• Shenzhen Apaltek Co., Ltd. v. Asetek Danmark A/SInstituted
  PTAB · Feb 6, 2023 · IPR2022-01318 · APJ Jason W Melvin · IPR · Institution

  The Board instituted inter partes review of claims 1, 2, 5, 6, and 8 based on a reasonable likelihood of unpatentability over Duan, and Duan with Wu.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied

    “involved two petitioners accused of infringement based on the same product—made by one petitioner and incorporating technology licensed from the other. Valve I, at 9–10 (finding a significant relationship between the two petitioners “with respect to Patent Owner’s assertion” of the challenged patent); Valve II, at 10 (same); see Prelim. Reply 3. Patent Owner has asserted no such relationship here, and we conclude that Patent Owner has failed to establish that Petitioner has a significant relationship with the -522 IPR petitioner. Representation by the same counsel and being accused of infringing the same patent does not create a relationship that justifies discretionarily denying institution. Accordingly, Factor 1 weighs strongly against denying institution.” slip op. at 10

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

    “presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we conclude that Petitioner has shown a reasonable likelihood it will prevail in establishing the unpatentability of at least one challenged claim, and we institute inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. 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 does not dispute this definition of a person of ordinary skill. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references.” slip op. at 13

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

    “Based on our analysis of the issues in dispute at this stage of the proceeding, we conclude that no claim term requires express construction at this time. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 14

  Claim constructionDiscretionary denial
  Patents in suitUS 10,078,355
• Coolit Systems, Inc. v. Asetek Danmark A/SInstituted
  PTAB · Dec 28, 2021 · IPR2021-01195 · APJ Jason W Melvin · IPR · Institution

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

  RulingsInstitution decision

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

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

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

  RulingsFinal written decision

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

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

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

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

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

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

  Patent outcomesUS 8,504,696 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,504,696
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

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

  RulingsFinal written decision

  • BurdenNot shown unpatentable

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

  • ExcludeMotion to exclude, deniedMixed

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

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

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• 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
• Coalition For Affordable Drugs Vi LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01092 · APJ Grace Karaffa Obermann · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

    “qualifications of an ordinary artisan, over the somewhat different qualifications proposed by Petitioner, would materially alter the obviousness inquiry. The prior art references asserted in the Petition are representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (absence of specific findings on “level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent that a more specific definition of the ordinary artisan is required, we hold that the definition encompasses pharmacists and other persons having experience restricting the distribution of teratogenic drugs. Specifically, we find that the prior art references, like the ’501 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); Ex. 1005, 901 (Powell, disclosing guidelines for restricting the distribution of thalidomide); Ex. 1006, 101 (Mitchell, describing a method for restricting the distribution of the teratogenic drug Accutane); Ex. 1007, 899 (Dishman, describing a national registry for restricting distribution of the psychoactive drug Clozaril). Consistent with the prior art, Dr. Fudin testifies that the types of problems encountered by a person of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1002 ¶¶ 33–55. The prior art demonstrates that a person of ordinary skill in the art would have experience in controlling the distribution of a drug. We credit Dr. Fudin’s testimony that a person of ordinary skill in the art would encompass a pharmacist. Ex. 1002 ¶ 15. We also credit Dr. Frau’s testimony that an ordinary artisan would not be limited to pharmacists but also would encompass persons having at least two years of experience in risk management relating to pharmaceutical products, as pharmacists are not the only persons having restricted drug distribution experience and knowledge. Ex. 2059 ¶ 60. Accordingly, we find that a person of ordinary skill in the art would include pharmacists and persons having at least two years of experience in risk management relating to pharmaceutical products as pharmacists. Additionally, we determine that, even if we were to adopt verbatim Dr. Frau’s definition of ordinary skill in the art, Patent Owner has failed to present sufficient and credible evidence to persuade us that Patent Owner’s defined person of ordinary skill in the art would be led to a different outcome regarding the obviousness of the challenged claims. Specifically, Dr. DiPiro, testifying for Patent Owner, acknowledged that many” slip op. at 7

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

    “No claim term requires express construction for the purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). One issue of claim construction, however, requires some discussion. Patent Owner argues that the term “computer readable storage medium” in claim 1 should be read to require a “centralized” computer readable storage medium—namely “a centralized database that includes all registration information regarding the claimed prescribers, pharmacies, and patients.” Resp. 22, 35. We are not persuaded that the wording of the claim, or the disclosure of the ’501 patent specification, supports Patent Owner’s view.” slip op. at 9

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

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

  Patent outcomesUS 6,045,501 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 6,045,501
• Nestlé USA, Inc. v. Steuben Foods, Inc.All claims unpatentable
  PTAB · Jun 2, 2016 · IPR2015-00195 · APJ Christopher G Paulraj · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

  Patent outcomesUS 6,475,435 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 6,475,435
• Tiffany And Company v. Lazare Kaplan International, Inc.All claims unpatentable
  PTAB · Apr 13, 2016 · IPR2015-00024 · APJ Jeffrey W Abraham · IPR · Final written decision

  Claims 1 and 7 are unpatentable as obvious over Fine Diamonds with the ILR Article and over Gresser with the ILR Article.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “motion, lasers, and optics.” Ex. 1003 (“Trumper Declaration”) ¶ 17. Patent Owner and its declarant, Dr. Bokor, adopted the level of ordinary skill in the art advanced by Dr. Trumper. PO Resp. 43–44 and n.4; Ex. 2005 (“Bokor Declaration”) ¶ 22. For purposes of this decision, we credit the testimony provided by the declarants for both parties and hold that one of skill in the art would possess at least a bachelor’s degree in mechanical, electrical, manufacturing, or optical engineering, plus a few years of experience in the design and control of machines involving precision motion, lasers, and optics. This level of ordinary skill is reflected not only by the information presented by the parties, but also 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 7

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

    “For the reasons explained below, we determine that Petitioner has shown by a preponderance of the evidence that claims 1 and 7 are unpatentable under either of the proposed constructions of the “controlling” limitations. Accordingly, we determine that it is unnecessary to resolve the parties’ dispute over the term “controlling.” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We provide below an analysis of the challenged claims under both constructions.” slip op. at 10

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

    “patterning and ablations of diamonds with a UV laser source. Ex. 1009, 2. The ILR Article depicts a computer in Figure 2, and refers to the “[i]ntegration of a computer into the direct-write system.” Id. at 3. The ILR Article further discloses that “[v]ideo images generated by the viewing system can be digitized and processed to derive information used for” various “operations that make the laser tool easier and faster to use.” Id. We credit the testimony of Dr. Trumper that “the ILR Article makes clear that the computer digitizes and processes the optical images of a gemstone, and the automated feedback derived from the images is used for controlling the directing of the focused laser energy,” as it is consistent with the ILR Article’s disclosure of integrating a computer into the diamond ablation system. Ex. 1003 ¶ 56. Thus, despite the fact that the ILR Article does not expressly state that the computer is used to digitize and process the video images, it would have been obvious to a person of ordinary skill in the art that integrating the computer into the direct write system would include using the computer (shown in Fig. 2) to digitize the video images generated by the viewing system and process them to conduct the various operations that make the laser tool easier to use. KSR Int’l Co. v. Teleflex Inc., 550 US 398, 421 (2007) (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). Furthermore, as noted above, the ILR Article teaches that “[c]omputer control of work surfaces allows direct production of CAD-generated shapes” on diamond surfaces. Ex. 1009, 2. Petitioner contends, and Patent Owner does not contest, that the CAD/CAM programs correspond to the required “marking instructions.” Pet. 25–26 (citing Ex. 1009, 2); Ex. 1003 ¶ 56 (Dr. Trumper stating “marking instructions (e.g., motion programming of the CAD/CAM program)”). Additionally, the ILR Article discloses that the “CAD/CAM interface . . . allows electronic control of processing speed, exposure parameters, and other features” of the laser tool that “simplifies set-up [and] accelerates process development.” Ex. 1009, 3. As Petitioner points out, the next sentence in the very same paragraph discusses digitizing and processing the video images. Reply 13. In view of this, we determine that a person of ordinary skill in the art, reviewing the ILR Article, would have understood the ILR Article to disclose or suggest using the computer to control and operate the laser tool to generate shapes based on a combination of two inputs, the CAD/CAM programs (i.e., “marking instructions”) and images fed back to the computer and digitized therein (i.e., electronic image information), which “simplif[y] set-up [and] accelerate[] process development” and “make the laser tool easier to use.”2 Ex. 1009, 3; Reply 13; Ex. 1003 ¶ 55.” slip op. at 19

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

    “contrary to Patent Owner’s arguments, we determine that a person of ordinary skill in the art would have understood that the ILR Article discloses or suggests that images are fed back to a processor and combined with marking instructions for, at the very least, setting up the laser inscription machine. Thus, although Patent Owner also argues that its proposed construction of the controlling limitations “distinguishes over systems that use gemstone images for setup—independent of ‘marking instructions’” (PO Resp. 29 (emphasis added)), the ILR Article discloses or suggests using images for set up in combination with marking instructions. Moreover, as Patent Owner points out, the Federal Circuit stated that the “controlling” limitations include “control based on . . . feedback derived from optical images of a gemstone, before or during the laser burn process.” Ex. 1006, 14 (emphasis added); PO Resp. 31–32. We note that Patent Owner argues that its proposed construction is consistent with the 2010 Federal Circuit opinion. PO Resp. 29–32. For all of the reasons discussed above, we determine that the ILR Article discloses or suggests the “controlling” limitations of claims 1 and 7. Petitioner has identified sufficiently where the additional limitations of claims 1 and 7 are present in Fine Diamonds and the ILR Article, and Patent Owner does not argue otherwise. We, therefore, conclude that Petitioner has shown by a preponderance of the evidence that Fine Diamonds and the ILR article disclose or suggest all elements of claims 1 and 7.” slip op. at 22

  Patent outcomesUS 6,476,351 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 6,476,351

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.