• 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
• 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
• 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
• Google Inc. v. Better Food Choices LLCAll claims unpatentable
  PTAB · Aug 18, 2016 · CBM2015-00071 · APJ Minn Chung · CBM · Final written decision

  Claims 1–20 are unpatentable under § 101; claims 1–10 are also indefinite under § 112, ¶ 2 because the specification lacks an algorithm for the claimed correlating function.

  RulingsFinal written decision

  • BurdenOther

    “As an initial matter, Patent Owner asserts that Petitioner has not met its burden of proof because Petitioner relies only on the ’115 patent and its prosecution history to argue unpatentability and does not present any other evidence, such as a witness. PO Resp. 6–7, 13–20. Patent Owner argues that Petitioner has presented no evidence of unpatentability because the ’115 patent and its file history “shows the Patent Owner has a valid, issued patent and nothing more.” Id. at 7. We are not persuaded because, as discussed below, in this case we need to look only to the ’115 patent and its prosecution history to support a finding of unpatentability under §§ 101 and 112. See In re TLI Comm. LLC Patent Litig., 823 F.3d 607, 613–14 (Fed. Cir. 2016) (the patent alone is sufficient to sustain a finding of unpatentability under § 101).” slip op. at 12

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “rebuttable presumption that the limitation is written in a means-plus-function format under 35 U.S.C. § 112, ¶ 6. TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir. 2008) (citation omitted). If, in addition to the word “means” and the functional language, the claim recites sufficient structure for performing the described functions in their entirety, the presumption is overcome, and § 112, ¶ 6 does not apply. Id. “Sufficient structure exists when the claim language specifies the exact structure that performs the functions in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure.” Id. at 1259–60.” slip op. at 28

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

    “with the Supreme Court and Federal Circuit precedents on step one analysis under the Alice framework. In step one of the Alice analysis, to determine whether the challenged claims are directed to an abstract idea, the inquiry is to ask, considered in light of the Specification, whether “their character as a whole” is directed to an abstract idea, not, as Patent Owner contends, identifying the “core invention” of the patent. See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015)). Relying on the distinction made in Alice between, on one hand, computer-functionality improvements and, on the other, uses of existing computers as tools in aid of processes focused on “abstract ideas,” the court in Enfish clarified that a relevant inquiry in step one of the Alice framework is to ask whether the “focus” of the claims is on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an “abstract idea” for which computers are invoked merely as a tool. Enfish, 822 F.3d at 1335–36 (citing Alice, 134 S. Ct. at 2358–59). In this inquiry, claims “directed to an improvement in the functioning of a computer” are contrasted with claims “simply adding conventional computer components to well-known business practices” or “generalized steps to be performed on a computer using conventional computer activity.” See TLI, 823 F.3d at 612 (quoting Enfish, 822 F.3d at 1338). The Federal Circuit further clarified recently and described the first-stage inquiry as “looking at the ‘focus’ of the claims, their ‘character as a whole.’” Elec. Power Grp., LLC v. Alstom S.A., No. 2015-” slip op. at 17

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptUnpatentable

    “claims fail to recite any elements that individually or as an ordered combination transform the abstract idea of collecting and correlating information to provide personalized nutritional information of food products to shoppers into a patent-eligible application of that idea. It is well-settled that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea. TLI, 823 F.3d at 613. Rather, the recited components must involve more than performance of “‘well- understood, routine, conventional activit[ies]’ previously known to the industry.” Alice, 134 S. Ct. at 2359 (quoting Mayo, 132 S. Ct. at 1294).” slip op. at 22

  Patent outcomesUS 5,841,115 unpatentable
  Claim construction§ 101 eligibility§ 112 disclosurecites Alice · Mayo · Bilski · Enfish · Nautilus
  Patents in suitUS 5,841,115
• Lower Drug Prices For Consumers, LLC v. Forest Laboratories Holdings LimitedInstitution denied
  PTAB · Jul 1, 2016 · IPR2016-00379 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution for claims 1–6 under § 325(d), finding substantially the same prior art and arguments had been presented during prosecution.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “the Petition under § 325(d) because Petitioner’s obviousness challenge is based on (i) the same primary reference addressed during prosecution, including by the Board in an appeal; and (ii) the same arguments regarding that primary reference and how it allegedly would have been modified. Prelim. Resp. 56–60. Upon reviewing the Petition, Preliminary Response, and the prosecution history of the ’040 patent, we agree. During prosecution, the examiner rejected the claims as obvious over Van Lommen. Here, Petitioner also relies primarily on Van Lommen to argue the claims are obvious. We, therefore, find that substantially the same prior art was previously presented to the Office. We also find that substantially the same arguments were previously presented to the Office, including to the Board. Petitioner argues that a person of ordinary skill in the art would have selected Compound 84 of Van Lommen as a base compound for investigation and would have been motivated to stereochemically separate the stereoisomers of Compound 84 using the chromatography techniques disclosed in the secondary prior art references. Pet. 33. As Patent Owner notes, however, the examiner repeatedly stated that “the skilled artisan would have seen optical isomer separation as a routine procedure leading to the compounds claimed herein.” Prelim. Resp. 57 (citing Ex. 1002, 48, 73, 88, 113). Thus, Petitioner asserts substantially the same argument that the examiner asserted during prosecution.” slip op. at 9

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

    “The claims recite a composition “consisting of” the claimed compound. The parties agree that the transitional phrase “consisting of” is a term of art in patent law that “closes” the claim and excludes other elements, steps, or ingredients not specified in the claim. Pet. 29–30; Prelim. Resp. 23. 4 Armstrong et al., Separation of Drug Stereoisomers by the Formation of β- Cyclodextrin Inclusion Complexes, 232 SCIENCE 1132–35 (1986) (Ex. 1007). expected impurities or additional components or steps that are unrelated to the invention. Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1360 (Fed. Cir. 2006). Accordingly, we determine that the term “consisting of” does not exclude the presence of ordinary expected impurities or the presence of additional components that are unrelated to the invention.” slip op. at 5

  • Obviousness (§103) › Objective indicia / secondary considerationsOther

    “concluding the applicants’ evidence of unexpected results sufficient, and implicitly finding a sufficient nexus between the evidence and the claimed invention. See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.”) (quoting Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010)). Finally, Petitioner argues that it has submitted “ample evidence” that the compounds of claims 1 and 2 would be the intended and expected result of combining the asserted references, and that claims 3–6 would not be an unexpected result of the suggested combination. Pet. 56 (citing Ex. 1050 ¶¶ 50, 56, 66, 73, 74, 81, 93, 106; Ex. 1052 ¶¶ 60–68, 93, 100). But Petitioner’s cited evidence relates to how a person of ordinary skill in the art would have considered separating and studying the stereoisomers of compound 84 to be ordinary and routine. See, e.g., Ex. 1050 ¶ 73 (“A POSITA at the time would have had an expectation that this stereochemical resolution could be easily achieved using known and commercially available techniques, without undue experimentation.”); Ex. 1052 ¶ 93 (“[I]t is my opinion that a POSITA at the time of the ’040 Patent’s priority date, would have been motivated to carry out standard new-drug investigation on each of the purified stereochemical forms in order to determine the effectiveness of each stereochemical form, to determine whether the drug could be administered as a racemic mixture or whether a purified enantiomer was required, to determine the interactions between stereoisomers if administered together, and to determine the effective amounts of each compound necessary for treatment of hypertension.”). The Board, however, assumed examiner established a prima facie case of obviousness. Ex. 1002, 199. Nevertheless, the Board still found the unexpected results evidence presented by the applicants to be sufficient. Finally, although the prior panel expressly set forth the deficiencies in the examiner’s position with respect to the evidence of unexpected results, the Petition is silent as to those deficiencies. In particular, Petitioner has not offered sufficient evidence to show why an ordinary artisan “would have expected the RSSS stereoisomer to have such [potentiating] properties” or to show “that the potentiating property, described in the declaration, is insignificant.” See Ex. 1002, 200. Because Petitioner has not addressed these issues, we are not inclined to reconsider the Board’s prior decision. Accordingly, under the facts and circumstances of this case, we find that readjudicating substantially the same prior art and arguments as those presented during prosecution would not be an efficient use of Board resources.” slip op. at 11

  Claim construction§ 103 obviousnessDiscretionary denial
  Patents in suitUS 6,545,040
• Nestlé USA, Inc. v. Steuben Foods, Inc.All claims unpatentable
  PTAB · Jun 2, 2016 · IPR2015-00195 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–10, 14, 16–21, 25, 27, 29, and 32–36 are unpatentable as obvious over either of two combinations of prior art.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “Petitioner’s new arguments and evidence do not persuasively demonstrate that the machines purchased as lines 1–6/7 were built to Petitioner’s specification, nor has Patent Owner demonstrated persuasively that the purchase agreements otherwise created privity between GEA and Petitioner. Even if the agreements for lines 1–6/7 were similar to the Line 8 Agreement as Patent Owner contends, we examined the relationship created by the Line 8 Agreement in detail, and determined that Petitioner and GEA were not privies. See Inst. Dec. 6–17. Given this, Patent Owner has added nothing new of significance since our Institution Decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “with the specification does not limit the claimed “sterilant concentration levels” to only airborne concentrations. We recognize that the specification, in one instance, refers to zones with “different concentration levels of gas laden sterilant (e.g., hydrogen peroxide in air).” Ex. 1001, 9:51–53. The specification, however, refers elsewhere to the “residual concentration” of H2O2, measured in terms of ppm. Id. at 12:46–47 (“The hot sterile air knives 208 also remove the hydrogen peroxide from the lids 200 so that the residual concentration of hydrogen peroxide is less than 0.5 PPM.”) (emphasis added); see also id. at 11:15–17 (“After bottle 12 has dried, the residual hydrogen peroxide remaining on the bottle 12 surface is less than 0.5 PPM.”) (emphasis added). Patent Owner acknowledges that “[o]ther discussions of ppm within the specification are in the context of residual sterilant on the bottle,” which is measured in accordance with the FDA Regulations (21 C.F.R § 178.1005(d) (Ex. 1013)) as the concentration in distilled water, but nonetheless asserts that “[t]his is consistent with the definition of ‘sterilant concentration’ in the context of the claim [as] parts of sterilant per million parts of carrier gas.” PO Resp. 6. However, insofar as it is undisputed that “residual” sterilant concentrations on the bottle surface are disclosed in the specification and encompassed by the claim scope, Patent Owner does not explain why the skilled artisan would have understood such a concentration would be measured as parts of sterilant per million parts of carrier gas (i.e., airborne) as opposed to parts of sterilant per million parts of distilled water in accordance with the FDA Regulations. See Ex. 1013, 326 (“No use of hydrogen peroxide solution in the sterilization of food packaging material shall be considered to be in compliance if more than 0.5 part per million of hydrogen peroxide can be determined in distilled water packaged under production conditions.”). In short, neither the claims nor the specification limit how or where within “the plurality of zones” the sterilant concentration levels should be assessed in order to determine whether the 5 to 1 ratio is satisfied. As such, we find no basis to limit the claimed sterilant concentration levels to only airborne concentrations.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “14 Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would possess “an undergraduate scientific or engineering degree in a relevant field (such as microbiology or mechanical, packaging, process, or food engineering), at least five years of experience in an aseptic packaging and/or processing field (or a graduate degree conferring similar expertise), and an understanding of the relevant principles of microbiology and food science and technology.” Pet. 12; Ex. 1004, ¶ 12. Patent Owner has not contested that definition in its Patent Owner Response, but its expert Dr. Sharon asserts that Petitioner’s definition is only partially correct insofar as it does not recognize that the POSITA could have a mechanical engineering Patent Owner’s arguments are directed primarily to the sterilant concentration ratio requirement recited in each of the challenged independent claims 1, 4, 17, and 33. Specifically, the challenged claims all require that the sterilant concentration levels in the plurality of zones within the sterilization tunnel “are maintained at a ratio of at least about 5 to 1.” Accordingly, we focus on that limitation, and treat the claims together for purpose of our analysis. 1. Scholle in view of Chambers, the FDA Regulations, Biewendt, Kelbrick, Elliott, Akai, and Kodera Petitioner asserts that, using partitions and pressure differentials, the apparatus of Scholle (Ex. 1004) is configured to prevent the H2O2 sterilant from migrating from the sterilizing compartment to the drying and filling compartments, and, thus, the sterilant concentration in the sterilization compartment of Scholle is necessarily different from the concentration in the drying and filling compartments. Pet. 20 (citing Ex. 1004 ¶ 55; Ex. 1005, 6:36–41). Petitioner also points to Scholle’s teaching of using a 30% solution of H2O2 in water (i.e., 300,000 ppm) as a sterilant (id. at 21 (citing Ex. 1004 ¶ 56; Ex. 1005, 5:18–22)), and asserts that the skilled artisan “would understand that to ensure consistent sterilization and residual peroxide levels, the concentration of applied sterilant must necessarily be ‘maintained.’” Id. degree. Ex. 2056, ¶ 12. We note, however, that Petitioner has included mechanical engineering as a “relevant field” within its definition. Accordingly, we apply Petitioner’s proposed level of skill in the art in our analysis.” slip op. at 19

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

    “A preponderance of the evidence supports the conclusion that the skilled artisan would have found it obvious to optimize the sterilant concentration levels within the different “zones” (i.e., compartments) of Scholle’s apparatus in such a manner. Several features of Scholle’s apparatus facilitate such an optimization. First, a 30-percent solution of H2O2 in water is atomized and continuously sprayed into the spraying compartment during operation. Ex. 1005, 5:18–26, 45–49. Second, the spraying zone is separated from other compartments by a partition with a narrow opening designed “to reduce the amount of [H2O2] mist passing through the opening.” Id. at 6:12-15. Third, in the drying compartment, the H2O2 is “evaporated” and vented out of the sterile tunnel. Id. at 6:33-36, 44- 55. And finally, the sterile air maintains a positive pressure in the filling and drying compartments, thus reducing any tendency of the H2O2 mist in the spray compartment to migrate through the narrow opening into those other compartments. Id. at 5:36–43, 6:36-41. Although the parties dispute the particular concentration of H2O2 that exists in the sterilization tunnel after it is sprayed, there is no dispute that the spraying compartment in Scholle’s apparatus will have a higher sterilant concentration than the filling compartment. Indeed, even if airborne concentration levels were to be considered, Patent Owner’s counsel acknowledged during oral argument that “there is going to be more sterilant in the air in the spray zone than in the fill zone.” Tr. 122:12–14; see also Ex. 1035, 122:21–123:3 (Patent Owner’s expert Dr. Sharon conceding that the airborne concentration is lower in the fill zone than in the spray zone). Furthermore, we find that the concentration of the 30% solution of H2O2 will remain close to 300,000 ppm in the liquid phase at some point after it is sprayed into the spraying compartment. Scholle discloses that the spray heads atomize the H2O2 solution into a “fine mist or fog,” which coats the exterior of the containers to kill microorganisms. Ex. 1005, 5:22–23, 8:8–13. Although Dr. Sharon asserts that the skilled artisan “would be motivated to use as little sterilant in the sterilization zone as necessary to get the job done” (Ex. 2056, ¶24), he nonetheless acknowledged that, after condensation, the concentration of liquid H2O2 that coats the containers is “somewhere in the neighborhood” of 30%, or 300,000 ppm. Ex. 1035, Tr. 105:17–106:15. Here, we also credit Dr. Heldman’s testimony who stated that although the process of atomizing H2O2 may “result in varying concentrations,” the skilled artisan nonetheless “would understand that to ensure consistent sterilization and residual peroxide levels, the concentration of applied sterilant must necessarily be ‘maintained.’” Ex. 1004 ¶¶ 51, 56.” slip op. at 22

  Patent outcomesUS 6,475,435 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 6,475,435

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.