• Aurobindo Pharma USA, Inc.No claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-01648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–25 were not shown unpatentable over Timmins and Cheng because Petitioner did not establish that the combination would have targeted the claimed mean Tmax range.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “In the Patent Owner Response, Patent Owner acknowledged the Board’s characterization of the knowledge of an ordinarily skilled artisan as consistent with the proposals of both parties (PO Resp. 12–13), and neither party further addressed the proper level of ordinary skill in the art or disagreed with our characterization from the Institution Decision. See PO Resp., Reply. Our determination regarding the patentability of the challenged claims does not turn on the differences between the parties’ definitions. We adopt Petitioner’s assessment, but note that our conclusions would be the same under Patent Owner’s assessment. C. Testimony of Dr. Akhlaghi” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We agree with Petitioner that Dr. Akhlaghi’s qualifications and deposition testimony, when read in context, indicate that Dr. Akhlaghi is sufficiently experienced to opine on the knowledge of one of skill in the art at the time of the ’866 patent. As noted in the August 13, 2018 update to our Trial Practice Guide: An expert witness must be qualified as an expert by knowledge, skill, experience, training, or education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). See Notice of Update to Office Patent Trial Practice Guide, 83 Fed. Reg. 156, (Aug. 13, 2018) (text of update available at https://www.uspto.gov/sites/default/files/documents/2018_Revised_Trial_Pr actice_Guide.pdf). In addition, we are well able to consider the value of an expert opinion and afford it appropriate weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) D. Claim Interpretation” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner

    “Tmax” In our Institution Decision, we noted that the term “Tmax” appears in each of the challenged claims, and that both parties agreed that Tmax should be construed as stated in the Specification: “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours).” Inst. Dec. 7 (citing Pet. 24; Prelim Resp. 18; Ex. 1001, col. 7, ll. 49–53). We concluded that the proposed definition was consistent with the Specification and defined the claim term with reasonable clarity, deliberateness, and precision, and we adopted the parties’ construction. Neither party addressed the issue of construction of Tmax in further briefing, but the parties disagree about how Dr. Akhlaghi applied the definition in her testimony. See, eg., Pet. Reply 9–10. For purposes of analyzing the patentability of the challenged claims, we continue to interpret the term as “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours),” because that definition is consistent with the Specification, and because the parties themselves agreed to the definition of Tmax. Inst. Dec. 7. E. Overview of the Prior Art slip op. at 11

  • BurdenNot shown unpatentable

    “Based on our review of the record, we determine that Petitioner has not shown sufficiently that combining the teachings of Timmins and Cheng as Petitioner contends would have resulted in a dosage form that provides a mean Tmax of metformin from 5.5 to 7.5 hours after administration.” slip op. at 19

  Patent outcomesUS 6,866,866 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,866,866
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.

  RulingsFinal written decision

  • Expert testimonyOther

    “3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7

  • Skill levelOther

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14

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

    “as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21

  Patent outcomesUS 9,271,731 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• Apple Inc. v. California Institute Of TechnologyNo claims unpatentable
  PTAB · Dec 27, 2018 · IPR2017-00219 · APJ Trevor M Jefferson · IPR · Final written decision

  Claims 1–8, 11–17, 19–22, and 24–33 were not shown unpatentable because the obviousness combinations lacked a reasonable expectation of success.

  RulingsFinal written decision

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

    “one” as recited in claims 1 and 3 is “within 50% of one.” Pet. 24–25. Petitioner argues that this is consistent with the ’710 patent specification, which states that the inner code 210 of Figure 1, “can have a rate that is close to one, e.g., within 50%, more preferably 10% and perhaps even more preferably within 1% of 1.” Pet. 24–25 (quoting Ex. 1201, 2:62–64 and citing Ex. 1206 ¶¶ 102–103) (emphasis omitted). Patent Owner does not provide an express claim construction in this proceeding. In related proceeding IPR2017-00210, Patent Owner argues that the term “close to one” does not require construction and that the ’710 patent explains that the rate of a coder is the number of input bits divided by the number of output bits. IPR2017-00210, Paper 35, 18. We determine that “close to one” as recited in the challenged claims is construed as “within 50% of one.”” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We determine that Petitioner’s proposed definition comports with the qualifications a person would have needed to understand and implement the teachings of the ’710 patent and the prior art of record. Accordingly, we apply Petitioner’s definition of the level of ordinary skill in the art.” slip op. at 11

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

    “As part of our obviousness analysis, we consider “the scope and content of the prior art.” See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In this regard, we credit Patent Owner’s testimony and evidence that an important aspect of the art in this case is the relative unpredictability of developing error-correction codes. See PO Resp. 5–6, 45–46 (citing Ex. 2004 ¶¶ 116–117; Ex. 2033, 256:21–257:12) (“The field of error correction coding has historically been characterized by significant experimentation and unpredictable results . . . . Even when well-performing codes are identified, the reasons for the improved performance are often not understood.”)); Ex. 2004 ¶ 47. We do not agree with Petitioner that the need to run experiments in an unpredictable field, such as error-correction coding, indicates anything about whether such experiments ultimately would have been successful at the time of the invention. Importantly, “[u]npredictability of results equates more with nonobviousness rather than obviousness, whereas that which is predictable is more likely to be obvious.” Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A., 865 F.3d 1348, 1356 (Fed. Cir. 2017). In the absence of any evidence rooted in the Petition that substantiates a reasonable expectation of success, Petitioner’s reliance on a known need for experimentation is not sufficient to support its obviousness rationale.9 See Arctic Cat Inc. v. Bombardier Recreational Prod. Inc., 876 F.3d 1350, 1360–61 (Fed. Cir. 2017) (“[W]here a party argues a skilled artisan would have been motivated to combine references, it must show the artisan would have had a reasonable expectation of success from doing so.” (internal quotation omitted)).” slip op. at 18

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedOther

    “with Patent Owner that “[i]t is completely irrelevant what Dr. Frey claims he could do in the year 2018 when armed with Caltech’s patent disclosures and publications, [the inventor’s] original coding work, contemporary resources, (e.g., Dr. Frey (¶51) used Matlab, a software program that received over 35 version updates since May 2000), and 18 years of post-filing date knowledge” PO Sur-Reply 7. Because this evidence is not tied to the state of the art at the time of the invention, it is not probative of anticipated success. See Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367 (Fed. Cir. 2017) (quoting Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)) (“Those charged with determining compliance with 35 U.S.C. § 103 are required to place themselves in the minds of those of ordinary skill in the relevant art at the time the invention was made, to determine whether that which is now plainly at hand would have been obvious at such earlier time.” (emphasis added)). As part of our obviousness analysis, we consider “the scope and content of the prior art.” See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In this regard, we credit Patent Owner’s testimony and evidence that an important aspect of the art in this case is the relative unpredictability of developing error-correction codes. See PO Resp. 5–6, 45–46 (citing Ex. 2004 ¶¶ 116–117; Ex. 2033, 256:21–257:12) (“The field of error correction coding has historically been characterized by significant experimentation and unpredictable results . . . . Even when well-performing codes are identified, the reasons for the improved performance are often not understood.”)); Ex. 2004 ¶ 47.” slip op. at 18

  Patent outcomesUS 7,116,710 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,116,710
• Apple Inc. v. California Institute Of TechnologyNo claims unpatentable
  PTAB · Dec 27, 2018 · IPR2017-00210 · APJ Trevor M Jefferson · IPR · Final written decision

  The Board held claims 1–8, 11–17, 19–22, and 24–33 not unpatentable because Apple did not prove anticipation by Frey or obviousness over the asserted combinations.

  RulingsFinal written decision

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

    “given reference qualifies as a prior art “printed publication” involves a caseby-case inquiry into the facts and circumstances surrounding its disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). The key inquiry is whether the reference was made “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989); In re Wyer, 655 F.2d 221, 226 (CCPA 1981). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citation omitted). Petitioner has put forth date stamp evidence that a copy of the conference proceedings including Frey was at least received in the Cornell University Library by March 20, 2000. Ex. 1015, 16. Petitioner also put forth a declaration of Pamela Stansbury, an employee in the Original Cataloging Unit of the Cornell University Library, who testifies that, based upon her review of library records and her knowledge of standard operating procedures, Frey was “publicly available at the Cornell University Library as of March 20, 2000.” Ex. 1031 ¶ 4; see also Paper 22, 5 (Petitioner’s motion to submit supplemental information, which includes a description of Exhibit 1031); Paper 32 (granting Petitioner’s motion to submit supplemental information). Patent Owner does not dispute that Frey was publicly available as of March 20, 2000. See PO Resp. 15. Based on Petitioner’s evidence, we determine that Frey qualifies as a prior art printed publication as of March 20, 2000.” slip op. at 13

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

    “It is well established that when a party seeks to prove conception via the oral testimony of a putative inventor, the party must proffer evidence corroborating that testimony. . . . There is no particular formula that an inventor must follow in providing corroboration of his testimony of conception. Rather, whether a putative inventor's testimony has been sufficiently corroborated is determined by a ‘rule of reason’ analysis, in which ‘an evaluation of all pertinent evidence must be made so that a sound determination of the credibility of the inventor's story may be reached.’ However, that ‘rule of reason’ analysis does not alter the requirement of corroboration of an inventor's testimony. Evidence of the inventive facts must not rest alone on the testimony of the inventor himself. Singh, 317 F.3d 1240–41 (internal citations omitted) (quoting Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993)). With respect to priority and antedating a reference, the Federal Circuit has stated the following regarding burdens and required documentary support: When the issue of priority concerns the antedating of a reference, the applicant is required to demonstrate, with sufficient documentation, that the applicant was in possession of the later-claimed invention before the effective date of the reference. Demonstration of such priority requires documentary support, from which factual findings and inferences are drawn, in application of the rules and law of conception, reduction to practice, and diligence. The purpose is not to determine priority of invention—the province of the interference practice—but to ascertain whether the applicant was in possession of the claimed invention sufficiently to overcome the teachings and effect of an earlier publication of otherwise invalidating weight. In re Steed, 802 F.3d 1311, 1316 (Fed. Cir. 2015) (emphases added); see also Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1008 (Fed. Cir. 2016) (citing Steed). “The principles are legal, but the conclusions of law focus on the evidence, for which the Board’s factual findings are reviewed for support by substantial evidence.” Steed, 802 F.3d at 1316; see also NFC Tech., LLC v. Matal, 871 F.3d 1367, 1371 (Fed. Cir. 2017).” slip op. at 14

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

    “2. Analysis To anticipate a patent claim under 35 U.S.C. § 102, “a reference must describe, either expressly or inherently, each and every claim limitation and enable one of skill in the art to practice an embodiment of the claimed invention without undue experimentation.” Am. Calcar, Inc. v. Am. Honda Motor Co., 651 F.3d 1318, 1341 (Fed. Cir. 2011) (citing In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009)). When evaluating a prior art reference in the context of anticipation, the reference must be “considered together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)). “[A] reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting In re Petering, 49 CCPA 993, 301 F.2d 676, 681 (1962)). We analyze the instant ground with these principles in mind.” slip op. at 20

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

    “We are persuaded by Patent Owner’s arguments that Petitioner failed to establish a reasonable expectation of success for the proposed modifications to Frey and Divsalar. Petitioner’s argument in response acknowledges the missing expectation of success evidence by relying on the experimental nature of the field. Pet. Reply 9. Petitioner states that [a]s [Patent Owner] concedes, rigorous mathematical analysis of codes is difficult, and, as a result, POSAs routinely developed codes by experimentation. POR, 4. Encouraged by Frey’s results, POSAs would have been motivated to use Frey’s irregularity in Divsalar. Indeed, this is exactly what Dr. Frey suggested to Dr. Divsalar in an email dated December 8, 1999. Ex. 1035, App. A; Ex. 1064, 185:5–8. The Petition showed that POSAs would have had a reasonable expectation of success because it was trivial to modify Divsalar to make it irregular by repeating some of the information bits more than others, which meets the limitations of the claimed invention. Pet., 44–47. . . . Dr. Mitzenmacher agreed that simply repeating the first two bits in Divsalar “q+10” times and the rest “q” times would make the code irregular. Ex. 1062, 153:11-154:8. Pet. Reply 9 (emphasis added). To buttress the argument that a skilled artisan would have had a reasonable expectation of success in the proposed modifications, Petitioner introduces new testimony and simulations from a new declarant, Dr. Frey, to confirm that using Frey’s irregularity in Divsalar would not have been difficult and would have yielded a reasonable expectation of success. Id. at 10 (citing Ex. 1068). Yet, even if we were to deem the testimony and simulation to be within the proper scope of a reply brief,6 they do not support a reasonable expectation of success at the time of the invention. We agree with Patent Owner that “[i]t is completely irrelevant what Dr. Frey claims he could do in the year 2018 when armed with Caltech’s patent disclosures and publications, [the inventor’s] original coding work, contemporary resources, and some 18 years of post-filing date knowledge.” PO Sur-Reply 6. Because this evidence is not tied to the state of the art at the time of the invention, it is not probative of anticipated success. See Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367 (Fed. Cir. 2017) (quoting Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)) (“Those charged with determining compliance with 35 U.S.C. § 103 are required to place themselves in the minds of those of ordinary skill in the relevant art at the time the invention was made, to determine whether that which is now plainly at hand would have been obvious at such earlier time.” (emphasis added)).” slip op. at 28

  Patent outcomesUS 7,116,710 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,116,710
• Delphi Technologies, LLC v. Microchip Technology Inc.Rehearing denied
  PTAB · Dec 11, 2018 · IPR2017-00864 · APJ Daniel N Fishman · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 1, 3–5, 7–9, 11–15, and 18–21 unpatentable because their scope did not require the buffer to store the specified information.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “party challenging the decision,” and, “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed” in the record. 37 C.F.R. § 42.71(d). III. DISCUSSION Patent Owner’s Request does not identify any arguments that we “misapprehended or overlooked” let alone “specifically identify” all such matters. Thus, Patent Owner’s Request fails to comply with our rules. Despite this failure of Patent Owner’s Request, we address the substance of Patent Owner’s argument as follows.” slip op. at 2

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

    “misapprehended any argument. Furthermore, we are unpersuaded that our Decision was in error regarding independent claims 1, 3, 7, 18, and 23 because these claims have a different scope than claims 17, 22, and 24. As Patent Owner correctly noted, our construction of “dedicated USB connection” is “a USB connection that may include some shared physical communication path and includes a buffer for maintaining dedicated address, configuration and response information for the connection.” Dec. 33. Thus, a dedicated USB connection must include a buffer that is capable of storing/maintaining “dedicated address, configuration and response information” regardless of whether such data is actually stored/maintained therein.” slip op. at 3

  Claim construction
  Patents in suitUS 7,523,243
• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.Rehearing denied
  PTAB · Dec 3, 2018 · IPR2016-01332 · APJ Kristina M Kalan · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 1–20 unpatentable under the Final Written Decision.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. THE REQUEST FOR REHEARING In pertinent part, 37 C.F.R. § 42.71(d) states: The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence.” slip op. at 2

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

    “Decision, particularly noting Patent Owner’s argument that “there is no prior art evidence that ketoconazole causes mineralocorticoid excess.” Dec. 17 (citing PO Resp. 18). We also considered Petitioner’s countervailing evidence (id. at 17–18), Patent Owner’s Identification of New Arguments and Evidence in Petitioner’s Reply (Paper 65), and Petitioner’s reply to the same (Paper 74). We also noted in our Final Written Decision that Petitioner’s motivation to combine appeared to be premised on the adverse effects caused by reduced production of cortisol. Dec. 13. We also relied, in the Final Written Decision, on Dr. Garnick’s testimony that CYP17 inhibitors undesirably suppressed the production of cortisol, which is necessary for other biochemical cycles in the body, and which led to adverse side effects. Id. at 12–13 (citing Ex. 1002 ¶¶ 42, 44, 58). We also relied on Dr. Garnick’s testimony that “in light of steroid synthesis inhibitors’ known effects on the adrenal pathways,” one of ordinary skill in the art “would have been motivated to administer a glucocorticoid with administered abiraterone acetate to counteract expected endocrine disruptions.” Dec. 17 (citing Ex. 1097 ¶¶ 21–66). We expressly addressed Petitioner’s arguments and evidence, Patent Owner’s arguments and evidence, and the respective testimony on this issue, and did not overlook Patent Owner’s testimony or other testimony regarding the relationship between ketoconazole and mineralocorticoid excess. Nor are we persuaded, given our consideration and analysis of the testimony and other evidence, that we misapprehended the import of this testimony and evidence, or Petitioner’s reliance on the same for Petitioner’s arguments to support motivation to combine the reliedupon references.” slip op. at 3

  • Strike new argumentNew argument disregardedDecided for petitioner

    “under 35 U.S.C. § 282. Patent Owner further argues that the Board overlooked or misapprehended that evidence that skilled artisans evaluated O’Donnell and nevertheless proceeded to undertake studies based on abiraterone acetate monotherapy. Req. 13. Patent Owner, however, does not point us to where these argument were raised previously. 37 C.F.R. § 42.71(d). Therefore, Petitioners did not have an opportunity to respond to these issues. Nor did Patent Owner previously address the question of why the presumption of validity in 35 U.S.C. § 282 controls inter partes review proceedings in light of the statement in 35 U.S.C. § 316(e) that “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.” Accordingly, because Patent Owner does not demonstrate that these arguments were raised previously, and because we cannot be assured that Petitioner has had any opportunity to respond, we do not consider these arguments in our present order.” slip op. at 6

  § 103 obviousness
  Patents in suitUS 8,822,438
• Shenzhen Kean Silicone Product Co., Ltd. v. Pkoh Nyc, LLCSome claims unpatentable
  PTAB · Dec 3, 2018 · IPR2017-01327 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–7, 10–13, 20–22, 24, 26, 28–32, and 35–38 are unpatentable as obvious; claim 14 was not shown unpatentable over Cho.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner’s expert, Mr. Goldman, proposes that a person of ordinary skill in the bottle/container field as of the time of the filing of the application that became the ’036 patent “would have a bachelor’s degree (or equivalent) in mechanical engineering and at least one or two years’ experience developing container technology.” Ex. 1014 ¶ 4. Patent Owner does not dispute Petitioner’s proposal, and based on the final record, we adopt it for purposes of this Decision.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction neededDecided for petitioner

    “The Specification of the ’036 patent describes “[t]he elastomeric material is . . . of an appropriate durometer, such as 40 Shore A, to make the squeeze bulb 200 substantially deformable yet resilient,” and the elastomeric material is preferably silicone. Ex. 1001, 2:54–63. Only the claimed wall portion of the receptacle is claimed to be “resiliently deformable.” Id. at 5:9–10. Nothing in the claim, however, precludes or requires any other portion of the receptacle (comprised of elastomeric material) from also being resiliently deformable. Id. at 4:47–48. Notably, the receptacle is claimed to be “flexible and resilient.” Id. Although the “flexible and resilient” receptacle and its wall being “resiliently deformable” are not necessarily identical, this distinction appears to be minor considering the written description of the ’036 patent. Based on the foregoing, we give each of these claim terms their plain and ordinary meaning as understood by a person or ordinary skill in the art. The surrounding claim language for each claim limitation focuses the scope of these terms such that any interpretation we could provide would not be as helpful in understanding the terms as the surrounding claim language. We determine that no terms require express construction for the purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “6 In our decision, we give little weight to Petitioner’s evidence of “scores of popular baby bottles currently on the market,” because the design of these new bottles does not indicate the state of the art at the time the ’036 patent was filed. Further, Petitioner has failed to provide any corroborating testimony related to these new bottles—recent advertisements do not convince us of what a person of skill in the art would have considered at the time of filing. See Pet. Reply 11 (emphasis added) (citing Exs. 1022, 1023, 1024). We likewise give little weight to Petitioner’s uncorroborated article (Ex. 1026) from Wikipedia concerning “Baby bottle.” The record before us does not establish the origin and scientific basis for this evidence, and thus, we weigh Mr. Goldman’s testimony (Ex. 1021 ¶ 13) based on this evidence in a similar manner. See 37 C.F.R. § 42.65(a); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,763 (“Affidavits expressing an opinion of an expert must disclose the underlying facts or data.”). This sentence, standing alone, supports Mr. Fletcher’s conclusion that “an elastomeric, flexible silicone” could be used in the body of Cho’s bottle. See Ex. 1014 ¶ 30. Further, we find persuasive Petitioner’s arguments, supported by the testimony of Mr. Fletcher, that “silicone is primarily known for its elastic properties, and has been widely used in medical applications, including implants and storage containers, due to its chemical inertness, high heat resistance, flexibility and resistance for at least 60 years.” Pet. 30 (citing Ex. 1014 ¶ 34). Petitioner also supports its argument as to the suitability of silicone in consumer products, including in baby bottles, with a 1991 New York Times article that explains the elastomeric properties of silicone. Pet. 12; Ex. 1018, 2 (describing “rubbery silicone”), id. at 3 (“When baby gets a bottle these days, the nipple is a rubbery version of silicone.”). The fact that silicone could also possess other properties, or hardness, does not dissuade us from the determination that Cho, as a whole, teaches using a soft, resilient silicone in the body of the bottle.” slip op. at 20

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “At the outset, Mueller is analogous art and Patent Owner’s arguments to the contrary flip the analysis from focusing on the problem faced by the inventor of the ’036 patent to the “specific problem(s) found in Cho’s baby bottle.” First, Cho and Mueller are in the same field of endeavor as the claimed invention—dispensing containers—as admitted by Patent Owner. See PO Resp. 36. We need not address the second portion of the analogous art test, which focuses on whether the prior art “is reasonably pertinent to the problem with which the inventor was concerned.” In re Kahn, 441 F.3d 977, 986–87 (Fed. Cir. 2006). We do note, however, that the parties have both misapplied this second portion of the analysis. This analysis is focused on the problem faced by the inventor of the ’036 patent, not necessarily the problems addressed in the prior art references. Because neither party sufficiently addresses the problems faced by the inventor of the ’036 patent, and because Mueller and Cho are in the same field of endeavor as the claimed invention, we need not address the second portion of the analogous art test.” slip op. at 39

  Patent outcomesUS 7,959,036 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,959,036
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

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

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13

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

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this 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 on 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)). C.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213

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.