Ex Parte Jones et alDownload PDFPatent Trial and Appeal BoardMar 15, 201713825601 (P.T.A.B. Mar. 15, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/825,601 11/08/2013 Robert M. Jones 20750-0160US1 2404 26204 7590 03/17/2017 FTSH fr RTfTTARnSON P C (ARF.NA PHARMAFFTITTFAT EXAMINER P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 RUSSEL, JEFFREY E ART UNIT PAPER NUMBER 1675 NOTIFICATION DATE DELIVERY MODE 03/17/2017 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT M. JONES, JUERG LEHMANN, WEICHAO CHEN, JEFFREY EDWARDS, GLEN MARQUEZ, MICHAEL E. MORGAN, ABU J.M. SADEQUE, and SUN HEE KIM1 Appeal 2016-003817 Application 13/825,601 Technology Center 1600 Before JOHN G. NEW, RICHARD J. SMITH, and RYAN H. FLAX, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL appellants state the real party-in-interest is Arena Pharmaceuticals Inc. App. Br. 1. Appeal 2016-003817 Application 13/825,601 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 27 and 60. Specifically, the claims stand rejected as unpatentable under U.S.C. § 101 as being directed to unpatentable subject matter. Claims 27 and 60 also stand rejected as unpatentable under U.S.C. § 102(b) as being anticipated by Yoshida et al. (US 2007/0259928 Al, November 8, 2007) (“Yoshida”). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. NATURE OF THE CLAIMED INVENTION Appellants’ invention is directed to compounds and methods useful in the treatment of, for example, a disorder selected from: a GPR1 19-receptor- related disorder; a condition ameliorated by increasing secretion of an incretin; a condition ameliorated by increasing a blood incretin level; a condition characterized by low bone mass; a neurological disorder; a metabolic-related disorder; type 2 diabetes; obesity; and complications related thereto. Abstract. REPRESENTATIVE CLAIM Claim 27 is representative of the claims on appeal and recites: 27. A method for increasing the secretion of an incretin in an individual or increasing a blood incretin level in an individual, or for treating a disorder selected from a GPR119-receptor-related disorder; a condition ameliorated by increasing secretion of an incretin; a condition ameliorated by increasing a blood incretin level; a condition characterized by low bone mass; a neurological 2 Appeal 2016-003817 Application 13/825,601 disorder; a metabolic-related disorder; and obesity; in an individual; the method comprising prescribing to said individual in need thereof, a compound according to claim 2 in combination with a second pharmaceutical agent. App. Br. 16—17. ISSUES AND ANALYSES A. Rejection of claims 27 and 60 as being directed to nonpatentable subject matter under 35 U.S.C. $ 101 Issue Appellants argue the Examiner erred by concluding that claims 27 and 60 are directed to a patent ineligible “abstract idea.” App. Br. 3. Analysis Appellants argue claims 27 and 60 are not drawn to abstract “methods of advertising” or “methods of marketing,” as the Examiner finds, but instead are drawn to methods of medical treatment using the particular novel pharmaceutical compounds described in the application. App. Br. 5. According to Appellants, one way of claiming such a method of treatment is a claim that recites a step of administering the medication to the patient and, Appellants point out, the Examiner has no issue with the patentability of, for example, claim 10. Id. Appellants therefore contend the Examiner admits there is nothing abstract about the treatment of disease using the compound of claim 2; Appellants note the Examiner has suggested that claims 27 and 60 could be amended to overcome the rejection by amending the claims to recite steps of synthesizing the compound, prescribing the compound by a medical practitioner, and administering the compound to the individual. Id. 3 Appeal 2016-003817 Application 13/825,601 However, Appellants argue, a person qualified to prescribe medications (such as a medical practitioner) typically treats a patient by first diagnosing the patient and making the judgment that the treatment is needed and medically appropriate, and then prescribing medication to the patient to provide the patient with the medication. Id. Appellants assert that claims 27 and 60 are directed to a process of treatment comprising “prescribing” in the sense that prescribing would be carried out by a person qualified to prescribe medication (such as a medical practitioner) to treat a patient through the administration of a medication. App. Br. 5. Appellants argue that the fact that a medical practitioner may not have a manufacturing plant available to synthesize chemical compounds and formulate them into medicines, and typically does not physically insert the medication into the patient's body, does not make the physician’s role in treatment, where the physician treats the patient by prescribing a specific medication to an individual in need of the treatment into an “abstract idea.” Id. Rather, Appellants argue, the familiar process of prescribing medication to a person “in need of’ such medication by a person qualified to prescribe medication, such as a medical practitioner, provides medication to the patient (via filling of the prescription) and thereby initiates treatment of the patient with the medication. Id. Appellants argue further that the claim term “prescribing” is a term of art when used in the context of medical treatment with pharmaceutical compounds and, in that context, is defined as “advis[ing] and authorizing] the use of (a medicine or treatment) for someone, especially in writing.” App. Br. 6 (citing Oxford Online Dictionary). Appellants argue that the term “prescribing” therefore includes two components: (1) directions 4 Appeal 2016-003817 Application 13/825,601 (typically to the patient) to administer the medication to carry out the treatment; and (2) authorization (typically to a pharmacist) to provide the medication for administration to the patient. Id. at 6—7. Appellants therefore argue that, in this context, “prescribing” is mentioned in Appellants’ Specification only in connection with methods of treatment, and each disclosure of prescribing is paired with a corresponding mention of a method of treatment that includes “administering” the medication. Id. at 7 (citing Spec. 14,11. 3—10, 26,11. 14—25, 29 11. 10-29). Appellants dispute the Examiner’s interpretation of the claims as being directed to an abstract idea such as “advertising,” “communicating,” or “marketing.” Id. Appellants contend that any mention of such commercial activities is absent from Appellants’ Specification. Id. The Examiner responds that the disputed claims recite only a single positive process step; “prescribing.” Ans. 4. The Examiner finds there is no claim limitation which necessarily requires an individual to receive or come into contact with the prescribed compound. Id. at 5. Although the claim term “treating” is used in the preamble to both claims 27 and 60 in conjunction with the listed disorders and conditions, the Examiner finds that treatment of an individual does not constitute a positive process step which must be performed as part of the claimed method. Id. The Examiner finds that prescribing a compound, without a requirement for actual administration to an individual, is an abstract idea which does not satisfy the requirements of 35 U.S.C. § 101. Id. The Examiner further finds the limitation of the preamble reciting “for increasing the secretion of an incretin in an individual or increasing blood incretin level in an individual” does not require the individual to be in actual 5 Appeal 2016-003817 Application 13/825,601 need of such increasing. Ans. 5. The Examiner also finds that individuals in this preamble limitation cannot be interpreted as having a condition requiring treatment, because the result of this interpretation would be a limitation which duplicates that found at lines 2-4 of each claim (“treating a disorder selected from ... a condition ameliorated by increasing secretion of an incretin; a condition ameliorated by increasing a blood incretin level”). Id. The Examiner finds Appellants’ Specification defines “treatment” as including prevention and concludes, therefore, that the claims do not substantially limit the individuals to whom the compounds can be prescribed. Id. The Examiner finds Appellants’ interpretation of the claim term “prescribing,” including the dictionary definition quoted by Appellants, does not support Appellants’ argument that “prescribing” is necessarily performed by a medical practitioner. Ans. 6 (citing, e.g., the second and third definitions of “prescribe” and accompanying examples). The Examiner finds that, in view of the presence of alternative and/or broader definitions of “prescribe” in the supporting document provided by Applicants, it cannot be assumed during ex parte prosecution that “prescribing” must necessarily be limited to the more narrow definition quoted by Appellants. Id. The Examiner further finds that the Specification does not use the term “medical practitioner,” but rather the term, “caregiver,” and lists, by way of example, physicians, nurses, nurse practitioners, researchers, and veterinarians. Id. (citing Spec. 17, 18). The Examiner finds that, absent explicit claim terminology, there is no legal basis for limiting the scope of the claims to caregivers who have 6 Appeal 2016-003817 Application 13/825,601 authority to prescribe medicines while ignoring the disclosure of other caregivers who do not have such prescriptive authority. Id. Finally, the Examiner finds that a functional relationship between the “prescribing” step and the compound of claim 2 is absent because the act of prescribing does not require the compound to have been synthesized and does not actually require the individual to actually consume the compound. Ans. 6—7. The Examiner finds the claimed prescribing step is no more than a step of conveying a message to an individual. Id. (citing MPEP § 2111.05(1)(B)). We are persuaded by Appellants’ arguments. As an initial matter, we decline to adopt the Examiner’s broad interpretation of the claim term “prescribing.” Appellants’ claims are read in view of their Specification and with the knowledge of one of ordinary skill in the art. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Furthermore, the Board determines the scope of claims in patent applications not solely on the basis of the claim language, but by giving claims their broadest reasonable construction in light of the Specification, as it would be interpreted by one of ordinary skill in the art. Cuozzo Speed Tech., LLC v. Lee, 136S. Ct. 2131, 2145 (2016) (The Patent Office, for more than 100 years, has applied the broadest reasonable construction standard in proceedings.). The Specification, as both Appellants and the Examiner agree, employs the term “prescribing” in manner restricted to a medical context. For example, the Specification discloses: One aspect of the present invention pertains to methods for modulating the activity of a GPR119 receptor, comprising prescribing to an individual in need thereof: a therapeutically effective amount of a compound of the present invention', a 7 Appeal 2016-003817 Application 13/825,601 composition of the present invention; or a pharmaceutical product of the present invention. Spec. 14 (emphasis added). The Specification also discloses: One aspect of the present invention pertains to methods for the treatment of a disorder selected from: a GPR119-receptor- related disorder, a condition ameliorated by increasing secretion of an incretin; a condition ameliorated by increasing a blood incretin level; a condition characterized by low bone mass; a neurological disorder; a metabolic-related disorder; and obesity; in an individual; comprising prescribing to the individual in need thereof: a therapeutically effective amount of a compound of the present invention; a composition of the present invention; or a pharmaceutical product of the present invention. Spec. 26 (emphasis added). In both of these contexts, the term “prescribing” is used in a medical context, viz., the prescribing of a therapeutically effective compound for the treatment of a medical condition to an individual in need thereof. Although, in the absence of an explicit definition in the Specification, the Examiner may employ the broadest reasonable interpretation of a claim term, such a definition must still be interpreted in view of, and consistent with, the disclosures of Appellants’ Specification. Renishawpic v. Marposs Societaper Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998) (“[A] claim must be read in view of the specification of which it is a part.”). We consequently adopt Appellants’ definition of “prescribing” as meaning: “advis[ing] and authorizing] the use of (a medicine or treatment) for someone, especially in writing.” See App. Br. 6. Nor are we persuaded by the Examiner’s finding that the examples of “caregiver” provided by Appellants’ Specification precludes the use of Appellants’ proposed definition of the claim term “prescribing.” See Ans. 6. The term “caregiver” is not present in the claims at issue, and the Examiner may not import limitations from the Specification into the claims. See 8 Appeal 2016-003817 Application 13/825,601 CollegeNet, Inc. v. ApplyYourself Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005). We agree with Appellants that a person of ordinary skill in the art, reading the claims in view of the Specification, would understand the term prescribing to mean “advis[ing] and authorizing] the use of (a medicine or treatment) for someone, especially in writing” to be performed by a person legally authorized to do so. Finally, we are not persuaded that the claims are directed to an abstract idea, as the Examiner concludes. In performing an analysis under Section 101, we apply the two-part test set forth by the Director in the 2014 Interim Guidance on Patent Subject Matter Eligibility (December 10, 2014), and subsequently updated in 2015 and 2016 (the “Interim Guidance”). First, we determine whether the claims on appeal are directed to a statutory category. Interim Guidance 10. In this instance, we conclude that they are: the claims are directed to a method or process, viz., “prescribing to said individual in need thereof, a compound according to claim 2 in combination with a second pharmaceutical agent.” Next, we determine whether the claims are directed to a judicially-created exception: a natural law or phenomenon of nature or an abstract idea. Id. at 12. The Examiner finds the claims are directed to an abstract idea, viz., the “prescribing” an individual a compound of claim 2. We disagree. Abstract ideas have been identified by the courts as including, by way of example, fundamental economic practices, certain methods of organizing human activities, an “idea of itself,” and mathematical relationships or formulae. Interim Guidance 13 (citing Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355—56 (2014). Examples of such abstract ideas have included mitigating settlement risk, hedging, creating a contractual 9 Appeal 2016-003817 Application 13/825,601 relationship, using advertising as an exchange or currency, processing information through a clearinghouse, comparing new and stored information and using rules to identify options, using categories to organize, store and transmit information, organizing information through mathematical correlations, managing a game of bingo, the Arrhenius equation for calculating the cure time of rubber, a formula for updating alarm limits, a mathematical formula relating to standing wave phenomena, and a mathematical procedure for converting one form of numerical representation to another. See Interim Guidance 13—15 (citing cases). We find that the language of Appellants’ claims reciting “prescribing to said individual in need thereof, a compound according to claim 2 in combination with a second pharmaceutical agent” does not correspond to any of these examples. Rather, we find that it corresponds to a concrete and definable process, viz., the prescribing of a compound of claim 2 to an individual in need thereof, and not simply an abstract idea. We agree with Appellants that the limitation, when read in view of their Specification, represents more than a mere transmission of information from one individual to another. Rather, it represents “advis[ing] and authorizing] the use of (a specific medicine or treatment)” by a person who is competent to do so. Moreover, the act of prescribing recited in claims 27 and 60 is directed to a specific audience (caregivers authorized to treat a patient for a specific disorder), a specific class of compounds (i.e., those of claim 2), and to a specific class of patients (i.e., individuals in need of treatment for a GPR119-receptor-related disorder). We therefore disagree with the Examiner’s conclusion that the claims are impermissibly directed to an abstract idea, and we agree with Appellants that the claims are directed to 10 Appeal 2016-003817 Application 13/825,601 patentable subject matter under 35 U.S.C. § 101. We consequently reverse the Examiner’s rejection of claims 27 and 60. B. Rejection of claims 27 and 60 under 35 U.S.C. $ 102(b) Issue Appellants argue the Examiner erred because Yoshida does not disclose the limitation reciting “a compound according to claim 2.” App. Br. 11. Analysis Appellants dispute the Examiner’s finding that the identity of the compound required by claims 27 and 60 to carry out the claimed method of treatment is not eligible to any weight in evaluating novelty because it “most closely resemble[s] nonfunctional descriptive material and/or conveying a message to an individual independent of a supporting product and as such do not serve to distinguish over the prior art.” App. Br. 11 (quoting Adv. Act. 3 (May 21,2015)). Appellants repeat their arguments with respect to the claim term “comprising” presented supra, and argue the methods of treatment disclosed by Yoshida that includes prescribing combinations of medications to treat type 2 diabetes, but not the compounds defined in claim 2, are different from the methods claimed in Appellants’ claims 27 and 60. Id. The Examiner responds that claims 27 and 60 recite a single method step; that of prescribing to an individual a compound according to claim 2, optionally in combination with a second pharmaceutical agent. Final Act. 3. The Examiner finds that claims 27 and 60 do not require the compound 11 Appeal 2016-003817 Application 13/825,601 according to claim 2 to have ever been synthesized or exist, and do not require the individual actually to consume the compound or the combination in response to the prescribing. Id. The Examiner finds Yoshida discloses that it is well known in the art to prescribe two or more antidiabetic agents to patients with diabetes mellitus. Final Act. 4 (citing 15). The Examiner therefore finds Yoshida discloses the one method step recited in claims 27 and 60 and, therefore, anticipate the claim. Id. We agree with Appellants. It is well accepted that, to show anticipation, the examiner must show “that the four comers of a single, prior art document describe every element of the claimed invention.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000)). In this case, the claims at issue require “prescribing to said individual in need thereof, a compound according to claim 2 in combination with a second pharmaceutical agent.” The claims thus explicitly incorporate the limitations of claim 2, which recites: “A compound according to claim 1 selected from 3-fluoro-4-(5-fluoro-6-(4-(3-(2-fluoropropan-2-yl)-1,2,4- oxadiazol-5-yl)piperidin-l-yl)pyrimidin-4-ylamino) -N,N - dimethylbenzamide and pharmaceutically acceptable salts, solvates, and hydrates thereof.” Both Appellants and Examiner agree that the compounds of claim 2 are not disclosed by Yoshida. We disagree with the Examiner that the subject matter of claim 2, which is incorporated into claims 27 and 60, constitute non-functional descriptive matter: on the contrary, the language of the claim explicitly 12 Appeal 2016-003817 Application 13/825,601 requires that a specific compound, as recited in claim 2, be prescribed to an individual in need thereof.2 Nor are we persuaded that the lack of claim language describing synthesis or actual ingestion of the compound recited in claim 2 is relevant to whether Yoshida anticipates the claims at issue. The claims are directed to prescribing a specific compound to an individual in need. That compound is described in claim 2 in sufficient detail to meet the requirements for allowance and, in fact, have been allowed. See Final Act. 1. We consequently find that Yoshida cannot anticipate claims 27 and 60 because it does not disclose the compound recited in claim 2, which is required by both of the claims. We consequently reverse the Examiner’s rejection of the claims. DECISION The Examiner’s rejection of claims 27 and 60 as unpatentable under 35 U.S.C. § 101 is reversed. The Examiner’s rejection of claims 27 and 60 as unpatentable under 35 U.S.C. § 102(b) is reversed. REVERSED 2 By way of contrast, we note that claim 27’s recitation of “a condition ameliorated by increasing secretion of an incretin; a condition ameliorated by increasing a blood incretin level; a condition characterized by low bone mass; a neurological disorder; a metabolic-related disorder; and obesity” is non-functional descriptive material, because it serves no functional purpose in the claim, but merely describes characteristics of a “GPR119-receptor- related disorder.” 13 Copy with citationCopy as parenthetical citation