• CQV Co., Ltd. v. Merck Patent GmbHNo claims unpatentable
  PTAB · Oct 14, 2025 · PGR2021-00054 · APJ Kristina M Kalan · PGR · Remand

  Claims 1–22 were not shown unpatentable because Sample C was not proven publicly available as prior art, and the original decision found the remaining grounds insufficient.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “We agree with Patent Owner that Petitioner’s evidence in Kuntz (Ex. 1026), the Annual Report (Ex. 1028), Masuko (Ex. 1029), and Pfaff (Ex. 1034) is insufficient to show that Xirallic® Sample C was available to the public before the effective filing date of the ’861 patent. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26. Kuntz, the Annual Report, Masuko, and Pfaff may support a finding that the Xirallic® line of products was available to the public, but these documents do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public. We also agree with Patent Owner that the Technical Data Sheets (Exs. 1005–1010), Certificates of Analysis (Exs. 1011–1017), and Material Safety Data Sheet (Ex. 1025) are insufficient to show that Xirallic® Sample C was available to the public. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26–27. Regardless of how the Technical Data Sheets were used in the Opposition against the European counterpart of the ’861 patent (Exs. 1040, 1041) and during the prosecution of the application from which the ’861 patent issued (Ex. 1003, 102–104), the Technical Data Sheets do not refer to or describe the lot of Xirallic® from which Sample C was taken. Moreover, as noted by Patent Owner, the Technical Data Sheets (Exs. 1005–1010) indicate that they are “preliminary” and Petitioner has not provided any evidence that the Technical Data Sheets were ever issued to the public, as opposed to just issued internally. See PO Resp. 18–19. We also find persuasive Patent Owner’s argument that the Technical Data Sheets are preliminary because other, later-dated technical data sheets (Exs. 2012, 2013) lack the “preliminary” label and list characteristics that are different from those in Exhibits 1005–1010. See PO Resp. 19 (comparing, e.g., Ex. 1009 and Ex. 2013; Ex. 1005 and Ex. 2012). The Technical Data Sheets may support a finding that the Xirallic® products they describe existed as of the dates on the documents, but they do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedOther

    “witnesses. See Elbit Systems of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (citing Trs. of Columbia Univ. v. Illumina, Inc., 620 F. App’x 916, 922 (Fed. Cir. 2015); Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982)). We have reviewed the witness testimony in the record and, more particularly, Mr. Choi’s deposition answers regarding Petitioner’s purchase of the lot of Xirallic® from which Sample C came. We find that Mr. Choi’s responses cast doubt on the credibility of his declaration testimony, namely with regard to the public availability of Sample C. Mr. Choi represented that he was involved in the purchase of the lot of Xirallic® from which Sample C was taken. Ex. 2011, 48:1–23. Mr. Choi stated that he instructed Petitioner’s marketing team manager to buy the sample from a distributor of Patent Owner’s products located in Europe. Id. at 48:24–49:4. Mr. Choi stated that he has evidence of the transaction, but refused to reveal the name of the company from which Petitioner purportedly purchased the lot of Xirallic® (id. at 49:5–50:3) and refused to produce an email in his possession that would corroborate his testimony regarding Petitioner’s acquisition of the product (id. at 50:8–16, 51:10–23). Mr. Choi represented that he does not remember how much Petitioner paid for Sample B. Id. at 56:4–5. Mr. Choi admitted that the entity from which Petitioner acquired the lot of Xirallic® from which Sample C was taken is “not currently a Merck distributor” (Ex. 2011, 50:4–7) and was not “a Merck distributor at the time” that “samples B and C were purchased” (id. at 51:25–52:2). According to Mr. Choi, the company is a “former distributor” of Patent Owner’s products. Id. at 52:3–6. Mr. Choi did not know, according to his testimony, when that unnamed entity first obtained the lot of Xirallic® (id. at 52:7–10) and he stated that he did not have personal knowledge of how the entity obtained the lot of Xirallic® (id. at 52:12–19). Instead, Mr. Choi assumed the entity was “able to obtain the sample through the routine course or process” the entity uses “to take samples or get samples.” Id. at 52:12–19. Mr. Choi believed the sample of Xirallic® from which Sample C was taken was sealed when Petitioner received it because samples from dealers are sealed, and he remembered observing that the package was from a dealer. Id. at 52:24– 54:25. However, Mr. Choi admitted that he did not obtain a technical data sheet or certificate of analysis for the lot of Xirallic® from which Samples B and C were taken. Id. at 59:6–11. Mr. Choi also answered questions regarding Petitioner’s purchase of Samples D and H. Ex. 2011, 62:20–66:8, 67:7–9, 73:12–13, 73:17–22. Similar to his testimony regarding Samples B and C, Mr. Choi admitted withholding an email regarding the purchase of the lot of Xirallic® from which Sample D was taken. Id. at 62:20–63:9. Mr. Choi also admitted that he did not know how Akzo USA or Axalta obtained the Xirallic® the companies sold to him, and admitted that Akzo USA was not a distributor of Patent Owner’s products at the time Petitioner purchased the product. Id. at 63:10–66:8, 73:17–22. Mr. Choi also admitted that Petitioner did not pay Akzo USA for the lot of Xirallic® from which Sample D was taken, and did not pay Axalta for the lot of Xirallic® from which Sample H was taken. Id. at 67:7–9, 73:12–13. Although Petitioner presents declaration testimony from Mr. Choi representing that he purchased the lot of Xirallic® from which Samples B and C were taken in October 2011 (Ex. 1004 ¶ 16), Mr. Choi’s declaration testimony lacks corroborating evidence, and his deposition testimony does not support that the product was available to the public, as we found in our Final Written Decision. See Final Dec. 27–28. Notably, Petitioner produced corroborating evidence for Mr. Choi’s acquisition of Samples A, H, and I. See Ex. 1004 ¶¶ 13 (citing Ex. 1047), 18 (citing Exs. 1024, 1025). However, Mr. Choi withheld similar evidence for the Xirallic® lots from which Samples B, C, and D were taken. See Ex. 2011, 50:8–16, 51:10–23, 62:20– 63:9; Final Dec. 28. As Patent Owner argues, there is “no information to determine when a contract was established, that there was consideration for the exchange, that the product was available to be delivered when the alleged transaction took place, or even when the product was delivered. Choi has no memory of what was paid for the product.” Sur-Reply 24–25; see also PO Resp. 13–14; PO Br. Rem. 2–4.” slip op. at 34

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

    “Based on the evidence discussed above, we are not persuaded that Petitioner has shown by a preponderance of the evidence that Sample C was available to the public. Regardless of whether a company avoids wasting shelf life of its products (Ex. 1004 ¶¶ 15–16), there is no persuasive evidence in the record showing that the lot of Xirallic® from which Sample C was taken was released from quality control and then made available to the public by Patent Owner. Mr. Choi’s testimony shows that Petitioner obtained the lot of Xirallic® from which Sample C was taken in an atypical manner (i.e., not from Patent Owner or one of Patent Owner’s current distributors) (Ex. 2011, 49:5–50:7, 50:8–16, 51:10–23, 51:25–52:6, 52:12– 19), and there is no evidence in the record to show that the lot of Xirallic® was intended for sale, rather than for experimental use only or for some other restricted use. Accordingly, we determine Petitioner has not demonstrated by a preponderance of the evidence that Sample C qualifies as prior art against the ’861 patent, and we determine that Petitioner has not shown by a preponderance of the evidence that the ’861 patent is unpatentable over the grounds relying on Sample C.” slip op. at 38

  Patent outcomesUS 10,647,861 not shown unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 10,647,861
• 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
• 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
• Trans Ova Genetics, LC v. Xy, LLCNo claims unpatentable
  PTAB · Jun 26, 2019 · IPR2018-00250 · APJ David Cotta · IPR · Final written decision

  Claims 1–16 were not proven unpatentable because Petitioner failed to establish that Lu, relied on in every asserted obviousness ground, was prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artNot shown unpatentable

    “Inc. v. Apotex Inc., 754 F.3d 952, 968 (Fed. Cir. 2014); In re Katz, 687 F.2d 450, 454 (Fed. Cir. 1982). “The question of whether a reference is a work of others for the purposes of § 102(a) is, like that of inventorship, a question of law based on underlying facts.” Allergan, 754 F.3d at 969 (citing Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)). In determining whether a reference is the work of the named inventor(s), the inquiry focuses on whether the relevant content of the reference – which includes “the design, trial, and analysis of results” – was solely the work of the inventor(s). See Allergan, 754 F.3d at 969; Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity.”).” slip op. at 14

  • Expert testimonyPatent owner expert creditedOther

    “9 We acknowledge that Mr. Miles, as a former board member of XY, as well as XY’s long-time patent counsel and the filer of the ’769 priority provisional applications, may have some interest in the outcome of this IPR and that Mr. Miles is being compensated by XY for time spent relating to his testimony. Ex. 2003 ¶¶ 4–7; Ex. 1033, 21:7–14, 158:8–22. However, we note that Mr. Miles’ testimony was under oath and subject to cross-examination. We find Mr. Miles’ testimony to be credible as to the facts for which it is cited herein.” slip op. at 10

  • ExcludeMotion to exclude, deniedMixed

    “Exclude. Paragraph 12 of the Miles Declaration reads as follows: “Also[,] in the late 1990s, XY had a collaborative research agreement with a bull stud called Cogent in the United Kingdom.” Ex. 2003 ¶ 12.11 This statement is not itself hearsay because it was asserted by Mr. Miles while testifying in this proceeding, i.e., “at the current trial.” See Fed. R. Evid. 801(c). Petitioner contends that paragraph 12 is inadmissible because it is based, at least in part, on statements contained in Exhibits 2001 and 2002. We are not persuaded by this argument because paragraph 12 does not rely on Exhibits 2001 and 2002. See Ex. 2003 ¶ 12; Ex. 1033, 59:22–62:18 (Mr. Miles’ testimony on basis and meaning of paragraph 12 of his declaration). Petitioner also argues that paragraph 12 should be excluded as improper opinion testimony because it is based on Exhibits 2001 and 2002, to which, according to Petitioner, Mr. Miles is not competent to testify. Mot. 13–14. We are not persuaded by Petitioner’s argument because, as discussed, paragraph 12 does not rely on Exhibits 2001 and 2002.” slip op. at 22

  Patent outcomesUS 8,652,769 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,652,769
• Fujifilm Corporation v. Sony CorporationNo claims unpatentable
  PTAB · Dec 3, 2018 · IPR2017-01390 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board held that claims 1–18 were not shown unpatentable because the prior art did not establish the claimed volume concentration in the formed magnetic layer.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “define the term “volume concentration.” In the context of the ’331 patent, “volume concentration” refers to the volume concentration of the magnetic particles in the formed magnetic layer.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(1) a bachelor’s degree in materials science, physics, electrical engineering, mechanical engineering, chemistry, or a closely related field, and at least five years of experience in the field of magnetic recording, or (2) a Master’s degree or higher in materials science, physics, electrical engineering, mechanical engineering, chemistry, or a closely related field, with an emphasis in magnetic recording, and at least three years of experience in the field of magnetic recording. Pet. 12; Ex. 1017 ¶ 60. Although Patent Owner does not expressly define the appropriate level of skill in the art in the Patent Owner Response or its Supplemental Response, Patent Owner’s declarant, Dr. Bain, presents a definition of a person of ordinary skill in the art in his declaration that is nearly identical to Petitioner’s definition. Ex. 2001 ¶ 44. In view of this, for purposes of this Decision, we adopt Petitioner’s definition of a person of ordinary skill in the art.” slip op. at 16

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

    “information, is not sufficient evidence to establish that Mori discloses the “volume concentration” recited in claim 1. Patent Owner does not dispute that there is some magnetic alloy present “in the magnetic layer” of Mori. The relevant question, however, is how much and how Mori’s disclosed values were determined. Unlike the term “volume concentration,” for which the parties offered undisputed evidence regarding accepted meanings of the term in the art (i.e., packing fraction and pigment volume concentration), we have not been directed to similar evidence regarding the phrase “fill rate”/“filling rate” in Mori. Thus, although Mori states “[t]he filling rate by volume of the strongly magnetic alloy powder in the magnetic layer can be equal to or higher than 30%” (Ex. 1003 ¶ 11 (emphasis added)), Petitioner has not offered sufficient evidence demonstrating that the term “filling rate” in Mori refers to a final product-based value. As a result, we find that this language in Mori does not establish, by a preponderance of evidence, that Mori discloses the “volume concentration” recited in claim 1.” slip op. at 21

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

    “For all of the foregoing reasons, we find that Petitioner has failed to demonstrate, by a preponderance of evidence, that the combined teachings of Aonuma and Mori disclose or suggest “[a] dual layer magnetic recording medium comprising . . . a magnetic upper recording layer formed over [a] lower support layer, the magnetic upper recording layer comprising a volume concentration of at least about 35% of a primary magnetic particulate pigment,” as recited in independent claims 1 and 16. Ex. 1001, 11:14–20, 12:25–31. Claims 2–15, 17, and 18 depend from claim 1 or claim 16, and, therefore, include the “volume concentration” limitation of claims 1 and 16. As a result, we find that Petitioner has failed to demonstrate that Aonuma and Mori disclose or suggest each limitation of claims 1–18, and, therefore, has not demonstrated by a preponderance of evidence that claims 1–18 are unpatentable as obvious over Aonuma and Mori.” slip op. at 26

  Patent outcomesUS 7,115,331 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,115,331
• Daicel Corporation v. Celanese International CorporationNo claims unpatentable
  PTAB · Jun 23, 2016 · IPR2015-00171 · APJ Linda M Gaudette · IPR · Final written decision

  Claims 42–44, 47–51, 53, and 55–57 were not shown unpatentable: the ’095 patent did not establish the required amount of DME, and JP ’712 did not cure that deficiency.

  RulingsFinal written decision

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

    “Based on our analysis of the intrinsic and extrinsic evidence, we agree with Patent Owner that a person of ordinary skill in the art would understand the ’507 patent to speak in terms of effects, not molecules. See PO Resp. 4– 5; Tr. 41:8–16. We, therefore, construe the recitation “distilling [a mixture comprising water, acetic acid, methyl iodide, methyl acetate, methanol, and at least one PRC] to separate the mixture into a plurality of streams, at least one of said streams being a PRC enriched overhead stream comprising dimethyl ether” in step (a) of claim 42 as requiring the presence of dimethyl ether in the PRC enriched overhead stream in an amount that one of ordinary skill in the art would recognize as being more than trace or insubstantial. Such amount would be, for example, more than the amount produced in a conventional, prior art, low water carbonylation process that used the same initial reactor contents and conditions, and the same processing equipment. We further interpret this language as requiring the presence of DME in the PRC enriched overhead stream in an amount sufficient to cause (1) a reduction in the solubility of methyl iodide in water during the extraction of the PRC enriched overhead stream (claim 42, step (b)) and (2) an increase in the amount of methyl iodide recoverable during a subsequent extraction of the raffinate stream, which increase in recoverable methyl iodide would be recognized as more than insubstantial by the ordinary artisan.” slip op. at 42

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Mr. Jones and Dr. Porcelli agree the description in the ’507 patent implies that the inventive process is a low water process. Ex. 1039 ¶ 52; Ex. 2029 ¶ 26. As discussed in Section VI. B., below, these experts further agree that there are differences in the reactants and reaction products produced in high and low water processes. We find both Mr. Jones and Dr. Porcelli are qualified to give an opinion as to the level of ordinary skill in the art. Accordingly, for purposes of this proceeding we adopt Mr. Jones’s definition of the level of ordinary skill in the art, and add that the ordinary artisan also would have had a specific understanding of the low water carbonylation process for production of acetic acid and its implementation on an industrial scale.” slip op. at 27

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

    “We are not persuaded that Mr. Jones’s calculations provide a reliable method of determining the amount of DME present in a methanol carbonylation process. Mr. Miura and Dr. Porcelli agreed that it is extremely difficult to anticipate the presence or amount of a component such as DME in a methanol carbonylation system such as the one described in the ’095 patent. See Ex. 1046, 281:14–22; Ex. 2029 ¶ 112. Dr. Porcelli testified that Mr. Jones’s estimates of DME content in the ’095 patent Example were based on numerous assumptions that rendered his estimations of reactor and distillation overhead DME concentrations meaningless. See Ex. 2029 ¶¶ 137, 140, 151. Dr. Porcelli testified, for example, that it was “improper and incorrect” for Mr. Jones “to fail to account for DME lost with the vent stream in the reactor, especially because of the high volatility of DME.” Id. ¶ 148. Mr. Miura’s measured amount of DME present in the first overhead in Experiment 1 was less than half the amount Mr. Jones calculated would be present, supporting Dr. Porcelli’s testimony that the loss of DME via the vents would have had a marked impact on the actual amount of DME sent to distillation column 40 (from which the second overhead stream is produced) in the ’095 patent Example. See Ex. 1060 ¶ 153 (“(103 ppm (calc.) vs. 48 ppm (actual)) is likely to due to loss of DME with the vent gas from the splitter condenser, due to the very low boiling point of DME”); see also Ex. 1039 ¶ 99; Ex. 1060 ¶ 121 (wherein Mr. Jones agreed that the loss of DME from the vent stream in the separator (or decanter) after splitter column 14 in the ’095 patent process would be substantial).” slip op. at 56

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

    “In sum, we determine Petitioner has failed to meet its burden to show, by a preponderance of the evidence, that the ’095 patent describes a process that inherently results in dimethyl ether in a PRC enriched overhead stream (produced by distilling a mixture comprising water, acetic acid, methyl iodide, methyl acetate, methanol, and at least one PRC) in an amount that is (1) more than trace or insubstantial, and (2) sufficient to cause (a) a reduction in the solubility of methyl iodide in water during extraction of the PRC enriched overhead stream and (b) an increase in the amount of methyl iodide recoverable during a subsequent extraction of the raffinate stream, as required by the broadest reasonable interpretation of claim 42. Absent from the record is any evidence that DME is present in the second overhead in the ’095 patent Example in the amount required by independent claim 42 and its dependent claims 43, 44, 47–51, 53, and 55–57. Petitioner’s challenge with respect to claim 57 is based on obviousness over the combination of the ’095 patent and JP ’712. Petitioner relies on JP ’712 for a teaching that “methyl iodide concentration can be controlled by extraction temperature, . . . and that the concentration[] recited in [claim 57 is] well known in the art.” Pet. 55. Petitioner has not explained how JP ’712 cures the deficiency in the ’095 patent’s failure to describe step (a) of claim 42. Accordingly, we likewise determine Petitioner has failed to meet its burden to show unpatentability of claim 57 by a preponderance of the evidence. We conclude Petitioner has failed to meet its burden to show unpatentability of claims 42–44, 47–51, 53, and 55–57 of the ’507 patent.” slip op. at 59

  Patent outcomesUS 8,076,507 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,076,507
• Daicel Corporation v. Celanese International CorporationNo claims unpatentable
  PTAB · Jun 23, 2016 · IPR2015-00173 · APJ Linda M Gaudette · IPR · Final written decision

  Claims 58–60, 67, 69, and 71–72 were not shown unpatentable over the ’095 patent; claim 73 was not shown unpatentable over the ’095 patent and JP ’712 because the required amount of DME was not …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner relies on Mr. Jones’s testimony to establish the level of ordinary skill in the art. See Pet. 17. Mr. Jones testified that the person of ordinary skill in the art “as of March 2, 2004, the effective filing date of the ’507 Patent” (Ex. 1039 ¶ 15) would have been a chemist or chemical engineer with an advanced degree, or a Bachelor of Science degree and equivalent work experience (e.g., five years in an industrial setting producing acetic acid, acetic anhydride, or related chemicals), and would have generally understood acetic acid production on an industrial scale including the distillation processes and extraction processes that are used in acetic acid or acetic anhydride production. The person of ordinary skill in the art would have understood chemical reactions in general, and, particularly, the primary reactions and the side-reactions associated with acetic acid production (id. ¶ 16). Mr. Jones further testified that a person of ordinary skill in the art would have had separations experience, an understanding of industrial-scale processes, and experience in the production of acetic acid, acetic anhydride, or related chemicals. Id. ¶ 17. Dr. Porcelli, testified that he “generally agree[s]” with Mr. Jones’s opinion as to the level of ordinary skill in the art” (Ex. 2029 ¶ 15; see also Ex. 1065, 65:9–66:5). During cross-examination, however, Dr. Porcelli testified that one of ordinary skill in the art would require, more specifically, an understanding of the low water acetic process and its implementation on an industrial scale. See, e.g., Ex. 1065, 126:18–127:1.” slip op. at 26

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionOther

    “Based on our analysis of the intrinsic and extrinsic evidence, we agree with Patent Owner that a person of ordinary skill in the art would understand the ’507 patent to speak in terms of effects, not molecules. See PO Resp. 4– 5; Tr. 41:8–16. We, therefore, construe the recitation “distilling [a mixture comprising water, acetic acid, methyl iodide, methyl acetate, methanol, and at least one PRC] to separate the mixture into a plurality of streams, at least one of said streams being a PRC enriched overhead stream comprising dimethyl ether” in step (a) of claim 58 as requiring the presence of dimethyl ether in the PRC enriched overhead stream in an amount that one of ordinary skill in the art would recognize as being more than trace or insubstantial. Such amount would be, for example, more than the amount produced in a conventional, prior art, low water carbonylation process that used the same initial reactor contents and conditions, and the same processing equipment. We further interpret this language as requiring the presence of DME in the PRC enriched overhead stream in an amount sufficient to cause (1) a reduction in the solubility of methyl iodide in water during the extraction of the PRC enriched overhead stream and (2) an increase in the amount of methyl iodide recoverable during the subsequent extraction of the first raffinate stream (claim 58, step (b)), which increase in recoverable methyl iodide would be recognized as more than insubstantial by the ordinary artisan.” slip op. at 42

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We are not persuaded that Mr. Jones’s calculations provide a reliable method of determining the amount of DME present in a methanol carbonylation process. Mr. Miura and Dr. Porcelli agreed that it is extremely difficult to anticipate the presence or amount of a component such as DME in a methanol carbonylation system such as the one described in the ’095 patent. See Ex. 1046, 281:14–22; Ex. 2029 ¶ 112. Dr. Porcelli testified that Mr. Jones’s estimates of DME content in the ’095 patent Example were based on numerous assumptions that rendered his estimations of reactor and distillation overhead DME concentrations meaningless. See Ex. 2029 ¶¶ 137, 140, 151. Dr. Porcelli testified, for example, that it was “improper and incorrect” for Mr. Jones “to fail to account for DME lost with the vent stream in the reactor, especially because of the high volatility of DME.” Id. ¶ 148. Mr. Miura’s measured amount of DME present in the first overhead in Experiment 1 was less than half the amount Mr. Jones calculated would be present, supporting Dr. Porcelli’s testimony that the loss of DME via the vents would have had a marked impact on the actual amount of DME sent to distillation column 40 (from which the second overhead stream is produced) in the ’095 patent Example. See Ex. 1060 ¶ 153 (“(103 ppm (calc.) vs. 48 ppm (actual)) is likely to due to loss of DME with the vent gas from the splitter condenser, due to the very low boiling point of DME”); see also Ex. 1039 ¶ 97; Ex. 1060 ¶ 121 (wherein Mr. Jones agreed that the loss of DME from the vent stream in the separator (or decanter) after splitter column 14 in the ’095 patent process would be substantial). Dr. Porcelli testified that he believed removal of DME by rapid carbonylation would have had a significant effect on the presence of DME in the ’095 patent Example and that this irreversible reaction should have been considered by Mr. Jones in his calculations. Ex. 2029 ¶¶ 130–131. Mr. Jones conceded “some DME will be carbonylated in the reactor” (Ex. 1060 ¶ 45), and that the carbonylation of DME to make acetic acid under low water conditions is an irreversible reaction (Ex. 2026, 227:19–228:1). See also Ex. 1060 ¶ 27 (arguing Exhibits 2032, 2034 evidence DME formation in a batch reactor during methanol carbonylation, but admitting that as the water and methyl acetate start to diminish, DME concentration begins to drop and DME is eventually carbonylated into either acetic acid or acetic anhydride). Mr. Jones disagreed with Dr. Porcelli’s testimony that “carbonylation of DME is . . . known to have a fast reaction rate” and “would be consumed by carbonylation faster than it would be formed by methanol dehydration, especially under low water conditions” (Ex. 2029 ¶ 130). Ex. 1060 ¶ 44. Mr. Jones provided testimony explaining why he believes “the carbonylation of DME is not particularly fast.” Id.; see id. ¶¶ 45–48. Mr. Jones relied on a textbook by Gauthier-Lafaye (Ex. 1062), published in 1987, as evidence that the carbonylation of DME proceeds more slowly than the carbonylation of methyl acetate. Ex. 1060 ¶ 47. Mr. Jones testified that because the reaction liquid in the ’095 patent Example is reported to contain 1.6 wt% methyl acetate, and the carbonylation rate of DME is even slower than that of methyl acetate, then “it stands to reason that the carbonylation rate of DME is not going to be so fast as to ‘immediately’ react away any DME that is formed via the methanol dehydration equilibrium reaction.” Id. ¶ 48. Mr. Jones further testified that consideration of this competing side reaction was “irrelevant to calculating equilibrium concentration” of DME in the reactor in the ’095 patent Example. Id. ¶ 51. The disclosure in Gauthier-Lafaye relied upon by Mr. Jones relates to the carbonylation of methyl acetate into acetic anhydride (Ex. 1062, 9), i.e., a different reaction system than the ’095 and ’507 patents (see Paper 73, 8 (Observation #F.1)). This evidence, therefore, does not support Mr. Jones’s testimony that the carbonylation of DME in the ’095 patent reaction system was irrelevant to his calculation of equilibrium DME concentration. Rather we credit Dr. Porcelli’s testimony that removal of DME by rapid carbonylation would have had an effect on the presence, or at least the quantity, of DME in the ’095 patent Example, and that this factor should have been taken into consideration by Mr. Jones in his calculations. See Ex. 2029 ¶ 130. Mr. Jones testified that in view of the low boiling point of DME (-23.7 ºC), most of the DME will immediately flash from the reactor product . . . and be concentrated in the overhead streams. In view of the relatively low amount of DME in the reactor and overhead, DME’s very low boiling point, and the elevated temperatures in the reactor, special handling techniques would be needed to sample for such a compound in the reaction mixture. It is therefore not surprising that the presence of DME was not measured in the ’095 patent, despite the fact that it was undoubtedly present. Ex. 1060 ¶ 118. Given Mr. Miura’s testimony that he believed DME, if present, would have been detectable (Ex. 1046, 280:9–281:1), and Paulik’s disclosure that insubstantial amounts of DME were measurable as early as 1970 (see, e.g., Ex. 2037, 13:47–49, 15:32–34), Mr. Jones’s testimony (see, e.g., Ex. 1060 ¶ 101 (“It should be clear to someone skilled in the art that very dilute and trace components are frequently not reported in chemical analytical results or in listed process stream compositions.”)) does not show convincingly that DME was present in the second overhead in more than a trace quantity, if at all. See id. ¶ 90 (“[T]he only issue is whether some amount of DME exists (which clearly it does).”).” slip op. at 56

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

    “have been present in the distillation overhead in the ’095 patent Example in an amount sufficient to reduce solubility of methyl iodide in water during subsequent water extraction steps. Mr. Miura testified that 1.2 wt% DME was present in the second overhead in Experiment 1. Ex. 1005 ¶ 13, Table 1. Mr. Jones testified that he would expect the amount of DME in the second overhead in the ’095 patent process to be about three times the amount of DME in the overhead in Miura Experiment 1 (Ex. 2040, 289:10–– 298:7), because Mr. Miura’s experiment was carried out under conditions less favorable to DME formation as compared to the conditions in the ’095 patent Example (see Ex. 1060 ¶¶ 130, 139). A preponderance of the evidence, however, does not support a finding that DME was present, if at all, in more than a trace quantity/insubstantial amount in the second overhead of the ’095 patent Example, for the following reasons: Although Mr. Miura reported that the second overhead in his Experiment 1 contained 1.2% DME (Ex. 1005 ¶ 13, Table 1), he did not testify that this quantity would be present in the ’095 patent Example despite acknowledged differences in quantities of reaction components and operating conditions (see id. ¶ 21). Rather, Mr. Miura testified that Experiment 1 provided evidence that DME simply was present in some amount in the second overhead in the ’095 patent Example. Id. (“[T]he deviations would not affect the outcome with respect to the presence of DME in the first and second overheads.”). Mr. Miura testified that he supervised the ’095 patent Example and believed DME was present and accounted for in the 0.9 wt% reported as “others.” Ex. 1046, 241:17–242:9. Therefore, we are not persuaded by Mr. Jones’s testimony that the amount of DME in the second overhead in the ’095 patent process would be about three times the amount of DME in the overhead in Miura Experiment 1, i.e. 3.6 wt% (Ex. 2040, 289:10––298:7). See Tr. 70:3–8 (wherein Patent Owner’s counsel raises this inconsistency). We are not persuaded by Mr. Jones’s testimony that an amount as high as 3.6 wt% DME could have been present in the ’095 patent Example, but not reported (see Ex. 2040, 301:18–303:2; Paper 73, 5–6 (Observation #C.4)), since the prior art, e.g., Paulik, clearly indicates DME was considered an undesirable reaction byproduct in a carbonylation process. Mr. Miura did not testify as to what portion of the 0.9 wt% reported as “others” in the ’095 patent Example constituted DME, or whether the amount of DME would be considered more than a trace quantity/insubstantial amount. Nor is there any testimony or evidence that 0.9 wt% or less DME in the overhead/feed to the extractor would have been an amount sufficient to cause a reduction in the solubility of methyl iodide in water during extraction of the PRC enriched overhead stream and an increase in the amount of methyl iodide recoverable during the subsequent extraction of the first raffinate stream as required under the broadest reasonable interpretation of claim 58 of the ’507 patent. We are not persuaded that Mr. Jones’s calculations provide a reliable method of determining the amount of DME present in a methanol carbonylation process. Mr. Miura and Dr. Porcelli agreed that it is extremely difficult to anticipate the presence or amount of a component such as DME in a methanol carbonylation system such as the one described in the ’095 patent. See Ex. 1046, 281:14–22; Ex. 2029 ¶ 112. Dr. Porcelli testified that Mr. Jones’s estimates of DME content in the ’095 patent Example were based on numerous assumptions that rendered his estimations of reactor and distillation overhead DME concentrations meaningless. See Ex. 2029 ¶¶ 137, 140, 151. Dr. Porcelli testified, for example, that it was “improper and incorrect” for Mr. Jones “to fail to account for DME lost with the vent stream in the reactor, especially because of the high volatility of DME.” Id. ¶ 148. Mr. Miura’s measured amount of DME present in the first overhead in Experiment 1 was less than half the amount Mr. Jones calculated would be present, supporting Dr. Porcelli’s testimony that the loss of DME via the vents would have had a marked impact on the actual amount of DME sent to distillation column 40 (from which the second overhead stream is produced) in the ’095 patent Example. See Ex. 1060 ¶ 153 (“(103 ppm (calc.) vs. 48 ppm (actual)) is likely to due to loss of DME with the vent gas from the splitter condenser, due to the very low boiling point of DME”); see also Ex. 1039 ¶ 97; Ex. 1060 ¶ 121 (wherein Mr. Jones agreed that the loss of DME from the vent stream in the separator (or decanter) after splitter column 14 in the ’095 patent process would be substantial).” slip op. at 55

  Patent outcomesUS 8,076,507 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,076,507

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.