• 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
• Clearcorrect Operating, LLC v. Align Technology, Inc.All claims unpatentable
  PTAB · Mar 24, 2017 · IPR2016-00270 · APJ James J Mayberry · IPR · Final written decision

  Claims 1, 2, 9, and 10 are unpatentable under § 103(a) over Snow, Hultgren, and Kesling.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros. v. United States, 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.). We find that the prior art of record is primarily directed to computer modeling an individual patient’s teeth and orthodontics. For example, Snow is primarily focused on creating a three-dimensional computerized dental record for an individual patient. Ex. 1003, Abstract. Hultgren is related to generating electronic data by scanning dental and soft tissue of a specific patient. Ex. 1004, Abstract. The ’037 patent’s “Description of the Background Art” describes tooth positioners for orthodontic treatment and digital imaging for designing orthodontic appliances and orthodontic treatment. See Ex. 1001, 2:21–63; see also id. at 9:44–47 (“General techniques for producing plaster casts of teeth and generating digital models using laser scanning techniques are described, for example, in U.S. Pat. No. 5,605,459.”). Align contends “that digital modeling was in its very early stages in the relevant timeframe and that practitioners were still in the process of determining how best to measure 3D tooth models.” PO Resp. 35 (citing to Dr. Mah’s deposition testimony). This contention contradicts the ’037 patent, which discloses that generating three-dimensional digital data representing the shape and position of a patient’s tooth was known in the prior art. See, e.g., Ex. 1001, 9:44–48 (incorporating by reference into the ’037 patent U.S. Patent No. 5,605,459, which discloses generating three-dimensional electronic data representing a patient’s teeth); id. at 2:50–52 (identifying as background art U.S. Patent No. 5,011,405, which discloses a number of ways to generate accurate digital information defining the shape and location of a patient’s tooth).4 As ClearCorrect contends, the record is replete with evidence that the level of ordinary skill of a practicing orthodontist encompasses knowledge of making three-dimensional representations of the shape and location of an individual patient’s teeth. See Reply 14–15. Accordingly, based on our underlying factual findings discussed above, we determine that the level of ordinary skill in the art is a practicing orthodontist, including a person having a doctorate in dental science and three to five years of training and practical experience in orthodontics or a person with expertise in digital modeling and analysis and substantive knowledge of orthodontics.” slip op. at 7

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

    “Claim construction begins with the language of the claims. Source Vagabond Sys. Ltd. v. Hydrapak, Inc., 753 F.3d 1291, 1299 (Fed. Cir. 2014). We discern no language in the “providing” steps themselves that require that the digital data be three-dimensional representation of a patient’s actual teeth. The express phrase “plurality of digital data sets” is not further limited to the underlying source of the digital data, whether it be two-dimensional or three-dimensional data. Further, the claim language characterizes a plurality of digital data sets as representing a progression from an initial tooth arrangement, through at least one successive tooth arrangement, to a final tooth arrangement. Align fails to adequately explain how this language requires the initial and successive tooth arrangements to include the actual shape of individual teeth. As we discuss in greater detail below, claims 1 and 9 recite that the digital data sets representing these successive tooth arrangements serve as the basis for fabricating incremental position adjustment appliances, but the claim language does not otherwise limit these appliances to appliances requiring to fit precisely the actual shape of the patient’s tooth. See, e.g., Ex. 1001, 8:50–54 (defining appliances broadly to include, for example, retainers, which would not necessarily include tooth-receiving cavities that must be precisely fit to a patient’s actual tooth).” slip op. at 11

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

    “obviousness determination is a pure question of fact.’” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (quoting Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)). ClearCorrect reasons that a person of ordinary skill in the art at the time of the invention of the ’037 patent would have combined the teachings of Snow, Hultgren, and Kesling to arrive at the invention of claims 1 and 9 to provide more precise dental appliances and save manufacturing costs. Pet. 22. ClearCorrect explains that a skilled artisan would have been motivated to create a plurality of digital data sets and digitally reposition the teeth, as taught by Snow, and to use the digital data sets representing the repositioned teeth to control a fabrication machine to produce a plurality of positive casts of the successive tooth arrangements, as described by Hultgren. The positive casts would then be used for producing the plurality of dental incremental position adjustment appliances well known in the art, as negatives of the positive casts taught by Kesling. Id. (citing Ex. 1007 ¶¶ 54-55; Ex. 1008 ¶¶ 101-102). ClearCorrect further explains that Snow, Hultgren, and Kesling are all in the field of dentistry and are concerned with creating or manipulating three-dimensional models of a patient’s teeth. Pet. 22. ClearCorrect contends that the combination would result in more precise dental appliances as Snow’s digital data represents more precise tooth arrangements as compared to Kesling’s manual process. Id. at 22–23. Also, machine fabrication of positive models would save manufacturing costs as it replaces Kesling’s labor-intensive process. Id. at 23. As ClearCorrect further explains, the combination represents merely automating a known manual process. Id. Finally, ClearCorrect explains that the predictability in the art would have suggested to the artisan of ordinary skill that there was a reasonable likelihood of success. Id. (citing Ex. 1007 ¶ 55 and Ex. 1008 ¶ 105).” slip op. at 33

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

    “For objective evidence to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). “[T]here is a presumption of nexus for objective considerations when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘is the invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1329 (Fed. Cir. 2016) (internal citation omitted); see also PPC Broadband, Inc. v. Corning Optical Commc’ns RF, LLC, 815 F.3d 734, 747 (Fed. Cir. 2016) (“Because the evidence shows that the SignalTight connectors are ‘the invention disclosed and claimed in the patent,’ we presume that any commercial success of these products is due to the patented invention . . . . This is true even when the product has additional, unclaimed features.”) (internal citations omitted). “The presumption of nexus is rebuttable: a patent challenger may respond by presenting evidence that shows the proffered objective evidence was ‘due to extraneous factors other than the patented invention.’ Such extraneous factors include additional unclaimed features and external factors, such as improvements in marketing.” WBIP, LLC, 829 F.3d at 1329 (internal citation omitted). We find that Align is entitled to the presumption of a nexus. Align offers evidence that its method claimed in claims 1, 2, 9, and 10 is used in producing it products. See PO. Resp. 45–47. As discussed in greater detail below, we further find, however, that the record evidence rebuts this presumption. Accordingly, we afford little weight to Align’s commercial success evidence. We find that the record evidence demonstrates that the commercial success is attributable, in greater part, to the aesthetic appeal and convenience of products in addition to any computer implementation and fabrication reflected in the challenged claims. For example, Align’s 10-K for 2000 states that its products “significantly reduces the aesthetic and other limitations associated with braces.” Ex. 2018, 5.14 Align states that benefits of its products include excellent aesthetics, comfort, improved oral hygiene, reduced treatment time, reduced root absorption, and reduced emergency situations as broken aligners can be replaced. Id. at 8. Align fails to explain how these benefits are attributed to claimed features of the challenged claims. See also Ex. 2019, 7–8 (providing a 10-K for 2003 that provides benefits to dental professionals and patients, with only one benefit— 14 In referencing Align’s 10-K exhibits, we cite to the exhibit page number, not the 10-K page number. “[a]bility to visualize treatment and likely outcomes”—attributable to claimed features of the challenged claims); Ex. 2020, 7–8 (providing the 10- K for 2006 stating the same benefits); Ex. 2021, 10–11 (providing 10-K for 2008 stating same benefits); Ex. 2022, 12 (providing 10-K for 2011 stating favorability with respect to key competitive factors are “effectiveness of treatment; price; software features; aesthetic appeal of the treatment method; customer support; customer online interface; brand awareness; innovation; distribution network; comfort associated with the treatment method; oral hygiene; ease of use; and dental professionals’ chair time”); Ex. 2023, 13 (providing 10-K for 2014 with same statement as in 2011 regarding favorability with respect to key competitive factors); Ex. 2024, 12 (providing 10-K for 2015 with same statement as in 2011 regarding favorability with respect to key competitive factors). Other record evidence also supports a finding that any commercial success of Align’s products is attributable, at least in part, to unclaimed features. For example, Exhibit 2025 indicates that features such as the invisible nature of the aligners and comfort attribute to the products’ success. See Ex. 2025, A Stealth Substitute for Braces, Designed Only for Adults, col. 2. The article also notes Align’s $38 million advertising campaign. Id. at col. 3; see also Ex. 2012, 2 (explaining that Align initiated “the first effort by an orthodontics products company to appeal directly to consumers through television”). Further, the article quotes Dr. Jerrold, program director of postgraduate orthodontics at New York University’s School of Medicine, as saying “[t]he only reason that this is a better mousetrap is that it’s invisible.” Id. at col. 4. Further, as ClearCorrect argues, Dr. Valley testified that Align’s product success was attributable to factors that includes aligners that are less noticeable than braces, more comfortable than braces, and allows for better oral hygiene than braces. See Reply 21; Ex. 1056, 34:8–35:5. Still further, a finding that any commercial success of Align’s slip op. at 41

  Patent outcomesUS 6,699,037 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,699,037
• 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
• 10x Genomics, Inc. v. Raindance Technologies, Inc.All claims unpatentable
  PTAB · Jan 18, 2017 · IPR2015-01558 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1–17 are unpatentable: claims 1–7 and 10–17 as obvious over Link, and claims 8–9 as obvious over Link and Nguyen.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We accept Petitioner’s assertions regarding the level of ordinary skill in the art, as set forth in the paragraph bridging pages 3 and 4 of the Petition. Our finding is supported by Dr. Huck’s testimony (Ex. 1002 ¶ 12), as well as the prior art references cited by Petitioner, which reflect the level of skill in the art asserted by Petitioner. See, e.g., Ex. 1004 ¶¶ 160, 316 (discussing use of aqueous droplets in microfluidic devices as “nanoreactors” for chemical and biochemical reactions and assays); Ex. 1006, 2 (discussing principles of fluid dynamics relevant to droplet formation in microfluidic devices); Ex. 1009,1 2032 (review article addressing fluid dynamics of microfluidic droplets, including for “lab on a chip” applications in which chemical or biochemical reactions are performed in droplets). See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the level of skill in the art).” slip op. at 7

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

    “their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, we generally give claim terms their ordinary and customary meaning, as understood by a person 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). We construe claim terms only to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Construction of claims 1–3 is discussed below in connection with patentability of those claims over Link. Except for the terms of claims 1–3 discussed below, we determine that it is not necessary to provide an explicit construction of any other claim term for purposes of this decision.” slip op. at 6

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

    “Under a broadest reasonable construction, the phrase, “a reservoir,” in claim 2 means one or more reservoirs. See Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008) (“[A]n indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of ‘one or more’ in open-ended claims containing the transitional phrase ‘comprising.’”). Applying this construction in context, claim 2 requires that each carrier fluid channel be in fluid communication with one or more reservoirs, all of which apply a same constant pressure to the carrier fluid. Based on that construction, we do not accept Patent Owner’s position that claim 2 requires a common syringe for all of the oil channels in the system. PO Resp. 40.” slip op. at 34

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

    “droplet formation disclosed in Link relates to the step of “applying a same constant pressure to the carrier fluid in each of the immiscible carrier fluid channels.” Ex. 1001, 16:17–28. More specifically, we find that, although Link teaches controlling pressures applied to the carrier fluid and aqueous fluid channels to regulate droplet size and periodicity (Ex. 1004 ¶ 166), Link does not expressly disclose applying a “same constant pressure” to the carrier fluid in each of the immiscible carrier fluid channels, as recited in the penultimate step of claim 1. For the reasons discussed below, we find that the preponderance of the evidence supports that a person of ordinary skill in the art would have found it obvious to implement Link’s disclosures by applying a same constant pressure to the carrier fluid in each of the immiscible carrier fluid channels. This step of claim 1 includes two aspects: (1) applying a same pressure, and (2) applying a constant pressure. We discuss each aspect below.” slip op. at 16

  Patent outcomesUS 8,658,430 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,658,430
• Advanced Micro Devices, Inc. v. LG Electronics Inc.All claims unpatentable
  PTAB · Jan 4, 2017 · IPR2015-01411 · APJ Kalyan K Deshpande · IPR · Final written decision

  Claims 1, 9–13, 15, 19, and 20 are unpatentable as obvious over Zhang and Altmejd and over Orenstien and Filippo.

  RulingsFinal written decision

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

    “We interpreted “power conversion unit,” under the broadest reasonable interpretation, to mean “a system or device that changes power from one form or level to another” in our Decision to Institute. Dec. 5‒6. Patent Owner has not presented any further arguments that would require us to disturb that construction. Accordingly, on this record, we interpret “power conversion unit” to mean “a system or device that changes power from one form or level to another.” See id. 2. “power management unit” Claim 1 recites a “power management unit.” In our Decision to Institute, we interpreted “power management unit” to mean “hardware or software that manages or assists in managing of power.” Id. at 6‒8. Patent Owner does not present any arguments that would require us to disturb that construction. Accordingly, on this record, we interpret “power management unit” to mean “hardware or software that manages or assists in managing of power.” See id..” slip op. at 5

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

    “blocks and processor cores, including the vast differences in sizes and structure, communication patterns, timing issues, and redesign of circuitry are not persuasive because they assume a bodily incorporation of Altmejd’s functional units in to Zhang’s processor core system, whereas Petitioner’s rationale to combine is limited to power-management of processor cores of Zhang with the power-management policy taught by Altmejd. “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference. . . . Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, the issue is what the combination of Zhang and Altmejd would have suggested to a person with ordinary skill in the art. Altmejd discloses the adjustment of power to functional units based on usage amounts, and a person with ordinary skill in the art would have been motivated to combine the specifics of Altmejd’s power management policies in to Zhang. Pet. 16‒17 (citing Ex. 1002 ¶ 47). Specifically, a person with ordinary skill in the art would have been motivated to combine Altmejd’s power management policy to Zhang in order to provide a more granular and efficient power management policy, and, as explained by Mr. Gafford, Altmejd’s power management policy would lead to more cost savings. Id. at 17‒18 (citing Ex. 1002 ¶ 48). Petitioner identifies that this motivation is explicitly disclosed in the Zhang and Altmejd, where Zhang discloses the individual turning off of processor cores “may result in a reduction of the overall power consumed by the processor” (Ex. 1006 ¶ 30), and Altmejd discloses that “it is advantageous from a power savings perspective to reduce the voltage when possible because the power saved is proportional to the square of the voltage reduction, whereas the power savings is linear with respect to frequency reductions” (Ex. 1007, 7:9–13). Pet. 18‒19 (citing Ex. 1002 ¶ 49). Petitioner’s analysis demonstrates that the claimed combination is merely a combination of known elements, for their known use to achieve a predictable result. Accordingly, we are not persuaded by Patent Owner’s argument that a person with ordinary skill in the art would not have been led to combine the teachings of Zhang and Altmejd because of the difference between functional units and processor cores only. Rather, Petitioner has demonstrated by a preponderance of the evidence that a person with ordinary skill in the art would have been motivated to combine the power management policy described by Altmejd in to Zhang’s multi-core processor management system.” slip op. at 14

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

    “We disagree with Patent Owner. “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” Ricoh Co., Ltd. v. Quanta Computer, Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008) (citations and quotation marks omitted). We are unpersuaded by Patent Owner’s citations to Orenstien as criticizing an on/off scheme as teaching away from such a scheme. Orenstien’s disclosure of such a scheme’s impact on performance and latency is, at best, a general preference to minimize the use of an on/off scheme. A reference does not teach away if it merely expresses a general preference for an alternative invention from amongst options available to the ordinarily skilled artisan, but does not discredit or discourage investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Orenstien’s characterization is more fully understood as a preference, rather than discouragement or discrediting, because, as argued by Petitioner, Orenstien discloses an embodiment that turns a processor core off. Pet. Reply 15 (citing Ex. 1008, 6:6‒46, Fig. 4; Pet. 43; Ex. 1002 ¶ 103).” slip op. at 25

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

    “We disagree with Patent Owner. Claim 1 recites “a first power conversion unit configured to independently supply a first supply voltage to the first core” and “a second power conversion unit configured to independently supply a second supply voltage to the second core.” Claim 1 further recites “the first supply voltage being controlled based on the information relating to the usage amount of the first core and being controlled independent of the information relating to the usage amount of the second core” and “the second supply voltage being controlled based on the information relating to the usage amount of the second core and being controlled independent of the information relating to the usage amount of the first core.” As such, although we agree with Patent Owner that claim 1 explicitly requires that the voltages supplied to the first and second core are based on usage information of that core, and independent of the usage information of the other core, we agree with Petitioner that claim 1 does not recite the “based only on” language as alleged by Patent Owner. Regardless, we determine that the combination of Zhang and Altmejd discloses the claimed limitations under either construction. See id. As discussed above, Zhang discloses supplying voltages to each core” slip op. at 16

  Patent outcomesUS 7,664,971 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,664,971
• 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 · IPR2015-01102 · APJ Michael P Tierney · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Based 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 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; 2066. 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 ¶¶ 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 10

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

    “The specification defines prescription approval code such that the 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) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “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 22

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

    “Patent Owner states that Cunningham’s pharmacy approval code is part of a method of tracking and managing the dispensing of pharmaceutical trial products and has no connection to patient information at all. Id. at 38. Patent Owner also states that Cunningham’s pharmacy approval code is merely a number or identifier associated with samples of pharmaceutical products. Id. at 39. Patent Owner contends that a person of ordinary skill in the art would have therefore understood that Cunningham’s pharmacy approval code is not the same as the claimed prescription approval code. Id. at 39–40. Cunningham describes a method of dispensing, tracking, and managing pharmaceutical products whereby prescribers and pharmacies are linked to a central computing station. Ex. 1008, 1:6–11. Certain pharmaceutical drugs, such as thalidomide, were known in the art to require a prescription in order for a patient to be provided the drug whereby a prescriber would authorize a patient to receive a drug from a pharmacy. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421. Dr. Fudin testified that the use of an approval code of Cunningham could be like that of a consumer credit card approval code, and is used to track things and the technology should allow you to combine it with other materials that you could track. Ex. 2061 at 412:17–25, 429:18–430:10. Based on the record presented, we hold that a person of ordinary skill in the art would understand that an approval code used by prescribers and pharmacies to track and manage pharmaceutical products could likewise be used by prescribers and pharmacies to track and manage prescription pharmaceutical products. We further hold that the claimed improvement recited in the challenged claims represents 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).” slip op. at 25

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720

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.