• Shenzhen Apaltek Co., Ltd. v. Asetek Danmark A/SAll claims unpatentable
  PTAB · Jan 22, 2024 · IPR2022-01318 · APJ Jason W Melvin · IPR · Final written decision

  Claims 1, 2, 6 are unpatentable as obvious over Duan; claims 5, 8 are unpatentable as obvious over Duan and Wu.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner proposes that a person of ordinary skill would have been knowledgeable regarding liquid cooling systems for computer systems, would have had a Bachelor of Science (B.S.) in electrical or mechanical engineering, or similar advanced post-graduate education in this area, or would have possessed at least 2–3 years of experience in liquid cooling systems for computer systems or similar systems. A POSITA would be knowledgeable of the concepts, components, and their functions described as “prior art” in the ’355 patent such as, e.g., pumps, radiators, fans, reservoirs, and other techniques of heat dissipation and liquid cooling. (Ex- 1001,1:11–47.) In addition, a POSITA would be knowledgeable about electric motors and their components (e.g., electromagnetic coils, rotors, stators, AC/DC motors, etc.) Pet. 6–7 (citing Ex. 1003 ¶¶ 13–18). Patent Owner has not proposed a level of ordinary skill in the art. We adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references.” slip op. at 9

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

    “Based on our analysis of the proceeding, we conclude that no claim term requires express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 9

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

    “disclosures. Pet. 17–45. Petitioner maps the claimed reservoir to Duan’s “structure formed by an accommodation chamber 21, lower cover 225, cap 3, and cooling plate 1.” Id. at 18. Petitioner maps the claimed double-sided chassis to Duan’s accommodation chamber 21 and the claimed impeller cover to Duan’s lower cover 225. Id. at 22–27. Petitioner maps the claimed thermal-exchange chamber to Duan’s cap 3 and cooling plate 1, with heat-absorbing face 11 and cooling plate 1 corresponding to the claimed heat exchanging interface. Id. at 27–36. Petitioner maps the claimed radiator to Duan’s cooling stage 53. Id. at 36–39. Petitioner asserts that Duan’s inlet is “below a center of the impeller” because it is along the axis about which the impeller rotates. Id. at 39–41. Petitioner asserts that Duan’s lower cover 225 defines an outlet tangential to the impeller’s circumference. Id. at 41–45. In summary, Petitioner asserts that Duan, without modification, discloses all of claim 1’s limitations. Patent Owner does not challenge Petitioner’s contentions, as it has filed no Patent Owner Response. We have reviewed Petitioner’s contentions and conclude that they show by a preponderance of the evidence that claim 1’s subject matter would have been obvious over Duan. See Pet. 17– 45. We adopt Petition’s unchallenged contentions as our analysis.” slip op. at 11

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

    “As to claim 5, Petitioner asserts that it would have been obvious to use Wu’s approach to securing chassis and heat-exchanging interface to the heat generating component, because Duan discusses the need to assemble its components but does not provide detailed instruction. Id. Thus, the modification would provide the benefit of securing Duan’s cooling plate module and cooling plate to the CPU. Id. at 72. For claim 8, Petitioner asserts that it would have been obvious to use Wu’s approach to blowing air through the radiator using a fan driven by a motor separate from the pump’s motor. Id. at 72–73. Petitioner reasons that doing so would improve Duan’s performance by increasing heat dissipation. Id. at 74. We agree that Petitioner’s contentions support the modification with rational underpinning.” slip op. at 12

  Patent outcomesUS 10,078,355 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 10,078,355
• Coolit Systems, Inc. v. Asetek Danmark A/SInstituted
  PTAB · Dec 28, 2021 · IPR2021-01195 · APJ Jason W Melvin · IPR · Institution

  The Board instituted IPR on claims 1, 6, 7, 11, and 12, finding a reasonable likelihood that the Batchelder-based obviousness grounds would prevail.

  RulingsInstitution decision

  • PTAB / AIA Trials › Real party in interest / privityNot reached

    “Under the Board’s precedential decision in SharkNinja Operating LLC v. iRobot Corp., when no time-bar or estoppel would apply once determining Petitioner did not name all RPIs, the Board need not address the issue. IPR2020-00734, Paper 11 (Oct. 6, 2020) (precedential); see also Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00739, Paper 38 at 6 (PTAB Mar. 4, 2016) (precedential) (“[O]ur jurisdiction to consider a petition does not require a ‘correct’ identification of all RPIs in a petition.”); Mayne Pharma Int’l Pty. Ltd. v. Merck Sharp & Dohme Corp., 927 F.3d 1232, 1240 (Fed. Cir. 2019) (“[I]f a petition fails to identify all real parties in” slip op. at 8

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “the ’354 patent, the overlap in the asserted prior art, and our prior determination of unpatentability regarding the ’354 patent, we conclude that the merits of Petitioner’s case in this proceeding are substantively strong. Thus, this factor weighs strongly in favor of institution. 7. Holistic assessment of factors and conclusion We consider the above factors and take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv, Paper 11 at 6. In weighing the totality of the evidence, we decide not to exercise discretion under § 314(a) to deny institution.” slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “C. LEVEL OF ORDINARY SKILL IN THE ART Petitioner proposes that a person of ordinary skill would have been knowledgeable regarding liquid cooling systems for computer systems, would have earned at least a bachelor’s degree, such as a B.S. (bachelor of science), or equivalent thereof, in electrical or mechanical engineering or a closely related field, and would have possessed at least two or three years of experience in liquid cooling systems for computer systems or in similar systems. Pet. 7–8 (citing Ex. 1003 ¶¶ 23–26). Patent Owner does not dispute this definition of a person of ordinary skill. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 14

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

    “construe claim terms “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). The parties stipulated to constructions of “reservoir” and “chamber” in the district-court litigation. Ex. 1005, 2. Petitioner proposes additional constructions for “impeller” and “radiator.” Pet. 8–10. Patent Owner does not dispute those constructions. See generally Prelim. Resp. Based on our analysis of the issues in dispute at this stage of the proceeding, we conclude that none of the claim terms identified by the parties require express construction at this time. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 15

  Claim constructionDiscretionary denial
  Patents in suitUS 10,613,601
• Apple Inc. v. Virnetx Inc.All claims unpatentable
  PTAB · Jun 22, 2017 · IPR2016-00331 · APJ Karl D Easthom · IPR · Final written decision

  Claims 1–11, 14–25, and 28–30 are unpatentable as obvious over Beser and RFC 2401.

  RulingsFinal written decision

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

    “Patent Owner’s contentions are not persuasive. Patent Owner fails to explain sufficiently why the notion of “performing an additional evaluation” constitutes an implicit part of the claimed intercept clause. Addressing similar arguments by Patent Owner, a Board panel made a similar determination in the ’237 FWD relied upon by Petitioner. ’237 FWD 11 (“the record show[s] that the additional functionality urged by Patent Owner should not be imported into the intercepting phrase”).” slip op. at 8

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

    “broadest reasonable interpretation in light of the specification. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard under 37 C.F.R. § 42.100(b)). Under this standard, absent any special definitions, claim terms or phrases are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For the purposes of this Decision, only the claim terms or clauses below need express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms in controversy need to be construed and only to the extent necessary to resolve the controversy).” slip op. at 7

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

    “We find Dr. Tamassia’s testimony as to public accessibility of RFCs in general to be credible, especially given the independent support of RFC 2026 (Ex. 1036), the contents of which Patent Owner does not challenge.7 As part of routine discovery, see 37 C.F.R. § 42.51(b)(1)(ii), Patent Owner had the opportunity to cross-examine Dr. Tamassia, but does not point us to any discussion of this issue. Moreover, RFC 2401’s contents are consistent with the publication process described by RFC 2026 and Dr. Tamassia, including the inclusion of a date “November 1998” on the top right corner of the first page of the document. Ex. 1008, 1. In addition, this document—a request for suggestions and improvements for an Internet standards protocol, 7 As addressed below, Patent Owner objects and moves to dismiss a number of Exhibits based on hearsay and relevancy. See Paper 20 (Motion to Exclude). having no indication of being a mere draft or internal paper—is precisely the type of document whose very purpose is public disclosure, including on the Internet. Both of the magazine articles, Exhibits 1064 and 1065, further corroborate the indicia of availability on the face of RFC 2401, although they are not necessary to our finding of public accessibility. We do not rely on the testimony of Sandy Ginoza, Exhibits 1060 and 1063, which Patent Owner seeks to exclude as discussed further below.” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Patent Owner does not articulate a persuasive reason for giving Dr. Tamassia’s declaration, as a whole, little or no weight in our analysis. We agree with Petitioner that experts are not required to opine on every relevant factual and legal issue in order to be accorded substantial weight. The cases upon which Patent Owner relies do not show otherwise. For example, Patent Owner cites Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304, 1315 (Fed. Cir. 2002), for the proposition that “[expert] testimony . . . ‘must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference.’” PO Resp. 52–53. Patent Owner’s quotation, however, mischaracterizes Schumer by omitting introductory words necessary to the meaning of the quoted sentence. In its entirety, the quoted portion of Schumer states the following: Typically, testimony concerning anticipation must be testimony from one skilled in the art and must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference. The testimony is insufficient if it is merely conclusory. Schumer, 308 F.3d at 1315–16. The Federal Circuit then adds that it is not the task of the courts to “attempt to interpret confusing or general testimony to determine whether a case of invalidity has been made out” and “if the testimony relates to prior invention and is from an interested party, as here, it must be corroborated.” Id. at 1316. So, instead of laying out a specific, required format for the content of all testimony regarding invalidity, as asserted by Patent Owner, this portion of Schumer confirms the unremarkable proposition that conclusory, overly general, confusing, and self-interested testimony should not be relied upon. Id.; see also Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004) (“General and conclusory testimony, such as that provided by Dr. Kazmer in this case, does not suffice as substantial evidence of invalidity.”). Patent Owner does not show that the whole of Dr. Tamassia’s testimony suffers from any of these failings. Under 35 U.S.C. § 316(e), the preponderance of the evidence standard governs in determining whether Petitioner establishes unpatentability. We exercise discretion to determine the appropriate weight to accord the evidence presented, including expert opinions, based on the underlying facts supporting the opinion. We accord relevant portions of Dr. Tamassia’s testimony the appropriate weight based on that particular testimony and supporting evidence.” slip op. at 14

  Patent outcomesUS 8,504,696 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,504,696
• Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentable
  PTAB · Mar 15, 2017 · IPR2016-01368 · APJ Scott C Moore · IPR · Final written decision

  Claims 3–26, 28–32, and 35 are unpatentable as obvious under the listed combinations of Kato and additional references.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The parties’ formulations as to the level of ordinary skill in the art are similar to one another, and neither party identifies with specificity an error in the opposing party’s formulation. The parties also agree that none of the disputes in this case turn on differences between the parties’ respective formulations. Tr. 33:1–6, 67:20–68:1. On the record presented we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either party’s proposed formulation.” slip op. at 8

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

    “usage, could encompass motorcycles. Tr. 41:12–23. Patent Owner further concedes that the ’034 patent does not contain an express lexicographic definition of the term “vehicle,” (Tr. 41:24–43:8), and instead argues that “the disclosure of the patent in the claims and the problem to be solved” make clear that the term “vehicle” excludes motorcycles (id. at 42:19–43:5). Patent Owner, however, does not sufficiently identify the portions of the specification that allegedly support its claim construction argument. See PO Resp. 6–7 (indicating that Patent Owner’s claim construction argument is based on “certain discussion throughout the specification of the ’034 patent, as noted throughout this Response”). Patent Owner cites to Paragraph 38 of the Katona Declaration (see PO Resp. 7), but this declaration testimony relates to the Kato reference and does not identify any portion of the ’034 patent that supports Patent Owner’s argument (see Ex. 2002 ¶ 38; Ex. 1007 ¶¶ 4–5). Moreover, we find that the “Claim Interpretation” section of the Katona Declaration is conclusory in nature because it does not identify any specific portion of the ’034 patent specification that supports Patent Owner’s argument. See Ex. 1002 ¶ 44. For the foregoing reasons, and based on the current record and our review of the specification of the ’034 patent, we are not persuaded that the intrinsic record contains a lexicographic definition or a disclaimer that would exclude motorcycles from the scope of the term “vehicle.” To the contrary, the specification makes clear that the term ”vehicle” is a broad term that is intended to encompass any type of vehicle. Accordingly, we determine that the term “vehicle,” as used in the specification and claims of the ’034 patent, encompasses motorcycles.” slip op. at 10

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

    “directed to different fields of endeavor, depends on its argument that the term “vehicle,” as used in the ’034 patent, excludes motorcycles. As discussed above, we reject this argument. In view of our determination that the ’034 patent’s use of the term “vehicle” does not exclude motorcycles, we are persuaded by Petitioner’s arguments (see Reply 7–8; Ex. 1037 ¶ 23) and find that Kato is directed to the same field of endeavor as the ’034 patent, i.e., automatic directional control systems for vehicle headlights. Compare Ex. 1001, 1:57–67, with Ex. 1007 ¶ 1. Even if the ’034 patent’s controller and Kato’s motorcycle controller were directed to different fields of endeavor, Kato’s controller would still be reasonably pertinent to the problem addressed by the ’034 patent. In particular, we find that Patent Owner is incorrect in its assertion that “[n]o crossover applicability exists [] between control devices for a motorcycle headlight and those of four-wheeled vehicles.” PO Resp. at 19. For example, Kato’s controller adjusts a headlight’s optical axis based upon changes to pitch angle or steering angle of a motorcycle. Ex. 1007 ¶ 11; see Ex. 1037 ¶ 33. The controller of the ’034 patent adjusts the aiming angle of vehicle headlights to account for operating conditions such as “steering angle” and “pitch.” Ex. 1001, 2:3–20. In view of the fact that the ’034 patent and Kato both disclose controllers that automatically adjust headlights of motorized vehicles according to steering angle and pitch, we are persuaded by Petitioner’s arguments (see Reply 8–13; Ex. 1037 ¶¶ 24–29) that Kato would “logically have commended itself” to the attention of an inventor considering the problem addressed by the ’034 patent, even if the problem addressed by the ’034 patent only related to four wheeled vehicles. See In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007). On this record, we find that Kato qualifies as analogous art.” slip op. at 18

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

    “teaches away from the use of Takahashi’s thresholds, or that such thresholds would render Kato’s system unsuitable for its intended purpose. Kato’s stated “Object of the Invention” is “to provide a headlight optical axis control device that can stably ensure a beam irradiation range of a headlight even when pitch, bank, steering angle or the like change while driving a motorcycle.” Ex. 1007 ¶ 6. Kato does disclose an embodiment that is able to correct direction of a headlamp “immediately” (id. ¶ 8), but we do not find that the portions of Kato cited by Patent Owner “criticize, discredit, or otherwise discourage investigation” into the use of a threshold of the type taught by Takahashi. Galderma Labs. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); see PO Resp. 28–29, Ex. 2002 ¶¶ 57–58. We also do not find that such thresholds would render Kato’s system unsuitable for its intended purpose. See PO Resp. 30–31; Ex. 2002 ¶¶ 57–58. Rather, we agree with Petitioner that a skilled artisan would have realized that Takahashi’s threshold values could have been set to minimize time delays while still realizing the advantages of Takahashi’s invention (i.e., avoiding unnecessary headlight adjustments due to short-term disturbances, such as those caused by a rough road surface). Reply 17–18; Ex. 1037 ¶¶ 34–39. Patent Owner also has failed to cite any persuasive evidence of improper hindsight. See PO Resp. 29, 33. We find on this record that combining Takahashi’s reference values with the Kato’s headlight optical axis control system would result in an obvious “combination of familiar elements according to known methods . . . [that] does no more than yield predictable results.” See KSR, 550 U.S. at 416. We also find on this record that a person of ordinary skill would have recognized that Takahashi’s thresholds could have been used to improve Kato’s motorcycle headlight controller in the same way they were used to improve Takahashi’s headlight controller. See id. at 417.” slip op. at 20

  Patent outcomesUS 7,241,034 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,241,034
• Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentable
  PTAB · Mar 15, 2017 · IPR2016-00079 · APJ Scott C Moore · IPR · Final written decision

  Claims 3–26, 28–32, and 35 are unpatentable under § 103(a) over the ten instituted combinations of prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The parties’ formulations as to the level of ordinary skill in the art are similar to one another, and neither party identifies with specificity an error in the opposing party’s formulation. The parties also agree that none of the disputes in this case turn on differences between the parties’ respective formulations. Tr. 33:1–6, 67:20–68:1. On the record presented we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either party’s proposed formulation.” slip op. at 8

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

    “The specification of the ’034 patent uses the term “vehicle” in a broad sense. For example, the Background of the Invention section of the ’034 patent uses the term “vehicle” to encompass “land vehicles, and many other types of vehicles (such as boats and airplanes, for example).” Ex. 1001, 1:20–21. The specification also makes clear that the claims are not limited to the specific vehicle types described in the Detailed Description of the Preferred Embodiment. See, e.g., id. at 2:60–3:3 (“The illustrated headlight 11 is, of itself, conventional in the art and is intended to be representative of any device that can be supported on any type of vehicle for the purpose of illuminating any area.”) (emphasis added).” slip op. at 9

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

    “Patent Owner’s first argument, that Kato and the ’034 patent are directed to different fields of endeavor, depends on its argument that the term “vehicle,” as used in the ’034 patent, excludes motorcycles. As discussed above, we reject this argument. In view of our determination that the ’034 patent’s use of the term “vehicle” does not exclude motorcycles, we are persuaded by Petitioner’s arguments (see Reply 7–8; Ex. 1037 ¶ 23) and find that Kato is directed to the same field of endeavor as the ’034 patent, i.e., automatic directional control systems for vehicle headlights. Compare Ex. 1001, 1:57–67, with Ex. 1007 ¶ 1. Even if the ’034 patent’s controller and Kato’s motorcycle controller were directed to different fields of endeavor, Kato’s controller would still be reasonably pertinent to the problem addressed by the ’034 patent. In particular, we find that Patent Owner is incorrect in its assertion that “[n]o crossover applicability exists [] between control devices for a motorcycle headlight and those of four-wheeled vehicles.” PO Resp. at 19. For example, Kato’s controller adjusts a headlight’s optical axis based upon changes to pitch angle or steering angle of a motorcycle. Ex. 1007 ¶ 11; see Ex. 1037 ¶ 33. The controller of the ’034 patent adjusts the aiming angle of vehicle headlights to account for operating conditions such as “steering angle” and “pitch.” Ex. 1001, 2:3–20. In view of the fact that the ’034 patent and Kato both disclose controllers that automatically adjust headlights of motorized vehicles according to steering angle and pitch, we are persuaded by Petitioner’s arguments (see Reply 8–13; Ex. 1037 ¶¶ 24–29) that Kato would “logically have commended itself” to the attention of an inventor considering the problem addressed by the ’034 patent, even if the problem addressed by the ’034 patent only related to four wheeled vehicles. See In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007). On this record, we find that Kato qualifies as analogous art.” slip op. at 18

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

    “Takahashi’s thresholds operate to “prevent the illumination of the lamp [] from being corrected inadvertently when a sudden change in the posture of the vehicle occurs temporarily or due to the wrong operation of the lamp [] caused by external disturbances.” Ex. 1007 ¶ 6. We are not persuaded that Takahashi’s thresholds could not be used to prevent the direction of Kato’s motorcycle headlight from being corrected inadvertently in the event of a temporary change in vehicle posture or external disturbance. Mr. Katona, Patent Owner’s expert, identifies several differences between motorcycles and four-wheeled vehicles, but does not persuasively and credibly explain why these differences would have prevented the use of such thresholds to prevent Kato’s headlight from being adjusted inadvertently in the event of a sudden and transient disturbance. See Ex. 1002 ¶¶ 54–56. We find credible the testimony of Petitioner’s expert, Dr. Wilhelm, that a skilled artisan would have realized that Takahashi’s thresholds could be used to prevent a motorcycle headlight controller from making undesirable adjustments to the headlight. Ex. 1019 ¶¶ 61–62; Ex. 1037 ¶¶ 34–36. We also are not persuaded by Patent Owner’s argument that Kato teaches away from the use of Takahashi’s thresholds, or that such thresholds would render Kato’s system unsuitable for its intended purpose. Kato’s stated “Object of the Invention” is “to provide a headlight optical axis control device that can stably ensure a beam irradiation range of a headlight even when pitch, bank, steering angle or the like change while driving a motorcycle.” Ex. 1007 ¶ 6. Kato does disclose an embodiment that is able to correct direction of a headlamp “immediately” (id. ¶ 8), but we do not find that the portions of Kato cited by Patent Owner “criticize, discredit, or otherwise discourage investigation” into the use of a threshold of the type taught by Takahashi. Galderma Labs. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); see PO Resp. 28–29, Ex. 2002 ¶¶ 57–58. We also do not find that such thresholds would render Kato’s system unsuitable for its intended purpose. See PO Resp. 30–31; Ex. 2002 ¶¶ 57–58. Rather, we agree with Petitioner that a skilled artisan would have realized that Takahashi’s threshold values could have been set to minimize time delays while still realizing the advantages of Takahashi’s invention (i.e., avoiding unnecessary headlight adjustments due to short-term disturbances, such as those caused by a rough road surface). Reply 17–18; Ex. 1037 ¶¶ 34–39. Patent Owner also has failed to cite any persuasive evidence of improper hindsight. See PO Resp. 29, 33. We find on this record that combining Takahashi’s reference values with the Kato’s headlight optical axis control system would result in an obvious “combination of familiar elements according to known methods . . . [that] does no more than yield predictable results.” See KSR, 550 U.S. at 416. We also find on this record that a person of ordinary skill would have recognized that Takahashi’s thresholds could have been used to improve Kato’s motorcycle headlight controller in the same way they were used to improve Takahashi’s headlight controller. See id. at 417.” slip op. at 20

  Patent outcomesUS 7,241,034 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,241,034
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Advanced Micro Devices, Inc. v. LG Electronics Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01409 · APJ Garth D Baer · IPR · Final written decision

  Claims 4, 8, and 9 are unpatentable under § 103; claim 30 was not shown unpatentable because the prior art did not teach shutdown based on total processor use below a threshold.

  RulingsFinal written decision

  • BurdenOther

    “III. ANALYSIS A. PRINCIPLES OF LAW Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).” slip op. at 7

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

    “Public accessibility” is the touchstone in determining whether a reference is a “printed publication.” In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986). A reference is publicly accessible upon a satisfactory showing that such document has been made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it. Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (quoting SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)). slip op. at 13

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

    “construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). We presume a claim term carries its “ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only those claim terms necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 8

  • Expert testimonyPetitioner expert creditedDecided for patent owner

    “We decline to disregard all of Mr. Gafford’s testimony. In light of Mr. Gafford’s education and experience (a Bachelor of Science Degree in Electrical Engineering and over 43 years working for corporations in the design, manufacturing, and support for computer systems and microprocessors, see Ex. 1011 ¶¶ 14–20), we see no reason why Mr. Gafford’s frequent participation in other cases—even to ultimately mixed results—makes his testimony here unhelpful in understanding the evidence in this case. See Fed. R. Evid. 702(a). In assessing the merits of this case, we have considered the proffered testimony from Mr. Gafford, as well as Patent Owner’s Declarant Dr. Friedman, and accorded weight based on the testimony’s substantive persuasiveness.” slip op. at 29

  Patent outcomesUS 7,636,863 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,636,863
• Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01096 · APJ Michael P Tierney · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over Thalomid PI in view of Cunningham, Keravich, Zeldis, and Mundt.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedOther

    “representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003, 1006, 1009, 1012, 1018. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1021 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 9

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

    “prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13

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

    “for close constant monitoring to identify noncompliance or other problems, but concluded by stating that Celgene was committed to making the program succeed and would be willing to make any modifications to the program necessary to ensure its effectiveness. Ex. 1012 at 329. This willingness to make any modifications is consistent with the understanding that the underlying drug remains a safety concern because controlling the distribution of the drug does not negate the actual side effects of the underlying drug. In dealing with such drugs, such as those capable of causing severe birth defects, the highest level of safety is desired. Under such circumstances, consistent with the teachings of Zeldis and the art of record one skilled in the art would understand that where significant safety risks exist with a drug, one would continuously search for safer ways to control the distribution of the drug. Put simply, where significant safety concerns exists, one of ordinary skill in the art would not wait until an accident occurred to seek out improvements.” slip op. at 23

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

    “limitations recited in independent claims 1 and 28, with the exception of the generation of a prescription approval code to be retrieved by a pharmacy before the prescription is filled. Pet. 52. Petitioner states that one skilled in the art, following the teachings of Thalomid PI and seeking to avoid treating pregnant women with thalidomide, would have implemented the methods disclosed in Cunningham to limit dispensation of a drug associated with adverse effects to certain risk groups. Id. at 54. We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 20

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720
• Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01103 · APJ Michael P Tierney · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over Mitchell and Dishman in view of Cunningham and the additional cited references.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2067. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 43–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10

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

    “their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b). Generally, Petitioner states that the claim terms are presumed to take on the ordinary and customary meaning that they would have to one of ordinary skill in the art. Pet. at 10. Petitioner proposes constructions for several claim terms including “consulted,” “teratogenic effect,” and “adverse side effect.” Id. at 10–11. Patent Owner does not propose distinct constructions of the identified terms. We determine that the identified claim terms should be given their ordinary and customary meaning, as would be understood by one with ordinary skill in the art, and need not be construed explicitly at this time for purposes of this Decision.” slip op. at 12

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

    “prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 14

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

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720
• Coalition For Affordable Drugs Vi LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01092 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–10 are unpatentable as obvious under § 103 over Powell, Mitchell, and Dishman.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

    “qualifications of an ordinary artisan, over the somewhat different qualifications proposed by Petitioner, would materially alter the obviousness inquiry. The prior art references asserted in the Petition are representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (absence of specific findings on “level of skill in the art does not give rise to reversible error ‘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))). To the extent that a more specific definition of the ordinary artisan is required, we hold that the definition encompasses pharmacists and other persons having experience restricting the distribution of teratogenic drugs. Specifically, we find that the prior art references, like the ’501 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); Ex. 1005, 901 (Powell, disclosing guidelines for restricting the distribution of thalidomide); Ex. 1006, 101 (Mitchell, describing a method for restricting the distribution of the teratogenic drug Accutane); Ex. 1007, 899 (Dishman, describing a national registry for restricting distribution of the psychoactive drug Clozaril). Consistent with the prior art, Dr. Fudin testifies that the types of problems encountered by a person of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1002 ¶¶ 33–55. The prior art demonstrates that a person of ordinary skill in the art would have experience in controlling the distribution of a drug. We credit Dr. Fudin’s testimony that a person of ordinary skill in the art would encompass a pharmacist. Ex. 1002 ¶ 15. We also credit Dr. Frau’s testimony that an ordinary artisan would not be limited to pharmacists but also would encompass persons having at least two years of experience in risk management relating to pharmaceutical products, as pharmacists are not the only persons having restricted drug distribution experience and knowledge. Ex. 2059 ¶ 60. Accordingly, we find that a person of ordinary skill in the art would include pharmacists and persons having at least two years of experience in risk management relating to pharmaceutical products as pharmacists. Additionally, we determine that, even if we were to adopt verbatim Dr. Frau’s definition of ordinary skill in the art, Patent Owner has failed to present sufficient and credible evidence to persuade us that Patent Owner’s defined person of ordinary skill in the art would be led to a different outcome regarding the obviousness of the challenged claims. Specifically, Dr. DiPiro, testifying for Patent Owner, acknowledged that many” slip op. at 7

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

    “No claim term requires 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))). One issue of claim construction, however, requires some discussion. Patent Owner argues that the term “computer readable storage medium” in claim 1 should be read to require a “centralized” computer readable storage medium—namely “a centralized database that includes all registration information regarding the claimed prescribers, pharmacies, and patients.” Resp. 22, 35. We are not persuaded that the wording of the claim, or the disclosure of the ’501 patent specification, supports Patent Owner’s view.” slip op. at 9

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

    “distribution of Accutane and Dishman’s method for controlling distribution of Clozaril—and apply those features to controlling the distribution of another potentially hazardous drug (thalidomide, which Powell discusses as requiring controlled distribution). Patent Owner’s contention that a person of ordinary skill in the art would not have recognized or applied the teachings of Mitchell or Dishman to the problem identified in Powell lacks merit. Resp. 49–53. On that point, Patent Owner itself identifies in the Response an article, which explains that Patent Owner’s “plan [for thalidomide] is built on experience with restrictions on such other drugs with severe side effects as Accutane . . . and Clorazil.” Ex. 2063, 1136; see Resp. 6 (quoting Ex. 2063, 1135). Furthermore, both of Patent Owner’s witnesses acknowledged the relevance of the programs disclosed in Mitchell and Dishman to the problem at hand, namely, controlling distribution of thalidomide. Specifically, Dr. DiPiro testified that, “in some of the literature where isotretinoin [Accutane] and clozapine [Clorazil] systems were discussed,” even researchers employed by Patent Owner recognized “that the results from these systems could guide an individual in either direction, as a way to do it or as a way not to do it. So in that sense they are relevant.” Ex. 1066, 326:23–327:5. Dr. Frau similarly acknowledged that the clozapine program was a restricted distribution program (Ex. 1067, 112:7–15; 113:3–8) and, thus, addressed the very same problem that would have been focused upon by a person of ordinary skill in the art. We find unpersuasive Patent Owner’s assertions that a person of ordinary skill in the art would not have been led to consider the combined disclosures of Mitchell, Dishman and Powell—all of which pertain to controlling the distribution of a drug to a subpopulation of patients likely to suffer serious side effects. Resp. 31–32, 38–41 (arguing that various features of known methods for controlling distribution of Accutane and Clozaril, as disclosed or suggested by the combined prior art, would not have been applied to controlling distribution of thalidomide in the manner claimed). Patent Owner, in essence, argues that an ordinary artisan would understand each applied reference only for its express teachings and would not have applied those teachings beyond the specific uses disclosed in the particular prior art reference. However, “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. In that regard, we are persuaded that the invention of claim 1 represents the “predictable use of prior art elements according to their established functions.” KSR Int’l, 550 U.S. at 417. Claim 1 is directed to a combination of known steps (registering patients, prescribers, and pharmacies in a computer readable storage medium; identifying and counseling a subpopulation of patients whose access to a teratogenic drug should be restricted; and authorizing drug therapy only for non-pregnant patients) to accomplish a known purpose (prescribing drug only to non-pregnant patients) and achieve a predictable result (preventing fetal exposure to the drug). Pet. 36–41 (claim chart). We agree with Petitioner that Patent Owner approaches this dispute as if the ground set for trial was based on anticipation. Reply 14 (pointing out that Patent Owner’s Response “reads as if [the ground set for trial] was based on an anticipation”). For example, Patent Owner focuses on specific features not present in one applied reference, without meeting head on the question whether all the features would have been suggested by the combined disclosures of the prior art. See Resp. 25–29, 31–32, 36–37 (attacking disclosures of each applied reference in isolation). Patent Owner’s attack on the individual disclosures of Powell, Mitchell, and Dishman is ineffective to counter Petitioner’s evidence that the subject matter of claim 1 would have been obvious over the combined disclosures of those prior” slip op. at 22

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “As an initial matter, we determine that Petitioner complies with our rules, and precedent of our reviewing court, by presenting Mann as objective support for Dr. Fudin’s opinion testimony. See 37 C.F.R. § 42.65(a) (opinion testimony that does not disclose underlying facts “is entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (lack of objective support for expert opinion “may render the testimony of little probative value in a validity determination”). We have considered, but find unpersuasive, Patent Owner’s counterview that the Board should disregard Mann because, according to Patent Owner, the reference is directed “to teratologists or reproductive toxicologists, not pharmacists or [] those focusing on risk management.” Resp. 44. Patent Owner’s position on that point is not persuasive in view of Patent Owner’s own prior reliance on information supplied by teratologists in connection with the controlled distribution of thalidomide. Reply 16–17 (citing Ex. 2094, 7, 130, 137). Taking account of the full record developed during trial, we credit Dr. Fudin’s testimony that a person of ordinary skill in the art would have recognized the desirability of identifying a subpopulation of male patients in view of Mann. Ex. 1002 ¶¶ 95–98. We are persuaded that Mann reveals the state of the art at the time of the invention, and supports Dr. Fudin’s testimony that an ordinary artisan would have 7 Passage of Chemicals into Human and Animal Semen: Mechanisms and Significance, Thaddeus Mann and Cecelia Lutwak-Mann, CRC Critical Reviews in Toxicology (1982) 11:1, 1–14 (Ex. 1018, “Mann”). understood the necessity of counseling males, capable of impregnating females, about the risks that attend fetal exposure to a teratogenic drug. Pet. 23 (quoting Ex. 1002 ¶¶ 95–98 (citing Ex. 1018, 7–8) (Mann, suggesting that thalidomide was known to become “strongly adsorbed by spermatozoa” and adversely affect the pregnancy in female rabbits mated to males that were administered thalidomide prior to conception)). We have considered, but are not persuaded by, Patent Owner’s counterview that one would not have considered Mann’s discussion of rabbit sperm to apply to human sperm. Resp. 44–45. As Petitioner points out, Patent Owner previously admitted that studies relating to rabbit sperm were relevant to evaluating the effects of thalidomide on human sperm. Reply 17 (citing Ex. 2064, 951). Dr. Fudin’s opinion—that it would have been “apparent that the sperm of male patients could be damaged by teratogenic drugs and consequently result in birth defects, if the male was to impregnate a female”—is supported by objective factual evidence, namely, Mann. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Ex. 1018, 7–8)). We recognize that Powell’s Patient Information Sheet, under a heading relating to “side effects,” contains this statement: “No effects on male sperm are recognized.” Ex. 1005, 903; Resp. 45. That isolated statement in Powell, standing alone, does not defeat the sufficiency of Petitioner’s evidence that one of ordinary skill in the art would have recognized that the sperm of male patients, treated with teratogenic drugs, could result in birth defects. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Mann (Ex. 1018, 7–8)). Significantly, the statement in Powell is preceded by a discussion of the necessity of using “adequate contraception throughout the duration of thalidomide therapy.” Ex. 1005, 903. When read in the context of the surrounding disclosure, Powell suggests that no contraceptive “effects on male sperm are recognized” as a side effect of thalidomide therapy. Id.” slip op. at 16

  Patent outcomesUS 6,045,501 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 6,045,501

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.