Matthias Koehler et al.Download PDFPatent Trials and Appeals BoardAug 14, 201913606088 - (D) (P.T.A.B. Aug. 14, 2019) 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. 13/606,088 09/07/2012 Matthias Koehler ROQ 0036 NA/30593 US 7668 67491 7590 08/14/2019 DINSMORE & SHOHL, LLP FIFTH THIRD CENTER ONE SOUTH MAIN STREET SUITE 1300 DAYTON, OH 45402 EXAMINER MORGAN, ROBERT W ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 08/14/2019 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): daytonipdocket@dinsmore.com jackie.pike@roche.com pair_roche@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte MATTHIAS KOEHLER, PETER BLASBERG, and MARIUSZ TRACZ ____________________ Appeal 2018-002734 Application 13/606,0881 Technology Center 3600 ____________________ Before JENNIFER S. BISK, LARRY J. HUME, and JULIET MITCHELL DIRBA, Administrative Patent Judges. HUME, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) of the Final Rejection of claims 1–20, which are all claims pending in the application. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the real party in interest is Roche Diabetes Care, Inc. App. Br. 2. Appeal 2018-002734 Application 13/606,088 2 STATEMENT OF THE CASE2 The Invention Appellants’ disclosed embodiments and claimed invention relate to “technologies in the field of diabetes care, especially an analysis system for performing an analysis of measured blood glucose values and a method for using the analyzing system.” Spec. 1, ll. 10–12. Representative Claims Claims 1 and 10, reproduced below, are representative of the subject matter on appeal (formatting added; emphases added to contested prior-art limitations): 1. A system for analyzing measured blood glucose values of a diabetic and providing statistical blood glucose level information based on the measured blood glucose values, the system comprising: a display, a memory device, an application module comprising program instructions, and a processor connected to the display, the memory and the application module, said program instructions which when executed cause the processor to: provide blood glucose measurement information which comprises plurality of measured blood glucose values collected within a measurement time frame, 2 Our decision relies upon Appellants’ Appeal Brief (“App. Br.,” filed June 15, 2017); Reply Brief (“Reply Br.,” filed Jan. 16, 2018); Examiner’s Answer (“Ans.,” mailed Nov. 14, 2017); Final Office Action (“Final Act.,” mailed Sept. 23, 2016); and the original Specification (“Spec.,” filed Sept. 7, 2012). Appeal 2018-002734 Application 13/606,088 3 perform a pre-analysis of the blood glucose measurement information, provide analysis data representing statistical blood glucose level information for the plurality of measured blood glucose values via an analysis performed by the processor with the plurality of measured blood glucose values, and provide as output of the system, output analysis data that represents the analysis data on the display, wherein the output analysis data comprises statistical blood glucose level information which characterizes a whole set of the measured blood glucose values collected in the measurement time frame instead of discrete single blood glucose values, wherein the processor performs the analysis and/or provides the output analysis data only if, in performance the pre-analysis a fidelity check is positive for the measurement time frame, in which the processor provides a positive result for the fidelity check if the plurality of measured blood glucose values comprises a set of measured blood glucose values being representative for the measurement time frame such that the statistical blood glucose level information, represented by the analysis data and provided by the processor on the display as the output analysis data, is only based on the measured blood glucose values which have a positive fidelity check, and wherein if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check such that the statistical blood glucose level information based on the whole set of the measured blood glucose values and displayed on the display by the processor as the output analysis data is representative only for the time period shorter than the measurement time frame. Appeal 2018-002734 Application 13/606,088 4 10. A method improving statistical blood glucose level information provided to a diabetic by a system performing an analysis of measured blood glucose values from the diabetic, the method comprising the steps of: providing as input blood glucose measurement information to a processor, the blood glucose measurement information comprising a plurality of measured blood glucose values collected within a measurement time frame, performing a pre-analysis of the blood glucose measurement information using the processor, providing analysis data representing statistical blood glucose level information which characterizes a whole set of the measured blood glucose values collected in the measurement time frame instead of discrete single blood glucose values by performing an analysis of the plurality of measured blood glucose values using the processor, and providing as output from the processor output analysis data representing the analysis data to a display, wherein the step of performing an analysis of the plurality of measured blood glucose values and/or the step of providing the output analysis data are performed by the processor only if, in the step of performing the pre-analysis a fidelity check for the measurement time frame is positive, the processor providing a positive result for the fidelity check if the plurality of measured blood glucose values comprises a set of measured blood glucose values being representative for the measurement time frame such that the statistical blood glucose level information, represented by the analysis data and provided by the processor on the display as the output analysis data, is only based on the measured blood glucose values which have a positive fidelity check, and wherein if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check such that the Appeal 2018-002734 Application 13/606,088 5 statistical blood glucose level information based on the whole set of the measured blood glucose values and displayed on the display by the processor as the output analysis data is representative only for the time period shorter than the measurement time frame. Prior Art The Examiner relies upon the following prior art as evidence in rejecting the claims on appeal: Kaufman et al. (“Kaufman”) US 2010/0174553 A1 July 8, 2010 Soni et al. (“Soni”) US 2011/0178820 A1 July 21, 2011 Rejections on Appeal R1. Claims 1–20 stand rejected under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. Final Act. 3. R2. Claims 1–20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over the combination of Kaufman and Soni. Final Act. 4. CLAIM GROUPING Based on Appellants’ arguments (App. Br. 7–26) and our discretion under 37 C.F.R. § 41.37(c)(1)(iv), we decide the appeal of patent-ineligible subject matter Rejection R1 of claims 1–20 on the basis of representative method claim 10; we decide the appeal of obviousness Rejection R2 of claims 1–9, 12–15 and 17–20 on the basis of representative system claim 1; and we decide the appeal of obviousness Rejection R2 of claims 10 and 11 Appeal 2018-002734 Application 13/606,088 6 on the basis of representative method claim 10. We address Rejection R2 of separately argued claim 16, infra.3 ISSUES AND ANALYSIS In reaching this decision, we consider all evidence presented and all arguments actually made by Appellants. To the extent Appellants have not advanced separate, substantive arguments for particular claims, or other issues, such arguments are waived. 37 C.F.R. § 41.37(c)(1)(iv). Based upon our review of the record, and the Revised Guidance discussed herein, we find a preponderance of the evidence supports particular arguments advanced by Appellants with respect to Rejection R1 of claims 1–20 under § 101 for the specific reasons discussed below. However, we disagree with Appellants’ arguments with respect to Rejection R2 of claims 1–20 under 35 U.S.C. § 103(a) and, unless otherwise noted, we incorporate by reference herein and adopt as our own: (1) the findings and reasons set forth by the Examiner in the action from which this appeal is taken, and (2) the reasons and rebuttals set forth in the Examiner’s Answer in response to Appellants’ arguments. We highlight and address specific findings and arguments regarding claims 1, 10, and 16 for emphasis as follows. 3 “Notwithstanding any other provision of this paragraph, the failure of appellant to separately argue claims which appellant has grouped together shall constitute a waiver of any argument that the Board must consider the patentability of any grouped claim separately.” 37 C.F.R. § 41.37(c)(1)(iv). In addition, when Appellants do not separately argue the patentability of dependent claims, the claims stand or fall with the claims from which they depend. In re King, 801 F.2d 1324, 1325 (Fed. Cir. 1986). Appeal 2018-002734 Application 13/606,088 7 1. § 101 Rejection R1 of Claims 1–20 Issue 1 Appellants argue (App. Br. 7–19; Reply Br. 2–10) the Examiner’s rejection of claim 1 under 35 U.S.C. § 101 as being directed to patent- ineligible subject matter is in error. These contentions present us with the following issue: Under the USPTO’s Revised Guidance, informed by our governing case law concerning 35 U.S.C. § 101, is claim 1 patent-ineligible under § 101? Principles of Law A. 35 U.S.C. § 101 “Eligibility under 35 U.S.C. § 101 is a question of law, based on underlying facts.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1166 (Fed. Cir. 2018). An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101.4 However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012) (brackets in original) (citing Diamond v. Diehr, 450 U.S. 175, 185 (1981)). 4 This threshold analysis of whether a claim is directed to one of the four statutory categories of invention, i.e., a process, machine, manufacture, or composition of matter, is referred to as “Step 1” in the USPTO’s patent- eligibility analysis under § 101. MPEP § 2106. Appeal 2018-002734 Application 13/606,088 8 In determining whether a claim falls within an excluded category, we are guided by the Supreme Court’s two-step framework, described in Mayo and Alice. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217–18 (2014) (citing Mayo, 566 U.S. at 75–77). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk . . . .”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diehr, 450 U.S. at 191); “tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Supreme Court held “[a] claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as nothing more than a process for molding rubber Appeal 2018-002734 Application 13/606,088 9 products and not as an attempt to patent a mathematical formula.”). Having said that, the Supreme Court also indicated that a claim “seeking patent protection for that formula in the abstract . . . is not accorded the protection of our patent laws, and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.” Id. (citation omitted) (citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”). Abstract ideas may include, but are not limited to, fundamental economic practices, methods of organizing human activities, and mathematical formulas or relationships. Alice, 573 U.S. at 217–21. Under this guidance, we must therefore ensure at step one that we articulate what the claims are directed to with enough specificity to ensure the step one inquiry is meaningful. Id. at 217 (“[W]e tread carefully in construing this exclusionary principle lest it swallow all of patent law.”). If the claim is “directed to” an abstract idea, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘“inventive concept”’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (citation omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. Appeal 2018-002734 Application 13/606,088 10 B. USPTO Revised Guidance The PTO recently published revised guidance in the Federal Register concerning the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (January 7, 2019) (hereinafter “Revised Guidance”) (https://www.govinfo.gov/content/pkg/FR-2019-01- 07/pdf/2018-28282.pdf). Under the Revised Guidance, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes);5 and (2) additional elements that integrate the judicial exception into a practical application (see Manual for Patent Examining Procedure (“MPEP”) §§ 2106.05(a)–(c), (e)–(h)).6 See Revised Guidance 52–53. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or 5 Referred to as “Revised Step 2A, Prong 1” in the Revised Guidance (hereinafter “Step 2A(i)”). 6 Referred to as “Revised Step 2A, Prong 2” in the Revised Guidance (hereinafter “Step 2A(ii)”). Appeal 2018-002734 Application 13/606,088 11 (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.7 See Revised Guidance 56. Step 2A(i) – Abstract Idea Informed by our judicial precedent, the Revised Guidance extracts and synthesizes key concepts identified by the courts as abstract ideas to explain that the abstract idea exception includes the following groupings of subject matter, when recited as such in a claim limitation: (a) Mathematical concepts—mathematical relationships, mathematical formulas or equations, mathematical calculations; (b) Certain methods of organizing human activity — fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and (c) Mental processes—concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Under the Revised Guidance, if the claim does not recite a judicial exception (a law of nature, natural phenomenon, or subject matter within the enumerated groupings of abstract ideas above), then the claim is patent- 7 Items (3) and (4) continue to be collectively referred to as “Step 2B” of the Supreme Court’s two-step framework, described in Mayo and Alice. Appeal 2018-002734 Application 13/606,088 12 eligible at Step 2A(i). This determination concludes the eligibility analysis, except in situations identified in the Revised Guidance.8 However, if the claim recites a judicial exception (i.e., an abstract idea enumerated above, a law of nature, or a natural phenomenon), the claim requires further analysis for a practical application of the judicial exception in Step 2A(ii). Step 2A(ii) – Practical Application If a claim recites a judicial exception in Step 2A(i), we determine whether the recited judicial exception is integrated into a practical application of that exception in Step 2A(ii) by: (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. The seven identified “practical application” sections of the MPEP,9 cited in the Revised Guidance under Step 2A(ii), are: 8 In the rare circumstance in which an examiner believes a claim limitation that does not fall within the enumerated groupings of abstract ideas should nonetheless be treated as reciting an abstract idea, the procedure described in of the Guidance for analyzing the claim should be followed. See Revised Guidance, Section III.C. 9 See MPEP §§ 2106.05(a)–(c), (e)–(h). Citations to the MPEP herein refer to revision [R-08.2017]. Sections 2106.05(a), (b), (c), and (e) are indicative of integration into a practical application, while §§ 2106.05(f), (g), and (h) relate to limitations that are not indicative of integration into a practical application. Appeal 2018-002734 Application 13/606,088 13 (1) MPEP § 2106.05(a) Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field (2) MPEP § 2106.05(b) Particular Machine (3) MPEP § 2106.05(c) Particular Transformation (4) MPEP § 2106.05(e) Other Meaningful Limitations (5) MPEP § 2106.05(f) Mere Instructions To Apply An Exception (6) MPEP § 2106.05(g) Insignificant Extra-Solution Activity (7) MPEP § 2106.05(h) Field of Use and Technological Environment See Revised Guidance 55. If the recited judicial exception is integrated into a practical application as determined under one or more of the MPEP sections cited above, then the claim is not directed to the judicial exception, and the patent- eligibility inquiry ends. See Revised Guidance 54. If not, then analysis proceeds to Step 2B. Step 2B – “Inventive Concept” or “Significantly More” Under our reviewing courts’ precedent, it is possible that a claim that does not “integrate” a recited judicial exception under Step 2A(ii) is nonetheless patent eligible. For example, the claim may recite additional elements that render the claim patent eligible even though a judicial exception is recited in a separate claim element.10 The Federal Circuit has held claims eligible at the second step of the Alice/Mayo test (USPTO Step 2B) because the additional elements recited in the claims provided “significantly more” than the recited judicial exception (e.g., because the 10 See, e.g., Diehr, 450 U.S. at 187. Appeal 2018-002734 Application 13/606,088 14 additional elements were unconventional in combination).11 Therefore, if a claim has been determined to be directed to a judicial exception under Revised Step 2A, we must also evaluate the additional elements individually and in combination under Step 2B to determine whether they provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).12 Under the Revised Guidance, we must consider in Step 2B whether an additional element or combination of elements: (1) “Adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present;” or (2) “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.” See Revised Guidance, III.B.13 11 See, e.g., Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300, 1304 (Fed. Cir. 2016); BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1349–52 (Fed. Cir. 2016); DDR Holdings v. Hotels.com, L.P., 773 F.3d 1245, 1257–59 (Fed. Cir. 2014). 12 The patent eligibility inquiry may contain underlying issues of fact. Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1325 (Fed. Cir. 2016). In particular, “[t]he question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact.” Berkheimer v. HP Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018). 13 In accordance with existing Step 2B guidance, an Examiner’s finding that an additional element (or combination of elements) is well understood, routine, conventional activity must be supported with at least one of the four specific types of evidence required by the USPTO Berkheimer Memorandum, as shown above. For more information concerning evaluation Appeal 2018-002734 Application 13/606,088 15 In the Step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds an evidentiary basis, and expressly supports a rejection in writing with, one or more of the following: 1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). . . . 2. A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) as noting the well- understood, routine, conventional nature of the additional element(s). 3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). . . . 4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). . . . See Berkheimer Memo. The analysis in Step 2B further determines whether an additional element or combination of elements: (a) Adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or of well-understood, routine, conventional activity, see MPEP § 2106.05(d), as modified by the USPTO Berkheimer Memorandum (USPTO Commissioner for Patents Memorandum dated Apr. 19, 2018, “Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.)” (hereinafter “Berkheimer Memo”). Appeal 2018-002734 Application 13/606,088 16 (b) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. Revised Guidance, and see Berkheimer Memo. If the Examiner or the Board determines under Step 2B that the element (or combination of elements) amounts to significantly more than the exception itself, the claim is eligible, thereby concluding the eligibility analysis. However, if a determination is made that the element and combination of elements does not amount to significantly more than the exception itself, the claim is ineligible under Step 2B, and the claim should be rejected for lack of subject matter eligibility. Analysis Based upon our de novo review of the record in light of recent Director Policy Guidance with respect to patent-eligible subject matter rejections under 35 U.S.C. § 101, we reverse the rejection of claims 1–20 for the specific reasons discussed below. Step 1: Statutory Category Claim 10, as a method (process) claim, recites one of the enumerated categories of eligible subject matter in 35 U.S.C. § 101. Therefore, the issue before us is whether the claim is directed to a judicial exception without significantly more. Appeal 2018-002734 Application 13/606,088 17 Step 2A(i): Does the Claim Recite a Judicial Exception? The Examiner determined claim 10 is directed to “the abstract idea of comparing new and stored information and using rules to identify options . . . [where] the abstract idea . . . is described, for example, by the providing, performing, providing and providing steps.” See Final Act. 3; Ans. 3. We find claim 10 does not recite the judicial exceptions of either natural phenomena or laws of nature. We evaluate, de novo, whether claim 1 recites an abstract idea based upon the Revised Guidance. Claim 10 recites “[a] method improving statistical blood glucose level information provided to a diabetic by a system performing an analysis of measured blood glucose values from the diabetic,” wherein the method includes the steps of: (1) “[P]roviding as input blood glucose measurement information to a processor, the blood glucose measurement information comprising a plurality of measured blood glucose values collected within a measurement time frame.” (2) “[P]erforming a pre-analysis of the blood glucose measurement information using the processor.” (3) “[P]roviding analysis data representing statistical blood glucose level information which characterizes a whole set of the measured blood glucose values collected in the measurement time frame instead of discrete single blood glucose values by performing an analysis of the plurality of measured blood glucose values using the processor, and (4) “[P]roviding as output from the processor output analysis data representing the analysis data to a display.” (5) “[T]he step of performing an analysis of the plurality of measured blood glucose values and/or the step of providing the output analysis data are performed by the processor only if, Appeal 2018-002734 Application 13/606,088 18 in the step of performing the pre-analysis a fidelity check for the measurement time frame is positive.” (6) “[T]he processor providing a positive result for the fidelity check if the plurality of measured blood glucose values comprises a set of measured blood glucose values being representative for the measurement time frame such that the statistical blood glucose level information, represented by the analysis data and provided by the processor on the display as the output analysis data, is only based on the measured blood glucose values which have a positive fidelity check.” (7) . . . “[I]f the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check such that the statistical blood glucose level information based on the whole set of the measured blood glucose values and displayed on the display by the processor as the output analysis data is representative only for the time period shorter than the measurement time frame.” Claims App’x. The Specification provides context as to what the claimed invention is directed to. In this case, the Specification discloses the invention “relates generally to technologies in the field of diabetes care, especially an analysis system for performing an analysis of measured blood glucose values and a method for using the analyzing system.” Spec. 1. Appellants’ Abstract provides additional description of the invention: A system and method for analyzing measured blood glucose values is disclosed, wherein the system includes a display device, a memory device, and a processor having program instructions which when executed cause the processor to provide blood glucose measurement information including a Appeal 2018-002734 Application 13/606,088 19 plurality of measured blood glucose values collected within a measurement time frame, perform a pre-analysis of the blood glucose measurement information, provide analysis data representing statistical blood glucose level information for the plurality of measured blood glucose values by performing an analysis of the plurality of measured blood glucose values, and provide output analysis data representing the analysis data, wherein the provision of analysis data and / or the provision of output analysis data are performed if, in the step of performing the pre-analysis, at least one of the following control checks is positive a fidelity check, and an adherence check. Spec. 18. Under the broadest reasonable interpretation standard,14 we conclude claim 10 recites steps that would ordinarily occur when measuring and analyzing blood glucose information to determine relevant statistics related thereto. See Final Act. 3; Ans. 3. For example, step (2) performing pre- analysis of blood glucose information by ensuring the fidelity of prior collected information, would be a common step in any statistical blood glucose level analysis to ensure the validity of measurement data. Also, step (3), providing results of the blood glucose level analysis, logically would be expected to occur after testing. Limitation (5) would also be expected to be carried out to ensure data validity, i.e., “performing an analysis of the 14 During prosecution, claims must be given their broadest reasonable interpretation when reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under this standard, we interpret claim terms using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Appeal 2018-002734 Application 13/606,088 20 plurality of measured blood glucose values” ensures the measurement time frame is valid, by checking whether “a fidelity check for the measurement time frame is positive.” Thus, under Step 2A(i), we generally agree with the Examiner that claim 10 recites an abstract idea. However, we differ in the characterization, and particularly conclude claim 1 recites a mental processes. Specifically, claim 1 recites a concept that can be performed in the human mind, i.e., an observation, evaluation, judgment, and/or opinion, which we further note may be performed without a computer using pen and paper. This type of activity, i.e., statistical analysis of blood glucose level information over a measurement period, includes longstanding conduct that existed well before the advent of computers and the Internet, and could be carried out by a human with pen and paper. See CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. 2011).15 15 Our reviewing court recognizes that “[a]n abstract idea can generally be described at different levels of abstraction.” Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir. 2016). That need not and, in this case does not, “impact the patentability analysis.” Id. at 1241. Further, “[t]he Board’s slight revision of its abstract idea analysis does not impact the patentability analysis.” Id. Moreover, merely combining several abstract ideas does not render the combination any less abstract. RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327 (Fed. Cir. 2017) (“Adding one abstract idea (math) to another abstract idea . . . does not render the claim non-abstract.”); see also FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093–94 (Fed. Cir. 2016) (determining the pending claims were directed to a combination of abstract ideas). Appeal 2018-002734 Application 13/606,088 21 We conclude claim 10, under our Revised Guidance, recites a judicial exception of mental processes, i.e., a concept performed in the human mind, and thus an abstract idea. Step 2A(ii): Judicial Exception Integrated into a Practical Application? If the claims recite a patent-ineligible concept, as we conclude above, we proceed to the “practical application” Step 2A(ii) in which we determine whether the recited judicial exception is integrated into a practical application of that exception by: (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. In addition to the abstract steps recited in limitations (2), (3), and (5) identified in Step 2A(i), supra, claim 10 further recites limitations (1) “providing as input blood glucose measurement information to a processor” and limitation (4) “providing as output from the processor output analysis data representing the analysis data to a display.” As to the specific limitations, we find limitation (1) recites insignificant data gathering. See MPEP § 2106.05(g). Data gathering, as performed by the steps or function in Appellants’ claims, is a classic example of insignificant extra-solution activity. See, e.g., In re Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom, Bilski v. Kappas, 561 U.S. 593 (2010). We also find limitation (4) recites insignificant post solution activity. The Supreme Court guides that the “prohibition against patenting abstract Appeal 2018-002734 Application 13/606,088 22 ideas ‘cannot be circumvented’ [by] adding ‘insignificant postsolution activity.’” Bilski, 561 U.S. at 610–11 (quoting Diehr, 450 U.S. at 191–92). However, for the reasons discussed below, we conclude conditional limitations (6) (“providing a positive result for the fidelity check if the plurality of measured blood glucose values comprises a set of measured blood glucose values being representative for the measurement time frame”) and (7) (“the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check”) integrate the abstract idea into a practical application as determined under at least one of the cited MPEP sections.16 For example, with respect to Figure 2, Appellants’ Specification discloses: If . . . the fidelity check . . . provides a successful result, analysis data representing statistical blood glucose level information for the plurality of measured blood glucose values is provided by performing a structured analysis of the plurality of measured blood glucose values (step 24). In step 25, output analysis data representing the analysis data derived before are provided for outputting to the user, for example via the display 2 of the analyzing device 1. Spec. 7. Along these lines, Appellants argue: 16 See, e.g., MPEP § 2106.05(a) “Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field,” and § 2106.05(e) “Other Meaningful Limitations.” Appeal 2018-002734 Application 13/606,088 23 [T]he application . . . describes a fidelity check step during the pre-analysis step to assess whether a set of data is representative of a measurement time frame such that sufficient statistical data is used in the analysis step to avoid analysis of insufficient data that may lead to medical misinterpretation, which bolsters a conclusion that the present claims are directed to an improvement in blood glucose analysis technology to improve the statistical blood glucose level information provided to a diabetic by a system performing an analysis of measured blood glucose values from the diabetic after performing a pre- analysis including a positive fidelity check such that a processor is provided with sufficient statistical data for improved processing and improved output results. App. Br. 11. We find Appellants’ argument persuasive that carrying out steps (6) and (7), conditioned upon successful data fidelity checks relating to a determination that measurement time frames are representative, provide improvements to the underlying technology or technical field, namely, statistical glucose level monitoring and analysis systems. See MPEP § 2106.05(a) or, alternatively, § 2106.05(e) “Other Meaningful Limitations.” With respect to these other meaningful limitations, we find guidance in MPEP § 2106.05(e), which summarizes and relies upon our reviewing court’s holdings in Diehr, cited supra, and Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the lower court’s prior holding of ineligibility in view of Bilski). In Diehr, the Court evaluated the additional non-abstract limitations, and found them to be meaningful, because they sufficiently limited the use of the (abstract idea) mathematical equation to the practical application of Appeal 2018-002734 Application 13/606,088 24 molding rubber products. MPEP § 2106.05(e) (citing Diehr, 450 U.S. at 184, 187). In Classen, the Court held that, although the analysis step was an abstract mental process that collected and compared known information, the (practical application) immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application.” MPEP § 2106.05(e) (citing Classen, 659 F.3d at 1066–68). We find these other meaningful limitations identified above provide a technological improvement to statistical glucose level analysis methods and systems. App. Br. 11. Accordingly, we conclude, when the claim is considered as a whole, the recited judicial exception is integrated into a practical application as determined under either MPEP sections 2106.06(a) or 2106.05(e) cited above, such that the claim is patent-eligible. Because the claims are directed to a patent-eligible concept, this concludes the patent-eligibility inquiry. Therefore, based upon the findings and legal conclusions above, on this record and in consideration of the Revised Guidance, we are persuaded the claims are directed to patent-eligible subject matter, such that we do not sustain the § 101 rejection of claim 10, and grouped claims 1–9 and 11–20 which stand therewith. See Claim Grouping, supra. Appeal 2018-002734 Application 13/606,088 25 2. § 103 Rejection R2 of Claims 1–9, 12–15 and 17–20 Issue 2 Appellants argue (App. Br. 19–26; Reply Br. 10–16) the Examiner’s rejection of independent system claim 1 under 35 U.S.C. § 103(a) as being obvious over the combination of Kaufman and Soni is in error. These contentions present us with the following issue: Did the Examiner err in finding the cited prior art combination teaches or suggests “[a] system for analyzing measured blood glucose values of a diabetic and providing statistical blood glucose level information based on the measured blood glucose values,” that includes, inter alia, “an application module comprising program instructions, and a processor connected to the display, the memory and the application module,” wherein if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check such that the statistical blood glucose level information based on the whole set of the measured blood glucose values and displayed on the display by the processor as the output analysis data is representative only for the time period shorter than the measurement time frame, as recited in claim 1 (emphasis added)? Analysis Appellants contend the Examiner’s reliance upon Soni is mistaken because “none of the cited portions of Soni actually do teach or describe the recitations of the entire last two paragraphs of claims 1 and 10, let alone at Appeal 2018-002734 Application 13/606,088 26 least the recitation of an automatically adjusted time frame in claims 1 and 10 to represent sufficient statistical blood glucose level information.” App. Br. 21. Appellants thereby conclude “the Examiner has not actually set forth or explained how any of the cited portions of Soni are actually supposed to teach at least such an automatically adjusted time frame as recited in claims 1 and 10 but has merely set forth citations to paragraphs from Soni without clearly articulating any reasoning as to how the cited portion teach the claim recitations of claims 1 and 10.” Id. In response, the Examiner determined “the concept included in the limitations regarding ‘an adjusted time frame’ is merely a reference to only performing calculations on data that is actually acquired during a certain (i.e., shorter) time frame which is a well-understood caveat of performing data analysis . . . . and an ‘adjustment’ is made when performing analysis on data such that missing data or information does not improperly skew the analysis and/or calculations.” Ans. 24. Appellants argue that the Examiner’s explanation does not clearly articulate “reasoning how any of the cited portions of Soni are actually supposed to teach at least such an automatically adjusted time frame,” but instead “appears to take improper official notice that such a feature is a well- understood caveat of performing data analysis.” Reply Br. 12 (citing Ans. 24). Appellants’ arguments do not persuade us of Examiner error. We agree with the Examiner that Soni discloses performing structured data collection that is automatically scheduled to occur “upon one or more entry criteria being met at some unknown time” and ends automatically “upon one Appeal 2018-002734 Application 13/606,088 27 or more exit criteria being met at some unknown time.” Soni Abstract, ¶¶ 10–11. Soni also discloses that an analysis of collected data may result in the rejection of certain data and that accepted data can be “defined by time- related . . . events.” Id. ¶¶ 49, 51. Finally, Soni notes that “a sampling group determination can be made as to which information has to be collected,” for example, “the sampling group can be . . . time based which can use a target time (e.g, used for an alerting feature), a lower time window bound, an upper time window bound, etc.” Id. ¶ 91. We agree with the Examiner’s finding that a person of ordinary skill in the art would have understood these disclosures of Soni to disclose the recited “adjusted time frame” and would have found it obvious to make such modification to Kaufman’s system. Here, Appellants “present[] no evidence that the [Examiner's proposed modification] was uniquely challenging or difficult for one of ordinary skill in the art.” Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). Appellants further allege, “nothing in Soni appears to reasonably disclose or suggest such a fidelity check, let alone a fidelity check as a pre-analysis requirement prior to analysis and/or output of analysis data.” App. Br. 22. With respect to Appellants’ lack of a “fidelity check” argument quoted above, the Examiner finds Kaufman in view of Soni teaches or suggests a “data-parsing layer that is responsible for validating the integrity of device data received.” Ans. 25 (citing Kaufman ¶ 41). We agree with the Examiner’s finding that Kaufman’s teaching or suggestion of a “fidelity check” (of data) reads on Kaufman’s data integrity validation, as cited by the Examiner. Appeal 2018-002734 Application 13/606,088 28 Appellants also submitted a declaration under 37 C.F.R. § 1.132 by inventor Matthias Koehler (hereinafter, “Declaration”) that purports to provide an understanding from the perspective of one skilled in the art that the combined teachings of Kaufman in view of Soni is deficient with respect to providing a teaching or suggestion of the contested limitations of claim 1. The Examiner provides a response indicating the Declaration merely proffers the opinion of the inventor, and does not provide evidentiary facts concerning how a person with skill in the art would interpret the reference combination. The Examiner makes additional findings with respect to the probative value of the Declaration. See Ans. 26. We agree with the Examiner’s evidentiary findings. Therefore, based upon the findings and legal conclusions above, on this record, we are not persuaded of error in the Examiner’s reliance on the cited prior art combination to teach or suggest the disputed limitation of claim 1, nor do we find error in the Examiner’s resulting legal conclusion of obviousness. Therefore, we sustain the Examiner’s obviousness rejection of independent claim 1, and grouped claims 2–9, 12–15 and 17–20, which fall therewith. See Claim Grouping, supra. Appeal 2018-002734 Application 13/606,088 29 3. § 103 Rejection R2 of Claims 10 and 11 Issue 3 Appellants argue (App. Br. 19–26; Reply Br. 10–16) the Examiner’s rejection of independent method claim 10 under 35 U.S.C. § 103(a) as being obvious over the combination of Kaufman and Soni is in error. These contentions present us with the following issue: Did the Examiner err in finding the cited prior art combination teaches or suggests “[a] method improving statistical blood glucose level information provided to a diabetic by a system performing an analysis of measured blood glucose values from the diabetic,” that includes the step of “performing a pre-analysis of the blood glucose measurement information using the processor,” wherein, inter alia, if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame for the fidelity check such that the statistical blood glucose level information based on the whole set of the measured blood glucose values and displayed on the display by the processor as the output analysis data is representative only for the time period shorter than the measurement time frame, as recited in claim 10? Analysis Appellants do not distinguish their arguments concerning independent method claim 10 from independent system claim 1, as set forth above in our analysis of Issue 2. Particularly, Appellants assert the Examiner’s reliance Appeal 2018-002734 Application 13/606,088 30 upon Soni is misplaced because “none of the cited portions of Soni actually do teach or describe the recitations of the entire last two paragraphs of claims 1 and 10, let alone at least the recitation of an automatically adjusted time frame in claims 1 and 10 to represent sufficient statistical blood glucose level information.” App. Br. 21. Appellants further allege, “nothing in Soni appears to reasonably disclose or suggest such a fidelity check, let alone a fidelity check as a pre-analysis requirement prior to analysis and/or output of analysis data.” App. Br. 22. In reply to Appellants’ contentions, the Examiner states: [T]he concept included in the limitations regarding “an adjusted time frame” is merely a reference to only performing calculations on data that is actually acquired during a certain (i.e., shorter) time frame which is a well-understood caveat of performing data analysis. That is to say, one cannot perform analysis on data one does not have and an “adjustment” is made when performing analysis on data such that missing data or information does not improperly skew the analysis and/or calculations. As such, Kaufman in view of Soni more than seemingly suggests the limitation regarding “output of the system” and “an adjusted time frame”, as recited by the Applicant. Ans. 24 (emphasis added). In reply to the Examiner, Appellants argue: Rather than clearly articulating how Kaufman and/or Soni expressly discloses or impliedly suggests at least the “adjusted time frame” feature of claims 1 and 10 as required to establish prima facie obviousness, the Examiner appears to take improper official notice that such a feature is a well-understood caveat of performing data analysis. Appeal 2018-002734 Application 13/606,088 31 Reply Br. 12. We note the contested limitation of claim 10 conditionally recites, in pertinent part, “if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame, an adjusted time frame which corresponds to the shorter time period identified by the processor is then used by the processor as the measurement time frame.” Claim App’x (emphasis added). As a matter of claim construction, we conclude the contested method step limitation is conditional, i.e., if the stated condition does not occur, then the adjusted time frame is not used by the processor. That is to say, the stated condition makes the rest of the limitation conditional on the pre- analysis determining that a shorter time frame is needed. Therefore, under the broadest reasonable interpretation standard,17 the shorter time frame is not needed if the pre-analysis provides that the plurality of measured glucose values is representative for a measurement time frame. As the Examiner determined, “one cannot perform analysis on data one does not have.” Ans. 24. Further, as an additional matter of claim construction in accord with our precedential holding in Schulhauser, the Examiner need not “present evidence of the obviousness of the remaining method steps . . . that are not required to be performed under a broadest reasonable interpretation of the claim.” Ex parte Schulhauser, Appeal No. 2013-007847, at *9 (PTAB, April 28, 2016) (precedential) (holding “The Examiner did not need to present evidence of the obviousness of the remaining method steps of 17 See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d at 1364. Appeal 2018-002734 Application 13/606,088 32 claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met.”)); see also Ex parte Katz, Appeal No. 2010-006083, 2011 WL 514314, at *4–5 (BPAI Jan. 27, 2011).18 We, therefore, agree under Schulhauser with the Examiner’s determination that if the pre-analysis provides that the plurality of measured glucose values is representative for a measurement time frame, the shorter time frame is not needed. Thus, “if the pre-analysis provides that the plurality of measured blood glucose values is only representative for a time period shorter than the measurement time frame” limitation of claim 10 is a conditional step that, under Schulhauser, the Examiner need not present evidence that teaches or suggests the conditional limitation. Accordingly, based upon the findings and legal conclusions above, on this record, we are not persuaded of error in the Examiner’s reliance on the cited prior art combination to teach or suggest the disputed limitation of claim 10, nor do we find error in the Examiner’s resulting legal conclusion of obviousness. Therefore, we sustain the Examiner’s obviousness rejection 18 See, also e.g., Applera Corp. v. Illumina, Inc., 375 Fed. Appx. 12, 21 (Fed. Cir. 2010) (unpublished) (affirming a district court's interpretation of a method claim as including a step that need not be practiced if the condition for practicing the step is not met); Cybersettle, Inc. v. Nat’l Arbitration Forum, Inc., 243 Fed. Appx. 603, 607 (Fed. Cir. 2007) (unpublished) (“It is of course true that method steps may be contingent. If the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed.”). Appeal 2018-002734 Application 13/606,088 33 of independent claim 10, and grouped claim 11, which falls therewith. See Claim Grouping, supra. 4. § 103 Rejection R2 of Claim 16 Appellants raised additional arguments for patentability of dependent claim 16, rejected on the same basis as claim 1 (App. Br. 23; Reply Br. 14–15); however, we find that the Examiner has rebutted each of those arguments in the Answer by a preponderance of the evidence. Final Act. 12; Ans. 25–26. The Examiner found, “providing a different ‘color code’ that is indicative of the statistical parameters falling in or out of a given target limit is arguably an ‘arrangement or style’ . . . . [as recited such that] Kaufman in view of Soni more than seemingly suggest ‘wherein each of the statistical parameters are displayed together with a color code.’” Ans. 25. We find Appellants have not demonstrated that the Examiner’s proffered combination of references relied upon to teach or suggest including a color code as a particular “arrangement or style” would have been “uniquely challenging or difficult for one of ordinary skill in the art.” See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007)). Nor have Appellants provided objective evidence of secondary considerations which our reviewing court guides “operates as a beneficial check on hindsight.” Cheese Sys., Inc. v. Tetra Pak Cheese and Powder Sys., 725 F.3d 1341, 1352 (Fed. Cir. 2013). Therefore, we adopt the Examiner’s findings and underlying reasoning, which we incorporate herein by reference. Consequently, based Appeal 2018-002734 Application 13/606,088 34 upon the findings above, on this record, we are not persuaded of error in the Examiner’s reliance on the cited prior art combination to teach or suggest the disputed limitations of claim 16, nor do we find error in the Examiner’s resulting legal conclusion of obviousness. REPLY BRIEF To the extent Appellants may advance new arguments in the Reply Brief (Reply Br. 2–16) not in response to a shift in the Examiner’s position in the Answer, arguments raised in a Reply Brief that were not raised in the Appeal Brief or are not responsive to arguments raised in the Examiner’s Answer will not be considered except for good cause (see 37 C.F.R. § 41.41(b)(2)), which Appellants have not shown. CONCLUSIONS (1) Under our Revised Guidance, governed by relevant case law, we conclude claims 1–20 are patent-eligible under 35 U.S.C. § 101, and we do not sustain Rejection R1. (2) The Examiner did not err with respect to obviousness Rejection R2 of claims 1–20 under 35 U.S.C. § 103(a) over the cited prior art combination of record, and we sustain the rejection. Because we have affirmed at least one ground of rejection with respect to each claim on appeal, we affirm the Examiner’s decision. See 37 C.F.R. § 41.50(a)(1). Appeal 2018-002734 Application 13/606,088 35 DECISION We affirm the Examiner’s decision rejecting claims 1–20. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). See 37 C.F.R. § 41.50(f). AFFIRMED Copy with citationCopy as parenthetical citation