• Thorne Research, Inc v. Trustees Of Dartmouth CollegeNo claims unpatentable
  PTAB · Aug 10, 2022 · IPR2021-00491 · APJ John E Schneider · IPR · Final written decision

  Claims 1–3 were not shown unpatentable because the relied-upon portions of the Cell Article and PCT Publication were not shown to be the work of another and thus were not prior art.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 (2018). As discussed above, the ’807 patent meets all four criteria set forth above for each application in the priority chain of the PCT application listed on the face of the ’807 patent. Since the claim of priority arises under Section 120, the provisions of the Paris Convention and PCT do not apply.” slip op. at 12

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artNot shown unpatentable

    “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

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

    “We are not persuaded by Petitioner’s arguments. Although the laboratory techniques and starting materials used by Drs. Brenner and Bieganowski may have been known in the art, that is not the claimed invention. The invention as recited in claim 1 is directed a composition comprising isolated NR combined with one or more of tryptophan, nicotinic acid, or nicotinamide and one of the recited carriers, wherein the composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. See Ex. 1001, col. 53. That the certain individual elements of the claimed composition may have been known elsewhere in the prior art does not lead to a conclusion that the relied-upon portions of the Cell Article are “by another.”” slip op. at 30

  Patent outcomesUS 8,197,807 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,197,807
• 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
• Fisher & Paykel Healthcare Limited v. Resmed LimitedSome claims unpatentable
  PTAB · Oct 23, 2018 · IPR2017-00501 · APJ James J Mayberry · IPR · Final written decision

  Claims 61–64 are unpatentable under § 103; claims 1–60, 65, and 66 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “(Paper 1, “Pet.”) requesting inter partes review of claims 1–66 (the “Challenged Claims”) of U.S. Patent No. 9,027,556 B2 (Ex. 1001, the “’556 patent”). Patent Owner, ResMed Ltd. (“ResMed”), filed a Preliminary Patent Owner Response to the Petition. Paper 7 (“Prelim. Resp.”). We instituted trial on claims 61–64 and 66 only. See Paper 8 (“Dec. on Inst.” or “Institution Decision”), 42–43 (instituting trial on claims 61–64 and 66 on four of the twelve asserted grounds); cf. Pet. 9–10 (listing the twelve asserted grounds).” slip op. at 2

  • BurdenOther

    “D. Asserted Grounds of Unpatentability In inter partes reviews, a petitioner bears the burden of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to the patent owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail in this proceeding, Fisher must support its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Accordingly, all of our findings and conclusions are based on a preponderance of the evidence.” slip op. at 27

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Petition, how Barnett teaches using a different material that is more rigid than silicone for neck 46 and ribs 56. The Petition lays out certain factual statements, but draws no conclusion from those statements, leaving us to somehow connect the dots.” slip op. at 33

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMixed

    “patent . . . that claims as innovation the combination of two known devices according to their established functions.” KSR Int’l Co., 550 U.S. at 418. Importantly, “obviousness must be determined in light of all the facts, and . . . a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (emphasis added); see also Winner Int’l, 202 F.3d at 1349 n.8 (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”). Accordingly, we weigh Fisher’s and ResMed’s evidence with respect to whether a person having ordinary skill in the art would have been motivated to modify Barnett with Ogden’s teaching of a main body of a cushion module using a material that is more” slip op. at 45

  Patent outcomesUS 9,027,556 mixed
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,027,556
• Celltrion, Inc. / Pfizer, Inc. v. Genentech, IncAll claims unpatentable
  PTAB · Oct 3, 2018 · IPR2017-02063 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–14 are unpatentable as obvious over Baselga 1996, Seidman 1996, and the 1995 TAXOL PDR entry; the contingent motion to amend is denied for lack of written-description support.

  RulingsFinal written decision

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

    “Id. The applicant responded that [T]he expression[] “extend the time to disease progression”. . . [is] clear from the specification . . . and would be readily understood by the skilled oncologist. Clearly, the combination of anti-ErbB2 antibody and taxoid is administered in an amount effective to extend the time to disease progression relative to an untreated patient. Id. at 416 (Response dated January 17, 2002) (emphasis added). In the next office action, the examiner withdrew the rejection. See Ex. 1004, 624 (Office Action dated March 27, 2002) (stating “[a]ll claims were allowable” but suspending prosecution due to potential interference). In other words, the applicant overcame the indefiniteness rejection by providing a specific definition of the term “extend the time to disease progression;” and our construction merely reflects that choice. See Paulsen, 30 F.3d at 1480 (holding an applicant may choose to be his own lexicographer).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Even if we were to disregard Petitioner’s reliance on the four principles of combination therapy, we still would find an ordinary artisan would have had a reason to combine trastuzumab and paclitaxel for metastatic HER2-positive breast cancer. Indeed, as detailed below, the prior art repeatedly and explicitly teaches this combination. Baselga 1996 teaches that “rhuMAb HER2 is well tolerated and” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “Patent Owner further argues that Yu13 discourages the use of taxoids in HER2-positive patients. PO Resp. 42. According to Patent Owner, Yu explicitly warns that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol.” Id. (citing Ex. 2029, 1362). Yu drew that conclusion, however, based on an in vitro study, using cell lines growing on culture plates. Ex. 2029, 1360–62. On this issue, we agree with Dr. Earhart and Petitioner that an ordinary artisan “would have regarded the in vivo preclinical and clinical results reported in Baselga-1996 and Seidman-1996, which were obtained from studies of actual tumor cells in live animals and human patients, as being far more predictive than Yu’s results, which were obtained in artificially-engineered cells on culture plates.” Reply 6 (citing Ex. 1054 ¶ 17); see also Ex. 1040, 222:11–224:9 (Dr. Kerbel, Patent Owner’s expert witness, testifying that a living animal model, though imperfect, is “closer” to a human and “better than a petri dish”). Moreover, in an obviousness inquiry, we must analyze the prior art as a whole, not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). Other evidence of record shows paclitaxel was known at the relevant time to be effective in treating HER2-positive cancers (see, e.g., Ex. 1011), demonstrates “strong synergy” of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1010,14 5; Ex. 1019, 4; 13 Yu et al., Overexpression of c-erbB-2/neu in Breast Cancer Cells Confers Increased Resistance to Taxol Via mdr-1-independent Mechanisms, 13 ONCOGENE 1359–65 (1996) (Ex. 2029). 14 Seidman et al., Memorial Sloan-Kettering Cancer Center Experience with Paclitaxel in the Treatment of Breast Cancer, 22 SEMINARS in ONCOL. (Suppl.) 108–16 (1995) (Ex. 1010, “Seidman 1995”) Ex. 1021,15 3), and suggests clinical trials of the claimed combination therapy (see, e.g., Ex. 1010, 5; Ex. 1020, 9). Weighing all evidence of record, we are not persuaded that Yu, a single reference based on an in vitro study, would have dissuaded an ordinary artisan from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers. See also MTA Sur-reply 6 (citing Ex. 1043,16 6–9 (noting a review paper regarding paclitaxel sensitivity in breast cancer does not cite Yu, but “cites Seidman ’96, Baselga ’96 and the Baselga xenograft studies as suggesting that HER2+ tumors are sensitive to paclitaxel, and that combining trastuzumab with paclitaxel increased its antitumor activity”).” slip op. at 24

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “For objective evidence of secondary considerations to be accorded substantial weight, its proponents must establish a nexus between the evidence and the merits of the claimed invention.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” Id. We find that the nexus between the merits of the invention and the evidence of long-felt-butunmet need, praise, and commercial success, if any, is weak. Patent Owner asserts that Herceptin is the commercial embodiment of the ’441 patent. PO Resp. 65. For commercial success, “if the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed.” Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000). The patent challenger, however, may rebut the presumed nexus. Id. And here, Petitioner has sufficiently rebutted that presumption. For example, each challenged claim in this proceeding requires the combination of an anti-HER2 antibody and a taxoid. Herceptin, however, was also approved for single-agent use. Reply 25 (citing Ex. 2012). Patent Owner has not shown what portion of the sales of Herceptin is attributable to the claimed combination, and not the single-agent use.29 Id. Furthermore, “evidence related solely to the number of units sold slip op. at 41

  Patent outcomesUS 7,846,441 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,846,441
• Google LLC v. Makor Issues & Rights Ltd.All claims unpatentable
  PTAB · Aug 9, 2018 · IPR2017-00816 · APJ Robert L Kinder · IPR · Final written decision

  Claims 4 and 6 are unpatentable over Xu, Vemuri, and Peterson; the Board found the TravTek-based grounds did not establish unpatentability.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). In that regard, Petitioner’s expert, Dr. Braasch, testifies that: a POSITA would have had a combination of experience and education in electrical engineering and navigation systems. This typically would consist of a minimum of a bachelor degree in electrical engineering or a related engineering field plus 2-5 years of work and/or research experience in the field of electrical engineering and its subfield of navigation systems. Ex. 1003 ¶ 20. Patent Owner does not contest this level of skill for the person of ordinary skill in the art. Based on the final trial record before us, we adopt generally Dr. Braasch’s assessment of a person of ordinary skill in the art. Namely, that the person of ordinary skill in the art would have (1) a bachelor of science in electrical engineering or a related engineering field, and (2) 2–5 years of experience in the field of navigation systems.” slip op. at 23

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

    “is focused on whether the term should be construed in a broader lay sense as proposed by Petitioner (Pet. Reply 5, 7) or whether the term should be construed in accordance with the more specific descriptions found in the Specification as proposed by Patent Owner (PO Resp. 4–10). As addressed in more detail below, we decline to adopt Patent Owner’s proposed claim construction in whole because it adds unnecessary ambiguity. For example, “irregular or abnormal” do not add clarity to the definition. PO Resp. 7. If a feature is not necessary to give meaning to what the inventor means by a claim term, it would be “extraneous” and should not be read into the claim. Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). The Specification, however, does convey that the term “traffic jam” is not used in a layman’s sense, but instead used as a description of a situation arising from a data comparison meeting certain criteria as discussed below.” slip op. at 14

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for petitioner

    “We determine that the claim limitation “statistical application for collecting structured GPS data . . .” is not in means-plus-function format because it does not recite traditional “means-for” language and also because the claim limitation has sufficiently definite structure. We find Dr. Braasch’s testimony persuasive that a POSITA would have understood “computing individual statistical travel time estimates” to simply describe averaging collected travel times. Ex. 1003 ¶ 144; Ex. 1034 ¶ 36. We agree with Petitioner’s argument that, “the ’783 patent discloses that the ‘statistical or empirical travel times’ are ‘averages by necessity.’” Pet. Reply 22 (quoting Ex. 1001, 10:22–36) (citing Ex. 1034 ¶¶ 36–38).” slip op. at 20

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

    “Based on the final record, Petitioner has not provided sufficient arguments or credible evidence to support a finding that TravTek teaches the traffic jam limitation. Specifically, Petitioner has not persuasively shown how TravTek teaches the use of measured time delays of sample vehicles for computing a real time traffic jam. As explained above, we construed the term “traffic jam” to mean “a sudden unpredictable change of traffic in a segment as compared to regular times, i.e., individual statistical travel time estimates,” and thus the claimed “measuring time delays” must also be in relation to regular times. Claim 4 also requires that the traffic jam identification is determined by utilizing the sample vehicles for measuring time delays. Petitioner has not directed us to record evidence sufficient to show that TravTek teaches these claim elements.” slip op. at 30

  Patent outcomesUS 6,480,783 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,480,783
• Fisher & Paykel Healthcare Limited v. Resmed LimitedSome claims unpatentable
  PTAB · Mar 7, 2018 · IPR2017-00059 · APJ James J Mayberry · IPR · Final written decision

  Claims 73–76, 78–82, and 84–86 are unpatentable under § 103; claims 23–72, 77, and 83 were not shown unpatentable because the proposed modification would change Ogden’s principle of operation.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “We find both parties assert very similar definitions of the level of ordinary skill in the art. Both definitions include a degreed engineer with two years of experience. Fisher identifies the fields of experience as “masks, respiratory therapy, patient interfaces or relevant product design experience” and ResMed, through Mr. Sleeper, defines the field of experience as “relevant product design experience.” Mr. Sleeper declares that additional experience may compensate for less education and additional education may compensate for less experience. We find, based on our review of the complete record, that the evidence of record supports a level of ordinary skill in the art consistent with the parties’ definitions—a person having a bachelor’s degree in mechanical engineering, biomedical engineering or other similar type of engineering degree combined with two years of experience in the field of masks, respiratory therapy, patient interfaces, or other relevant product design experience. We also find that additional experience may compensate for less education and additional education may compensate for less experience. Further, we note that our patentability analysis presented below would reach the same findings and determinations under either party’s definition of the level of ordinary skill in the art.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “ResMed takes the position that the plurality of tabs must form the snap-fit structure. See PO Resp. 27 (“Moreover, even if there was a ‘snap-fit,’ there would only be a snap-fit by a single tab (detent 43, illustrated below in Figure 1)—not the required plurality of tabs”); Tr. 35:7–9 (“The plurality of tabs are what need to have the snap-fit. And having one snap-fit for one tab is not enough to meet this claim language.”). As detailed below, we determine that the broadest reasonable construction of the disputed claim limitation encompasses a structure having a plurality of tabs, but the plurality of tabs not necessarily providing the snap-fit structure. That is, under the broadest reasonable construction, a single tab may provide the snap fit structure. First, the plain reading of claim 73 supports our construction. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (“[T]he context in which a term is used in the [claim at issue] can be highly instructive.”). As a starting point, the plain meaning of the phrase “plurality of tabs” is two or more tabs and we discern nothing in the record to indicate a contrary meaning. See, e.g., Dayco Prod., Inc. v. Total Containment, Inc., 258 F.3d 1317, 1327–28 (Fed. Cir. 2001) (“[W]e have held that ‘plurality,’ when used in a claim, refers to two or more items, absent some indication to the contrary.”). The plain language of the claim also requires the two or more tabs be structured to attach removably the headgear connector to the rigid mask frame. The claim language further requires this removable attaching be with a snap-fit. The language of the claim, however, does not require two or more tabs be associated with the snap-fit. That is, nothing in the plain language of the claim element precludes a structure that includes two or more tabs interfacing with the rigid mask, where only one of the tabs is associated with snap-fit aspect of the interfacing.” slip op. at 13

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

    “What a reference teaches and how a proposed modification of a reference would change its principle of operation are underlying factual inquiries in an obviousness analysis. See, e.g., Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1046 (Fed. Cir. 2017) (addressing the Board’s factual findings with respect to a reference’s principle of operation). We find that Ogden’s principle of operation is to employ a rigid plate loosely mounted to a rigid shell, such that “in use, the rigid plate is free to move relative to the rigid shell in response to any unequal forces being applied to it by the side straps as the patient, for example, turns his or her head from side-to-side.” Ex. 1102, 1:57–61; see also PO Resp. 52–53, 61 (indicating that Ogden’s principle of operation is its loosely-mounted rigid plate). Ogden’s disclosure as a whole supports our finding as to its principle of operation. As Ogden discloses, the loose-fitted rigid plate “rotate[s] to compensate for any unequally applied forces as the patient moves his or her head.” Ex. 1102, 4:17–20. [W]hen the patient turns his or her head and instead of tending to lift the shell 3 and its seal 5 off the patient’s face and breaking the seal as in FIG. 4, the rigid plate 9 of the present invention in FIG. 5 rotates relative to the rigid shell 3. This movement then compensates or equalizes the forces and keeps the shell 3 securingly in place with the center lines 69 and 71 of the shell 3 and the patient’s face aligned. Id. at 4:31–38; see also 4:61–5:3 (describing how Ogden’s facial mask compensates for any unequal applied forces by the side straps through the operation of loosely-mounted rigid place 9); Fig. 4 (illustrating how the seal at a patient’s face is broken by side-to-side movement with a rigid plate fixedly mounted to a rigid shell); cf. id. at 1:16–20 (“[A] common problem often arises that the mask will tend to unseat and leak as the patient turns his or her head (e.g., from side-to-side) or rolls over in bed and the straps contact and are deflected by a pillow, blanket, or other object.”); PO Resp. 52 (describing the problem addressed by Ogden).” slip op. at 32

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “A reference may be said to teach away when a person of ordinary skill, upon reading the reference . . . would be led in a direction divergent from the path that was taken by the applicant.” In re Haruna, 249 F.3d 1327, 1335 (Fed. Cir. 2001) (quoting Tec Air, Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1360 (Fed. Cir. 1999)); see, e.g., In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (holding that, to teach away, the prior art must “criticize, discredit, or otherwise discourage the solution claimed”). We find that Ogden’s disclosure fails to rise to the level of teaching away. Ogden provides a solution to a problem with fixed headgear connectors but does not criticize, discredit, or otherwise discourage fixed headgear connectors. Instead, Ogden illustrates that a specific prior art mask with a fixed headgear connector may result in leakage of supplied air to the mask and discloses an improvement to that specific mask. Ogden does not indicate that a fixed headgear connector renders a mask inoperable or otherwise indicates that a person having ordinary skill in the art would not consider a path that led to a mask with a fixed headgear connector. We also do not agree with ResMed’s characterization that Ogden expressly teaches away from the proposed combination. Ogden expressly teaches a solution, but does not expressly teach away from other solutions. We note that, “[w]here the prior art contains ‘apparently conflicting’ slip op. at 38

  Patent outcomesUS 8,960,196 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,960,196
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01413 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–13 and 16–19 are unpatentable as obvious over Royce, McGinity, Hoffmeister, Joshi, and PDR.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer 1 Royce, U.S. Patent 5,273,758, issued Dec. 28, 1993 (Ex. 1022) (“Royce”). 2 McGinity et al, WO 97/49384, published Dec. 31, 1997 (Ex. 1024) (“McGinity”). 3 Hoffmeister et al., U.S. Patent 4,070,494, issued Jan. 24, 1978 (Ex. 1010) (“Hoffmeister”). 4 Joshi et al., Pub. No. US 2002/0187192 A1, published Dec. 12, 2002 (Ex. 1014) (“Joshi”). 5 OxyContin entry in Physicians’ Desk Reference, 2569–74 (53d ed., 1999) (Ex. 1016)(“PDR”). chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 16 (citing Ex. 1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 27. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill of art in this proceeding is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Id. at 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10cp is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cp.” slip op. at 9

  • PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner

    “Under the doctrine of issue preclusion, also called collateral estoppel, a judgment on the merits in a first suit precludes relitigation in a second [proceeding] of issues actually litigated and determined in the first suit.” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994) (citing Lawlor v. National Screen Serv. Corp., 349 U.S. 322, 326 (1955)). The Federal Circuit has articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner

    “Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.10 The Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed 9 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening” agents by that time. See Ex. 2091, 5. Given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 10 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001, filing date. In his declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a” slip op. at 22

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 9,034,376
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01245 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable because the petitioner failed to establish obviousness over the instituted combinations.

  RulingsFinal written decision

  • Strike new argumentNew argument disregardedNew argument consideredMixed

    “As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id.; see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (Board did not err or abuse its discretion in declining to consider new contentions and evidence in reply advanced to supplement unpatentability rationale presented in petition).” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Ordinary Skill in the Art Petitioner contends that the relevant art is medicinal chemistry. Pet 12. As to the level of ordinary skill in that art as of March 15, 1996 (the earliest possible priority date of the ’551 patent), Petitioner contends as follows: [A] POSA [person of ordinary skill in the art] would have a Ph.D. in organic or medicinal chemistry and at least a few years of experience in medicinal chemistry, including in the development of potential drug candidates. Ex. 1002, ¶ 13 [Wang Decl.]. The POSA would also include a person having a Bachelor’s or Master’s degree (organic chemistry or medicinal chemistry) if such a person had more years of experience in medicinal chemistry and the development of potential drug candidates. Id. With experience in drug development, the POSA would have an appreciation of the diseases and ailments a particular drug candidate is intended to treat, but would not necessarily be a medical doctor or clinician. The POSA would know how to evaluate the physical and biological properties of chemical compounds and would be able to conduct, or otherwise have access to resources that could conduct, in vitro and in vivo evaluations of biological and toxicity properties of chemical compounds. Id. Pet. 12. Patent Owner does not controvert Petitioner’s characterization of the relevant art, or the level of ordinary skill in that art, nor does Patent Owner advance a specific assertion of its own as to the level of ordinary skill. See, generally, PO Resp. Accordingly, when evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration Petitioner’s assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 11

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

    “We agree with Patent Owner (PO Resp. 38) that, given Kohn 1991’s teaching that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), the expected substantial change to the conformation of the overall molecule is significant evidence that an ordinary artisan would not have been motivated to replace the methoxyamino group of compound 3l, the most potent compound taught in Kohn 1991, with a methoxymethyl group. In sum, we acknowledge Dr. Wang’s testimony, discussed above, that due to a methoxyamino group’s potential synthetic and stability issues, and uncommonness in commercial pharmaceuticals, an ordinary artisan may have had a reason to replace such a group with a more common and acceptable moiety, such as a methoxymethyl group, in chemical compounds generally. Nonetheless, as also discussed above, the evidence advanced by Patent Owner shows that, as to the specific FAA compounds of Kohn 1991, an ordinary artisan would have understood that compound 3l’s methoxyamino moiety was considered a basic C(α)-amino substituent that conferred significant activity to the compound, and replacement of that moiety with other substituents would have led to a reduction in activity. As also discussed above, Kohn 1991 teaches that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), whereas an ordinary artisan would have understood that substituting a methoxymethyl group for the methoxyamino group of Kohn 1991’s compound 3l would result in a compound with a significantly different conformation and biological activity. Thus, assessing Petitioner’s evidence of a more general motivation for substituting a methoxymethyl group for the methoxyamino group of compound 3l, against Patent Owner’s evidence specifically suggesting that an ordinary artisan would not have viewed the posited substitution as being desirable, we find that the weight of the evidence significantly favors Patent Owner’s position. Overall, the evidence before us indicates that an ordinary artisan lacked motivation, as well as a reasonable expectation of success, for making the specific substitution to Kohn 1991’s compound 3l, required to arrive at lacosamide. That is, we agree with Patent Owner that Petitioner has not shown sufficiently that the prior art of record would have suggested making the specific modification to compound 3l required to yield lacosamide.” slip op. at 23

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

    “this issue, we agree with Patent Owner (PO Resp. 56–58) that lacosamide satisfied a long-felt but unmet need in that lacosamide has been found to be useful for treating refractory patients for which other antiepileptic drugs were ineffective. Patent Owner’s witness on this issue, Dr. Bazil,20 testifies as follows: For many of my patients, lacosamide is a very important option, and it certainly fills a need in those patients who require a drug with the unique combination of properties as lacosamide possesses. Thus, lacosamide exhibits its biggest advantages in refractory patients. I have had numerous patients who were able to successfully control their seizures with lacosamide, but who had failed to do so previously with other antiseizure drugs. As director of Columbia’s Epilepsy Center, I have also heard many success stories from other neurologists about patients whose seizures were not controlled by other AEDs but were controlled when they switched to lacosamide. Ex. 2038 ¶ 79 (Bazil Decl.).” slip op. at 36

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01101 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: the prior art did not motivate the specific modification for claims 1–9, and the challenge to claims 10–13 was insufficiently supported.

  RulingsFinal written decision

  • Strike new argumentNew argument disregardedNew argument consideredMixed

    “As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id.; see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (Board did not err or abuse its discretion in declining to consider new contentions and evidence in reply advanced to supplement unpatentability rationale presented in petition).” slip op. at 5

  • ExcludeMotion to exclude, deniedMixed

    “In any event, Petitioner fails to explain adequately why the declarations of Patent Owner’s President, Shaun Kirkpatrick (Ex. 2185), and Vice President and General Counsel of a licensee, Paul Petigrow (Ex. 2187), are insufficient to authenticate the letters. Although Petitioner contends that “[n]either declaration demonstrates personal knowledge of the facts necessary to establish the business-records exception” (Pet. Reply Opp. 1 (Paper 81)), Petitioner does not support that assertion with specific explanation, other than asserting that Mr. Petigrow has worked for the licensee for less than a year (see id.). Petitioner does not, however, address with any specificity the substance of any of Mr. Petigrow’s other assertions, nor does Petitioner explain why they should not be credited. As to hearsay, as Patent Owner contends (PO Opp. 5–6), under FRE 703, the proponent of an expert opinion may disclose otherwise inadmissible evidence underlying that opinion to a jury, if the court determines that the “probative value in helping the jury evaluate the opinion substantially outweighs [its] prejudicial effect.” In the present case, Patent Owner’s expert Dr. Roush relied on Exhibit 2125 (see Ex. 2036 ¶ 314 (Roush Decl.)), and another expert witness, Dr. Vellturo, relied on Exhibits 2141–2170 (see Ex. 2132 ¶¶ 41–42 (Vellturo Decl.)). As is evident from our discussion above, the probative value of reviewing the documents substantially assisted our evaluation of Patent Owner’s contentions regarding skepticism. In addition, any prejudicial effect on Petitioner is minimal because we ultimately did not find Patent Owner’s evidence of skepticism to be probative. Lastly, we are not persuaded that Patent Owner’s alleged failure to submit controverting correspondence warrants exclusion of Exhibits 2125 and 2141–2170 under either FRE 106 or the Board’s discovery rules. FRE 106, which appears to be more pertinent to a live trial, as opposed to an administrative proceeding such as this case, provides that “[w]hen a writing or recorded statement or part thereof is introduced by a party, an adverse party may require the introduction at that time of any other part or any other writing or recorded statement which ought in fairness to be considered contemporaneously with it.” Thus, rather than providing a basis for excluding evidence, FRE 106 is a vehicle for entry of additional evidence, allowing an adverse party to a proffered writing or statement (in this case Petitioner) the opportunity to require entry of any other part of the proffered writing/statement, or any” slip op. at 47

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “12. As to the level of ordinary skill in that art as of March 15, 1996 (the earliest possible priority date of the ’551 patent), Petitioner contends as follows: [A] POSA [person of ordinary skill in the art] would have a Ph.D. in organic or medicinal chemistry and at least a few years of experience in medicinal chemistry, including in the development of potential drug candidates. Ex. 1002, ¶ 13 [Wang Decl.]. The POSA would also include a person having a Bachelor’s or Master’s degree (organic chemistry or medicinal chemistry) if such a person had more years of experience in medicinal chemistry and the development of potential drug candidates. Id. With experience in drug development, the POSA would have an appreciation of the diseases and ailments a particular drug candidate is intended to treat, but would not necessarily be a medical doctor or clinician. The POSA would know how to evaluate the physical and biological properties of chemical compounds and would be able to conduct, or otherwise have access to resources that could conduct, in vitro and in vivo evaluations of biological and toxicity properties of chemical compounds. Id. Pet. 12. Patent Owner does not controvert Petitioner’s characterization of the relevant art, or the level of ordinary skill in that art, nor does Patent Owner advance a specific assertion of its own as to the level of ordinary skill. See, generally, PO Resp. Accordingly, when evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration Petitioner’s assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 11

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “As stated in 37 C.F.R. § 42.65(a), “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” We, nonetheless, acknowledge Dr. Wang’s education and experience (Ex. 1002 ¶¶ 6–10, Appendix A), and note that Patent Owner does not dispute specifically the accuracy of Dr. Wang’s assertions in this regard. We thus acknowledge that, as a general principle in the art of medicinal chemistry, an ordinary artisan seeking to develop a commercial pharmaceutical compound ordinarily would have considered the substitution of a methoxyamino group with another more common and acceptable moiety, particularly because of any potential synthetic and stability issues associated with the methoxyamino group in the compound. Petitioner, however, does not identify a specific reason as to why that substitution would have been considered desirable for any of the prior art anticonvulsant compounds taught by Kohn 1991, let alone compound 3l identified as the lead compound.” slip op. at 18

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-00204 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: the Board found no sufficient motivation or reasonable expectation of success for the proposed compound modification, and the challenge to claims 10–13 was inadequately supported.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 12. Patent Owner does not controvert Petitioner’s characterization of the relevant art, or the level of ordinary skill in that art, nor does Patent Owner advance a specific assertion of its own as to the level of ordinary skill. See, generally, PO Resp. Accordingly, when evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration Petitioner’s assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12

  • Strike new argumentNew argument disregardedDecided for patent owner

    “As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id.; see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (Board did not err or abuse its discretion in declining to consider new contentions and evidence in reply advanced to supplement unpatentability rationale presented in petition).” slip op. at 5

  • ExcludeMotion to exclude, deniedMixed

    “In any event, Petitioner fails to explain adequately why the declarations of Patent Owner’s President, Shaun Kirkpatrick (Ex. 2185), and Vice President and General Counsel of a licensee, Paul Petigrow (Ex. 2187), are insufficient to authenticate the letters. Although Petitioner contends that “[n]either declaration demonstrates personal knowledge of the facts necessary to establish the business-records exception” (Pet. Reply Opp. 1 (Paper 81)), Petitioner does not support that assertion with specific explanation, other than asserting that Mr. Petigrow has worked for the licensee for less than a year (see id.). Petitioner does not, however, address with any specificity the substance of any of Mr. Petigrow’s other assertions, nor does Petitioner explain why they should not be credited. As to hearsay, as Patent Owner contends (PO Opp. 5–6), under FRE 703, the proponent of an expert opinion may disclose otherwise inadmissible evidence underlying that opinion to a jury, if the court determines that the “probative value in helping the jury evaluate the opinion substantially outweighs [its] prejudicial effect.” In the present case, Patent Owner’s expert Dr. Roush relied on Exhibit 2125 (see Ex. 2036 ¶ 314 (Roush Decl.)), and another expert witness, Dr. Vellturo, relied on Exhibits 2141–2170 (see Ex. 2132 ¶¶ 41–42 (Vellturo Decl.)). As is evident from our discussion above, the probative value of reviewing the documents substantially assisted our evaluation of Patent Owner’s contentions regarding skepticism. In addition, any prejudicial effect on Petitioner is minimal because we ultimately did not find Patent Owner’s evidence of skepticism to be probative. Lastly, we are not persuaded that Patent Owner’s alleged failure to submit controverting correspondence warrants exclusion of Exhibits 2125 and 2141–2170 under either FRE 106 or the Board’s discovery rules. FRE 106, which appears to be more pertinent to a live trial, as opposed to an administrative proceeding such as this case, provides that “[w]hen a writing or recorded statement or part thereof is introduced by a party, an adverse party may require the introduction at that time of any other part or any other writing or recorded statement which ought in fairness to be considered contemporaneously with it.” Thus, rather than providing a basis for excluding evidence, FRE 106 is a vehicle for entry of additional evidence, allowing an adverse party to a proffered writing or statement (in this case Petitioner) the opportunity to require entry of any other part of the proffered writing/statement, or any” slip op. at 47

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

    “Having considered the rationale and supporting evidence advanced by Petitioner alongside Patent Owner’s arguments and supporting evidence, Patent Owner persuades us that Petitioner has not shown sufficiently that the prior art of record would have suggested making the specific modification to compound 3l required to yield lacosamide. Petitioner relies on the uncorroborated testimony of its expert, Dr. Wang, as support for its contention that compound 3l’s methoxyamino group is an uncommon moiety among commercial pharmaceuticals that presents potential synthetic and stability issues, and also for its contention that the posited substitute, a methoxymethyl group, is a more common and acceptable moiety for pharmaceutically active compounds. See Pet. 44–45; see also Ex. 1002 ¶¶ 106, 107 (Wang Decl.) (citing no documentary support). As stated in 37 C.F.R. § 42.65(a), “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” We, nonetheless, acknowledge Dr. Wang’s education and experience (Ex. 1002 ¶¶ 6–10, Appendix A), and note that Patent Owner does not dispute specifically the accuracy of Dr. Wang’s assertions in this regard. We thus acknowledge that, as a general principle in the art of medicinal chemistry, an ordinary artisan seeking to develop a commercial pharmaceutical compound ordinarily would have considered the substitution of a methoxyamino group with another more common and acceptable moiety, particularly because of any potential synthetic and stability issues associated with the methoxyamino group in the compound. Petitioner, however, does not identify a specific reason as to why that substitution would have been considered desirable for any of the prior art anticonvulsant compounds taught by Kohn 1991, let alone compound 3l identified as the lead compound.” slip op. at 18

  Patent outcomesUS RE38,551 not shown unpatentable
  § 103 obviousnesscites KSR · Graham

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.