Cornblatt, Brian et al.Download PDFPatent Trials and Appeals BoardJan 14, 202014412176 - (D) (P.T.A.B. Jan. 14, 2020) 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. 14/412,176 12/30/2014 Brian Cornblatt 2043-807 1717 1009 7590 01/14/2020 KING & SCHICKLI, PLLC 800 CORPORATE DRIVE, SUITE 200 LEXINGTON, KY 40503 EXAMINER CHOI, FRANK I ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 01/14/2020 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): laura@iplaw1.net uspto@iplaw1.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BRIAN CORNBLATT, GRACE CORNBLATT, ANTON BZHELYANSKY, and ROBERT HENDERSON ____________ Appeal 2019-005191 Application 14/412,176 Technology Center 1600 ____________ Before DONALD E. ADAMS, DAVID COTTA, and MICHAEL A. VALEK, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 15–48 (see Appeal Br. 5). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Nutramax Laboratories, Inc. (Appellant’s December 14, 2018 Appeal Brief (Appeal Br.) 3). Appeal 2019-005191 Application 14/412,176 2 STATEMENT OF THE CASE Appellant discloses: The present invention relates to the combination of a sulforaphane precursor, an enzyme capable of converting the sulforaphane precursor to sulforaphane, an enzyme potentiator, and a milk thistle extract or powder. The present invention also relates to the combination of a sulforaphane or a derivative thereof and a milk thistle extract or powder. The present invention also relates to the combination of a broccoli extract or powder and a milk thistle extract or powder. The present invention provides compositions and methods relating to these combinations. (Spec. ¶ 2.) Appellant’s claims 15, 27, 42, and 44 are representative and reproduced below: 15. An orally administrable composition comprising a synergistic combination of a broccoli extract or powder and a milk thistle extract or powder. (Appeal Br. 24.) 27. An orally administrable composition comprising a synergistic combination of sulforaphane or a derivative thereof and a milk thistle extract or powder. (Id. at 25.) 42. An orally administrable composition, comprising a synergistic combination of a broccoli extract or powder and a milk thistle extract or powder providing a silibinin:sulforaphane ratio of 1:2 to about 35:1. (Id. at 27.) 44. A method of treating, reducing the occurrence of, decreasing the symptoms associated with, and/or reducing secondary recurrences of conditions associated with glutathione in a subject in need thereof, comprising administering to the subject an orally administrable composition comprising a synergistic combination of sulforaphane and silibinin. (Id.) Appeal 2019-005191 Application 14/412,176 3 Grounds of rejection before this Panel for review: Claims 15–48 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Kosbab,2 West,3 Schrieber,4 and Wu.5 Claims 15–23, 27–30, and 34–43 stand rejected under 35 U.S.C. § 101. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Kosbab “relates to nutrient compositions and to therapeutic compositions for the amelioration of cancer.” (Kosbab 1: 4–5). FF 2. Kosbab’s compositions can employ a mixture of different components having the same or similar biochemical or therapeutic functionality. These functionally similar components may differ in source (e.g., extracts of different plants), differ in chemical structure, differ in specific site of action and/or differ in effective half-life on administration. Such combinations of different components 2 Kosbab, WO 00/07607, published Feb. 17, 2000. 3 West et al., US 2008/0311192 A1, published Dec. 18, 2008. 4 Sarah J. Schrieber et al., Differences in the Disposition of Silymarin between Patients with Nonalcoholic Fatty Liver Disease and Chronic Hepatitis C, 39 Drug Metabolism and Disposition, 2182–2190 (2011). 5 Lingyun Wu et al., Dietary approach to attenuate oxidative stress, hypertension, and inflammation in the cardiovascular system, 101 PNAS 7094–7099 (2004). Appeal 2019-005191 Application 14/412,176 4 with similar activities provide synergistic nonadditive benefits and improvements. (Kosbab 2: 8–13.) FF 3. Kosbab discloses that its compositions may include “[s]ilymarin . . . an antioxidant bioflavonoid isolated from milk thistle” and “[s]ulforaphane . . . an isothiocyanate derived from Cruciferae,” wherein Kosbab discloses that “[b]roccoli sprout extracts are a good source of sulforaphane” (Kosbab 4: 25; id. at 7: 18; id. at 18: 19–21 (emphasis omitted)). FF 4. Kosbab discloses the following formulations: 3. Formula III which comprises: (i) pine bark extract, bilberry extract, grape seed extract (leucoanthocyanidin), and ginkgo biloba; (ii) vitamin C, vitamin E and vitamin A; (iii) monoterpene, e.g., limonene; (iv) antioxidant carotenoids, e.g., beta-carotene, lutein, lycopene, luteolin, zeaxanthin or apo-carotenal (beta-carotene being preferred); (v) tea polyphenols; (vi) absorbable zinc, calcium (e.g., calcium citrate, calcium malate or calcium maltate citrate) and magnesium (e.g., magnesium citrate, magnesium malate or magnesium malate citrate); (vii) genistein and chondroitin sulphate; (viii) L-arginine or amino acid complex; and (ix) a source of omega-3 fatty acids, particularly conjugated dienoic fatty acids, e.g., linoleic acid (ALA) and/or enosapentaenoic acid (EPA), a preferred source is ground flax seed;. 4. Formula IV which comprises: The components of Formula III; and Appeal 2019-005191 Application 14/412,176 5 protamine sulphate and/or glucosamine sulphate (a preferred glycosaminoglycan and source of glycosamine, a building block for collagen synthesis); vitamin D3, preferably derivatives thereof which induce little or substantially no hypercalcification (e.g., 22-oxa- vitamin D3); and branched amino acids. 5. Formula V which comprises: The components of Formula IV and quercitin; Saw palmetto; vitamin B12 and folic acid (or optionally vitamin B- complex); absorbable potassium and selenium; alpha-lipoic acid (also called thiotic acid); and allicin (or garlic extract); Formula 5A which comprises the components of Formula 5 where the antioxidant carotenoids are a mixture of beta-carotene and lutein. Formula 5B which comprises the components of Formula 5 which contains a mixture of chondroitin sulphate, protamine sulphate and shark cartilage and where the antioxidant carotenoids are a mixture of beta-carotene and lutein. 6. Formula VI which comprises: The components of Formula V, 5A or 5B and silymarin; curcumin; niacinamide; a source of essential fatty acids, particularly conjugated dienoic fatty acids; for example, linoleic acid and Appeal 2019-005191 Application 14/412,176 6 one or more of sodium bicarbonate, betaine HCl or pepsin. (Kosbab 24: 9 – 25: 32.) FF 5. Kosbab discloses that “[s]ulforaphane, an isothiocyate that can be provided in extracts of broccoli sprouts can be combined with any of Formulas I – XVIII to provide inhibition of carcinogenesis” (Kosbab 30: 29– 30). FF 6. Kosbab discloses that the “Average Adult Daily Dose Range (dose/day)” of “Silymarin (80% concentrate)” is “10 - 1,000 mg” (Kosbab 32). FF 7. Kosbab discloses that “Average Adult Daily Dose Range (dose/day)” of “Sulforaphane” is “1 mcg - 20 mg” (Kosbab 34). FF 8. Kosbab’s compositions can be provided in a variety of nutrient and dosage forms including pills, tablets, capsules, lozenges, powders, solutions, suspensions, injection dosage forms and the like. Compositions of this invention can be administered to individuals orally, intravenously, and by various forms of injection and various forms of absorption (e.g., dermal, sublingual). Active ingredients of the formulas of this invention can be combined with excipients, fillers, buffering agents and the like to prepare desired dosage forms. Generally preferred dosage forms are those appropriate for oral administration. In cases of use for cancer therapy, the optimum mode of administration can depend upon the type of cancer. (Kosbab 37: 21–29.) FF 9. West “relates to a composition comprising enteric-coated glucosinolate and enteric-coated betathioglucosidase enzyme particles” (West ¶ 1; see also id. ¶ 19). Appeal 2019-005191 Application 14/412,176 7 FF 10. West discloses that “to prepare an active agent mixture comprising glucosinolate, about 1 to about 50 percent glucosinolate is mixed with about 50 to about 99 percent composition comprising coating excipient and optionally diluent to form a dry glucosinolate mixture” (West ¶ 37; see also id. ¶ 62 (describing the preparation of glucosinolate particles)). FF 11. West discloses that “to prepare an active agent mixture comprising both glucosinolate and beta-thioglucosidease, the mixture is prepared by combining about 0.5 to about 50 percent beta-thioglucosidase, about 0.5 to about 50 percent glucosinolate, and about 1 to about 99 percent composition comprising coating excipient and optionally diluent” (West ¶ 38). FF 12. West discloses that “[t]he ingredients of the active agent mixture can be combined in any convenient order,” wherein “[t]he resulting mixture is stirred, mixed, blended, or agitated by any convenient means until a homogenous dry mixture is formed” (West ¶ 39). FF 13. Schrieber discloses the use of silymarin in the self-treatment of liver diseases (Schreiber 2182, Abstract). FF 14. Examiner relies on Wu to “disclose that glucoraphanin combined with myrosinase increases glutathione levels” (Non-Final Act.6 5 (citing Wu 7094)). FF 15. Appellant discloses that a study wherein cells of the human liver cancer cell line, HepG2, were treated with, inter alia, various concentrations of sulforaphane and silibinin, alone or in combination, demonstrating “that the combination of sulforaphane and silibinin at each of the tested dosages 6 Examiner’s October 6, 2017 Non-Final Office Action. Appeal 2019-005191 Application 14/412,176 8 had a synergistic effect compared to each component alone” (Spec.7 ¶¶ 91– 92; see also id. ¶ 93; Cornblatt Decl.8 ¶¶ 12–20). FF 16. Appellant discloses that “[s]ynergy refers to the effect wherein a combination of two or more components provides a result which is greater than the sum of the effects produced by the agents when used alone” (Spec. ¶ 59). ANALYSIS Based on the combination of Kosbab, West, Schrieber, and Wu, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious “to combine milk thistle extract or powder which contains silymarin or silymarin itself and broccoli sprout extract or powder which contains sulforaphane or sulforaphane itself with the expectation that the combination [of] silymarin and sulforaphane would be effective in the treatment of cancer via their antioxidant properties” (Ans.9 10). Examiner further reasons that because “one of ordinary skill in the art would [have] expect[ed] that the combination of silymarin and sulforaphane would also contain silibinins” it would have been prima facie obvious to treat liver disease with a composition comprising milk thistle extract and broccholi extract as suggested by the combination of Kosbab, West, Schrieber, and Wu, because Schrieber discloses that “silymarin, which is derived from milk thistle plant and contains silybins, is widely used for self-treatment of liver disease” (id.; see also Non-Final Act. 6). 7 Appellant’s December 30, 2014 Specification. 8 Declaration of Dr. Grace Cornblatt, signed July 14, 2017. 9 Examiner’s April 18, 2019 Answer. Appeal 2019-005191 Application 14/412,176 9 Although Examiner may be correct in concluding that the combination of Kosbab, West, Schrieber, and Wu suggests the treatment of cancer and/or liver disease with a composition comprising silymarin and sulforaphane, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Kosbab, West, Schrieber, and Wu makes obvious a composition comprising a synergistic combination of: (a) a broccoli extract or powder and a milk thistle extract or powder (see, e.g., Appellant’s claims 15 and 42), (b) sulforaphane or a derivative thereof and a milk thistle extract or powder (see, e.g., Appellant’s claim 27), or (c) sulforaphane and silibinin (see, e.g., Appellant’s claim 44), or methods that require the use of such a composition, as required by Appellant’s claimed invention (see FF 1–14; cf. FF 15–16; see Appeal Br. 20 (“Appellant’s claimed combination provides a synergistic effect that would not have been predictable to the skilled artisan, and so the Office’s finding of prima facie obviousness lacks proper support”)). Stated differently, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Kosbab, West, Schrieber, and Wu suggest, or otherwise make obvious, a composition that comprises the requisite components in a particular concentration that necessarily results in a synergistic combination. See In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”). To the contrary, as Examiner appreciates, extraction processes known in the art may result in an extract that does not contain the components, or concentration of components, necessary to produce a synergistic Appeal 2019-005191 Application 14/412,176 10 combination (see Non-Final Act. 8; see also Ans. 8 (an “extract or powder can be prepared or produced in such a way in which sulforaphane and/or silibinin are not present”); Final Act 7 (finding that evidence of unexpected results was not commensurate with the scope of the claims because the evidence “only tests the combination of sulforaphane and silibinin at specific concentrations”)). We recognize that Kosbab discloses that compositions within the scope of its disclosure “can employ a mixture of different components having the same or similar biochemical or therapeutic functionality” and that “[s]uch combinations of different components with similar activities provide synergistic nonadditive benefits and improvements” (FF 2 (emphasis added)). As Appellant’s explain, however, Kosbab “fails to specifically teach or suggest a synergistic combination as claimed by the Appellant” and, although, Kosbab suggests synergistic compositions, Kosbab “fails to provide any disclosure or guidance affording the skilled artisan any reasonable expectation of success of synergy of that combination” (Reply Br.10 4 (emphasis omitted); see id. at 5 (citing Kosbab 4–23) (Appellant contends that Kosbab “provides many potential candidates . . . with absolutely no guidance provided to lead the skilled artisan to select particular candidates even having the potential for synergy”)). For the foregoing reasons, we are not persuaded by Examiner’s conclusion that “one of ordinary skill in the art based on the teachings of . . . [Kosbab] would expect that the combination of silymarin and sulforaphane or silibinin and sulforaphane to exhibit synergistic activity” 10 Appellant’s June 17, 2019 Reply Brief. Appeal 2019-005191 Application 14/412,176 11 (Ans. 12). “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Examiner finds that Appellant’s claims, which are drawn to, for example, a milk thistle extract or powder and/or broccoli extract or powder without specifically claiming silibinin and sulforaphane [are] not sufficient [to support a claim to composition comprising a synergistic combination of a broccoli extract or powder and a milk thistle extract or powder, because] . . . the extract or powder does not require that both sulforaphane and silibinin be present in said extract or powder as the extract or powder can be prepared or produced in such a way in which sulforaphane and/or silibinin are not present. (Ans. 7–8; see also id. at 7 (Examiner finds that Appellant’s claims 42–46 are the only claims on Appeal that “specifically recite the combination of silibinin and sulforaphane”).) Thus, Examiner concludes that Appellant’s “evidence of synergy is not commensurate in scope with the claimed invention” (Ans. 12). We are not persuaded. As discussed above, all of Appellant’s claims require a composition, or method of using a composition, that exhibits synergism (see Appeal Br. 24–28). The obviousness rejection fails because Examiner has not made out a prima facie case with respect to the recited synergism requirement. We need not decide whether Appellant’s evidence is reasonably commensurate with the claims and sufficient to rebut the prima facie showing of obviousness because that showing has not been made on the record before us. In this regard, we note that Examiner does not reject the pending claims on the basis that that Appellant’s Specification provides adequate written Appeal 2019-005191 Application 14/412,176 12 descriptive support to cover and enable the full scope of Appellant’s claimed invention, i.e. a synergistic combination of: (a) a broccoli extract or powder and a milk thistle extract or powder (see e.g., Appellant’s claims 15 and 42), (b) sulforaphane or a derivative thereof and a milk thistle extract or powder (see e.g., Appellant’s claim 27), or (c) sulforaphane and silibinin (see e.g. Appellant’s claim 44), and methods that require the use of such compositions, as required by Appellant’s claimed invention. Thus, for the reasons set forth above, we find that Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Kosbab, West, Schrieber, and Wu makes obvious a composition, or method of using a composition, within the scope of Appellant’s claimed invention. CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 15–48 under 35 U.S.C. § 103(a) as unpatentable over the combination of Kosbab, West, Schrieber, and Wu is reversed. Subject Matter Eligibility: ISSUE Does the preponderance of evidence of record support Examiner’s finding that Appellant’s claimed invention is directed to patent-ineligible subject matter? ANALYSIS Although 35 U.S.C. § 101 provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or Appeal 2019-005191 Application 14/412,176 13 composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . .,” the Supreme Court has determined that there are exceptions to what is patentable. Specifically, “laws of nature, natural phenomena, and abstract ideas” are not eligible subject matter. See Diamond v. Diehr, 450 U.S. 175, 185 (1981). To determine if claimed subject matter is statutorily eligible in light of these judicial exceptions the Supreme Court has articulated a two-step framework in Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012), and later cases. Specifically, [f]irst, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. . . . If so, we then ask, “[w]hat 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. Alice Corp. v. CLS Bank Int’l, 573 U.S. 216, 217 (2014) (quoting Mayo, 566 U.S. at 78). Thus, we must determine whether the claim is directed to a judicially determined patent-ineligible concept and, if so, then ask if there is anything in the claim that transforms it into patent-eligible subject matter. On January 7, 2019 the USPTO published revised guidance on the application of § 101 (see 2019 Guidelines11). After determining that claimed subject matter falls within the four categories of patentable subject matter identified in 35 U.S.C. § 101, the 2019 Guidelines provides a “revised step 2A,” which corresponds to the first step of the Alice/Mayo test articulated above, to determine whether a claim is directed to a judicial exception (see 11 USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (2019). Appeal 2019-005191 Application 14/412,176 14 2019 Guidelines, 84 Fed. Reg. at 53-54). In a first prong of revised step 2A, the Examiner must determine whether the claim recites a judicial exception (see id. at 54). If a judicial exception is identified, the second prong requires a determination of whether the judicial exception is integrated into a practical application (see id.). If so, the inquiry ends and the claim is determined to be directed to eligible subject matter under the 2019 Guidelines (see id. at 54 (“When the exception is so integrated [into a practical application], then the claim is not directed to a judicial exception (Step 2A: NO) and is eligible. This concludes the eligibility analysis.”)). If not, the analysis continues to determine if the claim provides an inventive concept (see id. at 56). The USPTO subsequently updated the 2019 Guidelines (see October 2019 Update12). The October 2019 Update provides that when evaluating whether a claim recites a judicial exception at the first prong of step 2A, the claim is evaluated to determine whether it sets forth or describes a product of nature in accordance with the guidance in MPEP §§ 2016.04(b) and (c), including the markedly different characteristics analysis (see id. at 1). Applying the 2019 Guidance and October 2019 Update, we find that Appellant’s claims are directed to patent eligible subject matter. Step 1: Appellant’s claims 15–23, 27–30, and 34–43 are drawn to compositions, a statutory category of invention. 12 October 2019 Update: Subject Matter Eligibility, available at https://www.uspto.gov/PatentEligibility. Appeal 2019-005191 Application 14/412,176 15 Step 2A, Prong One: Appellant’s claims 15–23, 34–37, 42, and 43 recite mixtures of broccoli extract or powder and milk thistle extract or powder, i.e., plant extracts or powders, which are nature-based products (see Appeal Br. 24–28; Non-Final Act. 2–3; Ans. 3–5; see generally Appendix 1 to the October 2019 Update Example 44). Appellant’s claims 27–30 and 38–41 recite mixtures of sulforaphane or a derivative thereof and a milk thistle extract or powder (see Appeal Br. 25 and 27). Appellant discloses that sulforaphane, or a derivative thereof, may be obtained from plants, i.e., broccoli, and, therefore, is a nature-based product (see Spec. ¶ 40). Thus, Appellant’s claims 15–23, 27–30, and 34–43 recite mixtures of nature-based products. Because: (a)(i) broccoli extract or powder or (a)(ii) sulforaphane and (b) milk thistle extract or powder “do not occur together in nature, there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is compared to its naturally occurring components” ((a)(i) broccoli extract or (a)(ii) powder or sulforaphane and (b) milk thistle extract or powder) (cf. October 2019 Update Example 44). Because Appellant’s claims 15–23, 27–30, and 34–43 recite nature- based product limitations, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception (see October 2019 Update 1). Applying the markedly different characteristics analysis we find that there is no indication on this record that mixing these components changes the structure of the components, but the mixture has a changed functional property, specifically, Appellant’s claims require a composition, wherein the Appeal 2019-005191 Application 14/412,176 16 combined components exhibit synergism, which is different than the mere sum of the characteristics of the individual components (see FF 16; see also October 2019 Update Example 44). For the reasons set forth above with respect to the obviousness rejection, there is no evidence on this record to support a finding that a person of ordinary skill in this art would have expected the combination of components required by Appellant’s claimed invention would exhibit synergism. For the same reasons, we are not persuaded by Examiner’s assertions that Appellant’s claims do not “require both sulforaphane and silibinin in combination in synergistically effective amounts,” that the claimed extracts may not contain sulforaphane or silibinin, or that Appellant’s disclosure does not support claims drawn to a composition comprising a synergistic combination of: a broccoli extract or powder and a milk thistle extract or powder (see, e.g., Appellant’s claims 15 and 42) or sulforaphane or a derivative thereof and a milk thistle extract or powder (see, e.g., Appellant’s claim 27) (see Non-Final Act. 3; Ans. 5–7).13 Thus, Appellant’s claimed mixture is unlike the bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture continued to have “the same effect it always had,” i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013) (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). Because the 13 As previously noted, the Examiner has not rejected any of the pending claims for failure to comply with the written description requirement. Appeal 2019-005191 Application 14/412,176 17 claimed mixture here has a different effect (the changed glycemic control characteristics) than its natural counterparts, it has markedly different characteristics, and therefore is not a “product of nature” exception. Because no judicial exception is recited, the claim cannot be directed to an exception. Thus, Appellant’s claims are directed to patent-eligible subject matter. CONCLUSION The preponderance of evidence of record fails to support Examiner’s finding that Appellant’s claimed invention is directed to patent-ineligible subject matter. The rejection of claims 15–23, 27–30, and 34–43 under 35 U.S.C. § 101 is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15–48 103 Kosbab, West, Schrieber, Wu 15–48 15–23, 27–30, 34–43 101 Eligibility 15–23, 27–30, 34–43 Overall Outcome 15–48 REVERSED Copy with citationCopy as parenthetical citation