• Transgene / Bioinvent International AB v. Replimune LimitedInstituted
  PTAB · Jun 16, 2022 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Institution

  The Board instituted PGR on claim 13, finding it more likely than not unpatentable as obvious over Silvestre or over Du, Choi, and Zitvogel.

  RulingsInstitution decision

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

    “To institute a post-grant review, we must determine whether the information presented in the Petition, “if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that the evidence and arguments presented in the Petition are sufficient to satisfy the “more likely than not” standard regarding the asserted unpatentability of claim 13 in the ’513 patent. Therefore, we authorize a post-grant review to be instituted as to claim 13.” slip op. at 3

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “1. Legal Framework Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an post-grant review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art. or arguments previously were presented to the Office.” The Board evaluates two issues in addressing 35 U.S.C. § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). With respect to the first issue, previously “presented” art includes, among other things, “art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS), in the prosecution history of the challenged patent.” Id. at 7–8. With respect to the second issue, institution generally will be denied if a “petitioner fails to make a showing of material error,” and “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 8–9. “[T]his framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that a person of ordinary skill in the art (“POSA”) “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 Prelim. Resp. 16–17. At this stage of the proceeding and for purposes of our analysis in this Decision, 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 shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). It is from the perspective of such a person of ordinary skill that we consider the claims and prior art.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “Based on the present record, we find that Petitioner has shown that it is more likely than not that inserting the GM-CSF gene and the CTLA-4 inhibitor encoding gene in a back-to-back orientation in relation to each other would have been known to a person of ordinary skill in the art. Petitioner’s expert Dr. Bell states that “[w]hen inserting two genes into a given locus, the simplest and most common way to do so is to insert them in a back-to-back orientation under control of separate regulatory elements.” Ex. 1007 ¶ 230. While Patent Owner is correct in stating that no sources are cited in paragraph 230, Dr. Bell does cite back to paragraphs 73–81 and 87– 88 of his own declaration. See id. In those paragraphs, Dr. Bell explains that the “deletion of endogenous nucleotides requires either pre-existing knowledge of the effect of disrupting the particular gene at the insertion site or requires a difficult and time-consuming trial-and-error process to gain such knowledge.” Id. ¶ 73 (citing Ex. 1035). Exhibit 1035 is a review article entitled “Unconventional viral gene expression mechanisms as therapeutic targets.” See Ex. 1035. Dr. Bell points to Figure 1 of this article as showing that certain viral genomes include genes that are overlapping and/or that encode polyproteins, which can add to a further level of difficulty in identifying a suitable insertion locus. Ex. 1007 ¶ 74 (citing Ex. 1035, 364, Fig. 1). Dr. Bell further explains that “inactivation of the neurovirulence factor ICP34.5 in HSV1 has been well-known to direct tumor-specific cell lysis, making HSV1 ICP34.5 knock-outs useful oncolytic virus vectors,” but also notes that “unless such a well-known insertion site is used, determining whether insertion of a heterologous gene at any particular site will be successful requires a difficult and time-consuming trial-and-error process.” Id. ¶ 77 (citing Ex. 1039, 292, Ex. 1040, 4–7, Ex. 1041, 575). Accordingly, within paragraphs 73–81 and 87–88, Dr. Bell provides evidentiary support for his conclusions in paragraph 230. See Ex. 1007 ¶¶ 73-81, 87-88. We are not persuaded by Patent Owner’s reliance upon the Arendi case to argue that Petitioner improperly relies upon common sense to supply a missing limitation. In Arendi, the court noted that “the Board’s presumption that adding a search for phone numbers to [the prior art refence] would be ‘common sense’ was conclusory and unsupported by substantial evidence, the missing limitation is not a ‘peripheral’ one, and there [was] nothing in the record to support the Board’s conclusion that supplying the missing limitation would be obvious to one of skill in the art.” 832 F.3d at 1366–67. But here, as noted above, Dr. Bell cites to several references in support of his rationale that one of ordinary skill in the art seeking to insert both the genes would have started with the known ICP34.5 locus rather than undertaking a rigorous trial-and-error process to find an altogether new insertion locus. We do not find the concern stated in Arendi about using common sense “as a wholesale substitute for reasoned analysis and evidentiary support” to be present in this case. See id. at 1362. Here, the “common sense” challenged by Patent Owner refers to the “common knowledge” of the ordinarily skilled artisan as of the invention referenced in the Petition and by Dr. Bell, and it is from such a person’s perspective that we must read Silvestre. Thus, based on the current record, we determine that Petitioner has provided sufficient evidence beyond merely a conclusory assertion of “common sense” to show that inserting the genes at issue in a back-to-back orientation would have been known in the art.7” slip op. at 14

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 10,947,513
• Sabinsa Corporation v. Franco CavaleriInstituted
  PTAB · Jun 15, 2022 · PGR2022-00015 · APJ Susan L C Mitchell · PGR · Institution

  Instituted PGR of claims 1–7 on all petition grounds; the Board found claims more likely than not indefinite because the claimed curcumin percentages lacked a clear measurement basis.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized by statute only when “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; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would comprise an individual with a Ph.D in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, or an M.S. or B.S. degree in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, with an additional 3–5 years of practical experience in pharmaceutical or nutraceutical product development of characterization.” Pet. 17 (citing Ex. 1019 ¶ 94 (Dr. Amiji Declaration)). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’970 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “Petitioner asserts that the term “about” in relation to the percentages of curcumin I, II, and III in claims 2 and 5 of the ’970 patent “should be given its ordinary meaning of ‘approximately’ rather than a particular numerical range.” Pet. 18. On this record, we agree with Petitioner that “about” generally means “approximately,” but how much this term numerically affects the express boundaries for ranges set forth in the claims that the term “about” modifies is not clarified by the proposed construction. See Ortho-McNeil Pharmas., Inc. v. Caraco Pharma., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (“Although both parties and the district court seem to agree that the term “about” means “approximately,” the parties and the district court disagree over the numerical limits that that term imparts to the limitation “1:5” in this case.”).” slip op. at 10

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteInstituted

    “We agree with Dr. Amiji’s analysis and determine, based on the present record, that Petitioner has established that it is more likely than not that claims 1–7 are indefinite. Claims 1–7 are unclear because these claims do not specify how the percentages of curcumin I, II, or III, are to be measured, but instead only provide raw percentages for each curcumin species. See Ex. 1001, 14:10–49. The Specification of the ’970 patent mentions a weight-by-volume measure for curcumin species for only Examples 6 through 8, but as Dr. Amiji testifies, these Examples are formulated as capsules with optional fillers that may be liquid including water. See id. at 13:15–19, 34–38. The remaining Examples 4 and 5 setting” slip op. at 15

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,945,970
• 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
• Samsung Electronics Co., Ltd. v. Netlist, Inc.Instituted
  PTAB · May 5, 2022 · IPR2022-00063 · APJ Bryan F Moore · IPR · Institution

  The Board instituted IPR on claims 1–34 and all asserted grounds after finding a reasonable likelihood that Samsung would prevail on obviousness over Ellsberry and Jeddeloh.

  RulingsInstitution decision

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

    “another patent asserted in the Related Case was filed within a week of the Preliminary Response. Id. We decline to attempt to predict how the District Court would proceed should a stay be requested by either of the parties. Accordingly, we find that this factor neither favors nor weighs against discretionary denial of inter partes review. C. Factor 2 — Proximity of Court’s Trial Date Patent Owner admits that “[t]he district of Delaware has not yet set a trial date.” Id. Accordingly, this factor weighs against exercising our discretion to deny inter partes review.” slip op. at 8

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “Given the facts above, because Averbuj was not presented in combination with the other references asserted here and is only used in two of the four grounds, the combination of references asserted in the Petition do not qualify as art that was “previously presented” to the Office. Thus, we find that the combination of references asserted in the Petition, were not previously presented to the Office. Additionally, Patent Owner does not assert or explain sufficiently that Ellsberry, Jeddeloh, and/or Lee are cumulative of any reference cited during prosecution of the ’523 patent. Prelim. Resp. 41–43. On this record, we are not persuaded that Ellsberry, Jeddeloh, and Lee are cumulative of any reference cited during prosecution of the ’523 patent. Accordingly, the first condition of the first part of the Advanced Bionics framework is not satisfied, and we need not consider whether Petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Conclusion After evaluating the Becton, Dickinson factors within the Advanced” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Bachelor’s degree in electrical engineering, computer engineering, or in a related field and at least one year of work experience relating to memory systems, and would be familiar with the design of memory devices, memory modules, and BIST.” Pet. 6. Patent Owner does not dispute Petitioner’s characterization or offer its own. Accordingly, for purposes of this decision, we adopt Petitioner’s characterization of the level of ordinary skill, which we determine is consistent with the ’523 patent written description and the asserted prior art. slip op. at 14

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

    “Petitioner offers constructions of several terms which are not disputed by Patent Owner. Pet. 13–15. Nevertheless, we determine that it is not necessary to provide an express interpretation of any of the terms of the claims at this juncture. 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.”).” slip op. at 15

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,217,523
• Maxlite, Inc. v. Jiaxing Super Lighting Electric Appliance Co., Ltd.All claims unpatentable
  PTAB · Apr 29, 2022 · IPR2020-00208 · APJ Bryan F Moore · IPR · Final written decision

  Claims 1, 7, and 12–18 are unpatentable as anticipated by Duan under § 102(a)(1).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “a B.S. degree in electrical engineering, or an equivalent field, as well as at least 2-4 years of academic or industry experience in lighting design, including knowledge of LEDs and related technology for driving LEDs. A person of ordinary skill in the art with a higher level of education may have fewer years of academic or industry experience, or vice versa. Pet. 22 (citing Ex. 1002 ¶ 10). Patent Owner does not contest Petitioner’s articulation of the level of skill in the art. PO Resp. 4–5. We regard Petitioner’s definition as consistent with the prior art before us. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself may reflect an appropriate level of skill). Thus, we adopt Petitioner’s proposal.” slip op. at 5

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

    “embodiments that operate with a low frequency driving signal in a double-ended configuration, Patent Owner did not recite “low frequency” or “double-ended” in its claims and instead chose the broader term “first driving mode.” See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.”). The fact that a limitation in the specification may define over the prior art does not justify importing that limitation into the claims unless a term is expressly defined such that the patentee becomes his own lexicographer or there is an express disavowal of claim scope. See GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1308–09 (Fed. Cir. 2014). There is no evidence of an express disavowal here. As to lexicography, we disagree with Patent Owner’s contention that the Specification defines the phrase “first driving mode.” Patent Owner relies on the mere fact that the specification describes an embodiment with a first driving mode that has a low frequency driving signal and is in a “double-ended” configuration, but this is not sufficient to define the term. The specification does not require that a low frequency driving signal must necessarily be used. In fact the specification, although not entirely clear, suggests that the driving signal may be from a high frequency ballast. Ex. 1001, 51:8–14. Thus, the fact that the patent here discloses a low frequency driving signal does not mean that all the claims are directed to such a driving signal. See E-Pass Tech., Inc. v. 3Com Corp., 343 F.3d 1364, 1368–69 (Fed. Cir. 2003). Indeed, dependent claim 15 recites “the first driving mode is performed when the external driving signal is a relatively low frequency or voltage signal,” while the independent claims were directed to a more general driving signal. The doctrine of claim differentiation suggests that the independent claims here should not include explicit limitations of a dependent claim. See Phillips, 415 F.3d at 1315 (“[T]he presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.”); Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004).” slip op. at 7

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “We determine that Patent Owner has not shown sufficiently that the Chinese priority patent applications it relies on—the ’636 Chinese Application and the ’586 Application—provide written description support for the limitation of “a mode determination circuit, configured to generate a first determined result signal based on the external driving signal” and “a mode switching circuit, coupled to the filter circuit and the driving circuit, configured to determine whether to perform a first driving mode or a second driving mode based on the first determined result signal,” recited in claim 1. PO Resp. 31–34, 60–67. Specifically, Patent Owner relies on structures in the ’636 Chinese Application and the ’586 Application that are not sufficiently similar to structures in the ’826 patent i.e., DR Circuit 140, excluding diodes D5 and D6, as shown in Figs. 24i-j and 29b. Id. at 27 (citing Ex. 2001, 23–24, 29, and 33, Fig. 24i–j and 29b).” slip op. at 11

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “For the reasons above, Patent Owner has not established that claim 1 of the ’826 patent is entitled to the effective filing date of the ’636 Chinese Application (i.e., June 10, 2015) or the ’586 Application (i.e., March 26, 2015). Because the remaining asserted claims are dependent claims, Patent Owner has also not established that claims 7 and 12–18 of the ’826 patent are entitled to the effective filing date of the ’636 Chinese Application or the ’586 Application. The application that led to the ’826 patent was filed on March 25, 2016. The ’826 patent claims it is a continuation-in-part of application No. 15/055,630 (“the ’630 Application”), filed on February 28, 2016. So, even if the challenged claims were entitled to the earlier February 28, 2016 filing date, Duan issued on July 1, 2015, and is, thus, prior art to the challenged claims of the ’826 patent under 35 U.S.C. § 102(a)(1).” slip op. at 18

  Patent outcomesUS 9,807,826 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
  Patents in suitUS 9,807,826
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCInstituted
  PTAB · Apr 25, 2022 · IPR2022-00193 · APJ John G New · IPR · Institution

  Instituted IPR on claims 1–20 and all asserted grounds after finding a reasonable likelihood that Levi anticipates or renders obvious at least one challenged claim.

  RulingsInstitution decision

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

    “prosthetic heart valve depicted in Figure 42 of Levi is necessarily a drafter’s error, we conclude that Petitioner has established a reasonable likelihood that it will prevail in demonstrating that Levi anticipates claims 1–8, 10–18, and 20 of the ’538 patent at trial. Furthermore, because we conclude that Petitioner is reasonably likely to prevail at trial in demonstrating that challenged claims 1–8, 10–18, and 20 are anticipated by Levi, we similarly find, and for the same reasons, that Petitioner has shown a reasonable likelihood of prevailing at trial in demonstrating that the challenged claims are obvious over Levi.14 See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (holding that “[i]t is well settled that ‘anticipation is the epitome of obviousness’” (quoting Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983))).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Other

    “proceeding, weighs in favor of showing that Petitioner has a reasonable likelihood of prevailing at trial on these grounds. Specifically, we find that Petitioner has sufficiently shown that Levi alone anticipates or renders obvious the challenged claims.13 We are not persuaded, at this stage of the proceedings, that a person of skill in the art would recognize that the exemplary embodiment depicted in Figure 42 of Levi depicting the “fibrous network extend[ing] over at least two circumferentially extending rows of grids formed in the open cell configuration” is necessarily a drafter’s error. Nowhere in the disclosures of Levi do we discern a requirement that the upper edge of the outer skirt 18 is, or must be, attached via stitches to 13 Unlike the claims in the other related cases, the claims of the ’538 patent do not require the fibers to be “radially” or “outwardly” extending. See, e.g., IPR2021-01527, Paper 15, 31–37. Accordingly, on this record, we find that Petitioner has sufficiently shown that Levi’s outer skirt formed of a woven PET material satisfies the claim requirements of a “fibrous network.” Patent Owner does not dispute that Levi’s outer skirt satisfies this aspect of the claims. struts 24, such that only a single row of the frame gridwork is covered. Rather, Levi’s Specification employs the conditional language “can be,” stating that “each projection 164 can be sutured to the second rung II of struts 24 of the frame 12” and that “projections 164 can be folded over respective struts of rung II and secured with sutures 168.” Ex. 1008, col. 13, ll. 58–61. This disclosure does not prohibit the projections 164 of the outer skirt 16 from being stitched to struts 26 of rung III (see id. at Fig. 5), as is depicted in Levi’s Figure 42. We acknowledge that Levi indicates that Figures 42 and 43 each show views of the exemplary heart valve depicted in Figure 1 of Levi. See Ex. 1008, col. 5, ll. 12–13. But, again, there is nothing in the disclosures of Levi that requires the upper edge projections 164 of the outer skirt 18 be stitched to the struts 24, as depicted in Figure 43, and not to the struts 26, as depicted in Figure 42. It would be reasonable that a person of ordinary skill in the art would regard these to be minor variations of the same embodiment, rather than necessarily being a drafter’s error. We find that this is a reasonable inference at this stage particularly because stitching the outer skirt 18 to struts 26 such that it “extends over at least two circumferentially extending rows of grids formed in the open cell configuration” is plainly depicted in Figure 42, and is not expressly or implicitly contradicted or prohibited by any of the disclosures of Levi. See, e.g., Default Proof Credit Card System, Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 1300 (Fed. Cir. 2005) (Figure in specification accorded little probative weight when it appeared to contradict language of the claim). In this instance, we find based on the present record that the disclosures of the Specification and the language of the claims in Levi do not contradict, preclude, or render inoperative the device depicted in Figure 42, and we accord that Figure probative weight in accordance with what it plainly depicts, rather than merely dismiss that figure as a self-evident drafter’s error. See Duramed Pharms., Inc. v. Watson Lab’ys, Inc., 413 F. App’x 289, 294 (Fed. Cir. 2011) (“A reference … is prior art for all that it discloses”).” slip op. at 28

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

    “Based on the present record, we find that Petitioner has satisfied the threshold standard set forth in Hulu to identify, with particularity, evidence sufficient to establish a reasonable likelihood that the Walther and Cribier references were publicly accessible before the priority date of the ’172 patent. As noted by Petitioner, each of the references are articles published in known journals with dates and other indicia of publication on the face of the references themselves. The Hulu decision specifically notes that “the indicia on the face of a reference, such as printed dates and stamps, are considered as part of the totality of the evidence” that should be taken into account. Hulu, Paper 29 at 17–18; see also id. at 19 (noting that “[t]he face of Dougherty bears a copyright date of 1990, a printing date of November 1992, and an ISBN date of 8/94” and the fact that the book was from “an established publisher”). We also take into account that journal articles, unlike, perhaps, other disputed publications, are “the type[s] of document[s] intended for public dissemination,” and that the Walther and Cribier references “bear[] no designations, such as ‘draft’ or ‘confidential,’ that might suggest that [they were] not intended for public distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018). Additionally, we have considered the declaration of Dr. Hall-Ellis and the supporting evidence cited therein as further evidence of public accessibility.18 We find that it was appropriate for Petitioner to submit this evidence with its Preliminary Reply. Indeed, the Hulu case recognizes that a petitioner may provide additional evidence “in a reply to a patent owner preliminary response,” and “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu Paper 29 at 14–15. Here, we determined that Petitioner satisfied the good cause requirement of 37 C.F.R. § 42.108(c) for submitting its Preliminary Reply with the Hall-Ellis declaration and other supporting evidence in order to respond to Patent Owner’s challenges to the printed publication status of Walther and Cribier. See related case IPR2021-01528, Ex. 1071, 13–14, ll. 23–24 (Transcript of teleconference call from February 14, 2022). Accordingly, in view of the totality of the evidence currently in the record, we find that Petitioner has established a reasonable likelihood that 18 Contrary to Patent Owner’s arguments, we are not of the view that a librarian declaration is always necessary to show public accessibility of a journal article, especially where the article itself bears credible indicia of publication.” slip op. at 57

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther

    “Based on the present record, we determine that Petitioner has made a persuasive showing that a POSITA would have found it obvious to substitute the woven PET outer skirt taught by Levi with a fibrous material, such as the outer cloth taught by Walther or the compressible material taught by Spenser II, to arrive at a heart valve structure that meets the claimed structural requirements. We further determine that, on the present record, Petitioner has persuasively shown that a person of ordinary skill in the art would have been motivated to deliver such a modified device endovascularly, either using the transfemoral approach or through the common iliac artery, with a reasonable expectation of success. We find that the modification to Levi’s device proposed by Petitioner would entail the “simple substitution of one known element for another” to obtain predictable results. See KSR, 550 U.S. at 417. In this regard, we note that Walther’s outer cloth, Spenser II’s compressible material, and Levi’s outer skirt all serve similar functions of helping reduce paravalvular leakage for a prosthetic heart valve. Ex. 1007, 1; Ex. 1008, col. 14, ll. 7–9; Ex. 1011 ¶ 145. Walther and Spenser II provide an additional motivation to incorporate fibrous cloth materials as the outer layer insofar as they teach that the fibers may encourage blood coagulation and tissue ingrowth to further fill in the gaps and prevent leakage. Ex. 1007, 1; Ex. 1011 ¶ 145.” slip op. at 45

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 10,881,538
• Restem, LLC. v. Jadi Cell, LLCInstituted
  PTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution

  The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’176 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited 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 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)Term construed patent owner constructionOther

    “Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted

    “the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,803,176
• Vudu, LLC v. Ideahub, Inc.All claims unpatentable
  PTAB · Apr 14, 2022 · IPR2020-01688 · APJ Monica S Ullagaddi · IPR · Final written decision

  Claims 1, 3, 4, 6, 8, 11, 13, 15, 18, 19, 21, and 23 are unpatentable over DIS 23009-1; the revised contingent motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSA”) in the relevant field as of the earliest priority date would have had at least the equivalent of a Bachelor’s degree in electrical engineering, computer engineering, computer science, or a related subject and two or more years of experience in the field of media streaming over the Internet. Pet. 18–19 (citing Ex. 1003 ¶ 82). Patent Owner does not dispute Petitioner’s assertions regarding the level of ordinary skill in the art, nor 6 Patent Owner does not present objective evidence of nonobviousness. does it present its own definition. We adopt Petitioner’s definition as it is consistent with the specification of the ’830 patent and the cited references.” slip op. at 10

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

    “Petitioner proposes that we construe “adaptation set,” “SegmentBase,” and “SegmentTemplate.” Pet. 19–21. Patent Owner does not address claim construction in its briefing. We need not construe any claim term to resolve any issues before us, and therefore, do not expressly define any claim term in our Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for terms that are in dispute, and only as necessary to resolve the controversy).” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDenied

    “not describe additional configuration information nor user characteristic information. Instead, it describes “an additional configuration to select a representation based on a user characteristics and terminal characteristics.” Ex. 2004 ¶ 232. It is unclear from Patent Owner’s argument whether Patent Owner intends for the claimed “user characteristic information” to include or refer to additional configuration information, accessibility features of a representation, or both. Reply Rev. Opp. 1 (citing Ex. 2004 ¶¶ 232, 234, 253). In any event, merely because paragraph 253 uses the term “[h]ereinafter” before it discloses “two simple attributes [] for the above-described purpose”––and not even in close proximity to the “user characteristics” and “additional configuration” in paragraph 232––is not sufficient to provide support for “the user characteristic information includ[ing] the usedWith attribute and the equivalentTo attribute,” as recited 8 Ex. 2005 is Application No. 16/168,933 (“the ’933 application”). in limitations [38.6], [40.6], and [46.6]. None of the cited portions (i.e., Ex. 2004 ¶¶ 232, 234, 253, 255–257, Table 13; Ex. 2005 ¶¶ 254–256, Table 13) indicates a sufficient connection or relationship, or the claimed inclusive relationship, between user characteristic information and the usedWith and equivalentTo attributes. Contra Reply Opp. Rev. MTA 1 (Patent Owner arguing that the cited disclosures “clearly show this relationship between the claimed attributes and user characteristic information”). For the foregoing reasons, we determine that claims 38, 40, and 46 do not find sufficient written description support in the ’644 application nor in the ’933 application, whether considered individually or collectively, and thus, these claims contain new matter.” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “rationale for combining DIS 23009-1 with M20060, Petitioner persuasively contends that: A POSA would have been motivated to add the additional “metadata” described in M20060 to the MPDs described in the DIS 23001-6 or DIS 23009-1 references in order to enable the client to choose the most suitable version of media content among alternative versions of media content. For example, M20060 describes that the additional metadata (e.g., the extended accessibility element and the usedWith, equivalentTo, bitDepth, minBitDepth, and maxBitDepth attributes) helps “both users and clients to select appropriate representations” by, for example, “1) supporting accessibility, 2) describing relationships of representations, and 3) describing media’s bit depth.” Moreover, a POSA would have had an expectation of success in modifying the MPDs in DIS 23001-6 or DIS 23009-1 to include the additional metadata described below because it simply would have been a matter of adding additional metadata to the MPD XML schemas described in DIS 23001-6 or DIS 23009-1. Id. (citing Ex. 1094 ¶ 33; Ex. 1097 § 1, 1). Dr. Bestavros persuasively explains that “M20060 expressly references the DIS 23001-6 reference and proposes specific modifications to the MPEG DASH metadata included in the MPD XML schema.” Ex. 1094 ¶ 34 (citing Ex. 1097 § 1, 1 (introduction of M20060); Ex. 1097, 7 (references cited by M20060)).” slip op. at 41

  Patent outcomesUS 10,270,830 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,270,830
• Vudu, Inc. v. Ideahub, Inc.All claims unpatentable
  PTAB · Apr 14, 2022 · IPR2020-01689 · APJ Monica S Ullagaddi · IPR · Final written decision

  Claims 1, 11, 25, 27, and 29 are unpatentable as anticipated by and obvious over DIS 23009-1; the revised contingent motion to amend proposing claims 31–35 is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level Of Ordinary Skill In The Art Petitioner contends that: A person of ordinary skill in the art (“POSA”) in the relevant field as of the earliest priority date would have had at least the equivalent of a Bachelor’s degree in electrical engineering, computer engineering, computer science, or a related subject and two or more years of experience in the field of media streaming over the Internet. Pet. 19 (citing Ex. 1003 ¶ 82). Patent Owner does not dispute Petitioner’s assertions regarding the level of ordinary skill in the art, nor does it present its own definition in any of its briefing. We adopt Petitioner’s definition as it is consistent with the Specification of the ’414 patent and the cited references.” slip op. at 10

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

    “Petitioner proposes that we construe “adaptation set,” and “SegmentTemplate.” Pet. 19–21. Patent Owner does not address claim construction in any of its briefing. 6 Patent Owner does not present objective evidence of nonobviousness. and therefore, do not expressly define any claim term in our Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for terms that are in dispute, and only as necessary to resolve the controversy).” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “The newly-cited portion in paragraph 232 does not describe additional configuration information nor user characteristic information. Instead, it describes “an additional configuration to select a representation based on a user characteristics and terminal characteristics.” Ex. 2004 ¶ 232. It is unclear from Patent Owner’s argument whether Patent Owner intends for the claimed “user characteristic information” to include or refer to additional configuration information, accessibility features of a representation, or both. Reply Rev. Opp. 1 (citing Ex. 2004 ¶¶ 232, 234, 253). In any event, merely simple attributes [] for the above-described purpose”––and not even in close proximity to the “user characteristics” and “additional configuration” in paragraph 232––is not sufficient to provide support for “the user characteristic information includ[ing] the usedWith attribute and the equivalentTo attribute,” as recited in limitations [31.11], [32.12], and [35.7]. None of the cited portions (i.e., Ex. 2004 ¶¶ 232, 234, 253, 255–257, Table 13; Ex. 2005 ¶¶ 254–256, Table 13) indicate a sufficient connection or relationship, or the claimed inclusive relationship, between user characteristic information and the usedWith and equivalentTo attributes. Contra Reply Opp. Rev. 1 (Patent Owner arguing that the cited disclosures “clearly show this relationship between the claimed attributes and user characteristic information”). For the foregoing reasons, we determine that claims 31, 32, and 35 do not have sufficient written description support in the ’644 application and the ’092 application, either individually or collectively, and as such, contain new matter.” slip op. at 29

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

    “are not entitled to a priority date earlier than March 16, 2012 (the filing date of PCT ’922), because the disclosure of KR10-2011-0023271 does not support at least the limitations of: “the adaptation set includes one or more attributes or elements that are common to each of the representations for that adaptation set,” as recited in independent claims 1 and 11, and the “SegmentTemplate” recited in independent claims 25. Patent Owner has not asserted, after institution, that the challenged claims are entitled to an earlier date. See Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327–28 (Fed. Cir. 2008) (indicating that patent owner bears a burden of production in arguing that the asserted references are not prior art based on entitlement to an earlier priority date). As such and for the reasons discussed below, Petitioner has persuasively demonstrated that DIS 23001-6, DIS 23009-1, and 3GPP TS 26.247 qualify as prior art to the challenged claims, because Petitioner has sufficiently demonstrated that the references were publicly accessible prior to the applicable priority date of March 16, 2012.” slip op. at 12

  Patent outcomesUS 10,313,414 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,313,414
• 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

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.