PTAB
Advanced fields
2 decisions · 900msnewest first
  • PTAB · Sep 9, 2021 · PGR2020-00037 · APJ Julia Heaney · PGR · Final written decision

    Claims 1–10, 14–28, 32–38, 51, 52, 55–57, 59, 64–72, and 76–82 were not shown unpatentable for indefiniteness or obviousness over Hiltzik, Clontz WIPO, and Clontz SAE.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “art include “(1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field.” Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Petitioner argues a person of ordinary skill in the art at the time of the invention “would possess at least a B.S. in chemistry or chemical or mechanical engineering and would have at least one year of experience working on control of automotive evaporative emissions,” and “would also understand the chemistry and physics associated with the phenomena of fuel vapor adsorption, desorption, and diffusion.” Pet. 28 (citing Ex. 1003 ¶ 17). Patent Owner does not dispute the level of ordinary skill in the art. We adopt Petitioner’s definition of the level of ordinary skill in the art because it is consistent with the ’553 patent and the asserted prior art.” slip op. at 11

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and standards that confirm persons of ordinary skill in the art understood that gravimetric and volumetric measurement techniques would provide consistent results when proper experimental protocols are followed and the instruments’ accuracy and precision are taken into consideration. See Ex. 2022 ¶¶ 88–91, 119–127. This evidence is essentially unrebutted by Petitioner. We find that the evidence submitted by Patent Owner as to the gravimetric and volumetric measurement techniques demonstrates that they were well established in the art as comparable methods of measuring adsorption capacity, and accordingly, not a basis for determining claim” slip op. at 16

    • ExcludeMotion to exclude, grantedGranted in part

      “Exhibit 2027. Paper 57 (“Pet. Mot.”). We do not discuss or cite Exhibit 2080 or paragraph 39 of Exhibit 2027 in this Decision, and consideration of them played no part in our determinations set forth herein. Because their presence in the record would not affect our analysis in this Decision, we dismiss as moot Petitioner’s motion with respect to these exhibits. B. Patent Owner’s Motion to Exclude Patent Owner filed a motion to exclude Exhibits 1015–1016, 1023– 1025, 1032, 1038–1039, 1042 (certain paragraphs), 1044, 1046–1049, and 1052–1054. Paper 56 (“PO Mot.”). Patent Owner groups these exhibits into four categories, which we apply in discussing the motion below. 1. Patent Owner moves to exclude Exhibits 1015 and 1046 as “irrelevant determinations from other adjudicative bodies regarding different patents.” PO Mot. 1. We do not discuss or cite these exhibits in this Decision, and have not considered them in reaching our decision herein. Because the presence of these exhibits in the record would not affect our analysis in this Decision, we dismiss as moot Patent Owner’s motion with respect to these exhibits. 2. Patent Owner moves to exclude Exhibits 1023, 1024, 1025,” slip op. at 46

    • Disclosure Requirements (§112) › Definiteness (Nautilus)Written description adequateNot shown unpatentable

      “Petitioner has not shown by a preponderance of the evidence that the gravimetric and volumetric methods provide fundamentally different measurements of adsorption capacity. Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and” slip op. at 16

    Patent outcomesUS 10,323,553 not shown unpatentable
    § 103 obviousness§ 112 disclosurecites KSR · Graham · Nautilus
    Patents in suitUS 10,323,553
  • Illumina, Inc. v. Natera, Inc.No claims unpatentable
    PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

      “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

    • ExcludeMotion to exclude, deniedDenied

      “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

    • Strike new argumentNew argument disregardedDecided for patent owner

      “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

    Patent outcomesUS 8,682,592 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,682,592

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.