• Guest-Tek Interactive Entertainment Ltd. v. Nomadix, Inc.Rehearing denied
  PTAB · Aug 22, 2018 · IPR2018-00392 · APJ Stephen C Siu · IPR · Rehearing

  The Board denied rehearing of its denial of institution on the obviousness ground over Slemmer and Vu, finding no abuse of discretion.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. 35 U.S.C. § 314(a). Notably, we must base our determination of a “reasonable likelihood” that Petitioner would “prevail” on “the information presented in the petition,” specifically. In the present case, Petitioner has not provided a basis, legal or otherwise, in support of its position that we must determine a “reasonable likelihood” based on information presented in some other petition, much less based on some other evidence of record in another proceeding. For example, in IPR2016-00077, the panel based its decision on a “Declaration by Mr. Keith Olsen.” That evidence is not of record in this proceeding.” slip op. at 3

  • BurdenDecided for patent owner

    “35 U.S.C. § 314(a). Notably, we must base our determination of a “reasonable likelihood” that Petitioner would “prevail” on “the information presented in the petition,” specifically. In the present case, Petitioner has not provided a basis, legal or otherwise, in support of its position that we must determine a “reasonable likelihood” based on information presented in some other petition, much less based on some other evidence of record in another proceeding. For example, in IPR2016-00077, the panel based its decision on a “Declaration by Mr. Keith Olsen.” That evidence is not of record in this proceeding.” slip op. at 3

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

    “supporting Petitioner’s position that it would have been obvious to one of ordinary skill in the art to have combined the cited references. Req. Reh’g. 8–10. In particular, Petitioner reiterates previous arguments presented in the Petition such as “Vu is one of the first prior art references to teach the handshake” but that “other prior art references also teach it.” Req. Reh’g 8. These arguments were previously addressed. Decision 6–7. Although Petitioner may disagree with our resolution of the arguments that Petitioner presented in its Petition, such arguments were considered fully in our Decision.” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,725,899
• Guest-Tek Interactive Entertainment Ltd. v. Nomadix, Inc.Rehearing denied
  PTAB · Aug 22, 2018 · IPR2018-00376 · APJ Stephen C Siu · IPR · Rehearing

  The Board denied rehearing and upheld denial of institution on the Slemmer and Vu obviousness ground because the petition did not show a reasonable likelihood of prevailing.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “When rehearing a decision on a petition, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co.,, 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. 35 U.S.C. § 314(a). Notably, we must base our determination of a “reasonable likelihood” that Petitioner would “prevail” on “the information presented in the petition,” specifically. In the present case, Petitioner has not provided a basis, legal or otherwise, in support of its position that we must determine a “reasonable likelihood” based on information presented in some other petition, much less based on some other evidence of record in another proceeding. For example, in IPR2016-00077, the panel based its decision on a “Declaration by Mr. Keith Olsen.” That evidence is not of record in this proceeding.” slip op. at 3

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

    “supporting Petitioner’s position that it would have been obvious to one of ordinary skill in the art to have combined the cited references. Req. Reh’g. 8–10. In particular, Petitioner reiterates previous arguments presented in the Petition such as “Vu is one of the first prior art references to teach the handshake” but that “other prior art references also teach it.” Req. Reh’g 9. These arguments were previously addressed. Decision 7–8. Although Petitioner may disagree with our resolution of the arguments that Petitioner presented in its Petition, such arguments were considered fully in our Decision.” slip op. at 4

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

    “construction for the term ‘TCP connection hand shake completion data,’ which resulted in an incorrect determination.” Req. Reh’g. 5. In particular, Petitioner now proposes a broadest reasonable construction of the term “TCP connection hand shake completion data” to mean “two devices initiating a communication session by the first device sending information to a second device, and the second device then responding to the first device.” Req. Reh’g. 7. Based on this newly proposed construction of the term “TCP connection hand shake completion data,” Petitioner argues that Vu discloses this feature. Req. Reh’g. 6–8. Under 37 C.F.R. § 42.71(d), Petitioner must “identify all matters [Petitioner] believes the Board misapprehended or overlooked.” Petitioner did not present this proposed construction in the Petition. See generally Req. Reh’g.; see generally Pet. We could not have “misapprehended or overlooked” what was not presented.” slip op. at 4

  Claim construction§ 103 obviousness
  Patents in suitUS 8,266,266
• Apple Inc. v. Andrea Electronics Corp.Some claims unpatentable
  PTAB · Jul 12, 2018 · IPR2017-00627 · APJ Jeremy M Plenzler · IPR · Final written decision

  Claims 1–5, 10–16, 21–23, 25, and 38–46 are unpatentable; claims 6–9, 17–20, 24, and 47 were not shown unpatentable.

  RulingsFinal written decision

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

    “Although the dictionary defines “periodically” as “from time to time” or “at regular intervals of time,” based on the record before us, we agree with Patent Owner that its proposed construction is how one skilled in the art would have understood that term in the context of the ’345 patent Specification. Turning first to the intrinsic evidence, the Specification explains that “[t]he future and current minimum values are calculated continuously and initiated periodically, for example, every 5 seconds.” Ex. 1001, 8:37–39. Although the Specification later notes that “[i]t will be appreciated that, while specific values are used as in the several equations and calculations employed in the present invention, these values may be different than those shown” (id. at 8:64–67), this passage does not mean that the Specification contemplates arrangements where “periodically” is simply “from time to time.” Rather, we determine that statement from the Specification indicates that the specific amount of time (i.e., every 5 seconds) may vary. Turning now to the extrinsic evidence, the testimony of Dr. Douglas supports our conclusion, explaining that “at regular intervals of time” is the “only . . . definition . . . consistent with the understanding of a person skilled in the art in light of the specification of the ’345 Patent and its use in the particular field of audio signal processing” because [l]ike the “period” of an audio signal itself, which is the amount of time it takes for a signal to repeat itself, “periodically” as recited in claims 6 and 9 and throughout the remainder of the specification of the ’345 Patent refers to actions that occur at regular intervals (e.g., every 5 seconds rather than merely “from time to time”). Ex. 2002 ¶ 48. Moreover, Petitioner’s declarant, Dr. Hochwald testifies that outside of the context of the ’345 patent Specification, “periodically” means “at regular time intervals” (Ex. 2005, 99:13–15), and when asked about that term’s meaning in the context of the ’345 patent Specification, Dr. Hochwald simply noted that “all I can do is read what it says,” which is that “[i]t’s doing something periodically, for example, every five seconds” (id. at 100:4–6). Accordingly, the testimony from Dr. Douglas, as well as that from Dr. Hochwald, supports Patent Owner’s construction. In summary, we adopt Patent Owner’s construction of “periodically,” requiring “at regular intervals of time,” because (1) this is consistent with how this term is used in the context of the ’345 Patent Specification; and (2) this is supported by the testimony of both experts.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Patent Owner responds that, because Helf uses average values (i.e., the average of eight consecutive values), it does not disclose using a minimum value. PO Resp. 17–23. Patent Owner acknowledges that the ’345 patent, itself, uses a “smoothing process [that] produces frequency bins with multiple smoothed magnitude values, ultimately finding the minimum of all of the values,” but contends that “Helf’s averaging process produces a single output representing one average of the original samples.” Id. at 20–21 (underlining omitted) (citing Ex. 1001, 8:14–28; Ex. 2002 ¶¶ 52, 63–72). We disagree with Patent Owner’s characterization of the differences between Helf and the ’345 patent. While Helf may ultimately produce a single minimum value, as discussed above, that value is based on a minimum value of the averages calculated over the given time period. At oral hearing, Patent Owner acknowledged that Helf determines many averages values (i.e., the averages of the eight consecutive frames) and determines a minimum of those values. See, e.g., Tr. 22:2–6. The claim simply requires a “future minimum value,” and does not preclude that value from being a minimum value taken from a set of average values. Indeed, such an interpretation of the claim would be inconsistent with the ’345 patent’s use of smoothed values noted by Patent Owner. Ex. 1001, 8:14–28. The testimony of Dr. Douglas cited by Patent Owner does not convince us otherwise. See Ex. 2002 ¶¶ 52, 63–72 (effectively repeating Patent Owner’s contentions, which are unpersuasive for the reasons set forth above). Accordingly, we are persuaded that Helf’s minimum value (Mk) corresponds to the “future minimum value” recited in claims 4 and 39.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed

    “With respect to its “running minimum estimator,” Helf explains that the “running minimum estimator” is used “when either the speech signal is never absent for more than a second or the background noise itself is never constant in spectral shape.” Ex. 1010, 8:11–15. Helf acknowledges that its “running minimum estimator” is “much less accura[te]” than its “stationary estimator,” which is typically used for background noise estimates. Id. at 8:15–17. As a result, Helf only uses its “running minimum estimator” if “[i]t has been more than 10 seconds since the last update of the background noise spectral estimate due to the Stationary Estimator,” and “[t]he difference, D, between the past background noise estimate, which may have resulted from the Stationary Estimator or the Running Minimum Estimator, and the current Running Minimum Estimator is great.” Id. at 8:32–42. We see no persuasive reason to set Helf’s current background noise estimate (Nk and Ck, considered the “current minimum” by Petitioner) to the minimum estimate (Mk) from the “running minimum estimator” (considered the “future minimum” by Petitioner). The testimony of Dr. Douglas supports this conclusion. See, e.g., Ex. 2002 ¶¶ 119, 120. Addressing the portions of Helf noted above, Dr. Douglas testifies that “Helf only relies on Mk in a ‘worst case’ scenario” and “disfavors the use of Mk, even where Bk is unavailable,” and concludes that “one of ordinary skill would not be motivated to force the use of the disfavored Mk every ten seconds even where the much more accurate Bk estimate is available.” Id. ¶ 119. Dr. Douglas further testifies that “one of ordinary skill would not have been motivated to abandon[] the comparison of D to a threshold” because “one of ordinary skill in the art would recognize that Helf is a signal-dependent system, and it would not abandon its ability to adapt to varying signal conditions in favor of a blind periodic update using a disfavored estimate.” Id. ¶ 120. We credit the testimony of Dr. Douglas over that of Dr. Hochwald in this regard. See Ex. 1004 ¶¶ 157–159; Ex. 2002 ¶¶ 115–120. The testimony from Dr. Douglas is consistent with the disclosure of Helf, while that of Dr. Hochwald is based on conclusory statements. For example, the only portions of Dr. Hochwald’s testimony cited in the Petition in connection with the rationale provided in this challenge are conclusory statements that “[a] person of ordinary skill would have found it obvious to modify Helf to update the background noise estimate after every 10 second period based on the teachings of Martin,” and “[t]he skilled person would have recognized it was beneficial to periodically update the minimum noise value to ensure it accurately reflected the current noise level,” which are contrary to the disclosure of Helf noted above. Ex. 1004 ¶¶ 158, 159.” slip op. at 21

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedOther

    “We see no persuasive reason to set Helf’s current background noise estimate (Nk and Ck, considered the “current minimum” by Petitioner) to the minimum estimate (Mk) from the “running minimum estimator” (considered the “future minimum” by Petitioner). The testimony of Dr. Douglas supports this conclusion. See, e.g., Ex. 2002 ¶¶ 119, 120. Addressing the portions of Helf noted above, Dr. Douglas testifies that “Helf only relies on Mk in a ‘worst case’ scenario” and “disfavors the use of Mk, even where Bk is unavailable,” and concludes that “one of ordinary skill would not be motivated to force the use of the disfavored Mk every ten seconds even where the much more accurate Bk estimate is available.” Id. ¶ 119. Dr. Douglas further testifies that “one of ordinary skill would not have been motivated to abandon[] the comparison of D to a threshold” because “one of ordinary skill in the art would recognize that Helf is a signal-dependent system, and it would not abandon its ability to adapt to varying signal conditions in favor of a blind periodic update using a disfavored estimate.” Id. ¶ 120. We credit the testimony of Dr. Douglas over that of Dr. Hochwald in this regard. See Ex. 1004 ¶¶ 157–159; Ex. 2002 ¶¶ 115–120. The testimony from Dr. Douglas is consistent with the disclosure of Helf, while that of Dr. Hochwald is based on conclusory statements. For example, the only portions of Dr. Hochwald’s testimony cited in the Petition in connection with the rationale provided in this challenge are conclusory statements that “[a] person of ordinary skill would have found it obvious to modify Helf to update the background noise estimate after every 10 second period based on the teachings of Martin,” and “[t]he skilled person would have recognized it was beneficial to periodically update the minimum noise value to ensure it accurately reflected the current noise level,” which are contrary to the disclosure of Helf noted above. Ex. 1004 ¶¶ 158, 159.” slip op. at 21

  Patent outcomesUS 6,363,345 mixed
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,363,345
• Apple Inc. v. Andrea Electronics Corp.Some claims unpatentable
  PTAB · Jul 12, 2018 · IPR2017-00626 · APJ Jeremy M Plenzler · IPR · Final written decision

  Claims 1–3, 12–25, 38, and 47 are unpatentable; claims 4–11 and 39–46 are not shown unpatentable, chiefly because the proposed Hirsch–Martin combination was not supported.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “In its Reply, Petitioner contends that, “[i]n this configuration [where W = 1], any purported distinction between windows and sub-windows in Martin vanishes and [Patent Owner]’s argument is irrelevant,” acknowledging that the proposed modification eliminates Martin’s sub-windows. Pet. Reply 5. Petitioner further contends that Patent Owner “incorrectly argues that the use of sub-windows is central to Martin’s algorithm” and “[n]othing in Martin suggests that the use of sub-windows is required.” Id. at 7 (citing Ex. 1023 ¶¶ 6–8). We disagree with Petitioner, and credit the testimony of Dr. Douglas over that of Dr. Hochwald with respect to Martin’s use of sub-windows because, as discussed below, Dr. Hochwald’s testimony is not consistent with the disclosure of Martin, while the testimony of Dr. Douglas is consistent with that disclosure. See, e.g., Ex. 1023 ¶¶ 6–9 (asserting that Martin does not expressly require sub-windows); Ex. 2002 ¶¶ 94–96 (discussing Martin’s use of at least two sub-windows for monotonic determination). As noted above, Martin’s algorithm requires a determination of whether or not “the minimum power of the last W windows with M samples each is monotonically increasing.” Ex. 1006, 1094. We are not persuaded by Petitioner’s argument that one skilled in the art would have found it obvious to modify Hirsch’s system based on a scenario from Martin where W = 1 because such a scenario is counter to the entire purpose of Martin. Even Petitioner’s Declarant, Dr. Hochwald, acknowledges that a single data point (i.e., W = 1) cannot be used to determine whether something is monotonically increasing. See Ex. 2005 69:10–17 (explaining that you need at least two data points to make such a determination, meaning W ≥ 2). Petitioner fails to provide persuasive reasoning as to why one skilled in the art would have modified Hirsch’s teachings in a manner that is contrary to the express disclosure of Martin.” slip op. at 14

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Petitioner attempts to cure these deficiencies in its Reply, contending that, “[e]ven where Martin’s algorithm is configured to use multiple sub-windows, it still teaches the claimed ‘future minimum.’” Pet. Reply 8. We do not consider this new argument, as it is a new theory of unpatentability presented for the first time in the Petitioner’s Reply. See Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed Cir. 2016) (“A patent owner . . . is undoubtedly entitled to notice of and a fair opportunity to meet the grounds of [unpatentability].”) (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015)). For at least these reasons, Petitioner has failed to establish by a preponderance of the evidence that claims 4–11, 39–42, and 46 are unpatentable over the combined teachings of Hirsch and Martin.” slip op. at 15

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

    “Hirsch is directed to “techniques . . . to estimate the noise spectra or the noise characteristics for noisy speech signals” that “can be combined with a nonlinear spectral subtraction scheme.” Ex. 1005, 153. Hirsch discusses use of “FFT based spectral analysis” (id. at 154), for example, which Petitioner cites as corresponding to the “generating the frequency spectrum of said audio signal thereby generating frequency bins of said audio signal” recited in claim 1 (Pet. 27). Hirsch discusses use of an “adaptive threshold” for each frequency bin to distinguish between speech and noise (Ex. 1005, 153), which Petitioner cites as corresponding to the “setting a threshold for each frequency bin using a noise estimation process” recited in claim 1 (Pet. 27). Hirsch describes comparing spectral components to their corresponding thresholds to determine if speech is present (Ex. 1005, 153), which Petitioner cites as corresponding to the “detecting for each frequency bin whether the magnitude of the frequency bin is less than the corresponding threshold, thereby detecting the position of noise elements for each frequency bin” recited in claim 1 (Pet. 27–28). Based on the record before us, we are persuaded that Hirsch discloses each and every element of claim 1. We also are persuaded that Hirsch discloses each and every element of claim 38 for the reasons discussed above in connection with claim 1, as well as the “subtracting said noise elements . . . from said audio signal” additionally recited in claim 38. With respect to the recited “subtracting,” Petitioner cites Hirsch’s discussion of spectral subtraction. Pet. 25–26 (citing Ex. 1005, 153–155). As Petitioner notes, “[t]he spectral subtraction technique shown in Hirsch subtracts the noise estimate from each sub-band or ‘bin’ and sets any negative values to zero” (id. (citing Ex. 1005, 153)), which “is the same technique used in the ’345 patent” (id. (citing Ex. 1001, 6:58–61, 7:16–27)). Claims 2, 3, 12, 13, 21, and 23 depend from claim 1, and Petitioner cites to relevant portions of Hirsch as disclosing the additional limitations of those claims. See Pet. 28–31. We are persuaded by Petitioner’s unrebutted arguments and evidence related to how Hirsch properly accounts for each and every element of these dependent claims, which we adopt for purposes of this decision. Specifically, we find that Hirsch discloses the additional limitations recited in those claims based on the citations to Hirsch therein and the supporting expert testimony. See id. Based on our review of the record before us, the preponderance of the evidence supports Petitioner’s contentions that claims 1–3, 12, 13, 21, 23, and 38 are anticipated by Hirsch.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed

    “Initially, we agree with Petitioner that one skilled in the art would have considered Martin’s teachings, generally, when reviewing the teachings of Hirsch, as Martin is specifically referenced in Hirsch itself. Nevertheless, we are not persuaded that one skilled in the art would have modified Hisch’s system based on the teachings of Martin in the particular manner proposed by Petitioner. Consistent with Patent Owner’s contentions noted above, Martin describes determining “[t]he noise power estimate is based on the minimum of signal power within a window of L samples” and “[f]or reasons of computational complexity and delay the data window of length L is decomposed into W windows of length M such that M * W = L,” and provides an example where W=4. Ex. 1006, 1094. Martin distinguishes between “slowly varying noise power” and “rapidly varying noise power” to determine its noise power estimate, with a determination of whether the minimum power in successive sub-windows is monotonically increasing central to its estimation. Id. “If the minimum power of the last W windows with M samples each is monotonically increasing we decide on rapid noise power variation” and “the noise power estimate equals the power minimum of the last M samples Pn(i) = PMmin(i = r * M).” Id. “In case of non monotonic power the noise power estimate is set to the minimum of the length L window.” Id. Regardless of whether the noise power calculation is that for “slowly varying noise power” or “rapidly varying noise power,” Martin requires that first a determination is made as to whether or not “the minimum power of the last W windows with M samples each is monotonically increasing.” Id. (emphasis added). To the extent there can be any dispute on this issue, the testimony from Dr. Douglas supports the understanding that at least two subwindows are required to determine which noise power calculation to use. See Ex. 2002 ¶¶ 95, 96. In its Reply, Petitioner contends that, “[i]n this configuration [where” slip op. at 13

  Patent outcomesUS 6,363,345 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 6,363,345
• SK Hynix Inc. / SK Hynix America Inc. et al. v. Netlist, Inc.All claims unpatentable
  PTAB · Jul 5, 2018 · IPR2017-00692 · APJ Matthew R Clements · IPR · Final written decision

  Claims 1–15 are unpatentable: claims 1–14 as anticipated by Best and obvious over Best, and claim 15 as obvious over Best, Mills, and Bonella.

  RulingsFinal written decision

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

    “construction “requires two layers of IC packages, in which a first IC package (the Board’s ‘carrier’) contains one or more second IC packages (the Board’s memory chips).” PO Resp. 39. Petitioner counters that “[t]he Board’s construction does no such thing.” Pet. Reply 18–19. We agree with Petitioner. Patent Owner’s argument is predicated upon the erroneous assertion that “[e]ach memory chip in the Board’s ‘carrier’ requires a different IC package (i.e., a second IC package) that encloses at least one memory die.” PO Resp. 39. Each memory chip does not require its own integrated circuit package. On the contrary, it may be, as Best discloses, a die enclosed with another die in a single IC package. Having considered the arguments and evidence, we maintain our construction of “memory module” to mean “a carrier that contains one or more memory chips,” where “carrier” encompasses an integrated circuit package.” slip op. at 14

  • Skill levelSkill level board ownOther

    “Otherwise, we determine that no express finding on a specific corresponding level of technical education and experience is necessary. Here, the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 15

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We have reviewed the arguments provided by Patent Owner and determine such arguments are insufficient to have Mr. Maltiel’s declaration excluded in its entirety. Rather, it is within our discretion to assign the appropriate weight to be accorded evidence. See 37 C.F.R. § 42.65(a); see also, e.g., Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”); and Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“In giving more weight to prior publications than to subsequent conclusory statements by experts, the Board acted well within [its] discretion.”). Based on the record before us, we are not persuaded that we should give the entirety of Mr. Maltiel’s declaration no weight.” slip op. at 16

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

    “8–14. Pet. 30–37, 44–49. Notwithstanding Patent Owner’s arguments, which we have considered and which we address below, we are persuaded by Petitioner’s showing, which we adopt as our own findings and conclusions, that claims 1–14 are unpatentable under 35 U.S.C. § 102 as anticipated by Best.” slip op. at 24

  Patent outcomesUS 8,874,831 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,874,831
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21

  • Expert testimonyOther

    “Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  Patent outcomesUS 9,283,239 unpatentable
  § 112 disclosure
  Patents in suitUS 9,283,239
• Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution denied
  PTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution

  The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2

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

    “reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 7,429,572
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-02002 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. The Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art at the time of the invention would have had a B.S. or M.S. in biochemistry, polymer chemistry, medicinal chemistry, pharmaceutical chemistry, or a related field with “several years” of practical experience. Alternatively, according to Petitioner, the ordinary artisan would have had less practical experience but a Ph.D. in one of those fields, or an M.D. in dermatology, plastic surgery, or a specialty related to the clinical use of dermal fillers. Pet. 10 (citing Ex. 1041 ¶¶ 12–13). Patent Owner does not contest that argument in the Preliminary Response. For purposes of this decision, we accept Petitioner’s definition, which, on this record, is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reveal the level of ordinary skill in the art).” slip op. at 8

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

    “Second, a term in a patent preamble is limiting when it “breathes life and meaning into the patent claims.” In re Wertheim, 541 F.2d 257, 269 (CCPA 1976). “Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entire” patent disclosure “to gain an understanding of what the inventors actually invented and intended to encompass by the claim.’” Catalina Mktg. Int’l. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). Our review of the ’475 patent persuades us that the inventors “actually invented and intended to encompass by” claim 1 a stable composition as defined in the specification. Catalina Mktg. Int’l., 289 F.2d at 808. The inventors disclosed and claimed a “stable” composition containing both HA and lidocaine that overcame the “relative inferior stability properties” of prior art compositions. Ex. 1001, 2:6–32. In that regard, the specification repeatedly refers to the ability of the claimed compositions to remain stable after high-temperature sterilization procedures (such as autoclaving) or shelf-storage storage for prolonged lengths of time. See, e.g., id. at 2:42–49 (contrasting the “enhanced stability” of the claimed compositions “relative to conventional HA-based compositions including” “lidocaine” “when subjected to sterilization techniques such as autoclaving” or “when stored for long periods of time at ambient temperature”);” slip op. at 10

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

    “One final point pertaining to the “stable” limitation requires discussion. The specification makes clear that stability, in the context of the ’475 patent, relates to the “shelf life” of the composition “when stored for a lengthy period of time” prior to injection into a patient, for example, “for a period of time of at least 6 months to a year or more.” Id. at 6:51–53, 13:51; see id. at 2:26–27 (objective of invention is to provide “HA-based injectable compositions which incorporate lidocaine” that are not “prone to” degradation “when placed in storage for any significant amount of time”), 4:42–43, 5:33–38 (composition has “enhanced stability” “when stored at ambient temperature for an extended period of time”), 8:4–5 (the composition of the invention will “remain stable when stored for long periods of time at room temperature”). Accordingly, we determine that the preamble term “stable” (Ex. 1001, 16:40) “breathes life and meaning into” claim 1 and, therefore, is limiting. In re Wertheim, 541 F.2d at 269. We adopt for purposes of this decision the following definition of “stable,” which is advanced by Petitioner: soft tissue filler that is free of viable microorganisms as determined by a sterility test recognized by a regulatory authority, the filler can be sterilized by any method known in the art, and is resistant to degradation such that the composition maintains one or more of the following aspects: transparent appearance, pH, extrusion force and/or rheological characteristics, hyaluronic acid (HA) concentration, sterility, osmolarity, and lidocaine concentration, after being effectively sterilized by autoclaving and subsequently stored at a temperature of at least about 25° C for at least about two months. Pet. 11. That construction is not opposed by Patent Owner at this stage of the proceeding (Prelim. Resp. 3–4) and is substantially consistent with an express definition set forth in the specification. Ex. 1001, 5:17–20.” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,450,475
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-01906 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “printed publication” that was “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). The touchstone of public accessibility is whether an ordinary artisan “exercising reasonable diligence” would have been able to locate the document prior to the critical date. SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008). Petitioner availed itself of two opportunities to make out that showing, but has not done so adequately. See Pet. 4, 14; Reply 1–5. slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “favored providing Petitioner an opportunity to respond to the evidence, presented in the Preliminary Response, which undercuts the Petition’s bare attorney argument that the Elevess Summary qualifies as a printed publication. Paper 11 (providing Petitioner an opportunity to file a Reply and Patent Owner to file a Sur- Reply on that issue). In the Reply, however, Petitioner abandons the evidence presented in the Petition, does not address the evidence presented in the Preliminary Response, and instead advances an entirely new theory of public accessibility. Reply 1–5 (citing Exs. 1067, 1068, 1069, and 1070). Petitioner’s Reply to the Preliminary Response is not the proper place to raise such information, which should have been presented in the Petition. Because the argument and evidence presented in the Reply exceeds the scope of a proper reply, we have discretion to exclude it. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition or patent owner response.”).” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “in claim 1 requiring a composition “wherein the lidocaine is freely released in vivo” (after injection in a patient). Ex. 1001 19:31. On that point, we agree with Patent Owner that the Petition fails to address adequately how the presence of HI in Hunter’s composition would affect the free release of lidocaine from the HA gel in vivo. See Pet. 20–21; Prelim. Resp. 14–15 (pointing out that the Petition includes no showing that the lidocaine in Hunter’s composition “would necessarily be ‘freely released’ in vivo” where Hunter discloses “very different compositions” that include both “hyaluronic acid and an inhibitory compound” that “can inhibit the activity of hyaluronidase” (quoting Ex. 1004, 11)).” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,357,795
• Apotex Inc. / Apotex Corp. et al. v. Osi Pharmaceuticals LLCRehearing denied
  PTAB · Mar 5, 2018 · IPR2016-01284 · APJ Lora M Green · IPR · Rehearing

  The Board denied the Patent Owner’s rehearing request and left intact its determination that claims 44–46 and 53 are unpatentable as obvious over Schnur combined with OSI’s 10-K or Gibbs.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a final written decision the Board reviews the decision to determine whether we misapprehended or overlooked a matter. See 37 C.F.R. § 42.71(d). Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial 1 Schnur et al., U.S. Patent No. 5,747,498, issued May 5, 1998 (Ex. 1009) (“Schnur”). 2 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Fiscal Year Ended September 30, 1998, Commission File Number 0-15190, OSI Pharmaceuticals, Inc. (Ex. 1011) (“OSI’s 10-K”). 3 J.B. Gibbs, “Anticancer Drug Targets: Growth Factors and Growth Factor Signaling,” 105 J. CLIN. INV. 9‒13 (2000) (Ex. 1010) (“Gibbs”). Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for petitioner

    “In declining to adopt Petitioner’s definition of skill of the ordinary artisan, we noted that the claims encompassed cancers other than non-small cell lung cancer, and, thus, found that “the ordinary artisan would be a medical oncologist who would hold an M.D. degree and would have completed several years of practice in the field of oncology.” FWD 9. We did not just rely on Dr. Bunn’s testimony as to the level of skill on the ordinary artisan, however, but noted that “the level of ordinary skill in the art in this proceeding is reflected by the prior art of record.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)). In defining the level of ordinary skill, we also stated: [D]uring oral hearing, counsel for both parties opined that the outcome of the obviousness analysis would be the same under either parties’ definition of the ordinary artisan. Tr. 22:3‒8, 37:9‒11. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition of the ordinary artisan. FWD 9.” slip op. at 5

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “weight in determining whether the Gibbs reference was referring to CP- 358,774 when referring to “good anti-cancer activity” and “an acceptable therapeutic index,” we cited the Gibbs reference itself, which explicitly discloses: The EGF receptor is also the target for the development of inhibitors of the intracellular tyrosine kinase domain. ZD-1839 and CP-358,774, competitive inhibitors of ATP binding to the receptor’s active site, are currently in clinical trials (12, 13). Their mechanism of action has led to some concern about safety, given the variety and physiological significance of protein kinases and other enzymes that bind ATP. However, these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. Id. at 39 (quoting Ex. 1010, 10). That is, Gibbs refers to two compounds, ZD-1839 and CP-358,774, and refers to compounds in the plural in stating that the compounds have anticancer activity. See id. Thus, we found that “the clear inference [of the Gibbs reference] is that erlotinib has anti-cancer activity against non-small cell lung cancer.” Id. In that regard, we credited the testimony of Dr. Giaccone, noting that Dr. Giaccone testified that the statement in Gibbs “is a pretty strong and precise statement saying, there is activity in non-small cell lung cancer patients.” Ex. 2020, 115:12‒20. In addition, Dr. Giaccone testified further that statement by Dr. Gibbs would have been based on the information he had at the time, and that as Dr. Gibbs was a reputable pharmacologist, and as the statement was made in “a peer-reviewed journal of high impact,” he would have trusted that Dr. Gibbs “was saying something very important.” Ex. 2020, 115:12‒20. Id.” slip op. at 8

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

    “In finding that Patent Owner’s evidence of long-felt need was weak, however, we noted that “[a]ll types of objective evidence of nonobviousness must be shown to have a nexus to the claimed invention.” Id. at 42‒43 (citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus 4 Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774, an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase. 57 CANCER RESEARCH 4838‒4848 (1997) (Ex. 1016) (“Moyer”). generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need)). In particular, we stated that the challenged claims were not limited to the treatment of patients with non-small cell lung cancer, but included treatment of mammals, and that the challenged claims did not require a clinical effect. Id. at 43. In addition, we noted that Patent Owner acknowledged in its Response that “the FDA required it to change its label as it is only effective in treating approximately 10% of patients with non-small cell lung cancer.” Id. Therefore, our finding that the evidence of long-felt need is weak relied primarily on a lack of nexus. Id. at 42. To the extent we relied on the testimony of Dr. Giaccone that erlotinib was only approved for treatment of subset of non-small cell lung cancer, that testimony is supported by Patent Owner’s admission that “Tarceva is currently approved for the treatment of a subset of NSCLC patients,” as well as the evidence that Patent Owner relied upon to support that statement. PO Response 12 (citing Ex. 2030, 1; Ex. 2021 ¶¶ 41, 102‒107; Ex. 2023 ¶ 7).” slip op. at 12

  § 103 obviousness
  Patents in suitUS 6,900,221

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.