• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by 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))).” slip op. at 7

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

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

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

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Transgene / Bioinvent International AB v. Replimune LimitedNo claims unpatentable
  PTAB · May 25, 2023 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Final written decision

  The Board held claim 13 not unpatentable over Silvestre or Du, Choi, and Zitvogel, finding insufficient motivation to combine and reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “or “POSITA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post-Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See PO Resp. 5. We adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the prior art. 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” slip op. at 11

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

    “claim terms of the ’513 patent for purposes of determining whether to institute trial. For purposes of our analysis in this Final Written Decision, however, we find that it would be useful to clarify the scope of “oncolytic virus.” We agree with Petitioner that the Specification defines an “oncolytic virus” as “a virus that infects and replicates in tumor cells, such that tumor cells are killed.” Ex. 1001, 9:10–12. The Specification further clarifies that “the virus is replication competent,” and is preferably selectively replication competent in tumor tissue. Id. at 9:12–13. “A patentee is free to be his own lexicographer.” Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, consistent with its express definition in the Specification, to be a virus that infects and replicates in tumor cells, such that tumor cells are killed, wherein such a virus is replication competent.” slip op. at 12

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

    “but contends that “oncolytic virus” should not be construed to encompass “viral vectors” such as those disclosed in Zitvogel. PO Resp. 5. Although Petitioner does not expressly contend otherwise, we agree with Patent Owner that “oncolytic virus” would not encompass Zitvogel’s “viral vectors,” which are defined in that reference to be “replication-defective” or “replication-impaired.” Ex. 1004, 19:26–29. We do not construe any other claim terms. See Vivid Techs., Inc. v.” slip op. at 13

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

    “Petitioner acknowledges that “while the bulk of Silvestre’s disclosure, including the working examples, is directed towards creating an oncolytic poxvirus, Silvestre discloses preparing modified oncolytic virus using other virus types, including HSV.” Pet. 44. It is undisputed, however, that Silvestre does not disclose a single embodiment of an oncolytic HSV that includes both a heterologous GM-CSF encoding gene and a heterologous CTLA-4 inhibitor encoding gene. Rather, Petitioner points to where each element could be found among broader lists of possible oncolytic virus classes, immune checkpoint targets, and therapeutic genes. Ex. 1002, 7:10– 15:49. As noted by Dr. Chiocca, if one were to randomly select any of the 11 We need not decide whether Silvestre anticipates independent claim 1, as the sole challenged claim 13 depends directly from claim 11. Thus, our determination that Petitioner has not shown that claim 11 is anticipated is sufficient to establish that Petitioner has not met its prerequisite burden for claim 13. Ex. 2009 ¶ 29. This type of picking and choosing is not anticipation. See Arkley, 455 F.2d at 587–88.” slip op. at 19

  Patent outcomesUS 10,947,513 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,947,513
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

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

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

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

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

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

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. 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)).” slip op. at 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Laboratoire Francais Du Fractionnement Et Des Biotechnologies S.A. v. Novo Nordisk Healthcare AGNo claims unpatentable
  PTAB · Apr 13, 2022 · IPR2017-00028 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–15 were not shown unpatentable under the remaining Tolo anticipation and Eibl ’023 combination grounds; Patent Owner’s motion to exclude was granted in part.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “We agree that a motion to exclude is not the appropriate vehicle for consideration of whether a party has improperly raised new arguments. Our Trial Practice Guide delineates between a motion to exclude and a motion to strike, indicating that a motion to strike is the preferred mechanism “[i]f a party believes that a brief filed by the opposing party raises new issues, is accompanied by belatedly presented evidence, or otherwise exceeds the proper scope of reply or sur-reply . . . .” See Trial Practice Guide Update 17 (Aug. 2018); Patent Trial and Appeal Board Consolidated Trial Practice Guide 80 (Nov. 2019).10 Although a motion to exclude is pre-authorized in the Scheduling Order, see Paper 64, 4 (Supplemental Scheduling Order), a motion to strike is not, and Patent Owner did not request prior authorization to file its motion to strike. Petitioner did, however, have an opportunity to respond and did so respond to Patent Owner’s contentions that the allegedly new evidence and argument exceeded the proper scope of a reply. See Paper 87, 3–8. Therefore, we find that Petitioner had an appropriate opportunity, of which it took advantage, to respond to Patent Owner’s arguments regarding the alleged new arguments and evidence. Accordingly, we determine that Petitioner is not prejudiced by our consideration of Patent Owner’s motion to exclude as, in effect, a motion to strike.” slip op. at 11

  • Skill levelSkill level board ownDecided for patent owner

    “Owner’s proposed levels of skill in the art to be somewhat deficient. Paper 53, 8. We found that Petitioner’s proposed skill level does not address the specific problems concerning the nanofiltration of FVIIa that is the subject of the ’762 patent at issue in this proceeding. Id. We also found, however, that we were unaware of any basis in the record for Patent Owner’s contention that the hypothetical skilled artisan must be a “team” of scientists and engineers with two different areas of “expertise.” Id. Nonetheless, based on our consideration of the record, we found that the skilled artisan would need skills and knowledge with respect to both the biochemistry of coagulation factors (particularly FVII/FVIIa) and separation/purification/processing techniques used in the biotechnology industry for such proteins (particularly nanofiltration). Id. We agreed with both Petitioner and Patent Owner that such skills and knowledge may be obtained through some combination of education and industry/laboratory experience, wherein a skilled artisan with a doctorate degree (Ph.D.) could have fewer years of experience than required for a skilled artisan with a Master’s or Bachelor’s degree. Id. In general, we found that the “ordinary skill” level of a scientist or engineer in this art is relatively high. Id. As explained by Dr. Chtourou, “[e]xtensive academic training and laboratory experience are necessary for producing recombinant coagulation proteins and removing viruses from compositions of such proteins.” Id. at 8–9 (citing Ex. 1010 ¶ 27). We further took into account that this level of skill is also reflected in the prior art of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and we found that the parties’ declarants in this proceeding meet the requirements for this skill level. Id. at 8–9. The parties have not challenged these findings and we see no reason to depart from them for our analysis in this Decision.” slip op. at 22

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

    “As we stated in our Final Written Decision, Petitioner offered constructions for the following claim terms: “cell culture supernatant” and “Factor VII polypeptides.” See Paper 53, 9 (citing Pet. 10–15). We noted that Patent Owner did not disagree with Petitioner’s proposed construction for “cell culture supernatant,” and asserts that “Factor VII [poly]peptide[]” is expressly defined in the Specification of the ’762 patent. PO Resp. 6; see also Paper 67, 4. We previously found that no explicit construction of any claim term was necessary to resolve the issues in this case. No new claim construction issues have been raised in this proceeding, and we again find no explicit construction of any claim term is necessary in this proceeding. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 24

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

    “First, we begin with the unassailable fact that Tolo does not disclose expressly or inherently any particular concentration of FVII. See Ex. 1006, 7:25–34 (only mention of Factor VII in Tolo with no express statement concerning a concentration for FVII). In fact, we found in our Final Written Decision that: The record in this proceeding does not show persuasively that the skilled artisan would have reasonably expected that the same concentration disclosed in Example 3 of Tolo for IFN-α (0.04 mg/mL) could be successfully used for the nanofiltration of FVIIa. To the contrary, the evidence shows that IFN-α and FVIIa differ significantly in many respects, including molecular weight, size, and structure, such that the skilled [artisan] would not have necessarily considered them interchangeable in a nanofiltration process. Paper 53, 38 (citations omitted).” slip op. at 34

  Patent outcomesUS 9,102,762 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 9,102,762
• Medtronic, Inc. / Medtronic Vascular, Inc. v. Teleflex Life Sceinces LimitedNo claims unpatentable
  PTAB · Feb 23, 2022 · IPR2020-01344 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 25–55 were not determined unpatentable: the Board found the obviousness showing deficient, found Root was not prior art, and credited objective evidence of nonobviousness.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention training program, and (c) experience working as an interventional cardiologist;” or (2) an engineer who “would have had (a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 11–12. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 12. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1405 ¶ 27; Ex. 1442 ¶¶ 24-25). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 7. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ‘413 patent. 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)).” slip op. at 13

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

    “In view of the issues we address below, we determine it is not necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). C. Scope and Content of the Prior Art” slip op. at 15

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

    “catheter or stent . . . . through the side opening.” E.g., Ex. 1401, 14:16–25. The parties do not dispute that Kontos does not teach the claimed “segment defining a side opening” as required by independent claims 25 and 52. Pet. 18; PO Resp. 12. As set forth above, the Petition provides multiple reasons why one of ordinary skill in the art would have wanted to remove the funnel of Kontos and provide a partially cylindrical opening proximal of the tubular structure, as taught by Ressemann. Patent Owner provides several arguments in response as to why the modifications suggested by Petitioner are grounded in hindsight. Upon review of the parties’ arguments and supporting evidence, we agree with Patent Owner that Petitioner fails to establish why a person of ordinary skill in the art would have substantially redesigned Kontos (including removing the funnel portion) to provide the side opening configuration of independent claims 25 and 52 and the “one French size” differential of independent claim 25. We agree with Patent Owner, for the reasons Patent Owner provides as summarized above, that Petitioner’s rationale is insufficient, and adopt Patent Owner analysis, as supported by the cited evidence, as our own. Furthermore, while Petitioner may have established that side openings were known in the art, they appear in devices intended to receive an interventional cardiology device when positioned within a guide catheter. Switching to a side opening in Kontos to beneficially increase the available real estate within the catheter or to reduce the size of the guide catheter would require extensive modifications. Reply 5. To that point, we agree with Patent Owner that Petitioner fails to establish that a person of ordinary skill in the art would have been “motivated to completely redesign Kontos, with at least six additional changes,” including (1) “recess[ing]” Kontos’s marker bands; (2) attaching the distal soft tip in-line rather than with overlapping structure; (3) removing Kontos’s base portion 18; (4) “taper[ing] the pushrod” down to less than 0.005 inches; (5) “attach[ing]” the thin-tapered pushrod to Kontos’s tube wall without base portion 18, and (6) “increase[ing]” the diameter of “tube 16.” Sur-reply 3–6. We further note that the funnel portion of Kontos appears to be crucial to the device’s ability to receive and facilitate exchange of balloon catheters:” slip op. at 36

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia with nexusDecided for patent owner

    “products had on the field of interventional cardiology, but contends that prior art devices, including those taught by Itou, Kontos, and Ressemann, “are RX, configured to deliver a wide variety of IVCDs, and provide increased backup support when extended partially past the end of a [guide extension catheter].” Reply 25. The evidence of record persuasively demonstrates, however, that the long-felt need for improved backup support was unresolved in the art prior to introduction of the GuideLiner devices. As noted by Petitioner, Kontos and Ressemann both provide some level of backup support, but there is no persuasive evidence that either of these products resolved the long-felt need in the art for a device that would avoid backout problems when difficult lesions are encountered during a procedure. See Ex. 2151 ¶¶ 8–9. And although mother-and-child devices were known to provide additional backup support, Patent Owner’s declarants persuasively demonstrate that a mother-and-child approach was not a safe or time- and cost-effective solution to the backout problem addressed by the GuideLiner products. PO Resp. 63–64; Ex. 2151 ¶¶ 6–8; Ex. 2145 ¶¶ 69– 75; Ex. 2215 ¶¶ 16–19 (Dr. Thompson testifying that the problems related to the mother-and-child approach led to very limited use of this technique). Indeed, in view of its inherent limitations, the mother-and-child approach was rarely, if ever, used by interventional cardiologists. Ex. 2145 ¶ 75 (Dr. Graham testifying that the mother-and-child approach “had many significant drawbacks” and he was “not aware of any instances in which a mother-andchild system was successfully marketed.”); Ex. 2215 ¶ 16 (“The mother-andchild approach was rarely, if at all, used by interventional cardiologist for a number of reasons.”). In view of the foregoing, we credit the testimony of Drs. Graham, Thompson, and Azzalini and find that the GuideLiner products solved a long-felt but unmet need in the art, allowing physicians to perform previously impossible coronary procedures.” slip op. at 42

  Patent outcomesUS RE46,116 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
• Medtronic, Inc. / Medtronic Vascular, Inc. v. Teleflex Innovations S.à.R.L.No claims unpatentable
  PTAB · Feb 7, 2022 · IPR2020-01341 · APJ James A Tartal · IPR · Final written decision

  Claims 1, 2, 4, 5, and 7–14 were not proven unpatentable because Itou did not disclose the claimed ordered method, and Petitioner did not establish a sufficient reason to modify or combine the references.

  RulingsFinal written decision

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

    “Ex. 1001, 10:28–11:6; see also, supra, Section I.D. (reproducing claim 1 and labeling six steps [1.a] to [1.f]). Whether the steps recited in a method claim must be performed in a particular order is properly a part of claim construction. See, e.g., Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1371–72 (Fed. Cir. 2003). Steps in a method claim need not necessarily be performed in the order they are written, but if grammar, logic, the specification, or the prosecution history require the steps to be performed sequentially, then the claims are so limited. Id. at 1369; see also Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (“Although not every process claim is limited to the performance of its steps in the order written, the language of the claim, the specification and the prosecution history support a limiting construction in this case.”). “Interactive Gift recites a two-part test for determining if the steps of a method claim that do not otherwise recite an order, must nonetheless be performed in the order in which they are written.” Altiris, 318 F.3d 1369 (citing Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001)). “First, we look to the claim language to determine if, as a matter of logic or grammar, they must be performed in the order written.” Id. “If not, we next look to the rest of the specification to determine whether it directly or implicitly requires such a narrow construction.” Id. at 1370 (citation omitted).” slip op. at 18

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

    “We find an express construction of “interventional cardiology device” is not required for purposes of this Decision because, even if we assume Petitioner shows that the asserted art discloses an “interventional cardiology device,” Petitioner has not shown by a preponderance of the evidence the unpatentability of any of the Challenged Claims for the reasons detailed below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”). 3. Other Claim Terms We find no other claim term requires an express construction for purposes of this Decision.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art at the time of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention training program, and (c) experience working as an interventional cardiologist;” or (2) an engineer who would have had (a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 11–12. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 12. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 6. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ’413 patent. 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)).” slip op. at 16

  • ExcludeDenied

    “II. MOTION TO EXCLUDE The party moving to exclude evidence bears the burden of proving that it is entitled to the relief requested—namely, that the material sought to be excluded is inadmissible under the Federal Rules of Evidence (“FRE”). See 37 C.F.R. §§ 42.20(c), 42.62(a) (2019). In an inter partes review in which we both decide admissibility and serve as the fact-finder, we are wellpositioned to determine and assign appropriate weight to evidence presented, and we recognize that a complete record of the evidence is preferable to facilitate public access as well as appellate review. See, e.g., Sony Computer Entm’t Am. LLC v. Game Controller Tech. LLC, IPR2013-00634, Paper 32 at 31 (PTAB Apr. 14, 2015); see also Gnosis S.p.A. v. S. Alabama Med. Sci. Found., IPR2013-00118, Paper 64 at 43 (PTAB June 20, 2014) (citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)” slip op. at 13

  Patent outcomesUS 8,142,413 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,142,413
• Medtronic, Inc., And Medtronic Vascular, Inc. v. Teleflex Life Sciences LimitedNo claims unpatentable
  PTAB · Feb 7, 2022 · IPR2020-01342 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 2, 4, 5, and 7–14 were not shown unpatentable because the asserted combinations did not establish the claimed ordered method steps.

  RulingsFinal written decision

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

    “In determining whether steps of a method must be performed in order, we must first look to the claim language to determine whether, “as a matter of logic or grammar,” the method steps must be performed in the order written. See Altiris, 318 F.3d at 1369. Patent Owner argues, and we agree, that the method of claim 1 “only makes sense if the steps take place in order.” PO Resp. 13. As Patent Owner explains, step 1b (positioning the standard guide catheter) cannot logically occur until after step 1a (inserting the standard guide catheter), steps 1c–1e (inserting various parts of the coaxial guide catheter) must occur in sequence, and step 1e (advancing the coaxial guide catheter beyond the standard guide catheter) necessarily (citing Ex. 1401, 10:39–67; Ex. 2138 ¶ 102; Ex. 2145 ¶¶ 102–106; Ex. 2244, 61:24–62:3; Ex. 2245, 87:24–88:14, 89:21–90:3, 90:13–23). As to the disputed step 1f, Patent Owner further explains, and we agree, “as a matter of logic and grammar, . . . claim 1 requires that step 1.f (insertion and advancement of the ICD) occur after steps 1.c-1.e. (insertion of the coaxial guide catheter in the guide catheter).” Id. at 16. Specifically, Patent Owner shows “the ICD would not be inserted ‘into and through’ the lumen of the guide catheter ‘alongside of’ the substantially rigid portion of the coaxial guide catheter unless the coaxial guide catheter is already in the guide catheter.” Id. at 14 (citing Ex. 2138 ¶ 103; Ex. 2145 ¶ 103). That is, in the context of the claim, “inserting an ICD ‘alongside of the substantially rigid portion’ means that the substantially rigid portion is already in place inside the guide catheter, and when the ICD is inserted into the guide catheter it moves ‘alongside’ the already positioned substantially rigid portion.” Id. at 14–15 (citing Ex. 2138 ¶ 103; Ex. 2145 ¶ 103). Furthermore, as Patent Owner notes, “Petitioner’s own expert, Dr. Hillstead, agrees that ‘alongside’ in this context means that the substantially rigid portion is already in place in the guide catheter when the ICD is inserted ‘alongside’ of it.” Id. at 15 (citing Ex. 2244, 63:6–64:1).” slip op. at 15

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

    “above, and are not persuaded that Petitioner has established by a preponderance of evidence that a person of ordinary skill in the art would have combined the disclosures of Kontos and Adams to achieve the claimed method. We begin by noting that, while Adams discloses the use of guide seal 20 and delivery catheter 17, those devices are described as having limited functionality related to the specific deployment of distal protection device 15. As noted by Patent Owner, the next figure in the series of illustrations provided by Adams, is Figure 2F (reproduced below). Ex. 1435, Fig. 2F; PO Resp. 11. Figure 2F shows that mesh guide seal 20 has been “withdrawn . . . out of the guide catheter,” thereby “resulting in the deployment of distal protection device 15.” Ex. 1435 ¶ 64. Then, after the guide seal has been removed from the guide catheter, a “treatment device” such as a “balloon” or “stent . . . may be advanced . . . to the treatment site.” Id.; see also Ex. 2138 ¶ 142 (same), ¶ 144 (“Adams emphasizes that occluding blood flow is undesirable, and therefore teaches that the guide seal is deployed only during deployment of the filter and not during the subsequent delivery of interventional cardiology devices such as balloons and stents.”). Thus, the positioning of guide seal 20 distal to guide catheter 10 for the subsequent delivery of an ICD, such as Konto’s PTCA catheter, is not disclosed by Adams. In this regard, Petitioner’s discussion of Adams motivated a person of ordinary skill in the art to advance an ICD into an already-positioned extended coaxial guide catheter as required by the claims. We also note Petitioner’s contention that, “[t]o the extent not taught by Kontos, a POSITA would have been motivated to, as provided by Adams, maintain the distal end of the extension catheter beyond the distal end of the guide catheter, and then advance the interventional device into the coronary artery alongside the substantially rigid portion.” Pet. 51 (citing Ex. 1405 ¶ 203). To that point, however, we are persuaded by Patent Owner’s contentions, in the specific context of the step recited in element 1f, that [T]here are numerous fundamental differences between Kontos and Adams, which Petitioner’s experts acknowledge. For example, Kontos discloses a support catheter assembly to protect a fragile balloon catheter. E.g., Ex. 1409, 1:9-16, 1:30-37, 5:52- 56; Ex-2244, 103:12-15; Ex-2245, 129:7-11; Ex-2138, ¶¶122, 212; Ex-2145, ¶¶146-47. Adams, on the other hand, is a device whose sole purpose is to temporarily create stasis (by occluding blood flow) during delivery of an embolic protection filter. E.g., Ex-1435, Abstract; Ex-2145, ¶155; Ex-2244, 110:14-23; Ex- 2245, 143:11-15, 144:4-7. PO Resp. 20. The discussion set forth in the Petition fails to account for those differences. Pet. 50–52. That is, even assuming that the proposed combination is technically possible and a person of ordinary skill in the art could have combined the disclosures in the manner proposed by Petitioner, the record lacks sufficient guidance as to why a person of ordinary skill in the art would have been motivated to make the changes necessary to achieve the claimed sequence of steps required by claim 1.” slip op. at 27

  Patent outcomesUS 8,142,413 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,142,413
• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

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

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214
• 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

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.