• Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing denied
  PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

  The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise 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. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

    “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

    “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

  Claim construction§ 112 disclosure
  Patents in suitUS 10,155,039
• Gilead Sciences, Inc. v. Regents Of The University Of MinnesotaRehearing denied
  PTAB · Dec 21, 2020 · IPR2017-01753 · APJ Zhenyu Yang · IPR · Rehearing

  The Board denied Gilead’s rehearing request, leaving institution denied because Petitioner did not show the Board abused its discretion or misapprehended the obviousness record.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “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. When rehearing a decision on institution, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). It is not an abuse of discretion to have made an analysis or conclusion with which a party disagrees. Instead, an abuse of discretion occurs 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).” slip op. at 2

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

    “before us did not support Petitioner’s alleged reasons to modify the references (Dec. 16–22), nor establish a reasonable expectation of success of doing so (id. at 22–23). In reaching this conclusion, we did not rely solely on references presented by Patent Owner. Instead, we mainly relied on the express teachings of the art cited by Petitioner, including Marquez I and Marquez II. Id. at 17–20. Our plain reading of the prior art persuades us that Petitioner has not demonstrated a reasonable likelihood of prevailing in its patentability challenge. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not precluded “from relying on arguments made by a party and doing its job, as adjudicator, of drawing its own inferences and conclusions from those arguments, even when the result is use of the party’s submissions against it”).” slip op. at 5

  • BurdenDecided for patent owner

    “Under Rule 42.108(c), The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. Thus, under the Rule, it is only genuine issues of material fact created by testimonial evidence provided by a patent owner with its preliminary response that we view “in the light most favorable to the petitioner.” 37 C.F.R. § 42.108(c) (2017).2 Because Patent Owner did not provide testimonial evidence in this proceeding, there is no “genuine issue of material fact created by such testimonial evidence.” Accepting Petitioner’s argument that we must always resolve any genuine dispute of material fact in the light most favorable to the petitioner would compel institution in every case where a petitioner presents unrebutted expert testimony. But a patent owner has no obligation to rebut the petitioner’s contentions or to submit an expert declaration rebutting the petitioner’s expert testimony. See 37 C.F.R. §§ 42.107(a) (“The patent owner may file a preliminary response to the petition.” (emphasis added)); 42.108(c) (“The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence.” (emphasis added)). And the Board is not required to accept every statement made by a petitioner’s expert as established fact simply because the patent owner does not submit contradictory expert testimony. Fanduel, Inc. v. Interactive Games LLC, 966 F.3d 1334, 1344 (Fed. Cir. 2020). Instead, “it is the Board’s duty to independently assess the strength of a petitioner’s argument and evidence.” Id., see also id. (“[I]n every case, it remains the Board’s essential function to make factual findings based on its view of the record.”).” slip op. at 3

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

    “In the Decision denying institution, we concluded that the evidence before us did not support Petitioner’s alleged reasons to modify the references (Dec. 16–22), nor establish a reasonable expectation of success of doing so (id. at 22–23). In reaching this conclusion, we did not rely solely on references presented by Patent Owner. Instead, we mainly relied on the express teachings of the art cited by Petitioner, including Marquez I and Marquez II. Id. at 17–20. Our plain reading of the prior art persuades us that Petitioner has not demonstrated a reasonable likelihood of prevailing in its patentability challenge. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not precluded “from relying on arguments made by a party and doing its job, as adjudicator, of drawing its own inferences and conclusions from those arguments, even when the result is use of the party’s submissions against it”).” slip op. at 5

  § 103 obviousness
  Patents in suitUS 8,815,830
• Rimfrost As v. Aker Biomarine AsRehearing denied
  PTAB · Oct 1, 2020 · IPR2018-00295 · APJ John E Schneider · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left in place its finding that proposed substitute claims 49–56 were unpatentable over the cited combinations including Randolph.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. LEGAL STANDARD 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 in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). The burden of showing a decision should be modified on a request for rehearing lies with the party challenging the decision. Id.” slip op. at 4

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “We next turn to the guidance the POP provided in Hunting Titan. First, the POP held that “the Board may, in certain rare circumstances, raise a ground of unpatentability that a petitioner did not advance, or insufficiently developed, against substitute claims proposed in a motion to amend.” Id. at 4. The rare circumstances exemplified in the decision include cases where the petitioner has ceased to participate in the proceeding; where the petitioner has not opposed the motion to amend; or “where certain evidence of unpatentability has not been raised by the petitioner, but is readily identifiable and persuasive such that the Board should take it up in the interest of supporting the integrity of the patent system, notwithstanding the adversarial nature of the proceedings.” Id. at 12–13. The POP also held that where the Board intends to raise a new ground of unpatentability in connection with a motion to amend, the patent owner must be given notice and an opportunity to address the proposed new grounds. Id. 15.” slip op. at 6

  • Strike new argumentNew argument consideredDecided for petitioner

    “We next turn to the guidance the POP provided in Hunting Titan. First, the POP held that “the Board may, in certain rare circumstances, raise a ground of unpatentability that a petitioner did not advance, or insufficiently developed, against substitute claims proposed in a motion to amend.” Id. at 4. The rare circumstances exemplified in the decision include cases where the petitioner has ceased to participate in the proceeding; where the petitioner has not opposed the motion to amend; or “where certain evidence of unpatentability has not been raised by the petitioner, but is readily identifiable and persuasive such that the Board should take it up in the interest of supporting the integrity of the patent system, notwithstanding the adversarial nature of the proceedings.” Id. at 12–13. The POP also held that where the Board intends to raise a new ground of unpatentability in connection with a motion to amend, the patent owner must be given notice and an opportunity to address the proposed new grounds. Id. 15.” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundTeaching away not foundDecided for petitioner

    “We are not persuaded that our Decision was in error. As Petitioner points out, Dr. Tallon testified about the motivation to combine the various references. Supp. Resp. 7–8. Specifically, Dr. Tallon testified that astaxanthin was a known “potent antioxidant,” and that a person of ordinary skill in the art would have been motivated to combine krill oil of the cited references because of the health benefits associated with, inter alia, see also MTA Opp. 24–25 (Petitioner’s argument as to motivation to combine). With respect to the amount of astaxanthin ester, we are not convinced that Randolph teaches away from the claimed range. While Randolph does teach that the amount of astaxanthin may be 1% or greater, in the same paragraph Randolph states that the amount of astaxanthin is typically from about 0.5 mg to 50 mg. Ex. 1011 ¶ 44. Thus, while Randolph may teach high amounts of astaxanthin, it also teaches lower amounts that yield astaxanthin ester amounts within the range recited in the proposed substitute claims. Similarly, other teachings in the art do not dissuade one skilled in the art from using lower amounts of astaxanthin ester. A reference does not teach away “if it merely expresses a general preference for an alternative invention but [does] not criticize, discredit or otherwise discourage investigation into the claimed invention.” Depuy Spine v. Medtronic Sofmaor, 567 F.3d 1314, 1327 (Fed. Cir. 2009). Patent Owner has not pointed to nor have we discerned any teaching in the art that would dissuade one skilled in the art from using a lower amount of astaxanthin ester. As discussed above, Randolph specifically teaches lower amounts of astaxanthin, which in turn teaches lower amounts of astaxanthin ester. Ex. 1011 ¶ 44; Ex. 1086 ¶¶ 199–202.” slip op. at 18

  § 103 obviousness
  Patents in suitUS 9,320,765
• LKQ Corporation / Keystone Automotive Industries, Inc. v. GM Global Technology Operations LLCInstitution denied
  PTAB · Aug 10, 2020 · PGR2020-00020 · APJ Christopher G Paulraj · PGR · Institution

  The Board denied institution because Petitioner did not show that the sole design claim was more likely than not unpatentable under the asserted grounds.

  RulingsInstitution decision

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

    “A post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a) (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine, for the reasons set forth below, that Petitioner has failed to demonstrate that it is more likely than not that the challenged claim is unpatentable based on the grounds presented. Therefore, we do not institute a post-grant review of that claim.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. The Designer of Ordinary Skill Petitioner contends that: a designer of ordinary skill would be an individual who has at least an undergraduate degree in transportation or automotive design and work experience in the field of transportation design, or someone who has several years’ work experience in the field of transportation or automotive design. Pet. 31 (citing Ex. 1003 ¶¶ 37–42; Ex. 1004 ¶¶ 35–42). Patent Owner argues, without citation to evidence, that: [a] designer of ordinary skill in the art relevant to the ’099 Patent would have at least an undergraduate degree in automotive design, or other related industrial design field, with at least two years of relevant practical experience in designing automotive body parts. An increase in experience could compensate for less education, and an increase in education could likewise compensate for less experience. Prelim. Resp. 10. The parties do not identify, and we do not discern, any material difference between the parties’ proposed definitions. For purposes of this decision and on the record currently before us, which includes testimony by Petitioner’s declarants, we adopt Petitioner’s proposed definition of the ordinary designer. Also, we point out that adopting Patent Owner’s definition would not alter the outcome of this Decision.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “November 13, 2018, we apply the same claim construction standard used in district courts. See 37 C.F.R. § 42.200(b) (2019). Generally in the context of a design patent, an illustration, rather than a verbal description, is the better representation of the claimed design. “As the Supreme Court has recognized, a design is better represented by an illustration ‘than it could be by any description and a description would probably not be intelligible without the illustration.’” Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 679 (Fed. Cir. 2008) (quoting Dobson v. Dornan, 118 U.S. 10, 14, (1886)). Although preferably a design patent claim is not construed by providing a detailed verbal description, it may be “helpful to point out . . . various features of the claimed design as they relate to the . . . prior art.” Id. at 679–80; cf. High Point Design LLC v. Buyers Direct, Inc., 730 F.3d 1301, 1314–15 (Fed. Cir. 2013) (remanding to the district court, in part, for a “verbal description of the claimed design to evoke a visual image consonant with that design”). Here, the overall visual appearance of the vehicle grille bezel design shown in Figures 1–5 of the ’099 design is clearly exemplified in the drawings. In other words, the elements and features of the ’099 design which contribute to the overall appearance of the design are readily discernable and apparent to any observer. We determine that the best description of the ornamental features of the ’099 design comes from the drawings themselves. Accordingly, we determine that no articulated verbal description is necessary to describe the overall ornamental nature of the ’099 design. Nonetheless, we have taken into account Petitioner’s verbal description of the design in our analysis, but agree with Patent Owner’s contention that Petitioner’s verbal description is an incomplete description of the actual design. Although we do not undertake a specific verbal construction, we acknowledge in our following analyses the relevant design characteristics of the ’099 design, including key similarities and distinctions in comparison to the prior art. See MRC Innovations, Inc. v. Hunter Mfg., LLP, 747 F.3d 1326, 1332 (Fed. Cir. 2014) (Affirming that a verbal claim construction was unnecessary, the Federal Circuit explained that “the district court did not err by failing to provide an express verbal description of the claimed design; rather, it described the claimed design in the context of comparing it to the prior art.”).” slip op. at 6

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

    “particular, we agree with Patent Owner that Petitioner’s analysis is deficient insofar as it fails to sufficiently consider the claimed design from the side perspective as shown in Figure 3 of the ’099 patent. The only photograph that Petitioner relies upon to show how the grille bezel of the 2014 Buick Enclave allegedly meets the claimed design from the side does not adequately show the features depicted in Figure 3. Petitioner provides a side-by-side comparison of Figure 3 of the ’099 Patent with the 2014 Buick Enclave, as reproduced below. The image above is offered by Petitioner to compare Figure 3 of Exhibit 1001 to page 1 of Exhibit 1007 to allegedly show that “the bezel is horizontally convexly curved, and the bottom of the u-shaped portion is forward of the substantially horizontal portion.” Pet. 44–45 (color in original). However, that photograph shows more of the front than the side of the grille bezel. It is not clear from the comparison photograph provided whether “the bottom of the u-shaped portion is forward of the substantially horizontal portion,” as required by Petitioner’s own textual claim construction. It is also not clear from the photograph that the “short, downward-pointing diagonal bezel segment at each end” as described in Petitioner’s textual construction extends backward from the “horizontal top portion” to meet the top end of the “substantially u-shaped bottom portion.” Petitioner does not explain why the ordinary observer would not have considered these features from the side perspective in determining the overall visual impression created by the claimed design. We agree with Patent Owner that Petitioner impermissibly ignores the full three-dimensionality of the claimed design.” slip op. at 19

  Claim construction§ 103 obviousness
• Qiagen North American Holdings, Inc. v. Handylab, Inc.No claims unpatentable
  PTAB · Jul 14, 2020 · IPR2019-01493 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  The Board held claims 1–33 not shown unpatentable under the asserted §103 grounds because the petitioner did not establish the claimed separate sample inlets or a reasonable expectation of success in combining the references.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We agree with the parties that a POSA would have had an engineering background and experience with microfluidic devices, which is consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Our determination regarding the patentability of the challenged claims does not turn on the differences between Petitioner’s and Patent under either assessment.” slip op. at 9

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

    “We also agree with Patent Owner that the specification defines the structure of the sample lane. PO Resp. 12. The specification states: A sample lane is an independently controllable set of elements by which a sample can be analyzed, according to methods described herein as well as others known in the art. A sample lane comprises at least a sample inlet, and a microfluidic network having one or more microfluidic components as further described herein. Ex. 1002, 12:66–13:4. The embodiments described in the specification include sample inlets associated with each of the sample lanes. See, e.g., id.” slip op. at 13

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

    “Petitioner has failed to sufficiently demonstrate that the combination of Zou I and McNeely or Pease teaches multi-lane microfluidic cartridges, because Petitioner has failed to establish by a preponderance of the evidence that a POSA would reasonably have expected to be successful in combining Zou I’s microfluidic chip with a cartridge as taught by McNeely or Pease. In order to demonstrate that the challenged claims are obvious, a petitioner must demonstrate “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327 (Fed. Cir. 2012) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). A petitioner must combination(s) of elements in specific references would yield a predictable result, or [3] how any specific combination would operate or read on the asserted claims.” Id. at 1327–28. Focusing on the parties’ arguments pertaining to how Zou I and McNeely or Pease could be combined, which combination of elements in the references would yield a predictable result, and how the combination would operate or read on the challenged claims, we determine that the evidence on this record is not sufficient to show that a POSA could have had a reasonable expectation of success in attempting to combine the teachings of Zou I with McNeely or Pease. Although the Petition sets forth various rationales for why a person of ordinary skill would have had reason to combine the teachings of Zou I and McNeely or Pease, the rationales are general in nature and do not address any specific modification to either of the references. Pet. 28–33. The Petition includes a single reference to reasonable expectation of success, in a conclusory statement that “a POSA would have been motivated to combine the multiplexing PCR unit of Zou I with a conventional integrated machine such as in McNeely or Pease, with a high expectation of success.” Id. at 28–29. The First Gale Declaration is similarly conclusory as to how Zou I and McNeely or Pease could be combined and does not elaborate on reasonable expectation of success. See Ex. 1001 ¶¶ 116–127. Such conclusory assertions, lacking factual substantiation, are insufficient for evaluating reasonable expectation of success as part of an obviousness determination. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017).” slip op. at 35

  • Strike new argumentNew argument disregardedGranted in part

    “Patent Owner also filed a Motion to Strike certain portions of Petitioner’s Reply. Paper 38. Petitioner filed an Opposition. Paper 39. We granted Patent Owner’s Motion to Strike in part, striking the arguments in Section II.B.ii from Petitioner’s Reply. Paper 42, 6–8, 13. We did not consider those arguments in the course of preparing this Final Written Decision.” slip op. at 2

  Patent outcomesUS 7,998,708 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,998,708
• Qiagen North American Holdings, Inc. v. Handylab, Inc.No claims unpatentable
  PTAB · Jul 14, 2020 · IPR2019-00488 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claims 1–33 were not shown unpatentable because the asserted combinations did not establish the claimed multi-lane cartridge or a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “We agree with the parties that a POSA would have had an engineering background and experience with microfluidic devices, which is consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Our determination regarding the patentability of the challenged claims does not turn on the differences between Petitioner’s and Patent under either assessment.” slip op. at 9

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

    “We also agree with Patent Owner that the specification defines the structure of the sample lane. PO Resp. 12. The specification states: A sample lane is an independently controllable set of elements by which a sample can be analyzed, according to methods described herein as well as others known in the art. A sample lane comprises at least a sample inlet, and a microfluidic network having one or more microfluidic components as further described herein.” slip op. at 13

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

    “In an obviousness analysis, a sufficient reason must be shown as to why a POSA would have thought of combining or modifying the prior art to achieve the patented invention. See Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008). Here, Petitioner offers only the general proposition that drilling access holes into the glass cover of Zou I’s microfluidic chip was a “common technique,” but this does not provide a reason why a POSA would have been motivated to modify Zou I’s microfluidic chip. Pet. Reply 7. Petitioner’s argument and Dr. Gale’s that does not apprise us of why a POSA would have modified Zou I with access holes that would operate as separate sample inlets for each sample lane as required by the claims of the ’708 patent. Here, Petitioner attempts to imbue a POSA with the knowledge of the claimed invention, when no prior art reference, references of record, or other evidence conveys or suggests that knowledge. Petitioner’s argument that a POSA would have modified Zou I in this way appears to be premised on Petitioner’s knowledge of the ’708 patent disclosure. This is improper hindsight reasoning. Petitioner needed to explain what would have led a POSA at the time of the invention to consider modifying Zou I to include a separate sample inlet with each sample lane. Petitioner failed to provide such an explanation. See W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983) (In an obviousness analysis, we must “cast the mind back to the time the invention was made” and “occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.”).” slip op. at 31

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

    “Petitioner has failed to sufficiently demonstrate that the combination of Zou I and McNeely or Pease teaches multi-lane microfluidic cartridges, because Petitioner has failed to establish by a preponderance of the evidence that a POSA would reasonably have expected to be successful in combining Zou I’s microfluidic chip with a cartridge as taught by McNeely or Pease. In order to demonstrate that the challenged claims are obvious, a petitioner must demonstrate “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327 (Fed. Cir. 2012) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). A petitioner must combination(s) of elements in specific references would yield a predictable result, or [3] how any specific combination would operate or read on the asserted claims.” Id. at 1327–28. Focusing on the parties’ arguments pertaining to how Zou I and McNeely or Pease could be combined, which combination of elements in the references would yield a predictable result, and how the combination would operate or read on the challenged claims, we determine that the evidence on this record is not sufficient to show that a POSA could have had a reasonable expectation of success in attempting to combine the teachings of Zou I with McNeely or Pease. Although the Petition sets forth various rationales for why a person of ordinary skill would have had reason to combine the teachings of Zou I and McNeely or Pease, the rationales are general in nature and do not address any specific modification to either of the references. Pet. 28–33. The Petition includes a single reference to reasonable expectation of success, in a conclusory statement that “a POSA would have been motivated to combine the multiplexing PCR unit of Zou I with a conventional integrated machine such as in McNeely or Pease, with a high expectation of success.” Id. at 28–29. The First Gale Declaration is similarly conclusory as to how Zou I and McNeely or Pease could be combined and does not elaborate on reasonable expectation of success. See Ex. 1001 ¶¶ 116–127. Such conclusory assertions, lacking factual substantiation, are insufficient for evaluating reasonable expectation of success as part of an obviousness determination. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017).” slip op. at 35

  Patent outcomesUS 7,998,708 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 7,998,708
• Qiagen North American Holdings, Inc. v. Handylab, Inc.No claims unpatentable
  PTAB · Jul 14, 2020 · IPR2019-00490 · APJ Julia Heaney · IPR · Final written decision

  Claims 1–22 were not shown unpatentable because the asserted combinations failed to establish the required multi-lane cartridges and a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “year of related experience.” Pet. 7. Patent Owner argues that Petitioner’s proposed definition “is not narrowly drawn to experience in ‘microfluidic systems that carry out PCR,’” and contends that a POSA “would have had a degree in Mechanical Engineering, Bioengineering, or a similar field, and three years of experience with microfluidic devices that carry out PCR, or would have an advanced degree in a similar field with at least one year of related experience.” PO Resp. 8 (citing Ex. 2036 ¶¶ 25–26). Patent Owner’s declarant Dr. Northrup states that, although he disagrees with Petitioner’s proposed definition of a POSA, his “opinions would not change under” that definition. Ex. 2036 ¶ 28. We agree with the parties that a POSA would have had an engineering background and experience with microfluidic devices, which is consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Our determination regarding the patentability of the challenged claims does not turn on the differences between Petitioner’s and Patent Owner’s definitions, and we note that our conclusions would be the same under either assessment.” slip op. at 9

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

    “We agree with Patent Owner that the specification defines the structure of the sample lane. PO Resp. 12. The specification states: A sample lane is an independently controllable set of elements by which a sample can be analyzed, according to methods described herein as well as others known in the art. A sample lane comprises at least a sample inlet, and a microfluidic network having one or more microfluidic components as further described herein. Ex. 1003, 13:4–9. The embodiments described in the specification include sample inlets associated with each of the sample lanes. See, e.g., id. at 14:41–52, Figs. 10A, 10B (describing an exemplary microfluidic cartridge depicted in Figures 10A and 10B as showing “[m]ore than one inlet 202 . . . wherein one inlet operates in conjunction with a single sample lane”), 17:60–64, Fig. 13 (describing and depicting a 48-sample cartridge with separate inlets 602 for each sample lane). In contrast, when describing other elements (such as inlet ports and valves) that may be included in a sample lane, the specification clearly conveys that these other elements are optional. Id. at 13:10–13 (“In various embodiments, a sample lane can include a sample inlet port or valve, and a microfluidic network that comprises, in fluidic communication one or more components selected from the group consisting of” specified valves, vents, pumps, and chambers. (emphasis added)).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundDecided for patent owner

    “In an obviousness analysis, a sufficient reason must be shown as to why a person of ordinary skill in the art would have thought of combining or modifying the prior art to achieve the patented invention. See Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008). Here, Petitioner offers only the general proposition that drilling access holes into the glass cover of Zou I’s microfluidic chip would have been a common technique Pet. Reply 7. Petitioner’s argument and Dr. Gale’s testimony with respect to the modification of Zou I leaves an analytical gap that does not apprise us of why a person of ordinary skill would have modified Zou I with access holes that would operate as separate sample inlets for each sample lane as required by the claims of the ’900 patent. Here, Petitioner attempts to imbue a person of ordinary skill with the knowledge of the claimed invention, when no prior art reference of record or other evidence conveys or suggests that knowledge. Without such evidence, Petitioner’s argument that a person of ordinary skill would have modified Zou I in this way appears to be premised on Petitioner’s knowledge of the ’900 patent disclosure. This is improper hindsight reasoning. Petitioner needed to explain what would have led a person of ordinary skill at the time of the invention to consider modifying Zou I to include a separate sample inlet with each sample lane. Petitioner failed to provide such an explanation. See W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983) (In an obviousness analysis, we must “cast the mind back to the time the invention was made” and “occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.”).” slip op. at 31

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

    “Petitioner has failed to sufficiently demonstrate that the combination of Zou I and McNeely or Pourahmadi teaches multi-lane microfluidic cartridges, because Petitioner has failed to establish by a preponderance of the evidence that a person of ordinary skill in the art would reasonably have expected to be successful in combining Zou I’s microfluidic chip with a cartridge as taught by McNeely or Pourahmadi. In order to demonstrate that the challenged claims are obvious, a petitioner must demonstrate “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327–28 (Fed. Cir. 2012) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). A petitioner must articulate “[1] how specific references could be combined, [2] which combination(s) of elements in specific references would yield a predictable result, or [3] how any specific combination would operate or read on the asserted claims.” Id. Focusing on the parties’ arguments pertaining to how Zou I and McNeely or Pourahmadi could be combined, which combination of elements in the references would yield a predictable result, and how the combination would operate or read on the challenged claims, we determine that the evidence on this record is not sufficient to show that a person having ordinary skill in the art would have had a reasonable expectation of success in attempting to combine the teachings of Zou I with McNeely or Pourahmadi. Although the Petition sets forth various rationales for why a Zou I and McNeely or Pourahmadi (Pet. 27–32), the rationales are general in nature and do not address any specific modification to either of the references. Further, the Petition includes a single reference to reasonable expectation of success, in a conclusory statement that “a POSA would have been motivated to combine the PCR unit of Zou I with a multi-cartridge integrated machine such as in McNeely or Pourahmadi, with a high expectation of success.” Pet. 27. The Gale Declaration is similarly conclusory as to how Zou I and McNeely or Pourahmadi could have been combined by the ordinary artisan, and does not elaborate on the artisan’s reasonable expectation of success. Such conclusory assertions, lacking factual substantiation, are insufficient for evaluating reasonable expectation of success as part of an obviousness determination. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017). Thus, Petitioner did not make out its obviousness case based on combining Zou I and McNeely or Pourahmadi, in the Petition. 35 U.S.C. § 312(a)(3).” slip op. at 36

  Patent outcomesUS 8,323,900 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 8,323,900
• Eis GmbH v. Novoluto GmbHRehearing granted
  PTAB · 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 obviousness
  Patents in suitUS 9,937,097
• Agilent Technologies, Inc. v. Bio-Rad Laboratories, Inc.No claims unpatentable
  PTAB · Jun 2, 2020 · IPR2019-00271 · APJ Christopher G Paulraj · IPR · Final written decision

  The Board held claims 1–18 not unpatentable under §103 because Li lacked the construed wells and the petitions did not adequately establish motivation to combine Pantoliano with Miller.

  RulingsFinal written decision

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

    “Although we agree that “wells”/“sample wells” are where the samples to be analyzed are placed in the device, we find Petitioner’s definition to be incomplete as it does not require any particular structure. We decline to adopt Petitioner’s purely functional claim construction and find that a POSITA would have understood “wells”/“sample wells” to require a certain structure as described in the ’043 patent. In this regard, the specification of the ’043 patent consistently uses the term “wells” to refer to the structures that cradle the sample tubes in the “thermal cycler” or “sample unit” and that are closed at one end. See, e.g., Ex. 1001, Abstract (“A fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler and methods of use are provided.”); id. at 2:47–50 (describing “[a]ccording to one aspect of the invention, a fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler”); id. at 3:12–13 (“Each sample is placed in a respective one of a number of sample wells of a thermal cycler instrument.”); id. at 4:26–27 (“Sample unit 202 contains a number of sample wells 210 arranged in a regular array.”). All the embodiments of the invention described in the ’043 patent refer to sample wells depicted with a closed end. See, e.g., id. at Fig. 6 (sample well 210). We further agree with Patent Owner that the specification draws a distinction between “wells” in which the samples are placed for analysis and “holes” through which light passes to reach the sample. See, e.g., id. at 4:56 (“Lid heater 204 has holes 220 therethrough.”); id. at 5:42 (referring to “holes 220 in lid heater 204”); id. at 6:52–53 (“Openings 502, 504, 506, 508 may simply be holes through the bottom surface of detection module 234.”).” slip op. at 10

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

    “Independent claim 1 of the ’043 patent recites a “fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler.” Ex. 1001, claim 1.12 Likewise, independent claim 12 recites “placing each sample in a respective one of a plurality of sample wells.” Id. at claim 12. As discussed above, we have construed “wells”/“sample wells” to mean “a depression, open on one end and closed on the opposite end, into which a reaction vessel can be placed.” Li does not teach this requirement. Although the certified translation of Li refers to elements 21 of the disclosed apparatus as a “plurality of wells,” those elements are not closed on one end as required by our construction. Thus, notwithstanding the terminology used by Li, we agree with Patent Owner that elements 21 do not qualify as the claimed “wells.” PO Resp. 11. As explained by Dr. Niekirk: Rather than use “wells,” Li has holes that traverse the temperature cycling unit. Li is constructed so that the sample tubes are placed into the temperature cycling unit from the top, and the fluorescence detection unit is in optical communication with the sample tubes from the bottom via the holes. The fluorescence detection unit is placed on a belt that moves in one direction located below the samples and is concealed in an enclosure beneath the sample wells. As such, Li does not suggest the possibility of detaching and replacing the detection module. Rather than employing a shuttle that is translated in two directions using a stepper motor coupled to multiple lead screws. In using holes rather than wells, it is my opinion that Li discloses an overall system very different from the claimed invention of the ’043 patent. 12 The parties do not dispute that the preamble is limiting. See Pet. 38 (arguing that Li discloses the preamble of claim 1); PO Resp. 10 (arguing that Li does not disclose “wells” as recited in the preamble). We likewise determine that the preamble is limiting as it provides antecedent basis for “wells” recited in the body of the claim. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).” slip op. at 26

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

    “references, including the assertion that they share the same goal, that their approaches are compatible, and that Miller offers a “compact, versatile, lightweight, and low-cost design for rapid scanning.” Id. at 64. We agree with Patent Owner that the asserted reasons are conclusory and insufficient to support a motivation to combine Pantoliano and Miller. See, e.g., TQ Delta, LLC v. CISCO Sys., Inc., 942 F.3d 1352, 1359 (Fed. Cir. 2019) (“[A] conclusory assertion with no explanation is inadequate to support a finding that there would have been a motivation to combine” (quoting In re Van Os, 844 F.3d 1359, 1361–62 (Fed. Cir. 2017))); Microsoft Corp. v. Enfish, LLC, 662 F. App’x 981, 990 (Fed. Cir. 2016) (“[The] Board correctly concluded that [the petitioner] did not articulate a sufficient motivation to combine. With respect to [certain challenged claims], [the petitioner] gave no reason for the motivation of a person of ordinary skill to combine [the two references] except that the references were directed to the same art or same techniques.”). As noted in our Institution Decision, the Petition does not explain clearly why the POSITA would have chosen to use Miller’s design with multiple light generators within the same scan head in lieu of the fiber optic system taught by Pantoliano, which could already be used to analyze multiple samples simultaneously. Inst. Dec. 31. In our Institution Decision, we also took into account the testimony of Petitioner’s expert, Dr. Landers, who provides more detail in his declaration as to why there were known problems with the use of optical-fiber-based systems, such as those taught by Pantoliano, including the fact that fiber optics lose the ability to transmit certain frequencies of light over time and that light transmission characteristics could change when fiber optics are physically moved. Id. at 32; Ex. 1008 ¶¶ 30–31, 115 n.8. Petitioner, however, did not rely upon that testimony to support a motivation to combine Pantoliano and Miller. See Pet. 35 (citing foregoing portions of Landers declaration only with respect to Ground I). Moreover, as explained below, even if Dr. Landers’ declaration statements concerning the known drawbacks of fiber optics systems are taken into account, we are not persuaded that those alleged drawbacks would have provided a sufficient motivation to combine the teachings of Pantoliano and Miller in the manner asserted by Petitioner. We agree with Patent Owner that the goals and structure of the apparatus taught by Pantoliano are significantly different from the claimed invention. We further agree with Patent Owner that a preponderance of the evidence does not support a motivation to modify Pantoliano’s apparatus to include Miller’s scan head based on either a desire to detect multiple wavelengths simultaneously or to solve any problems associated with the fiber optics used in Pantolonio’s apparatus. Although Pantoliano mentions in one instance that “the assay apparatus of the present invention can be used to perform polymerase chain reaction” (Ex. 1021, 42:57–58), it is primarily directed to performing “thermal shift assays” used to assess the extent of thermal denaturation of proteins under various conditions. Id. at 1:23–25 (“[T]he present invention relates to a method and apparatus for performing assays, particularly thermal shift assays.”); id. at 5:5–25 (describing a method of simultaneously heating “[a] multiplicity of containers” and “measuring in each of the containers a physical change associated with the thermal denaturation of the target molecule resulting from heating”). Dr. Neikirk explains that thermal shift assays can be used to assess various parameters of a target protein, such as stability under certain conditions, shelf-life, crystallization tendencies, the affinity of the target protein for other molecules, and optimal refolding conditions. Ex. 2001 ¶ 138. According to Dr. Neikirk, the apparatus of Pantoliano would not benefit from the ability to deliver and detect multiple light wavelengths in the same sample because “fluorescence is used in Pantoliano to assess whether and to what extent a protein has denatured, not to detect and quantify various types of target molecules” or to “distinguish between molecules.” Id. ¶¶ 155–157. As noted above, the embodiment of Pantoliano relied upon by Petitioner utilizes fiber optic cables to transmit light and detect spectral emissions from the sample. Ex. 1021, 35:7–35, Fig. 31. Dr. Landers identified two main problems with such optical-fiber-based systems: (1) “fiber optics lose the ability to transmit certain frequencies of light over time” and (2) “light transmission characteristics change when fiber optics are physically moved.” Ex. 1008 ¶¶ 31–32; see also id. ¶ 115 n.8. We are not persuaded that these issues with fiber optics would have served as a motivation to combine Pantoliano with Miller in the manner asserted by Petitioner. Dr. Neikirk testifies that “at the time of the invention, practitioners were still employing fiber optics as a way to deliver specific wavelengths of light to samples despite the known problems with fiber optics.” Ex. 2001 ¶ 159. Indeed, as noted by Dr. Neikirk, Miller itself discloses embodiments that utilized fiber optics. See id. ¶ 160; Ex. 1013, 5:35–42 (describing an alternate embodiment in which the detector is “positioned remotely and connected to the scan head via an optical fiber”). As to the issue of transmission decay over time with fiber optics, Dr.” slip op. at 31

  • BurdenNot shown unpatentable

    “¶ 165). But Petitioner does not clearly rely upon the structures of Miller or Randrianarivo to assert that the claim requirement for “wells” or “sample wells” is satisfied. As discussed above, Petitioner’s obviousness theory with respect to Ground I only requires a modification of Li’s apparatus to include “a plurality of excitation/detection pairs.” To the extent that Petitioner’s contentions are based on further modifications to Li, we agree with Patent Owner that Petitioner fails to satisfy the particularity requirement of 35 U.S.C. § 312(a)(3). PO Resp. 14–23; see Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (“[T]he Petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” (emphasis added)). For the foregoing reasons, Petitioner has not demonstrated by a preponderance of the evidence that the combination of Li, Miller, and Randriarivo as set forth in Ground I renders claims 1–17 obvious. Petitioner does not rely upon the teachings of Bjornson or Heffelfinger to remedy the deficiencies in Ground I. Accordingly, we also determine that Petitioner has not met its burden with respect to Grounds II and III.” slip op. at 28

  Patent outcomesUS 7,148,043 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,148,043
• Gilead Sciences, Inc. v. Regents Of The University Of MinnesotaInstitution denied
  PTAB · May 28, 2020 · IPR2017-02005 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–9, 11, 12, and 28 were obvious over the ’787 patent and Brox.

  RulingsInstitution decision

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

    “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.” 35 U.S.C. § 314(a) (2012). For the reasons provided below, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2

  • Parallel petitionsNot reached

    “ANALYSIS Discretionary Denial Patent Owner contends that we should exercise our discretion and deny institution because Petitioner filed four petitions to challenge the claims of the ’830 patent. Prelim. Resp. 11–12, 68. According to Patent Owner, “[f]our parallel petitions are inappropriate and have placed a substantial and unnecessary burden on the Board and Patent Owner.” Id. at 68. Petitioner points out that all four petitions were filed in 2017, before the Office started to disfavor multiple petitions against the same patent. Paper 33, 1. According to Petitioner, but for Patent Owner’s “efforts to stop these proceedings before they began” by asserting sovereign immunity, these proceedings would have concluded before the policy shift. Id. at 1–2. Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to consider whether institution should be denied on a discretionary basis.” slip op. at 7

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

    “Patent Owner discusses the terms “alkyl” and “aryl.” Prelim. Resp. 37–55. According to Patent Owner, “alkyl” means “a hydrocarbon group containing only single bonds.” Id. at 50. It points to Mcgraw-Hill Dictionary of Scientific and Technical Terms, which defines “alkyl” as “[a]n organic group that results from removal of a hydrogen atom from an acyclic, saturated hydrocarbon;” and “saturated hydrocarbon” as “[a] saturated carbon-hydrogen compound with all carbon bonds filled; that is, there are no double or triple bonds as in olefins and acetylenics.” Id. (quoting Ex. 2315, 64. 1754). Patent Owner argues that its construction is consistent with the disclosures of the ’830 patent. Id. at 50 (noting that in the ’830 patent, alkyl denotes “both straight and branched groups”) (quoting Ex. 1301, 5:15–16), Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November 13, 2018). 9 52 (observing that each named group of (C1-C6)alkyl in the ’830 patent is a hydrocarbon group containing only single bonds) (citing Ex. 1301, 6:37–39). Petitioner, although not offering any construction of the term, acknowledges that “alkyl” is “commonly understood” to include only saturated hydrocarbons. Pet. 21. On this record, we find Patent Owner’s argument persuasive and agree that “alkyl” is “a hydrocarbon group containing only single bonds.”” slip op. at 8

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

    “For the R4 position, Petitioner argues that “aryl, aryl(C1-C6)alkyl” of the ’830 patent encompasses the “Ar” of the ’787 patent. Id., see also id. at 40 (“[B]oth the ’787 patent and the ’830 patent include an aryl substituent.”). We find that for the following two reasons, despite using the same term “aryl,” the R4 substituent options claimed in the ’830 patent does not encompass the “Ar” substituent selections of the ’787 patent. First, as discussed in the claim-construction section, the parties agree that “aryl,” as defined in the ’830 patent, excludes heteroaryl groups. Supra at 9; Pet. 21; Prelim. Resp. 42. “Aryl” in the ’787 patent, in contrast, “may be a heteroaromatic group containing one, two, three or four” heteroatoms. Ex. 1302, 4:65–5:3, see also id. at 3:56–58 (“Ar is a monocyclic aromatic ring moiety or a fused bicyclic aromatic ring moiety, either of which ring moieties is carbocyclic or heterocyclic and is optionally substituted.”). Second, when “aryl” is an ortho-fused bicyclic carbocyclic radical, the ’830 patent limits the system to “about nine to ten ring atoms.” Ex. 1301, 5:14–22. In contrast, in the ’787 patent, “an aryl group means an aromatic group containing 5 to 14 ring atoms.” Ex. 1302, 4:65–66. Because of at least these two differences, the “Ar” substituent selections of the ’787 patent are broader than the “aryl” substituent selections of the claims of the ’830 patent.” slip op. at 13

  Claim construction§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,815,830

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.