- Shenzhen Apaltek Co., Ltd. v. Asetek Danmark A/SAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 10,078,355 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00012 · APJ Sheldon M Mcgee · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the remaining anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). And, although there are no bright-line rules for the amount of disclosure needed in an unpredictable art, that amount “necessarily changes with each invention” and “changes with progress in the field.” Ariad, 598 F.3d at 1351. Here, we find that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. Thus, we conclude that the ’525 application requires a more-detailed disclosure than would be required in a predictable field to adequately demonstrate possession of a heat-transfer composition consisting essentially of HFO-1234yf and PAG for use in AAC. (iii) Disclosure in the ’525 Application With these background findings in mind, we now turn to the four corners of the ’525 application—and we find that the ’525 application does not contain the detailed disclosure needed in this case to reasonably convey possession of a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for use in AAC.” slip op. at 37
- Skill levelSkill level board ownDecided for patent owner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“Tr. 114:15–115:18 (emphases added). Thus, we find that Patent Owner does not contest that a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for AAC was in public commercial use before the March 26, 2014, filing date of the ’017 patent. Accordingly, we find that Petitioner’s evidence, together with Patent Owner’s concessions, demonstrates by a preponderance of evidence that the claimed subject matter of the ’017 patent was in commercial use before its March 26, 2014, effective filing date. See Ex. 1002 ¶¶ 399–409. In particular, as to claims 1, 3–10, 12, 13, and 15–20, we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant AAC composition of the Ford Transit Custom Bus, the Mazda CX 5 (2.0i and 2.2D), and the Opel Mocca used HFO-1234yf and a PAG lubricant as early as 2012. Ex. 1002 ¶ 399 (citing Ex. 101324, 2, 38, 55, 70). We also credit Dr. Brown’s 24 Behr Hella Services, Refrigerant and Oil Filling Quantities Passenger Cars & Commercial Vehicles 2014–15. PGR12 Ex. 1013. (“Service Guide”). PGR12 Ex. 1013. The Service Guide provides tables setting forth specifications for refrigerant type, refrigerant quantity, vehicle manufacturers’ original equipment compressor oil type, and oil filling quantity for the air-conditioning system of each vehicle listed in the tables. Id. at 2–3. Petitioner and Dr. Brown direct us to the Sevice Guide’s entries calculations, which show that the Ford Transit Custom Bus had an AAC refrigerant-lubricant composition of 26.7% of PAG lubricant and 73.3% of HFO-1234yf (Ex. 1002 ¶ 401 (citing Ex. 1013, 38)); the Mazda CX 5 2.0i had 16.7% PAG lubricant and 83.3% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 55)); the Mazda CX 5 2.2D had a 17.5% PAG lubricant and 82.5% HFO-1234yf (id.); and the Opal Mocca had 11.6% PAG lubricant and 88.4% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 70)). As to dependent claims 2, 11, and 14, which all require that the lubricant is present “in an amount from about 30% to about 50% weight,” we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant composition of the Ford Transit Custom Bus recited lubricant amount. Ex. 1002 ¶ 403. In particular, we agree with Dr. Brown that, because the lubricant accounts for 26.7% of the AAC refrigerant-lubricant composition in the Ford Transit Custom Bus, the lubricant makes up “about 30%” of the refrigerant-lubricant composition as claimed. Id. For these reasons, we find that Petitioner has met its burden to show that claims 1–20 are unpatentable for anticipation under § 102(a)(1).” slip op. at 55
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00011 · APJ Grace Karaffa Obermann · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the other anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Skill levelSkill level board ownDecided for petitioner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“We agree with Petitioner that the ’525 application’s statement that the compounds are “adaptable for use” weighs against a finding of adequate written description. First, “adaptable for use” is vague, as Dr. Bivens acknowledges. See Ex. 1177, 151:15 (testifying that “adaptable for use can have a wide range of meaning”). Second, the ’525 application gives no direction on how a skilled artisan would need to adapt any particular composition for use in AAC, or even if any “adaptation” was necessary. We find that such a teaching is important in this case to show that the inventors had possession of the claimed invention, given our findings above that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. For completeness, we again reject Patent Owner’s argument that “[t]o show the inventors possessed claim 1 requires no more” than the statement in the written description that “‘the compositions of the present invention are believed to be adaptable . . . with or without system modification.’” PGR12 Resp. 27–28 (quoting Ex. 1001, 7:4–8). Regardless of the exact wording of claim 1, the inventors “still [had to have] describe[d] some way of performing the claimed methods.” Ariad, 598 F.3d at 1355. And here, with merely a passing reference to AAC, the ’525 application fails to provide any credible “technologic knowledge” to demonstrate to an ordinarily skilled artisan that Patent Owner “was in possession of the invention that is claimed.” Id.” slip op. at 43
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“unless . . . the claimed invention was . . . in public use . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). “The proper test for the public use prong . . . is whether the purported use was accessible to the public or was commercially exploited.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quotation omitted). “Commercial exploitation is a clear indication of public use . . . .” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).” slip op. at 53
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - Mylan Pharmaceuticals Inc. / Wockhardt Bio AG et al. v. Astrazeneca ABNo claims unpatentablePTAB · Aug 18, 2017 · IPR2015-01340 · APJ Rama G Elluru · IPR · Final written decision
Petitioners failed to prove claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 unpatentable under the instituted §103 grounds, chiefly because the proposed modifications lacked a reasonable expectation of success.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“C. Credibility of the Experts We give more weight to the testimony of Patent Owner’s expert, Dr. Weber, over that of Petitioners’ expert, Dr. Rotella, with respect to testimony that is in direct conflict. We favor Dr. Weber’s testimony because of her extensive experience in the design and development of DP 4 inhibitors for type-2 diabetes treatment. See Ex. 2056 ¶¶ 9–12; Ex. 2210, 1– 2. Moreover, Dr. Weber entered the DP 4 field at the relevant time, i.e., the time of invention, around 2000. Ex. 1073, 108:16–21; Tr. 35:16–22. We find that her testimony has been consistent, not just throughout this proceeding, but also with evidence predating this proceeding. See, e.g., Ex. 2056 ¶¶ 88, 115–118; 154–162; Ex. 1073, 51:2–54:14, 113:6–16, 119:19– 121:9; Ex. 2161, 558.” slip op. at 9
- Skill levelSkill level board ownOther
“The parties’ formulations as to the level of ordinary skill in the art are similar, and neither side identifies with specificity an error in the opposing side’s formulation. See PO Resp. 21; Pet. Reply 10. 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 side’s proposed formulation.” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“On the full record before us, we determine that Petitioners have not demonstrated by a preponderance of the evidence that a skilled artisan would have chosen Ashworth I’s compound 25 as a “lead compound.” Although Ashworth I indicates that compounds 24–29 were non-toxic in T cell assays up to 72 hours, and further indicates compound 25 was one among four compounds that were comparable to boroprolines, no further data is provided to guide the skilled artisan to select compound 25 among the other 2-cyanopyrrolidides as a lead compound for further modification to develop a DP 4 inhibitor. Ex. 1007, 1165–66. More importantly, the data reported in Ashworth I was based on in vitro data at room temperature, not in vivo data. PO Resp. 25 (citing Ex. 2174, 82:23–83:11). Indeed, Dr. Rotella states, “those studies were carried out at room temperature, which is roughly 20 degrees [Celsius]. I’ll point out that body temperature is higher than that, and that temperature has a direct effect on half-life. As you elevate temperature, you can expect half-life to decrease.” Ex. 2174, 82:23-83:11. Dr. Rotella further admits that he is not aware of any disclosure describing testing of Ashworth compounds in humans. Ex. 2174, 60:23-61:9. In addition, Ashworth I acknowledged that these compounds exhibited an intramolecular cyclization problem and that further work on optimization of the pyrrolidine ring was necessary and would be reported shortly. Ex. 1007, 1163–65. Others in the prior art also continued to seek solutions to the problem of intramolecular cyclization, such as those posed by Ashworth I compounds. See PO Resp. 27–28.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“(4) No Reasonable Expectation of Increasing Stability We are not persuaded that the skilled artisan would have had a reasonable expectation of success in achieving increased stability of Ashworth I’s compound 25 based on Hanessian I’s teachings concerning the cyclopropanation of proline. See Pet. 29. There was no disclosure in the prior art of cylopropanating the pyrrolidine ring of compound 25, or any similar compound. Indeed, Dr. Rotella admitted “that there wasn’t anything in the literature prior to the invention of saxagliptin that actually suggested that cyclopropanation of an Ashworth-One type DPP4 inhibitor would improve its stability.” Ex. 2174, 142:3-9. In addition, there is not sufficient evidence as to how the modified cyano-moiety would have been understood to affect compound 25’s stability. Given the structural differences, we find there is insufficient evidence suggesting that the skilled artisan could have reasonably predicted how cyclopropanating compound 25’s P1 group (as opposed to the proline compound discussed in Hanessian I) would have affected the cyano moiety’s (as opposed to the substituent in Hanessian I) orientation in space. Furthermore, there is insufficient evidence as to whether that modified orientation would have sufficiently decreased intramolecular cyclization. Indeed, Dr. Rotella testified that: [I]n the process of that modification of orientation in space [when you fuse two rings together], you may observe effects on potency, you may observe effects on solution stability, you may observe other effects on other properties that one might measure in connection with a drug discovery project. Ex. 2174, 119:10–120:2. When asked, “[a]nd those effects might be either positive or negative; correct?” Dr. Rotella replied, “[t]hey might be, yes.” Ex. 2174, 120:3–5. Dr. Rotella also testified that at the time of the invention, the objective of adding a cyclopropyl substituent to the pyrrolidine ring of compound 25 would have been exploratory. He testified: Q. Well, what is the objective of putting the cyclopropane on the molecule, in your opinion? A. There are two possible objectives based on the data -- there are at least two possible objectives based on the data available surrounding compound 25. Q. And what are they? A. One would be to explore whether or not you could improve potency. A second would be whether or not you could improve solution stability. One might also explore how that -- those changes, either by themselves or in combination with two changes, might also improve or change -- sorry -- to improve solid-state stability. Furthermore, since nothing is known, at least at this point in time, about other properties associated with compound 25, you’d want to understand what those properties were and adjust them as need be. Generally speaking, those properties are things that we call, collectively, pharmaceutical properties. Ex. 2174, 115:11–116:13 (emphasis added). This testimony does not sufficiently support Petitioners’ contention that a skilled artisan would have reasonably expected cyclopropanating the pyrrolidine ring of compound 25 to increase its stability.” slip op. at 26
Patent outcomesUS RE44,186 not shown unpatentable§ 103 obviousnesscites KSR · Graham - Apple Inc. v. Virnetx Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,504,696 - Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,241,034 - Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,241,034 - Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentablePTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision
Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“We have jurisdiction under 35 U.S.C. § 6. 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 facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundMixed
“Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner
“Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43
Patent outcomesUS 8,618,135 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,618,135 - Advanced Micro Devices, Inc. v. LG Electronics Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,636,863 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents 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.