Ex Parte HurstDownload PDFPatent Trial and Appeal BoardJun 12, 201713344752 (P.T.A.B. Jun. 12, 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. 13/344,752 01/06/2012 Katherine L. Hurst 36407-0002 7663 46273 7590 06/12/2017 KIRK HAHN 14431 HOLT AVENUE SANTA ANA, CA 92705 EXAMINER COBANOGLU, DILEK B ART UNIT PAPER NUMBER 3686 MAIL DATE DELIVERY MODE 06/12/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KATHERINE L. HURST Appeal 2016-002210 Application 13/344,752 Technology Center 3600 Before JEAN R. HOMERE, DEBRA K. STEPHENS, and JON M. JURGOVAN, Administrative Patent Judges. HOMERE, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from a Final Rejection of claims 1—18 and 22, which are all of the pending claims.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the real party in interest as Katherine L. Hurst. App. Br. 2. 2 Claims 20 and 21 are cancelled, and claims 19 and 23 are withdrawn. See App. Br. 4 (Status of Claims). Appeal 2016-002210 Application 13/344,752 Introduction Appellant’s invention relates to a method for determining a dose of anticoagulant drug for a patient to thereby obtain a specific International Normalized Ratio (INR) for the patient. In particular, upon receiving the patient’s responses to a questionnaire including the patient’s health factors (e.g., vitals, illness and drug history), a health professional enters corresponding values into a computer containing a mathematical model program, to generate an equation of a line representing the relationship between the anticoagulant dosage and the INR. The health professional subsequently uses the generated equation to calculate the daily dosage corresponding to the desired therapeutic INR score. Spec. 9—10. Representative Claim Independent claim 1 is representative, and reads as follows: 1. A method of determining a dose of anti-coagulant drug for a patient in need of anti-coagulant therapy to obtain a specific International Normalized Ratio (INR) comprising the steps of: a) conducting a patient intake by a health care professional comprising questions concerning health factors[:] current average daily dose of anti-coagulant drug in milligrams, current international normalized ratio value, patient's weight in kilograms, patient's temperature, number of episodes of fevers, number of episodes of diarrhea, amount and type of alcohol ingested, current prescription drugs, including dosage, frequency and route of intake, percent compliance of taking anti-coagulant drug, kidney function, 2 Appeal 2016-002210 Application 13/344,752 liver function, amount and type of Vitamin K containing food eaten, and any change in the intake of these foods, number of bleeding episodes since last visit, and number of clotting episodes since last visit; b) recording the answers in step a) into a questionnaire to obtain values representing each category of question in step a); c) entering the values from step b) into a computer with a mathematical model program; d) generating an equation of a line representing the relationship between the dose amount of the anti-coagulant drug and the INR in the patient; and e) using the equation generated in step d) to calculate the daily dose of the anti-coagulant drug to obtain the desired therapeutic INR score. Rejections on Appeal Claims 1—18 and 22 stand rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter because the claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. Final Act. 3^4. Claims 1—8, 11, and 13—18 stand rejected under 35 U.S.C. § 102(e) as being anticipated by Mayer. Final Act. 4—10. Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of Mayer and Wikipedia. Final Act. 10— 11. Claim 12 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of Mayer and Official Notice. Final Act. 12. 3 Appeal 2016-002210 Application 13/344,752 ANALYSIS We consider Appellant’s arguments seriatim, as they are presented in the Appeal Brief, pages 9-18, and the Reply Brief, pages 4—11,3 We are unpersuaded by Appellant’s contentions. Except as otherwise indicated hereinbelow, we adopt as our own the findings and reasons set forth in the Final Action, and the Examiner’s Answer in response to Appellant’s Appeal Brief. Final Act. 2—14, Ans. 2—15. However, we highlight and address specific arguments and findings for emphasis as follows. Non-Statutory Subject Matter Rejection Appellant argues the Examiner erred in concluding that claims 1—18 and 22 are directed to the “abstract idea of a method of organizing human activities”. App. Br. 9. According to Appellant, “Although there are always ‘human activities’ involved when a method requires a human to do some ‘actions’, it is not these actions that are important, but it is the process of using the collected data and transformed values to generate an (sic) unique equation for the individual patient.” Id. In particular, Appellant argues because the claim recites a method that uses a particular machine programmed with a mathematical model to transform a particular article (collected data) to a different state or thing (an equation indicating the anticoagulant dosage for a patient), the claim amounts to significantly more than just an abstract idea. Id. at 10-16. These arguments are not persuasive. 3 Rather than reiterate the arguments of Appellant and the Examiner, we refer to the Appeal Brief (filed June 14, 2015), the Reply Brief (filed December 9, 2015), and the Answer (mailed December 21, 2015) (“Ans.”) for the respective details. We have considered in this Decision only those arguments Appellant actually raised in the Briefs. Any other arguments Appellant could have made but chose not to make in the Briefs are deemed to be waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2012). 4 Appeal 2016-002210 Application 13/344,752 The U.S. Supreme Court provides a two-step test for determining whether a claim is directed to patent-eligible subject matter under 35 U.S.C. § 101. See Alice Corp. Pty. Ltd. v. CLS Bank Inti, 134 S. Ct. 2347 (2014). First, we determine whether the claims at issue are directed to one of the four statutory categories of invention (i.e., process, machine, article of manufacture or composition of matter). Because claims 1—18 and 22 are directed to a method, they satisfy the first prong of the test. Second, we determine whether the claims are directed to one or more judicial exceptions (i.e., law of nature, natural phenomenon, and abstract ideas). Id. at 2355 (citations omitted) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1296-97 (2012))(“Mayo”).4 4 The Supreme Court identifies laws of nature, physical phenomena, and abstract ideas as three exceptions of subject matter ineligible for patent protection. Bilski v. Kappos, 561 U.S. 593, 601 (2010). In Alice Corp. v. CLS Banklnt 1, the Court provides the following framework for analysis: First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. If so, we then ask, “[wjhat else is there in the claims before us?” To answer that question, we consider the elements of each claim both individually and “as an ordered combination” to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application. We have described step two of this analysis as a search for an “‘inventive concept’”—i.e., an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.” 5 Appeal 2016-002210 Application 13/344,752 We agree with the Examiner that under part 2 of the Alice analysis, claim 1 is directed to the abstract idea of determining the anticoagulant dosage for a patient, which is a mental process of administering medication that could be performed in the human mind, or by a human using a pen and paper. Ans. 12. We further agree with the Examiner that the recited steps describe the concept of using answers to a questionnaire provided by the patient to calculate the patient’s daily dosage of anticoagulant using a mathematical equation. Id. We do not agree with Appellant’s contention that the claimed method is different from the method of Mayo. App. Br. 12. As in Mayo, such methods for determining dosage of medication for a patient were well known in the art, and the claimed method simply tells doctors to engage in a well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity as recited in the claim is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. Mayo, at 1291 (citing Parker v. Flook, 437 U.S. 584, 590). Although the claim recites “entering . . . into a computer with a mathematical model program” values obtained from the patient in response to a questionnaire, the claim does not require that the computer perform any of the subsequent steps including generating/using the equation. Because the claim does not require the use of a specially tailored computer for implementing the method, the steps as an ordered combination add nothing to the laws of nature that is not already present when the steps are considered separately. Further, it has been held that the “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’” Bilski, supra, at__957_ (slip op. at 14) (quoting Diehr, 450 U.S. at 191— 6 Appeal 2016-002210 Application 13/344,752 192). Moreover, it has been held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle. For the mathematical formula had “no substantial practical application except in connection with a digital computer.” See Gottschalkv. Benson, 409 U.S. 63, 71 (1972). Because the steps in the claimed process involve a well-understood, routine, conventional activity previously engaged in by others in the field, we agree with the Examiner that the steps recited in claim 1 do not amount to “significantly more” than the abstract idea under part 2 of Alice. Ans. 12. As discussed supra, “determining the anticoagulant dosage for a patient” as recited “could be performed in the human mind, or by a human using a pen and paper. The Federal Circuit recently reconfirmed “[w]e have held that ‘analyzing information by steps people [can] go through in their minds, or by mathematical algorithms, without more . . . [are] mental processes within the abstract-idea category.’” Coffelt v. NVIDIA Corp., 2017 WL 999217 *1 (Fed. Cir. 2017) (brackets in original) (quoting Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016)). Accordingly, we sustain the Examiner’s non-statutory subject matter rejection of claim 1, as well as claims 2—18 and 22 not separately argued. Prior Art Rejections Appellant argues that Mayer does not quality as prior art against the claims in the present application because of the declarations submitted by the inventor of record (Dr. Hurst) and her representative (Dr. Hahn) on March 25, 2015 to antedate the Mayer application. App. Br. 16. According to Appellant, because the declarations substantiate that the claimed invention was reduced to practice prior to the effective filing date (September 22, 7 Appeal 2016-002210 Application 13/344,752 2010) of the Mayer application, the latter reference does not qualify as prior art. Id. This argument is moot because the Examiner did not enter the cited declarations. In particular, the Examiner refused to enter the declarations subsequent to the final rejection because Appellant has not shown good cause as to why the declarations were not presented earlier. Advisory Act. of April 13, 2015; Ans. 13. Because the declarations were not entered by the Examiner, they are not before us for review. See MPEP § 715.09.5 Accordingly, we summarily sustain the Examiner’s prior art rejections of claims 1—18 and 22. DECISION For the above reasons, we affirm the 35 U.S.C. §§ 101, 102, and 103 rejections of claims 1—18 and 22. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 5 Review of an examiner’s refusal to enter an affidavit as untimely is by petition and not by appeal to the Patent Trial and Appeal Board. In re Deters, 515 F.2d 1152, 185 USPQ 644 (CCPA 1975); Ex parte Hale, 49 USPQ 209 (Bd. App. 1941). See MPEP § 715,08 regarding review of questions of propriety of 37 CFR 1.131(a) affidavits and declarations. 8 Copy with citationCopy as parenthetical citation