-01165 · APJ William V Saindon · IPR · Final written decision

  Claims 1–21 were not shown unpatentable because Zhou does not teach the claimed low-light high-pass or stickiness parameter limitations.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “4. Conclusion for the Prior Art Analysis In sum, we find that Zhou does not disclose the low-light high-pass parameter or the stickiness parameter. Petitioner’s grounds for both independent claims 1 and 16 rely on Zhou for teaching a low-light high-pass parameter or a stickiness parameter. Pet. 23–28, 64. Because we find Zhou does not teach these limitations, all of Petitioner’s grounds fall for this reason. III. CONCLUSION For the reasons given above, we determine that Petitioner has not established by a preponderance of the evidence that any claim of the ’840 patent would have been obvious in view of the prior art cited.” slip op. at 18

  • Skill levelSkill level petitioner adoptedOther

    “A person of ordinary skill in the art (POSITA) in the field of the ’840 patent would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras. Alternatively, a POSITA would have four years of experience working on image or video processing, or digital cameras. An advanced graduate degree in the disciplines cited above may make up for the work experience indicated above. Pet. 6 (citing Ex. 1002 ¶ 32). Patent Owner applies the same standard. PO Resp. 26–27. We use this agreed-upon standard for purposes of this Decision.” slip op. at 7

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “We review this testimony based on the strength of the underlying factual basis. 37 C.F.R. § 42.65(a); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value . . ..”). Here, the underlying factual basis is not very strong for either witness. That said, we find that Dr. Foroosh’s testimony is more logically sound and consistent with the ’840 patent disclosure. Based on our reading of the specification, we find a clear indication that “stickiness” has to do with the past. In order to control “the extent by which preceding portion(s) . . . impacts determination of the smoothed trajectory” (emphasis added), one must control the degree by which the past frames impact determination. And to control the degree of the past’s influence, one must, as a consequence, favor the past over the future. That is, the frame of reference of the stickiness parameter is the past. The specification could have used a time-agnostic term, like a “nearness” or “adjacency” parameter, but it did not. Thus, the fact that “stickiness” is used in conjunction with “preceding” indicates that it deals with a preference for preceding frames. On this basis, we find Dr. Katsaggelos’s testimony less persuasive than Dr. Foroosh’s.” slip op. at 10

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

    “That said, we do not construe a stickiness parameter as prohibiting consideration of future frames. Instead, we determine that the stickiness parameter’s value determines the impact of the preceding portions, versus the following portions. The ’840 patent recognizes this, when it says that a stickiness parameter value of “1,” representing a “lazy” stabilizer that maximally favors the past, would not override a violation of the margin constraint based on the look-ahead (i.e., would not allow the viewing window to fall out of bounds in the event of large future motion). See Ex. 1001, 22:26–30; see also id. at 12:61–13:29 (acknowledging that favoring the past may lead to a conflict with the viewing window determination), 15:39–60 (adjusting the viewing window to ensure it does not violate a margin constraint). Thus, while a past-favoring parameter by necessity favors the past over the future, it does not prohibit consideration of the future. In view of the above, we construe the claimed “stickiness parameter” as a parameter that controls the extent by which preceding portions of the trajectory impacts determination of the smoothed trajectory, with an understanding that in order to favor preceding portions, to some extent, the parameter must relatively disfavor following portions.” slip op. at 10

  Patent outcomesUS 10,958,840 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,958,840
• Microsoft Corporation / Affirmed Networks, Inc. v. Lemko CorporationNo claims unpatentable
  PTAB · Aug 30, 2024 · IPR2023-00529 · APJ Brian D Range · IPR · Final written decision

  Claims 1–8, 11–16, and 21 were not proven unpatentable over Mauer and Waylett because the asserted combinations did not teach key claim limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. LEVEL OF ORDINARY SKILL Petitioner defines the person of ordinary skill in the art as follows: As of February 2006, a person of ordinary skill in the art (“POSITA”) would have been a person with a degree in 1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Because the challenged claims of the ’414 patent have an effective filing date before the effective date of the applicable AIA amendments, we refer to the pre-AIA version of 35 U.S.C. § 103 throughout this Decision. 2 Mauer et al., U.S. Patent No. 7,395,085 B1, issued July 1, 2008 (Ex. 1005, “Mauer”). 3 Waylett et al., U.S. Patent No. 8,184,603 B2, issued May 22, 2012 (Ex. 1006, “Waylett”). computer science, electrical or computer engineering, physics, or a similar discipline . . . [and] would also have at least two years of relevant experience including, for example, work related to telecommunications networks. Pet. 3 (citing Ex. 1003 ¶ 54). The institution decision adopted Petitioner’s definition of a person having ordinary skill in the art. Dec. on Inst. 11–12. Patent Owner applied this definition for its response. Resp. 19. Petitioner’s undisputed definition of a person of ordinary skill in the art is reasonable and consistent with the prior art and ’414 patent specification. Based on the record before us, we adopt Petitioner’s undisputed proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

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

    “Petitioner does not submit constructions for any claim terms. According to Petitioner, “[t]he Board construes claims under the same standard used in civil actions in federal district court. The district court for the related litigation has not yet construed the claim terms.” Pet. 7. The parties provided briefing regarding construction of “distributed mobile architecture (DMA).” Resp. 19–34; Pet. Reply 1–3; PO Sur-reply 11–14. But we do not need to construe “distributed mobile architecture (DMA)” to resolve this inter partes review. We thus do not construe this claim term. We also do not discern a need to construe explicitly any other claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We discuss the meaning of ’414 patent claims to the extent necessary to resolve the issues we address below. Id.” slip op. at 14

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

    “a) Combination of Mauer and Waylett In support of both Ground 1 and Ground 2, Petitioner argues that a person of ordinary skill in the art would have been motivated to combine Mauer’s and Waylett’s disclosures, “using Waylett’s Network-in-a-box 224 in each of Mauer’s WWAN 14 and WLAN 12, resulting in at least two DMA systems.” Pet. 11–13. Asserting that “Mauer teaches providing sufficient network coverage by use of different kinds of networks, network interfaces, and protocols,” Petitioner contends that a person of ordinary skill in the art would have recognized that “Waylett discloses an inexpensive way to implement the same networks used in Mauer’s WWAN 14 and WLAN 12.” Id. Citing similarities in Mauer’s and Waylett’s systems, Petitioner argues that “a POSITA would have been able to modify Mauer’s WWAN 14 and WLAN 12 networks so that each network uses Waylett’s NIB 224.” Id. at 14. According to Petitioner, the combination would have included a number of beneficial features from Mauer. Id. at 14–15. Petitioner further advances three reasons that a person of ordinary skill would have had to combine the references’ teaching. Id. at 15–16. First, asserting that Waylett discloses cost benefits and Mauer discloses “an improved method and system for notifying mobile stations,” Petitioner contends the “references each provide reasoning” to combine their disclosures. Id. at 15. Second, Petitioner argues that a person of ordinary skill in the art would have been motivated to “improve Mauer’s distributed wireless network system by consolidating it into a single box, making it compact in design allowing for faster deployment.” Id. at 16. “Third, Waylett’s NIB would help mitigate the shared concern of Mauer—that is, reaching a mobile station as it roams or moves outside of the service or coverage area.” Id.” slip op. at 24

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

    “Petitioner does not establish that Mauer sends calls to voicemail based on the two determinations claim 1 recites. Resp. 55–56. In particular, as we explain above, claim 1 requires making use of the DPR after first determining the second mobile subscriber is not located within a first wireless coverage area based on HLR and VLR information and also determining that the second mobile subscriber is not located within a second wireless coverage area based on certain CLR information. The Petition, at best, attempts to establish that Mauer directs to voicemail when a “communication session cannot be established over the first or second wireless network.” Pet. 37. But a general determination that a “communication session cannot be established” does not teach or suggest claim 1’s specific requirements that first, the DPR is utilized in the specific circumstance that the second mobile subscriber is not located within the first wireless coverage area (with this determination being made based on HLR and VLR information), and second, that the DPR is also not located within the second wireless coverage area (with this determination being made based on CLR information). See PO Sur-Reply 8–9; Ex. 2001 ¶¶ 111–113. For the reasons above, Petitioner does not establish by a preponderance of the evidence that the combined art teaches or suggests the final “when” recitation of claim 1.” slip op. at 29

  Patent outcomesUS 7,653,414 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,653,414
• Illumina, Inc. v. Ravgen, Inc.No claims unpatentable
  PTAB · Jan 25, 2023 · IPR2021-01272 · APJ Timothy G Majors · IPR · Final written decision

  Illumina did not prove claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 unpatentable because the asserted grounds failed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner did not expressly contest this definition during trial, noting only that “Dr. Van Ness meets [this] definition” and “confirms his opinions are the same under either party’s definition.” PO Resp. 6 (citing Ex. 2239 ¶¶ 20–25). To the extent there are minor differences in the above definition and the alternative definition offered by Dr. Van Ness (Ex. 2239 ¶ 23), we find that Dr. Van Ness’s proposal is too broad for at least the reason that it does not require the POSA have experience collecting and analyzing cell-free DNA from blood samples—subject matter relevant to the claims and asserted art. Accordingly, we continue to apply Petitioner’s proposed definition here.14 In any event, the parties’ technical declarants meet or exceed either definition and there is no indication that their opinions would change depending on which definition was applied. Ex. 1056 ¶¶ 5–10 (overview of qualifications and experience); Ex. 2239 ¶¶ 4–7 (same).” slip op. at 17

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

    “that anticoagulant chelators are not the claimed “agent” and, accordingly, that “Landes’s disclosure of ACD (and its dextrose component) fails to meet the ‘agent’ limitation.” Id. at 17–19 (citing the aforementioned prosecution history). Second, even if the dextrose of ACD is not excluded from the scope of the “agent” term as a matter of claim interpretation, Patent Owner argues that Petitioner fails to provide evidence sufficient to show that dextrose in Landes’s ACD tubes and method necessarily “inhibits lysis of cells” as claimed. Id. at 19–20; 26–34 (arguing, inter alia, that a “mere possibility” of ACD’s dextrose component inhibiting lysis in Landes’s method is not enough); PO Sur-Reply 10–12 (arguing that Petitioner’s contentions about dextrose regulating “isotonicity” or providing a “nutrient source” for cells are belated and otherwise substantively flawed).23” slip op. at 32

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

    “warning against formaldehyde’s use and recommending other fixatives altogether. Id.; Ex. 2150 (Srinivasan), 6 (“A method to overcome the problems of formaldehyde is to use an alternative fixative that is better suited for the preservation of nucleic acids and proteins.”).33 Accordingly, Patent Owner contends that “significant evidence of negative perceptions of formaldehyde” would have dissuaded the modification of Lo proposed by Petitioner. PO Resp. 46–47; PO Sur-Reply 18–20.34 3. Analysis On the complete record developed through trial, we agree with Patent” slip op. at 56

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “warning against formaldehyde’s use and recommending other fixatives altogether. Id.; Ex. 2150 (Srinivasan), 6 (“A method to overcome the problems of formaldehyde is to use an alternative fixative that is better suited for the preservation of nucleic acids and proteins.”).33 Accordingly, Patent Owner contends that “significant evidence of negative perceptions of formaldehyde” would have dissuaded the modification of Lo proposed by Petitioner. PO Resp. 46–47; PO Sur-Reply 18–20.34 3. Analysis On the complete record developed through trial, we agree with Patent” slip op. at 56

  Patent outcomesUS 7,332,277 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,277
• Hanwha Solutions Corporation / Hanwha Q Cells USA, Inc. v. Rec Solar Pte. Ltd.No claims unpatentable
  PTAB · Dec 9, 2022 · IPR2021-00989 · APJ Brian D Range · IPR · Final written decision

  Claims 1–6, 11, and 13 were not shown unpatentable under either obviousness ground because Petitioner did not establish a motivation to combine Yagiura and Shimasaki.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner’s position is persuasive. We agree that documents from the Japanese Patent Office are self-authenticating official government documents. The technical issues regarding missing pages in the originally filed version of the document do not cause us to question authenticity. We also agree that Petitioner uses the documents to establish what the documents teach rather than establishing the truth of what the documents teach. In Reply, Patent Owner argues that Petitioner relies on the date printed on the document to prove up the truth of when the document was published. Mot. Excl. Reply 1–2. To the extent this is the case, an exception to hearsay applies because the document is a record of a public office. Fed. R. Evid. 803(8)(B) (a record of public office is an exception to the hearsay rule if the opponent does not show that the source of information or other circumstances “indicate a lack of trustworthiness”). Here, Patent Owner does not persuasively demonstrate a lack of trustworthiness; Patent Owner does not identify any substantively meaningful distinction in the missing pages of the originally filed document and does not identify any evidence to suggest that the missing pages were anything more than a harmless clerical error. For the reasons above, Patent Owner’s motion to exclude is denied with respect to these documents. B.” slip op. at 8

  • Skill levelSkill level board ownOther

    “Petitioner’s proposal is too broad. PO Resp. 8. For example, a person who merely installs solar panels for three years (satisfying “professional experience in solar energy”) while having some familiarity with module manufacturing would not be of ordinary skill in the design aspects of the ’060 patent as, for example, reflected by the claims at issue and the ’060 patent’s text and figures. See, e.g., Ex. 1101, Figs. 2a, 2b, 3a, 3b, 4a, 4b, 3:22–7:44. On the other hand, we also determine that Patent Owner’s proposal is too narrow. A person could, for example, have ordinary skill in the art of the ’060 patent by virtue of non-professional experience (for example, academic experience). When assessing relevant experience, research work done for a university (beyond mere classroom study) would have been just as valuable as research work done for a corporation. Also, ordinary skill in the art could be demonstrated by work that requires understanding of the ’060 patent’s field even if not “designing, developing, and/or researching” in the field itself We, thus, determine that a person of ordinary skill in the art of the ’060 patent would have been someone with a bachelor’s degree in electrical engineering, applied physics, or the like, and at least two years of (a) experience designing, developing, and/or researching in the field or (b) experience in solar energy that required an understanding of the ’060 patent’s field. Alternatively, that person would have had an advanced degree in electrical engineering, applied physics, or the like and at least one year of” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “qualifies as evidence in this matter. The Federal Circuit has held that expert testimony about the perspective of person of ordinary skill in the art (as Dr. Kimball provides here) must come from a person having at least ordinary skill in the art. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–78 (Fed. Cir. 2022) (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)) (holding that ITC Administrative Law Judge abused discretion by admitting expert testimony of witness who lacked the experience of a person having ordinary skill in the art); see Mot. Excl. 6–7 (arguing this point). Patent Owner, however, cites no authority that expert testimony on such matters come from a person having ordinary skill in the art at the time of the invention. Cf. Scentair Tech., LLC v. Prolitiec Inc., IPR2021-00012, Paper 22 at 61 (PTAB Apr. 22, 2022) (similarly noting a party’s lack of authority on this point). Beyond needing to come from a person of ordinary skill in the art, expert testimony is admissible if the expert has the “scientific, technical, or other specialized knowledge [that] will help the trier of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702. Furthermore, “[t]here is … no requirement of a perfect match between the expert’s experience and the relevant field.” USPTO, Patent Trial and Appeal Board Consolidated Trial Practice Guide, 34 (Nov. 2019). Here, Petitioner adequately establishes that Dr. Kimball qualifies as a” slip op. at 12

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

    “The Petition argues that all claim terms should be given their plain and ordinary meaning. Pet. 18. Patent Owner does not dispute this. PO Resp. 13. We determine that no claim term requires express construction for purposes of this Final Written Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms that are in controversy, and only to the” slip op. at 15

  Patent outcomesUS 10,749,060 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,749,060
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Nov 1, 2022 · IPR2021-01054 · APJ Timothy G Majors · IPR · Final written decision

  Claims 55–63, 66–69, 80, and 127–132 were not shown unpatentable under either § 103 ground because a skilled artisan would not have been motivated to add the proposed formaldehyde-based agents.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal genetic abnormalities in maternal samples, as described in the ’277 patent and the prior art here. See, e.g., Ex. 1001, 1:31–5:59 (Field of Invention and Background Art); Ex. 1003 (Chiu). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. 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 14 level and a need for testimony is not shown). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.13” slip op. at 14

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 ¶¶ 102–104; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. 27 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 39 Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 106–108. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 39

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

    “We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 ¶¶ 102–104; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. 27 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 39 Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 106–108. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 39

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner

    “(Ex. 1049)). If Petitioner wanted to assert a combination based on Chiu and Streck’s ’517 patent, it could have made that argument in the Petition. It did not. Petitioner also never proposed as part of its theory in any paper that a POSA would have further added “quenchers” to its combination of Chiu and Bianchi. The oral hearing is too late. (At best, Petitioner’s response at oral argument citing Cyto-Chex and Rao relates to its second ground, which we address below.) When pressed on the fact that Petitioner’s theory requires cffDNA undergo “sustained exposure to whatever the stabilizer is,” counsel shifted again, noting “different variables . . . that you could use, you could decrease the concentration of formaldehyde.” Id. at 22:7–19. This too is not explained sufficiently in Petitioner’s papers. It is of the “utmost importance” that a petitioner identify with particularity its theories and supporting evidence in the petition itself. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (explaining that such particularity is required by statute under 35 U.S.C. § 312(a)(3)). Finally, we agree with Patent Owner that, inasmuch as Petitioner is suggesting a POSA might simply “tailor” the processing conditions for using formaldehyde effectively, Petitioner’s argument fails. PO Sur-Reply 9–10. As Patent Owner explains persuasively, Petitioner leaves it “entirely unclear” what those specific conditions are and how they would be modified to render formaldehyde safe for use with Chiu’s and Lo’s cffDNA. Id. Petitioner’s suggestion is also at odds with testimony from its expert in the parallel litigation. Id. at 10 (citing Ex. 2300). Indeed, in that proceeding, Dr. Larry Dumont testified that “formaldehyde . . . ha[s] been demonstrated to degrade nucleic acids,” that “low concentrations of formaldehyde . . . 47 significantly inhibit[] (or eliminates altogether) the ability to successfully perform PCR amplification on DNA,” and that “literature suggests that these ‘agents’ would not be compatible with standard methods used to detect and analyze DNA.”)). Ex. 2300 ¶ 390.30 Petitioner has not shown sufficiently, on this record, that a POSA would have understood that paraformaldehyde could be used effectively with the Chiu/Lo cffDNA. The evidence presented by Patent Owner undermines Petitioner’s assertion that a POSA would have been motivated to modify Chiu/Lo as proposed.” slip op. at 47

  Patent outcomesUS 7,332,277 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,277
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Nov 1, 2022 · IPR2021-00902 · APJ Timothy G Majors · IPR · Final written decision

  Claims 81–96 and 133 were not shown unpatentable because a skilled artisan would not have been motivated to combine the asserted art with Chiu.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal genetic abnormalities in maternal samples, as described in the ’277 patent and the prior art here. See, e.g., Ex. 1001, 1:31–5:59 (Field of Invention and Background Art); Ex. 1003 (Chiu). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. Okajima v. Bourdeau, 261 F.3d 1350, 14 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). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.13” slip op. at 14

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

    “n.3; PO Sur-Reply 14–15; see generally Papers 51 and 52.14 It is not necessary for us to further construe those dependent claims to resolve this case. Petitioner relies on formaldehyde or formaldehyde donors, as disclosed in Bianchi, Granger, and Rao, to satisfy the claimed “agent” term, and urges the addition of such compounds to Chiu’s method for isolating and detecting cffDNA in a maternal sample. There is no dispute on this record that formaldehyde and formaldehyde donors meet the claimed “agent” term. We are, thus, able to determine if the asserted art discloses an “agent” as claimed and whether a POSA would have been motivated to add formaldehyde or a formaldehyde donor to Chiu, which issue we find is decisive here, without further interpreting dependent claims 90, 91, or 133. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms that are in controversy, and only to the extent necessary to resolve the controversy.”) (internal quotation marks omitted). 14 The disagreement on interpretation of this handful of dependent claims arose in relation to Rao’s prior-art status for those claims (Pet. Reply 5 n.3; PO Sur-Reply 14–15), and Patent Owner’s nexus showing for secondary considerations of nonobviousness (id. at 21). See Pet. Reply 3 n.2 (noting the priority “arguments are only relevant to Ground 3” because the prior art status of Chiu, Bianchi, or Granger is uncontested). But, as we discuss below, Petitioner’s challenge to the claims fails on this record regardless of the disagreement on Rao’s prior art status and, because Petitioner has not made the necessary threshold showing that a POSA would have combined the asserted art in the manner proposed, we need not reach secondary considerations of nonobviousness.” slip op. at 16

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

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

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

  Patent outcomesUS 7,332,277 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,277

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.