• 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
• The Gillette Company v. Shavelogic, Inc.Institution denied
  PTAB · Sep 9, 2016 · IPR2016-00699 · APJ Richard H Marschall · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–6 were unpatentable under any of six obviousness grounds.

  RulingsInstitution decision

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

    “Patent Owner’s arguments are persuasive. As discussed above, the claimed “longitudinal axis of inertia” at a minimum requires a longitudinal axis that passes through the center of mass of the handle. Petitioner, using only its own proposed construction in its analysis of the prior art, ignores this requirement. Petitioner never alleges that the axis disclosed by Ohtsubo and passing through the “center line of the gripping section” of the handle in Ohtsubo also passes through the center of mass of the handle. Petitioner never mentions the center of mass in the analysis of Ohtsubo or any of the other prior art references. In addition, the Petition and accompanying Slocum Declaration fail to set forth sufficient evidence from which we could find that the prior art discloses angles with respect to a longitudinal axis passing through the center of mass of the handle. Similarly, Petitioner’s argument that the claimed angle would have been an obvious matter of design choice relies on Petitioner’s flawed construction, and fails to allege, much less establish, that arriving at the claimed angle using a longitudinal axis passing through the handle’s center of mass would have been an obvious matter of design choice. Pet. 23–24. Accordingly, we find that Petitioner has failed to establish that the combination of Jian and Ohtsubo discloses this limitation, or that the claimed angle would have been an obvious matter of design choice. Because Petitioner failed to establish a reasonable likelihood that claim 1 is unpatentable, and the remaining claims 2–6 at issue in Ground I depend from claim 1, we decline to institute on Ground I.” slip op. at 12

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

    “The parties seem to agree that Figure 7E is controlling, as both parties cite to the figure in support of their respective positions. Pet. 10; POPR 10. For purposes of this Decision, we agree. The description of Figure 7E confirms that it “is a diagram illustrating how the longitudinal axis of inertia of the handle is measured.” Ex. 1001, 3:61–62; see also id. at 6:22–24 (“These angles are measured between the longitudinal axis of inertia of the handle (see FIG. 7E) and the skin surface.”). Because the specification indicates that Figure 7E illustrates how to measure the longitudinal axis of inertia, and the remaining text of the specification does not define the term, we rely on Figure 7E to construe “longitudinal axis of inertia” in claim 1. Figure 7E depicts the longitudinal axis passing through the center of mass of the handle. Id. at Fig. 7E. The figure identifies the center of mass with a symbol and explains that the center of mass corresponds to that symbol in a legend. Id. Petitioner’s construction, with reference to an axis extending “generally through the center of the gripping portion of the handle,” may be consistent with Figure 7E in a broad sense, but Petitioner’s proposed construction does not go far enough. Figure 7E does not merely disclose the longitudinal axis of inertia extending “generally through the center of the gripping portion of the handle,” but instead relies on the center of mass of the handle as a frame of reference to define the claimed axis. Id. Petitioner improperly employs broad language not found in the figure, while ignoring important details such as the intersection of the longitudinal axis of inertia with the center of mass that is specifically called out in the figure. On this record and for purposes of this Decision, we conclude that the correct construction of “longitudinal axis of inertia,” in light of the specification and in particular Figure 7E, at a minimum requires a longitudinal axis that passes through the center of mass of the handle.” slip op. at 8

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Patent Owner’s arguments are persuasive. As discussed above, the claimed “longitudinal axis of inertia” at a minimum requires a longitudinal axis that passes through the center of mass of the handle. Petitioner, using only its own proposed construction in its analysis of the prior art, ignores this requirement. Petitioner never alleges that the axis disclosed by Ohtsubo and passing through the “center line of the gripping section” of the handle in Ohtsubo also passes through the center of mass of the handle. Petitioner never mentions the center of mass in the analysis of Ohtsubo or any of the other prior art references. In addition, the Petition and accompanying Slocum Declaration fail to set forth sufficient evidence from which we could find that the prior art discloses angles with respect to a longitudinal axis passing through the center of mass of the handle. Similarly, Petitioner’s argument that the claimed angle would have been an obvious matter of design choice relies on Petitioner’s flawed construction, and fails to allege, much less establish, that arriving at the claimed angle using a longitudinal axis passing through the handle’s center of mass would have been an obvious matter of design choice. Pet. 23–24. Accordingly, we find that Petitioner has failed to establish that the combination of Jian and Ohtsubo discloses this limitation, or that the claimed angle would have been an obvious matter of design choice. Because Petitioner failed to establish a reasonable likelihood that claim 1 is unpatentable, and the remaining claims 2–6 at issue in Ground I depend from claim 1, we decline to institute on Ground I. Grounds II through VI rely on the same flawed arguments to establish that the combination of Jian and Ohtsubo discloses the claimed “planar rim surface being disposed at an angle of about 10 to 20 degrees with respect to a longitudinal axis of inertia of the handle.” Pet. 41–58. Patent Owner relies on additional references in these Grounds, but not in a manner that addresses the deficiencies noted above. Id. We therefore decline to institute on Grounds II through VI for the same reasons discussed above.” slip op. at 12

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,789,282
• 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
• Bioactive Laboratories v. BTG International Inc.Rehearing denied
  PTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

    “anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 8,048,414
• LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentable
  PTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision

  Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were not shown unpatentable under §103 over Oe and Etsuo because the proposed combinations lacked sufficient reasoned support.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “We have reviewed the testimony from both Dr. Escuti, and Patent Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.5 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 5 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12

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

    “disclosure in the specification of the ’600 patent to support Patent Owner’s proposed claim construction of “height” and “width.” Indeed, our review of the specification of the ’660 patent reveals that these terms are not defined explicitly or implicitly. For example, the specification states that “the deformities may vary in shape and/or size along the length and/or width of the panel members.” Ex. 1001, 5:43–44 (emphasis added). With respect to the planar optical conductor, claims 1 and 33 each recite, in relevant part, that the input edge has “at least one input edge with a greater cross-sectional width than thickness.” Ex. 1001, 9:11–12, 10:65–67 (emphasis added). Both claims 1 and 33 recite that the output distribution generated by the plurality of light sources is “defined by a greater width component than height component.”4 Id. at 9:15–16, 11:5–6 (emphasis added). Claim 33 recites that the plurality of LED light sources each have “a greater width than height.” Id. at 11:1–2 (emphasis added). Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam-” slip op. at 10

  Patent outcomesUS 7,404,660 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,404,660
• LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentable
  PTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision

  Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were held not unpatentable under § 103 over Oe and Etsuo because the combination lacked an adequately supported reason to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.4 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 4 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam- 3 In a related district court proceeding, the claim term “output distribution defined by a greater width component than height component” was determined to have its plain meaning. Ex. 2008, 47. See TR. 21:24–22:8. Webster.com, http://www.merriam-webster.com/dictionary/height, (last viewed July 10, 2015). Within the context of the claims, we are not persuaded by Patent Owner’s contentions that the term “width” is used other than according to its ordinary and customary meaning with respect to the shape of the input edge of the optical conductor, the output distribution of the light source, and the shape of the LED light source. Along this vein, we are not persuaded by Patent Owner’s contentions that the term “height” is used other than according to its ordinary and customary meaning with respect to the light output distribution. Based on this usage in the claims, no express construction is necessary.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component. We also consider Petitioner’s argument in the Reply that, in addition to Etsuo, Petitioner also relies on Oe’s explicit disclosure of “a plurality of point-like sources of light.” Reply 16–17. Petitioner directs us to the passage of Oe cited in its claim chart (Pet. 40), describing how the light source could be “a plurality of point-like sources of light arranged along the incident surface” (Ex. 1024, 7:30–31). Id. at 16. But Petitioner’s arguments in this regard do not address specifically its proffered reason to combine Oe and Etsuo. Indeed, Petitioner does not explain the relevance of the point-like sources of light to the claim element in question. See 37 C.F.R. § 42.22(a)(2) (requiring a full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent). Patent Owner contends that “Petitioner never argues that ‘point-like sources’ are equivalent to LEDs.” PO Resp. 10. We agree. Petitioner’s argument that “Oe discloses a plurality of light sources 4 adjacent to the input edges” (Pet. 35 (citing Ex. 1024, 6:5–13; Ex. 1004 ¶ 161)) makes no mention of the specific passage in Oe concerning the point-like sources of light. Indeed, the cited passage states that:” slip op. at 20

  Patent outcomesUS 7,404,660 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,404,660
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

  RulingsFinal written decision

  • Expert testimonyOther

    “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

  • ExcludeMotion to exclude, deniedOther

    “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

  • Strike new argumentNew argument disregardedOther

    “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

  Patent outcomesUS 8,846,112 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,846,112

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.