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  • PTAB · May 16, 2022 · IPR2021-00184 · APJ Erica A Franklin · IPR · Final written decision

    Claims 1–16 and 21–25 were not shown unpatentable because Banin’s gold clusters were not shown to be molecular cluster compounds, and the Zaban combinations lacked motivation to combine.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 18–19 (citing Ex. 1002 ¶ 70). Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art nor provides its own description. See PO Response. Accordingly, we adopt Petitioner’s definition as we find it is unopposed and consistent with the level of skill in the art at the time of the invention as reflected by the prior art in this proceeding.” slip op. at 10

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed

      “suggested formula” assigned to them is “based on a calculation that relied on the average of a wide distribution of particle sizes reported in the literature by Hutchison.” Ex. 2030 ¶ 103(citing Ex. 2017, 12891). We assign persuasive weight to her testimony because it is based upon the disclosures in Hutchison, which Banin explicitly identifies as the published procedures by which it synthesized its clusters. In particular, Dr. Cossairt’s testimony is supported by the following discussion in Hutchison: To calculate an average molecular formula for 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, Hutchison explains that it calculated an average molecular formula for its synthesized nanoparticles by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt has recognized, Banin’s “suggested formula” is exactly the same molecular formula that Hutchison discloses as the “average molecular formula” for its nanoparticles. Thus, we determine that the record as a whole supports finding that a person of ordinary skill in the art would have understood that Banin’s “suggested formula” represents an average molecular formula for a disperse mixture of gold clusters that are not identical and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs. slip op. at 23

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Specification expressly defines the term “molecular cluster” in a manner that refers to the cluster compound. According to the Specification, “Molecular cluster” is a term which is widely understood in the relevant technical field but for the sake of clarity should be understood herein to relate to clusters of 3 or more metal or nonmetal atoms and their associated ligands of sufficiently well defined chemical structure such that all molecules of the cluster compound possess the same relative molecular mass. Ex. 1001, 5:3–9. We note that the District Court determined that “the term ‘molecular formula’ as opposed to ‘molecular mass’ is most appropriate. By necessity, a compound with the same molecular formula will necessarily have the same molecular mass.” Ex. 1091, 16. The District Court explained also, “it appears that the difference between a molecular formula and a molecular mass, at least for purposes of this claim construction, in inconsequential.” Id. We agree and do not find any dispute on the current record from the parties on this matter. Accordingly, for purposes of this Decision, we agree with the District Court that the term “molecular cluster compound” means “clusters of 3 or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Id. at 18.” slip op. at 12

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

      “that Petitioner has not shown persuasively that a person of ordinary skill in the art would have considered Banin’s small Au clusters to be MCCs. According to Petitioner and Dr. Green, Banin’s gold clusters are MCCs because they are clusters of three or more metal atoms with their associated ligands and “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. To begin, we do not find that the record supports Petitioner’s contention or Dr. Green’s opinion that “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. Petitioner and Dr. Green do not identify any disclosure in Banin describing the clusters as being identical. Instead, they refer to Banin’s disclosure that the Au clusters have “the suggested formula Au101(PPh3)21Cl5” and are “1.4 nm in mean diameter.” In doing so, Petitioner and Dr. Green do not meaningfully address or adequately explain how Banin derived its “suggested” molecular formula for the gold clusters or why Banin reported a “mean” diameter for those clusters. To that end, Petitioner and Dr. Green have failed to provide any reason why a skilled artisan would have understood Banin’s disclosures of a “suggested formula” and a “mean diameter” to convey that the Au clusters are identical.” slip op. at 22

    Patent outcomesUS 7,803,423 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,803,423
  • PTAB · May 16, 2022 · IPR2021-00182 · APJ Christopher M Kaiser · IPR · Final written decision

    Claim 1 was not shown unpatentable because Petitioner did not establish that Dubrow’s disclosures concerned one embodiment or that separate embodiments should be combined.

    RulingsFinal written decision
    • Prior constructionPrior construction adoptedDecided for patent owner

      “of a first liquid phase in a second liquid phase” and invited the parties to address at trial whether that construction is correct. Inst. Dec. 16. In the parallel proceeding in the Eastern District of Texas, the court construed “emulsion” as “a colloidal dispersion of two or more immiscible liquids.” Ex. 2022, 35. Patent Owner argues that, for the purpose of resolving the unpatentability issues presented in this proceeding, “there is not a meaningful distinction between the Board’s or District Court’s construction of ‘emulsion,’” because “[b]oth constructions require the presence of two immiscible liquids (e.g., a suspension of a liquid in another liquid).” PO Resp. 14 (emphases omitted). Petitioner agrees that the unpatentability issue should be resolved identically under both our previous construction and that adopted by the District Court. Reply 2 n.2 (“Claim 1 is . . . unpatentable under [either] the district court’s construction [or the Board’s construction].”). Thus, both parties agree that there is no meaningful distinction between our previous construction and that adopted by the District Court. Accordingly, we maintain our previous construction, and we note further that the two liquid phases in the “suspension of a first liquid phase in a second liquid phase” must be immiscible. See Ex. 2022, 31–35.” slip op. at 6

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

      “b. To show anticipation, Petitioner must show that the separate portions of Dubrow on which it relies refer to the same embodiment When a prior-art reference discloses every limitation of the challenged claim only through a combination of multiple embodiments, it does not anticipate the challenged claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370–71 (Fed. Cir. 2008) (“it is not enough that the prior art reference discloses . . . multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention”). Accordingly, to prevail on its anticipation argument, Petitioner must show that both the “preferred embodiment” disclosure of Dubrow and the “experimental example” portion of Dubrow describe the same embodiment.” slip op. at 9

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

      “argument relies on a single embodiment of Dubrow. Unlike an anticipation argument, an obviousness argument need not rely on a single embodiment within a prior-art reference. However, regardless of whether an obviousness argument “is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.” In re Stepan, 868 F.3d 1342, 1346 n.1 (Fed. Cir. 2017). To the extent that Petitioner intends to argue that it relies on multiple embodiments of Dubrow to teach or suggest the limitation “forming an emulsion comprising a first phase that comprises a first polymer and quantum dots and a second phase that comprises a second polymer,” Petitioner does not provide a reason to combine the teachings of those embodiments. See Pet. 27–29. Instead, Petitioner relies solely on its anticipation argument as support for Dubrow teaching this limitation. Id. at 27 (citing Pet. 21–23). To the extent that Petitioner intends to argue that the multiple portions of Dubrow on which Petitioner relies all relate to a single embodiment, Petitioner does not prove this by a preponderance of the evidence, for the reasons discussed above with respect to the anticipation argument. Thus, Petitioner has not shown either (1) that Dubrow’s teachings regarding the “forming an emulsion” limitation all relate to a single embodiment or (2) that those teachings relate to multiple embodiments that a person of ordinary skill in the art would have had a reason to combine.” slip op. at 13

    Patent outcomesUS 9,680,068 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 9,680,068
  • PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing

    The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,808,039
  • PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing

    Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted

      “skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,808,039
  • PTAB · Jan 21, 2022 · IPR2021-01173 · APJ Patrick R Scanlon · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that Weiss-based grounds teach or suggest the claimed residual marine fuel oil.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2020). 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.”” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

      “D. Discretionary Denial Patent Owner argues that we should exercise our discretion under 35 U.S.C. § 314(a) to deny institution under Apple Inc. v. Fintiv, Inc., IPR2020- 00019, Paper 15 (PTAB May 13, 2020) (precedential). Prelim. Resp. 12–31. Petitioner disagrees. Pet. 6–12. Because we deny institution based on the merits of Petitioner’s unpatentability arguments, we need not decide whether to exercise discretion to deny institution.” slip op. at 17

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

      “We determine we need not expressly construe any terms of the challenged claims at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we 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))).” slip op. at 7

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

      “feedstock HMFO and the product HMFO of the challenged claims, as Petitioner argues it does, Petitioner must show that Weiss ’974 teaches or suggests four facts: (1) the pre-hydrotreatment HSFO is a residual petroleum 10 Petitioner defines “HSFO” as being a “high-sulfur HMFO” and “LSFO” as being a “low-sulfur HMFO.” Pet. 1. product, (2) the pre-hydrotreatment HSFO is ISO-8217-compliant, (3) the post-hydrotreatment LSFO is a residual petroleum product, and (4) the posthydrotreatment LSFO is ISO-8217-compliant. Petitioner does not show all four of these facts sufficiently to demonstrate a reasonable likelihood of prevailing in showing that the challenged claims are anticipated by Weiss ’974 or obvious over the combination of Weiss ’974 and Weiss ’515.” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 10,584,287
  • PTAB · Jan 21, 2022 · IPR2021-01249 · APJ Christopher L Ogden · IPR · Institution

    Instituted review of claims 1, 6, 11, 16, 19, 24, 26, 27, and 30 on all petitioned grounds; the Board found a reasonable likelihood of success on the Dimov–Kovac and Park–Kovac obviousness grounds.

    RulingsInstitution decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

      “Under the circumstances, we disagree with Patent Owner that the Petition is deficient under § 42.104(b)(3) because of how Petitioner addresses claim construction. Petitioner’s main argument is that we do not even need to construe “chamber” or “retaining position” explicitly in this proceeding. See Pet. 9, 12. We agree that neither term needs an explicit construction, at least for our decision to institute trial. 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))). That Petitioner alternatively offers two explicit constructions with which it does not agree—and which are, effectively, irrelevant at this stage because we do not need to construe these terms—does not render the Petition insufficient. We do not discern any substantial ambiguity or lack of clarity in how Petitioner applies the terms “chamber” and “retaining position” to the asserted prior art. To the extent that it may become necessary to construe any terms explicitly at trial, we will consider evidence on both sides, and as usual, Petitioner will have the burden of persuasion. 35 U.S.C. § 316(e).” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Relying on Dr. Meinhart’s testimony, Petitioner argues that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, molecular biology, (bio)chemistry, or an equivalent degree relevant to microfluidic biological cell analysis, and three to five years of experience with the construction of and application of microfluidic devices to cell culture and analysis.” Pet. 8–9 (citing Ex. 1002 ¶ 40). Patent Owner does not dispute this proposed level of ordinary skill in its Preliminary Response. See Prelim. Resp. 7. Because it is supported by testimonial evidence and appears reasonable at this stage in light of the subject matter of the ’408 patent, we adopt Petitioner’s proposed level of ordinary skill in the art for this decision. If Patent Owner proposes a different articulation at trial, we will consider any evidence that Patent Owner submits, in light of the full trial record.” slip op. at 10

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

      “To establish anticipation, a petitioner must find each and every element in a claim, arranged as recited in the claim, in a single prior art reference. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The limitations may be present in the reference “either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Further, an anticipating prior art reference must be enabling and must describe the “claimed invention sufficiently to have placed it in possession of a person of ordinary skill in the field of the invention.” See Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000). We do, however, consider the reference “together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)). Based on these principles, we agree with Patent Owner that Petitioner has not identified within the four corners of Dimov a sufficient disclosure of selectively recovering a cell based on the response in the monitoring step. Although Dimov discloses non-selective recovery, and although Petitioner has identified techniques that might theoretically be used for selective recovery, Dimov itself does not appear, based on the preliminary record, to disclose selective recovery based on a prior monitoring step. We also agree with Patent Owner that Petitioner’s reliance on Kennametal is misplaced. “Kennametal does not permit the Board to fill in missing limitations simply because a skilled artisan would immediately envision them.” Nidec II, 851 F.3d at 1274–75. Thus, on the present record, Petitioner has not shown sufficiently that Dimov anticipates claim 1.” slip op. at 16

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

      “was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). For a combination of known elements that are not explicitly found together in the prior art, we consider “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). A successful petition must “articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (citing KSR, 550 U.S. at 418); see also 35 U.S.C. § 322(a)(3); 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(4) (2020). We base our obviousness inquiry on factual considerations including (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) any objective indicia of obviousness or non-obviousness that may be in evidence.9 See Graham, 383 U.S. at 17–18. Based on these factors, we conclude that Petitioner has not made a sufficient showing that claim 1 would have been obvious over Dimov. Petitioner’s proposed modification of Dimov, though remarkably similar to the process of aspirating cells disclosed in the ’408 patent, does not seem to appear expressly in Dimov (see supra part II.B), nor has Petitioner demonstrated persuasively that one of ordinary skill in the art would have been motivated to make the proposed modification with a reasonable 9 At this stage, the parties do not identify any objective indicia of obviousness or non-obviousness, so this does not factor into our decision to institute an inter partes review. expectation of success based on Dimov alone. Thus, on the present record, Petitioner has not shown sufficiently that claim 1 would have been obvious over Dimov without combination with another prior art reference.” slip op. at 19

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,087,408
  • PTAB · Jan 21, 2022 · IPR2021-01250 · APJ Christopher L Ogden · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “§ 42.4(a), we may only institute an inter partes review when “the information presented in the petition . . . and any response . . . shows 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); see also 37 C.F.R. § 42.108(c) (2020). Applying that standard, we do not institute an inter partes review, for the reasons explained below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Relying on Dr. Meinhart’s testimony, Petitioner argues that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, molecular biology, (bio)chemistry, or an equivalent degree relevant to microfluidic biological cell analysis, and three to five years of experience with the construction of and application of microfluidic devices to cell culture and analysis.” Pet. 9 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute this proposed level of ordinary skill in its Preliminary Response. See Prelim. Resp. 5–6. Because it is supported by testimonial evidence and appears reasonable at this stage in light of the subject matter of the ’936 patent, we adopt Petitioner’s proposed level of ordinary skill in the art for this decision.” slip op. at 8

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

      “Regardless of whether Patent Owner is correct that the Petition is deficient under § 42.104(b)(3), our decision not to institute does not depend on the construction of “chamber” or whether claim 6 invokes § 112 para. 6. Thus, we do not need to construe either term explicitly for our decision. 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))).” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

      “Petitioner has the ultimate burden of persuasion on the question of whether a claim is entitled to the priority date of an earlier application. See Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015). “[A] patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). In particular, “[t]o be entitled to a parent’s effective filing date, a continuation must comply with the written description requirement of 35 U.S.C. § 112, ¶ 1.” In re Owens, 710 F.3d 1362, 1366 (Fed. Cir. 2013) (citations omitted). The test for the written description requirement “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A prior application need not contain precisely the same words as are found in the asserted claims. See Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995); Purdue Pharma LP v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”). On the other hand, “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997). A key factor in this written description analysis, which Petitioner did not clearly address in its Petition, is the meaning of “measuring a cell product” in limitation 1D. The ’936 patent discloses that “[t]he measuring the cell product [step] may be selected from one or more of: lineage staining; cell-surface protein staining; antibody staining; enzymatic assay; RT-PCR analysis; PCR analysis; sequencing; functional assay; and bead capture assay to characterize the cells.” Ex. 1001, 6:47–51. This appears to be definitional, such that the meaning of “measuring a cell product secreted by the individual clonal cell populations, or subset thereof,” as in limitation 1D, would include using any one of these listed techniques to analyze cell secretion products. This passage is also consistent with the other claims in the ’936 patent, such as claim 18, which depends from claim 1 and further states that the “measuring the cell product” step “comprises flowing a fluid comprising an immunostaining agent, an enzymatic reagent, a dye or a functionalized bead into the individual chambers.” Id. at 48:29–32; see also id. at 48:33–48 (similar limitations in claims 19–23). As Patent Owner persuasively shows on the present record, the ’213 application discloses many of these analytical techniques, including staining, functional assay, and bead capture. See Prelim. Resp. 15–17. We also find persuasive Dr. Pelanda’s testimony that a person of ordinary skill in the art would have understood that the references in the ’213 application to these analytical techniques relate to analysis of secreted cell products, and that a particular focus of the ’213 application was to use the microfluidic device for analyzing autocrine signaling, which involves detecting or analyzing cell secretions. See Ex. 2008 ¶¶ 22–32. For the above reasons, on the present record, Petitioner has not shown sufficiently that the ’213 application lacks disclosure such that Lecault is prior art to the challenged patent. Accordingly, we determine that Petitioner has not shown that there is a reasonable likelihood that it would prevail on its first and third grounds with respect to any of the challenged claims.” slip op. at 16

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,421,936
  • 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
  • PTAB · Nov 10, 2020 · PGR2019-00003 · APJ Sheridan K Snedden · PGR · Rehearing

    The Board denied Patent Owner’s rehearing request, leaving in place its determination that claims 1–14 are unpatentable.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “public accessibility, . . . . which involves examining the evidence for proof that each non-patent reference was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.’” Req. Reh’g 3 (quoting Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 773 (Fed. Cir. 2018)). We do not agree. On the contrary, we addressed with particularity the substantial evidence tending to show that each of Petitioner’s References “was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Dec. 12. Specifically, in our Decision, we properly credited indicia on the face of Petitioner’s References, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Using Varenna 2012 as an example, those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including the statement “Advance Access publication 30 November 2012,” and a conventional edition identifier from the journal Rheumatology. Dec. 15–16 (quoting Ex. 1005). In the same manner, the totality of evidence supports our finding that each of Petitioner’s References was publicly available prior to the critical date of the invention. Id. at 15– 18.” slip op. at 3

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “public accessibility, . . . . which involves examining the evidence for proof that each non-patent reference was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.’” Req. Reh’g 3 (quoting Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 773 (Fed. Cir. 2018)). We do not agree. On the contrary, we addressed with particularity the substantial evidence tending to show that each of Petitioner’s References “was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Dec. 12. Specifically, in our Decision, we properly credited indicia on the face of Petitioner’s References, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Using Varenna 2012 as an example, those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including the statement “Advance Access publication 30 November 2012,” and a conventional edition identifier from the journal Rheumatology. Dec. 15–16 (quoting Ex. 1005). In the same manner, the totality of evidence supports our finding that each of Petitioner’s References was publicly available prior to the critical date of the invention. Id. at 15– 18.” slip op. at 3

    § 102 anticipation
    Patents in suitUS 9,867,839
  • PTAB · Nov 10, 2020 · PGR2018-00092 · APJ Sheridan K Snedden · PGR · Rehearing

    The Board denied Patent Owner’s rehearing request, leaving unpatentable claims 1-4, 9, 10, 12, 14, 16-18, 23-25, and 27-29 based on Varenna 2012 anticipation.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. STANDARD OF REVIEW “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must (1) “specifically identify all matters the party believes the Board misapprehended or overlooked” and (2) identify the place “where each matter was previously addressed.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768.” slip op. at 2

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “acknowledged Acceleration Bay and addressed with particularity the evidence of record tending to show that each of Petitioner’s References “was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Dec. 15. Specifically, in our Decision, we credited indicia on the face of Verrena 2012, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including “the statement ‘Advance Access publication 30 November 2012,’” and a conventional edition identifier from the journal Rheumatology. Dec. 17 (quoting Ex. 1005). Patent Owner advanced no” slip op. at 4

    • Strike new argumentNew argument consideredDecided for petitioner

      “We are not persuaded by Patent Owner’s contentions and note that we addressed these same arguments in our Order denying Patent Owner’s motion to strike. Paper 24; see also Paper 13, 1 (Patent Owner contending that “Exhibit 1044 and related argument are new evidence and argument regarding the alleged accessibility of Varenna 2012 (Ex. 1005) that Petitioner could have submitted with the Petition, but chose not to.”). Rather than pointing out any matters that the panel misapprehended or overlooked, Patent Owner expresses disagreement with that decision, and attempts to offer additional reasoning and argument not advanced during trial. Req. Reh’g, 12–15. That effort is ineffective to establish reversible error. Furthermore, in our Final Written Decision, we noted that Even if we set aside Dr. Robinson’s Declaration, . . . we are persuaded that the indicia of publication on the face of Varenna 2012 are sufficient to establish that Varenna 2012 was “sufficiently accessible to the public interested in the art” and “disseminated or otherwise made available” to the interested public before the critical date, and consequently, a printed publication. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016). Dec. 19 n.4. For that reason also, Patent Owner shows no reversible error in our Final Written Decision holding that Dr. Robinson’s testimony bolsters” slip op. at 8

    • Expert testimonyPetitioner expert creditedDecided for petitioner
    § 102 anticipation
    Patents in suitUS 9,820,999

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.