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

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

  RulingsFinal written decision

  • BurdenOther

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

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

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

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

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

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

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

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

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

  RulingsInstitution decision

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

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

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

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

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

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

  Claim construction§ 103 obviousnessDiscretionary denial
  Patents in suitUS 6,545,040
• Sony Computer Entertainment America LLC / Microsoft Corporation Inc. v. Adc Technology Inc.All claims unpatentable
  PTAB · Jul 1, 2016 · CBM2015-00026 · APJ Michael P Tierney · CBM · Final written decision

  Claims 8–14 are unpatentable under §103 as obvious over the instituted prior-art combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “D. Level of Ordinary Skill in the Art Petitioner’s declarant, Mr. Garry E. Kitchen, testifies that, based on his experience in the commercial software art, a person of ordinary skill in the art at the time of the invention would have had a Bachelor of Science degree in electrical engineering, computer engineering, computer science or a related engineering discipline or equivalent experience or education. Declaration of Garry Kitchen, Ex. 1011 ¶ 33. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. We adopt the level of ordinary skill in the art identified by Mr. Kitchen as it is consistent with the prior art of record. See also 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 8

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Not reached

    “Petitioner provides specific constructions for each of the interference means appearing in the dependent claims. Pet. 22–24. Patent Owner disagrees that the dependent claims recitation of interference means requires “additional functional limitations piled on top of the disclosed structure.” PO Resp. 7. Specifically, Patent Owner contends that there is only one construction of interference means, namely that which Petitioner provided with respect to the interference means of claim 8. Petitioner disagrees with Patent Owner and contends that the four dependent claims themselves recite specific functions and must further limit the claim from which they depend. Reply 7. We determine that it is unnecessary to determine whether Patent Owner or Petitioner is correct as to the specific construction of the interference means recited in claims 11, 12, 13, and 14 as the claims are unpatentable under either construction. 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)).” slip op. at 10

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

    “Program, Data and Combination of Program and Data Claim 8 contains the recitation “the program, the data, and a combination of the program and data together.” Petitioner contends that the term should mean “the program and/or the data.” Pet. 28; Reply 9. Petitioner, however, contends that Patent Owner was silent as to the meaning of the term during ex parte reexamination. Pet. 29. Patent Owner generally contends that the claim recitation is definite and requires operations to be performed either on “a program, or on data, or on a combination of the program and data.” PO Resp. 8. We adopt Patent Owner’s construction (operations are performed either on “a program, or on data, or on a combination of the program and data”) as it is consistent with the plain and ordinary meaning of the term and appears to be substantially the same as Petitioner’s construction. Reply, 9–10, Ex. 1011, ¶ 54.” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “The obviousness-type double patenting rejection does not demonstrate that the earlier filed ’995 patent described the invention, with all its claimed limitations. First, the rejection was based on obviousness, not anticipation. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). (“One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.”). Second, the Examiner’s identification of “common subject matter” consists merely of that which appears in the preamble of challenged claim 8. Although the Examiner stated that there was no apparent reason why the present claims were not presented in the earlier application, Mr. Kitchen presents credible testimony that the clock means limitation “for keeping a predetermined time period after said executing means starts execution of the program or data processing,” did not appear in the earlier filed applications and written description support for it was added in the continuation-in-part ’784 application via new Figure 12. Ex. 1011 ¶¶ 46–47 and 49; compare Ex. 1001, Figures 1–14, with Ex. 1014, Figures 1–11. Based on the evidence of record, we credit Mr. Kitchen’s testimony as it is consistent with the evidence of record and hold that Petitioner has established that claims 8–14 are limited to the July 2, 1998, filing date of the ’784 application, which resulted in the issuance of the ’520 patent.” slip op. at 15

  Patent outcomesUS 6,193,520 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 6,193,520
• Daiichi Sankyo Company, Limited v. Alethia Biotherapeutics, Inc.All claims unpatentable
  PTAB · Jun 14, 2016 · IPR2015-00291 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–6, 8–11, and 15–23 are unpatentable under § 102(a) over Hiruma because the claims lack priority to the Parent Application and Hiruma was not antedated.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledNot entitled to earlier dateDecided for petitioner

    “of antibodies having the desired function would have required undue experimentation. In view of the forgoing, we find that practicing the methods of the challenged claims at the time of the filing of the Parent Application would have required excessive experimentation, even if routine. ALZA Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 941 (Fed. Cir. 2010).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “We are not persuaded by this reasoning. The challenged claims contain functional claim language concerning the biological properties of the recited antibody. The Federal Circuit, however, has on several occasions distinguished between claims not involving functional claim language and” slip op. at 16

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner

    “3. Conclusion In view of the forgoing, we conclude that the claims of the ’181 patent are not entitled to the priority date of February 13, 2007. Hiruma is thus prior art to the ’181 patent and anticipates the challenged claims under 35 U.S.C. § 102(a). D. Antedating Hiruma” slip op. at 19

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “presented in the Petition demonstrates, by a preponderance of the evidence, that claims 1−6, 8−11, and 15−23 are unpatentable under 35 U.S.C. § 102(a) over Hiruma. This is a final written decision of the Board under 35 U.S.C. § 318(a). Parties to the proceeding seeking judicial review of the decision must comply with the notice and service requirements of 37 C.F.R. § 90.2. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that claims 1–6, 8–11, and 15–23 of the ’181 patent are unpatentable;” slip op. at 25

  Patent outcomesUS 8,168,181 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 8,168,181
• 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
• Böhler-Edelstahl GmbH & Co. KG. v. Rovalma, S.A.All claims unpatentable
  PTAB · Apr 20, 2016 · IPR2015-00150 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–4 are unpatentable as obvious over EP ’813 combined individually with CH ’893, JP ’241, JP ’650, or JP ’706.

  RulingsFinal written decision

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

    “Prelim. Resp. 6–7. Rovalma asserts that the thermal conductivity of a steel having carbidic constituents can be set by acting on the internal structure of the steel regardless of the specific steel composition. Id. at 6, 10, 13. “In other words, the thermal conductivity of a steel having a specific composition can be set to different values by following the process steps claimed in the ’056 Patent.” Id. at 13. Consistent with their plain language, we construe the “setting” step of the challenged claims as requiring the setting of the thermal conductivity at room temperature to more than, e.g., 42 W/mK. Rovalma further argues that the step of “metallurgically creating an internal structure of the steel in a defined manner” should be construed to mean “heat treating the steel . . . under specific conditions selected to achieve the desired internal structure[,]” “and hence thermal conductivity.” PO. Resp. 38, 39. Rovalma argues that “the ‘defined manner’ will differ based on the steel composition used, the desired thermal conductivity, and the specific hot-work application for the tool steel.” Id. at 39–40.” slip op. at 14

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

    “advantages including “higher toughness, thermal conductivity and weldability” as compared to high chromium ferritic steels. Ex. 1003, 2:16– 20, 4:7–16. Tables 2 and 3 of the reference disclose the chemical composition of low chromium steels having a carbon component. Id. 10–11. Example 8 comprises, by weight, 1.07% chromium, 0% molybdenum, 2.61% tungsten, and 0.21% vanadium. Id. at 10. Example 32 comprises, by weight, 0.98% chromium, 1.05% molybdenum, 1.01% tungsten, and 0.23% vanadium. Id. at 11. Accordingly, we find that EP ’813 Examples 8 and 32 each include “carbidic constituents” (i.e., carbon in conjunction with carbide formers such as chromium, tungsten, and vanadium) and, “by weight, 2– 10% Mo+W+V” as set forth in the challenged claims. See PO. Resp. 58 (admitting that “the prior art disclosed ‘providing a hot-work steel, including carbidic constituents and, by weight, 2-10% Mo+W+V’—step 1 of the challenged claims”). As with EP ’813, CH ’893 discloses low-chromium steel compositions having valuable characteristics including “relatively high hot tensile strength, toughness and resistance against temperature variations.” Ex. 1002, p. 1 ¶3, p. 3, ¶ 6. The second embodiment disclosed on page 4 of the reference comprises 0.27% carbon, 3.32% tungsten, and no chromium, molybdenum or vanadium. CH ’893 thus discloses the benefit of high thermal conductivity (“resistance against temperature variations”) and at least one embodiment comprising “carbidic constituents and, by weight, 2– 10% Mo+W+V” as set forth in the challenged claims. 18 JP ’241 discloses low chromium steels having, e.g., improved high temperature abrasion. Ex. 1004, 2–3. Claim 2 of the reference encompasses a steel composition comprising, by weight, “C: 0.10–0.40%, Si: 0.10– 1.00%, Mn: 0.20–2.00%, Cr: less than 0.95%, Mo: 0.50–3.50%, W: 0.50– 3.50% and Nb: 0.10–1.00%, and further containing more than one or two variations selected from Ni: 0.50-3.50%, Co: 0.50–3.50% and V: 0.10– 1.00%.” Id. at 2, claim 2. JP ’241 thus discloses steel compositions comprising “carbidic constituents and, by weight, 2–10% Mo+W+V” as set forth in the challenged claims. JP ’706 discloses a low chromium steel plug compositions B and C for seamless pipe manufacturing comprising 0.30% carbon, 0.5% chromium, 1.50% molybdenum, 2.00% and 3.00% tungsten, respectively, and no vanadium. Ex. 1006, Table 1. Accordingly, JP ’706 discloses steel compositions comprising “carbidic constituents and, by weight, 2–10% Mo+W+V” as set forth in the challenged claims.” slip op. at 18

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

    “As noted above, one of ordinary skill in the art at the time of the invention would have recognized that thermal processing conditions affect internal structure and, thus, thermal properties of steel. Bayati and Elliot, for example, teach that heat transport “depends on lattice defects, microstructure, impurities, and the processing of the metal or alloy,” and that matrix structure “play[s] a significant role” in determining thermal conductivity. Ex. 2009, 265; Tr. 67:3–13. As Rovalma further explains at page 7 of its Patent Owner Response, Heat is transported through metals by phonons and free electrons. Ex. 2009 at 265. In pure metals, heat transfer is primarily influenced by the metal’s free electrons. Id. Lattice defects and impurities in a metal or alloy scatter the electrons within the metallic matrix, thus reducing the rate that heat can transfer through the metal. Id. In non-metals such as carbides, thermal conductivity is primarily influenced by vibration within the lattice of atoms or molecules (these vibrations are referred to by the quantum mechanical term “phonon”). Id.; Paper 14 at 3. Concurrent with this understanding of heat transfer through metallic matrices and metal carbide inclusions, one of ordinary skill in the art would also have understood that “optimization of the microstructure has been known for a long time.” Tr. 66:9–16; see PO Resp. 5 (citing Ex. 2006); id. at n.1). Thus, “[u]sing equilibrium phase diagrams and knowing the effects of processing operations, those skilled in the art [could] predict which carbides will be present in a given steel and their microstructural distributions following various heat treatments.” PO Resp. 4 (citing Exs. 2005, 2006). Similarly, “readily available thermo-chemical databanks and software programs such as Thermo-Calc, allow[ed] those skilled in the art to” slip op. at 21

  Patent outcomesUS 8,557,056 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,557,056
• 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.