• 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
• Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentable
  PTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision

  Claims 1–8 and 11–15 were not shown unpatentable over Xu-752 and Jones because the proposed combination did not establish obvious millisecond time resolution.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSA”) as of May 2009 “would have had a B.S. in electrical/mechanical/biomedical engineering or biological science, or a related field, and approximately 2 years of relevant experience or equivalent study in systems and methods for bioanalysis of cells.” Pet. 14 (citing Ex. 1003 ¶¶ 23–25). Patent Owner adopts this definition for purposes of this proceeding. PO Resp. 9 (citing Ex. 2009 ¶ 19). We find Petitioner’s description of the level of ordinary skill in the art to be consistent with the level of skill reflected in the ’508 patent and in the prior art of record. Accordingly, we apply Petitioner’s definition in this decision.” slip op. at 7

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

    “As used herein, “impedance measurement at millisecond time resolution” refers to the ability to perform a series of at least two consecutive impedance measurements within milliseconds of one another for each and every well of the system where each well is associated with an electrode array for impedance measurement. In each instance the time between two consecutive impedance measurements are less than 300 milliseconds from one another. Id. at 10:8–15. There does not appear to be any dispute as to the definitional nature of the first sentence in the passage above. That is, the parties agree that millisecond time resolution should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15 (proposing construction); Pet. Reply. 23 (“Axion also agrees that the term ‘millisecond time resolution’ is ‘the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.’”). The parties also agree that we do not need to determine whether the time interval between two consecutive impedance measurements is less than 300 milliseconds, as set forth in the definition portion of the specification, or whether it can be met by some other time interval, as suggested by other portions of the specification. See e.g., Ex. 1001, 23:49–55 (explaining that “[i]n some embodiments 500 millisecond time resolution is sufficient”), 24:37–39 (similar); PO Resp. 15 (arguing that “the distinction between 300 milliseconds and 500 milliseconds is immaterial to the dispute in this IPR because Jones teaches a 1.5 second update period, thus at least three times longer than the 500 milliseconds formulation”); Pet. Reply 23–24 (section headed “[Petitioner] Agrees That, In This IPR, The 300 Versus 500 Milliseconds Distinction is Immaterial To Addressing the Unpatentability of the Challenged Claims”), see also, Pet. Reply 24–26 (asserting that the claims are indefinite because it is not clear whether they require a 300 or a 500 millisecond time interval, but arguing that “the claims’ unpatentability can be determined without resolving the 300 versus 500 milliseconds indefiniteness issue”). We agree with the parties that “millisecond time resolution” should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15; Pet. Reply. 23. We further agree that resolution of this case does not require that we determine whether the period between two consecutive impedance measurements is less than 300 or less than 500 milliseconds because Petitioner has not carried its burden under either time interval.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1003 ¶ 179. But Dr. Kim does not cite to any additional supporting evidence or provide any technical reasoning to support his statements. The notion that one can reduce the time between measurements by, e.g., reducing the number of frequencies measured, has intuitive appeal and appears mathematically correct. However, the absence of technical reasoning and supporting evidence diminishes the persuasiveness of Dr. Kim’s testimony that the POSA would made such modifications to reduce the time between measurements. Dr. Kim does provide some technical reasoning in connection with his discussion of eliminating all reference channels as a way to get the time resolution down to the levels required by, e.g., claim 14, which recites a millisecond time resolution of “less than 5 milliseconds.” See e.g., Ex. 1003 ¶ 172 (“A POSA seeking to study biological cell phenomena occurring on the order of a few milliseconds would have recognized that after measuring the reference network channels at the start, the reference network channels would not need measured again for some time, e.g., because temperature and other drift factors do not change appreciably on a millisecond time scale.”). However, even if we were to credit this testimony, Dr. Kim still lacks support and reasoning for the selection of the other parameters in his noreference-channel calculations. See, e.g., id. ¶ 173 (positing, but not providing technical reasoning for using, a no-reference-channel impedance system with 16 wells, a single 10kHz measurement frequency, and 16 daughter boards that measure simultaneously rather than sequentially).” slip op. at 29

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

    “Given that Jones’s only exemplified embodiment targets a 1.5 second update period, that Jones does not suggest reducing the update period, and that much of Jones’s focus is on benefits other than speed of measurement, Jones’s impedance analyzer seems an unlikely choice for a POSA seeking to take measurements having millisecond time resolution. Put another way, we find no persuasive non-hindsight reason that supports Petitioner’s assertion that the POSA would have sought to apply Jones’s impedance analyzer to Xu-752’s system in order to take measurements in millisecond time resolution.” slip op. at 22

  Patent outcomesUS 11,906,508 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,906,508
• 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
• Illumina, Inc. v. Ravgen, Inc.No claims unpatentable
  PTAB · Jan 25, 2023 · IPR2021-01271 · APJ David Cotta · IPR · Final written decision

  Claims 1, 3–9, 21, 22, and 24–30 were not shown unpatentable because Illumina did not prove that glucose in the cited ACD samples necessarily impeded cell lysis.

  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 [that] 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 14 definition and the alternative definition offered by Dr. Van Ness (Ex. 2239 ¶ 23), 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 applied art. Accordingly, we continue to apply Petitioner’s proposed definition here.13 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, and no argument from the parties to the contrary. Ex. 1056 ¶¶ 5–10 (overview of qualifications and experience); Ex. 2239 ¶¶ 4–7 (same).” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer foundTerm construed board ownDecided for patent owner

    “presents is whether a claimed agent that inhibits cell lysis may be a chelator used as an anticoagulant. The Specification and prosecution history make clear that at least one anticoagulant chelator—EDTA—is excluded from satisfying the claimed agent as recited in claim 1. As discussed above, the Specification describes an example where a sample processed in a tube with only EDTA is described as processing a sample in the “absence” of an agent that inhibits cell lysis. Ex. 1001, 89:35–57 (describing, in contrast, the EDTA + formalin sample as showing an example in the “presence of inhibitors of cell lysis”). If EDTA alone could be read as meeting the “agent” limitation, that example would make no sense. Petitioner provides no persuasive argument otherwise. The prosecution history buttresses the exclusion of the anticoagulant chelator EDTA from being the claimed “agent.” For example, during prosecution of the related ’277 patent, the Examiner at one point expressly 20 identified the EDTA in the tubes of a prior art reference as satisfying the agent term, prompting applicant’s argument that the Office was “incorrect” in doing so, and further distinguishing EDTA as merely “a well-known chelator of calcium and magnesium” that is added to blood “as an anticoagulant due to its ability to chelate calcium.” Ex. 2064, 1196 (arguing “EDTA is clearly referred to as a chelator in Applicant’s specification, not as a cell lysis inhibitor”); supra Section I(E); Ex. 1001, 32:61–64 (listing EDTA and EGTA as chelators). This, in turn, convinced the Examiner to withdraw the finding that EDTA was an “agent” as claimed and move on to art that disclosed formaldehyde as meeting that claim term. Ex. 2064, 1024 (Examiner interview summary noting that “applicant pointed out [that] EDTA could not be defined as a cell lysis inhibitor but rather was simply an anticoagulant”). This colloquy during prosecution evidences a clear and unmistakable disavowal of EDTA as being the claimed “agent.” Having determined that Patent Owner disavowed EDTA as the claimed “agent,” we next consider whether the disavowal extends more broadly to other anticoagulant chelators and, specifically, to ACD. On this record, we find that it does as explained below. In distinguishing EDTA from being the “agent,” Patent Owner relied not on properties that are unique to EDTA, but on the fact that it was a “well-known chelator” used as an anticoagulant in this technical field. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was simply an anticoagulant chelator, we find that a POSA would also have understood other anticoagulant chelators as subject to Patent Owner’s disavowal.” slip op. at 20

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “20 Before institution, Patent Owner contested the sufficiency of Petitioner’s showing on whether Landes was entitled to the priority benefit of the filing date of the Landes provisional application. We disagreed that Petitioner’s showing was insufficient. Inst. Dec. 43–47. Patent Owner did not raise any issue during trial about Landes’s prior art status and, thus, has forfeited any argument that Landes is not prior art. On this record, we determine that Landes is § 102(a) prior art based on its July 31, 2003, publication date. On this record, we do not presume the claims of the ’720 patent are entitled to any earlier priority date of other applications listed in its ancestral chain. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (explaining that “there is simply no reason to presume that claims in a [CIP] application are entitled to the effective filing date of an earlier filed application”). That is especially true with the patent’s complex priority chain, involving several CIPs leading back to a provisional application filed 26” slip op. at 26

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

    “Altogether, considering the argument and evidence of record, Petitioner has shown, at best, that it is possible for glucose to help impede cell lysis by reason of isotonicity and providing a nutrient source. But such possibilities are not enough for Petitioner to prevail on its challenge to the claims as anticipated by Landes. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or 41 possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”) (internal quotation and citation omitted); Guangdong Alison Hi-Tech, 936 F.3d at 1364 (same). Petitioner has not, on this record, met its burden to show that the glucose component of ACD in Landes’s specific method is an “agent that impedes cell lysis” in the manner claimed.” slip op. at 41

  Patent outcomesUS 7,727,720 not shown unpatentable
  Claim construction§ 102 anticipationcites KSR · Graham
  Patents in suitUS 7,727,720
• 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
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Dec 12, 2022 · IPR2021-01026 · APJ David Cotta · IPR · Final written decision

  Claims 1–9 and 21–30 were not shown unpatentable: Lee did not establish that ACD dextrose impeded cell lysis, and Sorenson/Rao lacked motivation to combine because formaldehyde was known to damage nucleic acids.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Dr. Van Ness’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 a person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal 10 genetic abnormalities in maternal samples, as described in the ’720 patent. See, e.g., Ex. 1001, 1:22–5:44 (Field of Invention and Background Art). 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 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.12” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownDisclaimer foundDecided for patent owner

    “Owner relied not on properties unique to EDTA, but on the fact that it was a “well-known chelator” and anticoagulant: [T]he assertion by the Office that EDTA is a cell lysis inhibitor is simply incorrect. . . EDTA is not an “agent that inhibits cell lysis.” Rather, EDTA is a well-known chelator of calcium and magnesium. EDTA is routinely added to blood during the blood collection process as an anticoagulant due to its ability to chelate calcium. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was a chelator and an anticoagulant, we find that a POSA would have understood other chelators and anticoagulants to also be excluded from the scope of the claimed agent. Consistent with this understanding, during subsequent prosecution of the application that issued as the ’720 patent, Patent Owner argued that the Holodniy reference, which disclosed a method of detecting free nucleic acid in which blood was collected in tubes containing ACD, “fail[ed] to teach or suggest a method for detecting free nucleic acid comprising, inter alia, isolating free nucleic acid from a non-cellular fraction of a sample, wherein an agent that impedes cell lysis has been added.” Ex. 1003, 1428 (emphasis added). On the salient point here, the Examiner agreed, concluding that “Holodniy et al. teach a method of detecting free nucleic acid which comprises all of the limitations of Claim 1, except these authors do not teach that their samples comprise an agent that impedes cell lysis.” Id. at 1344 (emphasis added); see also id. at 1156 (finding that Adams et al., a reference that also collects blood in tubes containing ACD, taught “all of the limitations recited in Claim 1 except these authors do not teach adding an agent that impedes cell lysis to the sample.”). And Patent Owner argues 15 persuasively, without dispute from Petitioner, that ACD is the “only” addition to the collection tubes besides the blood sample itself. Sur-reply 4 (citing Ex. 1016, 2; Ex. 2023, 20:52–54). This supports that neither the Examiner nor the Patent Owner considered ACD as an anticoagulant chelator to be an “agent,” as that term is used in claim 1. Accordingly, we construe the phrase “agent that impedes cell lysis” to” slip op. at 15

  • Strike new argumentNew argument consideredDecided for petitioner

    “function to prevent cell lysis, “by: (1) interacting with and stabilizing the cell membrane; (2) maintaining osmolarity so that the cells do not rupture; and (3) providing a nutrient source.” Reply 3 (citing Ex. 1002 ¶¶ 22–23; 2001 ¶ 169; Ex. 1059 ¶ 5; Ex. 1054, 125:3–127:12; 1057, 3–4, and Ex. 1056, 7– 13, 15–19, 24). Patent Owner argues that the evidence as to how dextrose functions to prevent cell lysis should have been presented in the Petition. Sur-reply 16. On this record, we do not agree. While this evidence could have been included in the Petition, it is responsive to arguments raised in Patent Owner’s response. See PO Resp. 18–22. In any event, consideration of this evidence simply explains how and why dextrose has the capacity to impede cell lysis, and we have already found that the ’720 patent provides 25 evidence that dextrose has this capacity. Under the circumstances, it was therefore reasonable for Petitioner, in the Petition, to rely on such disclosures of the patent itself. Further, consideration of how and why dextrose impedes cell lysis largely benefits Patent Owner, by providing reasons why dextrose might not inhibit cell lysis under the specific circumstance present in Lee.” slip op. at 25

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “interact with and stabilize the cell membrane. Reply 3 (citing Ex. 1002 ¶¶ 22–23). In the cited testimony, Dr. Edwards states, “it was known that carbohydrates have a role in membrane stabilization” and that dextrose “is a membrane stabilizer.” Ex. 1002 ¶¶ 22–23. This is consistent with the teaching in the ’720 patent that glucose is “[a]n agent that stabilizes cell membranes.” See e.g., Ex. 1001, 6:49–56. The evidence thus supports that dextrose can help to stabilize cell membranes. However, this evidence is tempered by evidence supporting that the “impact of carbohydrates on biological membranes is extremely complex” and that it is “extremely difficult to predict how solutes such as carbohydrates will affect biological membranes.” Ex. 2231, 60:18–61:2, 83:14–18 (Dr. Edwards testimony). This is because “there’s a finite but long – long list of variables that will impact the – the mechanism by which carbohydrate interacts with the cell membrane.” Id. at 66:20–67:7; see also id. at 66:1–15 (identifying temperature, concentration and pressure as variables that play a role in how carbohydrates interact with biological membranes); id. at 68:1–17 (identifying prior and simultaneous exposure to other substances as variables that play a role in how carbohydrates interact with biological membranes). 26 Petitioner also provides evidence that dextrose helps prevent cell lysis by “maintaining osmolarity so that cells do not rupture.” Reply 3 (citing Ex. 2001 ¶ 169; Ex. 1056, 7–13, 24; Ex. 1059 ¶ 5). We agree that the cited evidence supports that dextrose has the ability to prevent cell rupture by maintaining isotonicity. In particular, Rapoport found that erythrocytes in an acid-citrate glucose solution underwent osmotic hemolysis at a slower rate than erythrocytes in a simple citrate solution. Ex. 1056, 613. However, Patent Owner introduces evidence, which we credit, that the failure to maintain isotonicity does not necessarily cause cell lysis. Ex. 2299, 237:4– 16 (Dr. Edward’s testimony). For example, cells placed in a hypertonic solution may “shrink or kind of shrivel” rather than burst, and cells placed in a hypotonic solution may swell, but will not necessarily lyse. Id. at 245:3– 16, 246:17–247:8.” slip op. at 26

  Patent outcomesUS 7,727,720 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,727,720
• 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
• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

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

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214
• Neptune Generics, LLC v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Feb 10, 2020 · IPR2018-01494 · APJ David Cotta · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under any asserted § 103 ground because the evidence did not establish the claimed serum-level testing and dose adjustment would have been obvious.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner has not met this burden here because the Petition does not clearly articulate why an optimization rationale would have led the skilled artisan to “adjust[] the daily dose of the patient to achieve mifepristone blood levels greater than 1300 ng/mL.” slip op. at 14

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner contends that the person of ordinary skill in the art (“POSA”) would have: either a Pharm. D. or a Ph.D. in organic chemistry, pharmacy, pharmacology, or a related discipline; or a Bachelor’s or Master’s degree in organic chemistry or a related field with at least four years of experience relating to the study of pharmacokinetics or dosing of drugs, their detection and quantification, or their metabolism. Pet. 12. Patent Owner does not challenge Petitioner’s definition. Accordingly, we accept Petitioner’s definition, which is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 9

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

    “Although the parties propose constructions for several claim terms (Pet. 12–15; PO Resp. 17–18), we determine that no explicit construction of any claim term is necessary to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”).” slip op. at 10

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

    “Finally, Petitioner asserts that it would have been obvious that “the daily dosing of the patient could be adjusted to optimize mifepristone blood level, whatever level that might be.” Pet. 30. This argument is not persuasive for several reasons. First, Petitioner must do more than show that the ordinary artisan could have done what was claimed. Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 15

  Patent outcomesUS 8,921,348 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,921,348

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.