• 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
• Cisco Systems, Inc. v. Centripetal Networks, Inc.Some claims unpatentable
  PTAB · May 18, 2020 · IPR2018-01760 · APJ J John Lee · IPR · Final written decision

  Claims 1–7, 10–12, 14–21, 24, and 25 are unpatentable as obvious over Sourcefire; claims 8, 9, 13, 22, and 23 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In its Response, Patent Owner does not dispute Petitioner’s definition of the level of skill in the art.3 Based on the complete trial record, we find 3 Dr. Orso testified to a slightly different description of the level of skill in the art (Ex. 2002 ¶ 36), but Patent Owner did not argue during trial that Dr. Orso’s description should be adopted instead of Petitioner’s description and waived any such argument as a result. See In re NuVasive, Inc., 842 Dr. Staniford’s testimony credible and persuasive (Ex. 1003 ¶¶ 21–24), and we adopt Petitioner’s definition as a result. B.” slip op. at 7

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

    “an unexpired patent are given their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b) (2018); see Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). In the Decision on Institution, we preliminarily construed the term “network-threat indicator” as an “indicator that represents the identity of a resource associated with a network threat.” Inst. Dec. 8. During trial, neither party disputed this preliminary construction. See PO Resp. 25; Pet. Reply 7–8; Tr. 10:22–11:9. We do not discern any evidence in the full record after trial indicating that this construction is incorrect or should be modified. Moreover, the Specification supports this construction, indicating that “network addresses, ports, fully qualified domain names (FQDNs), uniform resource locators (URLs), uniform resource identifiers (URIs), or the like” are examples of “network-threat indicators.” Ex. 1001, 3:18–26. Thus, we apply this construction in this Decision.” slip op. at 8

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

    “Based on the above facts and case law, we conclude that Sourcefire was publicly accessible. The evidence of record indicates that the Sourcefire 3D System was publicly marketed and sold, and that the Sourcefire reference was actually distributed to over 500 customers of the Sourcefire 3D System. Ex. 1005 ¶¶ 11, 19; Ex. 1042 ¶¶ 5–9. This vastly exceeds the distribution to six people in MIT and distribution of 80 copies in Garrett. Record evidence also supports Petitioner’s contention that the customers who received Sourcefire included entities interested in network security products, including persons of ordinary skill in the art. See Ex. 1042 ¶ 9; see also Ex. 1004, 1, 32–33 (identifying Sourcefire as a “User Guide” and indicating Sourcefire provides information for network administrators); Ex. 1005 ¶ 5 (indicating Sourcefire was drafted in consultation with, and reviewed by, engineers who designed the Sourcefire system). Moreover, similar to MIT and as discussed in Medtronic, the record indicates that the recipients of Sourcefire were not subject to confidentiality requirements restricting use or further distribution. See Ex. 1004, 2 (Sourcefire copyright page stating, “You may use . . . and otherwise copy and distribute [Sourcefire] solely for non-commercial use”).5 Although Patent Owner asserts that MIT and Klopfenstein are distinguishable because they involved “the free distribution of academic documents to conference and meeting attendees” (PO Sur-reply 7), case law indicates that distribution to commercial entities also may be sufficient. See Garrett, 422 F.2d at 878; Pet. Reply 3.6” slip op. at 15

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “Id. at 65. These largely conclusory arguments, however, fail to explain how refreshing an event view or event summary page, whether at a regular interval or otherwise, teaches generating different types of log entries at the same time for different portions of packets in the manner claimed. The cited testimony of Dr. Staniford does not provide any further illumination, instead repeating essentially the same conclusory statements made in the Petition. See Ex. 1003 ¶¶ 162, 173; 37 C.F.R. § 42.65(a). Petitioner’s Reply also fails to supply the necessary explanation or supporting evidence. Petitioner notes that “flow-log entries are generated from the packet-logs”—thus, flow-log entries must be generated after the corresponding packet-log entries and would reflect any changes made to those entries. Pet. Reply 19–21. Although true, these facts pertain only to a single portion of packets, i.e., that their packet-log entries are generated first, and that the related flow-log entries are generated afterward. The same is true even considering that this process can occur at a predetermined “refresh interval.” Petitioner does not identify any specific teaching or suggestion in Sourcefire that indicates how the generation of log entries for two different portions of packets would operate. Instead, Petitioner relies on a bare assertion—without any specific basis in Sourcefire—that “the processing of the packet-logs and the flow-logs are continually being updated or refreshed.” Without sufficient supporting evidence, that bare assertion and the conclusory testimony of Dr. Staniford are inadequate to meet Petitioner’s burden to prove the unpatentability of these claims by a preponderance of the evidence.” slip op. at 35

  Patent outcomesUS 9,413,722 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,413,722
• Ralph Lauren Corporation v. Lexos Media IP, LLCSome claims unpatentable
  PTAB · Mar 25, 2020 · IPR2018-01755 · APJ Sharon Fenick · IPR · Final written decision

  Claims 27, 33, 40, 41, 72, 81, and 82 are unpatentable under § 103; the remaining challenged claims are not determined unpatentable.

  RulingsFinal written decision

  • BurdenFwd mixedMixed

    “Decision issues under 35 U.S.C. § 318(a). Having considered the evidence of record, and for the reasons discussed below, Petitioner has demonstrated by a preponderance of the evidence that claims 27, 33, 40, 41, 72, 81 and 82 of the ’449 patent are unpatentable under 35 U.S.C. § 103(a), but has not demonstrated by a preponderance of the evidence that claims 1–3, 5–7, 12– 15, 28, 29, 31, 32, 38, 39, 53–56, 58–63, 73–75, and 77–80 of the ’449 patent are unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art would have had “at least a master’s degree in Computer Science, Computer Engineering, or a related field, or hold a bachelor’s degree in Computer 4 The record contains no evidence relating to secondary considerations. Science, Computer Engineering, or equivalent and have at least two years of relevant work experience in the fields of UI [(user interface)] design and OSs.” Pet. 10–11. In the Institution Decision, we preliminary adopted Petitioner’s proposed definition, noting that the prior art in this case demonstrated the level of ordinary skill in the art at the time of the invention. Inst. Dec. 10 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)). Patent Owner does not comment on or dispute Petitioner’s proposal, and instead cites Okajima’s holding regarding the level of skill in the prior art without raising any issues regarding whether the prior art here reflects a level of ordinary skill different from that proposed by Petitioner. PO Resp. 10 (citing Okajima, 261 F.3d at 1355). We adopt Petitioner’s definition as consistent with the ’449 patent and the asserted prior art.” slip op. at 10

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

    “Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). The Petitioner proposed construction of several claim terms in the Petition. Pet. 12–18. However, none of these claim terms require construction to resolve the controversy. Petitioner also argued for a construction of an additional term (“wherein said specified content information further comprises information to be displayed on said display of said user’s terminal”) in its Reply. Pet. Reply 13. Patent Owner contends that this argument is a new argument raised improperly for the first time in the Reply. PO Sur-Reply 10–11. We agree. Pursuant to 37 C.F.R. § 42.23(b), a reply “may only respond to arguments raised in the corresponding ... patent owner response.” See also Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359, 1369–1370 (Fed. Cir. 2016) (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Therefore, we will not address the new construction proposed for this claim term.” slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “A petitioner must choose which grounds of invalidity to assert in the petition and “the expedited nature of IPRs bring with it an obligation for petitioners to make their case in their petition to institute.” Intelligent Bio- Sys., 821 F.3d at 1369 (Fed. Cir. 2016); Wasica Fin. GmbH v. Cont'l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Circ. 2017) (a petitioner is foreclosed from “shifting” in post-petition arguments to a new theory of prima facie obviousness based on a different passage of a prior art reference than was used in the petition); see PTAB Consolidated Trial Practice Guide November 2019,5 73 (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g., to make out a prima facie 5 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated case of unpatentability.”); Trial Practice Guide Update August 2018,6 14 (same). Therefore, we evaluate Petitioner’s arguments with respect to limitation [c.i] relying upon Malamud’s message relating to a preview cursor in Malamud to teach the “specified content information.” Patent Owner does not make any arguments relating to whether Malamud’s message, in view of the teachings of Anthias, teaches limitation [c.i] of claim 1. See, e.g., PO Resp. 9–18.” slip op. at 19

  Patent outcomesUS 6,118,449 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,118,449
• 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
• 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
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01242 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: Petitioner failed to establish obviousness of claims 1–9 over Kohn 1991 and Silverman, or claims 10–13 over those references and the ’729 patent.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). Based on the record developed in this proceeding, we conclude that Petitioner has not established by a preponderance of the evidence that claims 1–9 of the ’551 patent are unpatentable for obviousness over Kohn 1991 and Silverman, nor has Petitioner established by a preponderance of the evidence that claims 10–13 of the ’551 patent are unpatentable for obviousness over Kohn 1991, Silverman, and the ’729 patent. slip op. at 4

  • 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

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “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

  • 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

  Patent outcomesUS RE38,551 not shown unpatentable
  Claim construction§ 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.