- Illumina, Inc. v. Natera, Inc.No claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,682,592 - Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing
Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,849,061 - PTAB · Jun 30, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood that claims 21–28 and 31 were obvious over Voyksner, Watson, and Rainbow.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The party challenging a decision in a request for rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. Upon a request for rehearing, the decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). III. ANALYSIS” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“precursor of 25-hydroxvitamin D2 having a molecule weight of 412.7 g/mol.” Id. (citing Pet. 27; Ex. 1002 ¶ 57). Petitioner’s arguments explain what a skilled artisan could have done, i.e., select an appropriate precursor ion. However, as discussed in the Decision, the Petition, even when considered along with Dr. Fitzgerald’s testimony, “does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion” (Dec. 19), when as discussed above, multiple precursors are possible.5 See 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 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“prior art teaches determining the presence or amount of 25-hydroxyvitamin D2 in a sample. However, as discussed in the Decision, claim 21 “requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample.” Id. at 18. Petitioner does not argue that our interpretation of the plain meaning of claim 21 is incorrect or that we should disregard the step of generating “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” See id. Accordingly, we are not persuaded that we overlooked Petitioner’s arguments. Further, we agree with Patent Owner that the Petition lacks sufficient explanation of why a person of ordinary skill in the art “would have chosen to [specifically] investigate 25-hydroxyvitamin D2 using Voyksner’s methods in the first place, particularly since Voyksner only discusses ‘dihydroxyvitamin D3’ for the purposes of evaluating the orientation of certain mass spectrometry equipment.” Opp. 5 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362–63 (Fed. Cir. 2016) (noting that it is error to accept general knowledge in the art without evidence on the record for limitations that are “not evidently and indisputably within the common knowledge of those skilled in the art”) (emphasis in original)).” slip op. at 9
§ 103 obviousnessPatents in suitUS 7,972,867 - Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing
Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6
§ 103 obviousnessPatents in suitUS 9,937,097 - Ethicon, Inc. v. Board Of Regents, The University Of Texas SystemInstitution deniedPTAB · Jun 10, 2020 · IPR2019-00406 · APJ Avelyn M Ross · IPR · Institution
The Board denied institution of IPR on all challenged claims, exercising § 314(a) discretion because the parallel district court case was advanced, overlapping, and likely to conclude first.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“waive a jury demand, a trial “will happen sooner if it is scheduled as a bench trial than it will as a jury trial.” Id. at 14:20–24. According to the Court, the parties should expect trial to occur within a year. See id. at 17:21–23 (“What I’m telling you is that you will get reached in sooner than a year, in all likelihood.”). Both parties withdrew their request for a jury demand. See Ex. 3006. Were we to institute inter partes review, a final written decision in this proceeding would issue in June 2021—leaving a year before resolution of this proceeding. Given the Western District of Texas’ emphasis that the parallel litigation should proceed as if still set for June 22, 2020, and its expectation of holding a bench trial within a year, this factor weighs strongly in favor of discretionary denial in this case.” slip op. at 10
Discretionary denialPatents in suitUS 6,596,296 - Genome & Company v. The University Of ChicagoAll claims unpatentablePTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision
Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See 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.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed
“evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26
Patent outcomesUS 9,855,302 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,855,302 - Edwards Lifesciences Corp. / Edwards Lifesciences LLC v. Evalve, Inc.Institution deniedPTAB · Mar 19, 2020 · IPR2019-01546 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution on all challenged claims under § 314(a), citing the advanced district court litigation, substantial overlap, and the trial scheduled well before a final Board decision.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“First, trial is set to conclude well before a final decision would be due in this proceeding. Here, the district court has scheduled a five-day jury trial to begin on May 6, 2020. Ex. 3001, November 21, 2019, minute order. The Court’s comments in the docket reflect an intent to preserve this trial date. Id. at docket entry 333 (considering Patent Owner’s motion to amend the complaint to be withdrawn because it would require a substantial of extension of the trial date). Also, it appears from the district court’s docket that extensive pre-trial briefing by the parties, including motions to exclude or strike expert testimony, is well underway. See Ex. 3001, docket entries 352–359. The parties are also seeking partial summary judgment on various issues in view of the upcoming trial. Id. at docket entries 340–351. Accordingly, we expect that the jury trial in the district court proceeding would conclude more than ten months before a final decision would be due. See Prelim. Resp. 9; 35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100; NHK, IPR2018-00752, Paper 8, 19–20 (exercising discretion to deny institution where trial was set to occur six months before the Board’s expected final decision). Second, there is substantial overlap between the arguments raised in the district court litigation and those raised in the Petition. Petitioner relies predominantly on the same prior art – Kuehn, Tremulis, Roth, and Skelton – in both proceedings to challenge patentability and articulates substantially the same arguments as to why the combination of the teachings of these references renders obvious claims 1, 4, 6, 10, 11, 14, 16, 1720, 22, 33, and 34 of the ’388 patent. Compare Pet. 30–79 (argument with respect to Grounds 1 and 2), with Ex. 2063, 193–238 and Ex. 2013 (redline comparison of arguments from the Petition and arguments in the invalidity contentions filed in the district court litigation). In addition, the claim constructions requested in this proceeding overlap with those addressed in the district court proceeding and would be decided under the same claim construction standard.9 Pet. 22–28; Ex. 2061, 2–3, 11–13; Ex. 2062, 2. Third, both the parties and the district court have already directed substantial time and energy toward resolving the district court litigation. 9 The claim construction standard to be employed in an inter partes review recently changed from broadest reasonable interpretation to “the same claim construction standard used by Article III federal courts . . . which follow According to Patent Owner, as of the filing of its Preliminary Response, the parties had “produced over 2 million pages of documents and . . . taken around 50 depositions.” Prelim. Resp. 8. Similarly, as already discussed, the district court has been asked to decide a motion of a temporary restraining order (Ex. 3001, docket entry 63), a motion for a preliminary injunction (id. at docket entries 164, 165, and 166),10 and claim construction (id. at docket entry 297). The District Court held lengthy hearings regarding the preliminary injunction motion and claim construction that involve many of the issues presented here. Id. at docket entry 122 (minute order giving the parties 3 hours each to present arguments regarding the preliminary injunction motion); id.at docket entry 219 (minute order allocating 3 hours to be split between the parties for a Markman hearing). The district court has also been asked to rule on numerous discovery disputes. Id. at docket entries 26, 66, 74, 75, 184, 265, and 305, and at March 22, 2019 minute order. Given how far advanced the litigation is, the continued indication that trial will proceed as scheduled, and the substantial work involving many of the same issues presented here already accomplished by the district court and the parties, institution of an inter partes review here cannot be considered to be an efficient or effective alternative to the litigation.” slip op. at 10
Discretionary denialcites PhillipsPatents in suitUS 7,736,388 - PTAB · Mar 9, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Institution
The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that the claimed precursor ion would have been selected.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review under 35 U.S.C. § 314, which provides that an inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Petitioner contends that a person of ordinary skill in the art “would have an advanced degree (e.g., M.S. or Ph.D.) in chemistry or a related discipline, such as pharmacology or biochemistry, and at least 2–3 years of experience in a clinical or research laboratory.” Pet. 18; see Ex. 1002 ¶ 12. Petitioner further contends that a person of ordinary skill in the art would typically have experience with MS and HPLC, and would have knowledge regarding the suitable parameters for optimizing MS and HPLC laboratory tests. See Pet. 18–19.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose any specific claim construction. See generally Pet. Patent Owner states that the “claim terms may be afforded their plain and ordinary meaning.” Prelim. Resp. 9. Patent Owner further notes, however, that “the term ‘precursor ion’ is interchangeable with ‘parent ion,’ which can then be fragmented to yield one or more ‘fragment ions,’ also known as ‘daughter ions’ or ‘product ions,’” indicating that this “distinction between ‘precursor/parent’ ions . . . and ‘fragment/daughter/product’ ions . . . is important to both a proper reading of the claims as well as the scope and content of the prior art.” Id. (citing Ex. 1001, 8:60–66). After reviewing the parties’ arguments and evidence, we determine that it is not necessary to expressly construe any term or phrase in order to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’”)).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Claim 21, however, requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample. The claimed method also requires the generation of a “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” Patent Owner argues that none of Voyksner, Watson, or Rainbow discloses this limitation of claim 21. Prelim. Resp. 19–20. We agree with Patent Owner that Petitioner does not explain sufficiently why a person of ordinary skill in the art would specifically choose the protonated, dehydrated 25-hydroxyvitamin D2 as a precursor for the tandem mass spectrometry described in Voyksner, as required by claim 21. According to Patent Owner, “25-hydroxyvitamin D2 can be converted to a variety of different precursor ions, only some of which may be useful in a mass spectrometric method.” Prelim. Resp. 22 (citing Ex. 1001, 10:60–11:1, 11:46–12:30). The ’867 patent confirms the importance of the specific precursor in the preferred embodiments. As described in the ’867 patent, “[g]enerally, the fragment ions that represent dehydrations or deaminations of the precursor ion are not specific fragment ions for a particular analyte. . . . Accordingly, in preferred embodiments of the invention, MS/MS is performed such that at least one fragment ion of a vitamin D metabolite is detected that does not represent only a loss of one or more water molecules and/or a loss of one or more ammonia molecules from the precursor ion.” Ex. 1001, 10:58–60, 11:2–6. It is not in dispute that none of the cited references include the claimed protonated and dehydrated precursor ion of 25-hydroxyvitamin D2 with a m/z ratio of 395.30±0.5. Petitioner asserts that “the selection of precursor and fragment ions was often simply determined by the selected equipment, the conditions for ionization, and the relative abundance of the ions and the specificity of the ions for the analyte of interest.” Pet. 29. (citing Ex. 1005, 10; Ex. 1002 ¶¶ 59–61). Petitioner, however, does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion as claimed. See Magnum Oil, 829 F.3d at 1380 (Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.”); NuVasive, 842 F.3d at 1382 (Petitioner must articulate a reason why a person of ordinary skill in the art would have modified the prior art references.); see also Metalcraft, 848 F.3d at 1366 (“In determining whether there would have been a motivation to combine prior art references to arrive at the claimed invention, it is insufficient to simply conclude the combination would have been obvious without identifying any reason why a person of skill in the art would have made the combination.”); Belden, 805 F.3d at 1073 (“[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.” (internal citations omitted)). Without an explanation as to the reasons for selecting the specific claimed precursor ion, Petitioner appears to rely on nothing more than impermissible hindsight to arrive at the claimed invention. See W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983) (“To imbue one of ordinary skill in the art with knowledge of the invention in suit, when no prior art reference or references of record convey or suggest that knowledge, is to fall victim to the insidious effect of a hindsight syndrome wherein that which only the inventor taught is used against its teacher.”). For at least these reasons, we are not persuaded that Petitioner has demonstrated a reasonable likelihood of success in showing that claim 21 would have been obvious in view of Voyksner, Watson, and Rainbow.” slip op. at 18
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,972,867 - Reactive Surfaces Ltd., LLP v. LG Chem Ltd.All claims unpatentablePTAB · Feb 24, 2020 · IPR2018-01520 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 are unpatentable as obvious; the contingent motion to amend is granted for substitute claims 9–16.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “anti-fingerprint coating” The phrase “anti-fingerprint coating” appears twice in claim 1: first in” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“fingerprint must “vaporize” from the coated surface.30 As discussed above (Section III(C)), the claimed “anti-fingerprint” functionality encompasses a coating that is capable of actively reducing transfer of a fingerprint or decomposing a fingerprint transferred to a surface of the coated substrate. Accordingly, notwithstanding Buchanan’s shortcomings in evidencing inherent vaporization of enzymatically decomposed fingerprint components, we are unpersuaded this is fatal to Petitioner’s challenge. Rather, for” slip op. at 43
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“conclusory” lack merit. Dr. Cairns has relevant expertise in this area, whereas Petitioner’s declarant, Dr. Rozzell, does not. Ex. 2035 (Rozzell dep.), 128:15–20 (“[Y]ou are not a person of ordinary skill in the art as it pertains to the use of haze values to assess visibility, are you? A. No.”); Ex. 2033 (Cairns Decl.) ¶¶ 2–9 (describing, inter alia, Dr. Cairns’s many years of experience working with and researching specialized coatings for display and touch-sensor applications and optical properties for such devices). Accordingly, Dr. Cairns’s testimony about there being a recognized and sufficiently definite correlation between haze and contaminant (including fingerprint) visibility on display devices is entitled to greater weight than Dr. Rozzell’s opinions on the topic. See, e.g., Ex. 2036 ¶¶ 62–67 (analyzing portions of the patent and prior art to support the opinion that haze is correlated to visibility); Ex. 2035 (Rozzell dep.) 125:1– 16 (“[W]hatever familiarity you have acquired with respect to the utilization of haze as a measurement of visibility has been acquired in the context of this IPR; correct? A That’s correct.”). Dr. Cairns’s opinions are also not conclusory as argued, but are supported with evidence from the patent and the prior art as noted. Ex. 2036 ¶¶ 62–67. slip op. at 83
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“have wanted to combine Amin’s and Wang’s coatings, Petitioner simply does not provide an adequate, evidence-backed analysis of how such person would have predictably done so. As Patent Owner points out, the evidence on this record raises doubts that the two coatings could have been successfully combined. MTA Reply 6–8. Specifically, evidence of record supports Patent Owner’s argument that a skilled artisan would not have reasonably expected “that the digestive enzymes of Wang could be successfully immobilized on the fluorine-coated surface of Amin.” Id.; Ex. 2036, ¶¶ 6–10; Ex. 2035, 15:5˗19:2. Notably, the testimony of Petitioner’s own declarant supports the conclusion that the combination Petitioner proposes would not have been reasonably predictable—if even possible at all. When Dr. Rozzell was asked if there were other materials (like enzymes) that could be adhered to the surface of Amin’s coatings, he did not know. Ex. 2035: 15:16–17:13 (“[Y]ou don’t know what any of those materials [that might adhere] are, sitting here today? A Not without doing some research on my end.”) (“So turning back to our discussion of immobilizing an enzyme on this [Amin’s coating], you don’t know of a way, today, that you could immobilize an enzyme on top of a fluorine-coated layer. A Well, I’ve personally not done exactly that type of experiment, but I can imagine that there would be approaches that would allow you to do that. Q But you don’t know any of them today? A I can’t tell you one as I’m sitting here today. Q Okay. And you’ve not recalled seeing this in a publication? A No.”).” slip op. at 87
Patent outcomesUS 8,932,717 unpatentableClaim construction§ 103 obviousnesscites Graham · NautilusPatents in suitUS 8,932,717 - Eis GmbH v. Novoluto GmbHInstitution deniedPTAB · Feb 10, 2020 · IPR2019-01444 · APJ John E Schneider · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–6 were unpatentable over the asserted obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we deny the Petition and decline to institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art would have had “a bachelor’s degree in mechanical engineering, biomechanical engineering, or the equivalent, and three or more years of experience in fluid mechanics and pump-based medical devices.” Pet. 4; Ex. 1002 ¶¶ 18–22. Petitioner also contends that “practical experience could qualify one not art], while a higher level of education could offset lesser experience.” Pet. 4; Ex. 1002 ¶¶ 18–22. Patent Owner contends that a person of ordinary skill in the art would have had “a bachelor’s degree or equivalent practical experience in mechanical engineering, biomechanical engineering, biomedical engineering, sexual health or human sexuality, or the equivalent, and three or more years of experience in research, development, or design of devices that interact with the human female body (and specifically the vulva).” Prelim. Resp. 1–2. Patent Owner also contends “[e]xperience in fluid mechanics and pump-based medical devices, though helpful, is not necessary. More practical experience could offset less education and vice versa.” Id. at 2. We have considered the contentions of the parties, and for purposes of this decision, we apply Petitioner’s definition of a person of ordinary skill in the art. Although the invention generally relates to a device for stimulating female erogenous zones, as seen from the discussion below, the design and operation of the device largely relate to issues of mechanical engineering and fluid flow. Thus, we conclude that experience in developing devices that interact with the female body is not needed to define a person of ordinary skill in the art.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“51,358 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b); effective November 13, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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))). Both the Petitioner and Patent Owner contend that no claim construction is needed at this stage of the proceeding. Pet. 4; Prelim. Resp. 7. As both parties appear to agree as to the meaning of “reference pressure” that is at the heart of the controversy here, we need not expressly construe the claim term here. See Ex. 1002, ¶ 28; Ex. 2001 ¶ 34.” slip op. at 8
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Guan’s bag would result in a negative pressure is based on unsupported assumptions as to how the device of Guan works. For example, Dr. Pisco opines that the rubber mouth described in Guan forms a largely air-tight seal. See Ex. 1002 ¶ 92. Dr. Prisco based this opinion on Guan’s teaching that the rubber mouth comes into contact with the body. Id. As Patent Owner’s declarant, Dr. Jansen, points out, merely bringing the mouth into contact with a body does not teach or imply that an air-tight seal is formed. Ex. 2001 ¶ 109. Other than the reference to the mouth contacting a body, nothing in Guan teaches or suggests an air-tight seal. See Ex. 1004, 3. Similarly, Dr. Prisco opines in detail as to how the device in Guan operates based on a supposition that appears to be guided by the disclosure in the ’851 patent. Ex. 1002 ¶¶ 89–92; see Ex. 2001 ¶¶ 97–108. Guan, however, only describes the different elements present in the disclosed device and provides no explicit discussion as to how those elements operate. opinions that the elements operate in the manner he describes. See Ex. 1002 ¶¶ 89–92. Based on the foregoing, we afford Dr. Prisco’s opinions little weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 (Fed. Cir. 1994). (“An expert opinion is no better than the soundness of the reasons supporting it.”).” slip op. at 12
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,763,851
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.