2020003673 (P.T.A.B. Mar. 9, 2021)

Neil BUCK et al.

Patent Trials and Appeals BoardMar 9, 2021

2020003673 (P.T.A.B. Mar. 9, 2021)

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. 13/467,414 05/09/2012 Neil Robert BUCK BHD-4662-2206 3443 23117 7590 03/09/2021 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER QAZI, SABIHA NAIM ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 03/09/2021 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): PTOMAIL@nixonvan.com pair_nixon@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte NEIL ROBERT BUCK, WOUTER CLAERHOUT, BRUNO H. LEUENBERGER, ELISABETH STOECKLIN, KAI URBAN, and SWEN WOLFRAM,1 ____________ Appeal 2020-003673 Application 13/467,414 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies DSM IP Assets BV as the real party- in-interest. App. Br. 2. Appeal 2020-003673 Application 13/467,414 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Non-Final Rejection of claims 1 and 2 as unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory subject matter. Claims 1 and 2 also stand rejected as unpatentable under 35 U.S.C. § 102 as being anticipated by Krammer et al. (US 2007/0082089 A1, April 12, 2007) (“Krammer”).2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to the use of 25-OH D3 (calcifediol) to increase muscle strength, muscle function, or both. Spec. 33. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A pharmaceutical, nutraceutical, food supplement or food composition comprising 25-hydroxyvitamin D3 (25-OH D3) and Vitamin D3 in a ratio of 1:6 to 6:1 in an amount sufficient to increase or retain or prevent the loss of muscle function or 2 Appellant does not argue the Examiner’s rejection upon this ground. We consequently summarily affirm the rejection. If a ground of rejection stated by the Examiner is not addressed in the Appellant’s Appeal Brief, Appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it. See Manual of Patent Examining Procedure (MPEP) § 1205.02. See also 37 C.F.R. § 41.37 (c)(iv) (“[A]ny arguments or authorities not included in the appeal brief will be refused consideration by the Board for purposes of the present appeal”). Appeal 2020-003673 Application 13/467,414 3 muscle strength in a human, wherein the amount of 25-OH D3 is selected from the group consisting of: a weekly dose of 7 μg -350 μg, and a monthly dose of 30 μg - 1500 μg. App. Br. 9. ISSUES AND ANALYSIS We decline to agree with, or adopt, the Examiner’s findings, reasoning, and conclusion that the claims are directed to nonstatutory subject matter. We address below the arguments raised by Appellant. Issue Appellant argues that the Examiner erred in concluding that the claims are directed to nonstatutory subject matter. App. Br. 5. Analysis The Examiner finds that the claims on appeal are directed to a judicially-created exception to Section 101, viz., a phenomenon of nature. Final Act. 3. The Examiner also finds that the claims do not recite any additional elements that are sufficient to amount to significantly more than the judicial exception because the combination of vitamin D3 and 25- hydroxyvitamin D3, separately or in combination, do not add significantly more to the exception. Id. The Examiner reasons that, because the composition contains the natural products vitamin D3 and 25-OH D3, the characteristics of each Appeal 2020-003673 Application 13/467,414 4 component are not significantly different from their naturally occurring counterparts because they have the same structure and function as they do in nature. Final Act. 3. Furthermore, finds the Examiner, the limitations recited in claim 1 do not add significantly more to the judicial exception because the recited ratios and ranges do not add significantly more to the natural product. Id. The Examiner finds that neither compound is markedly altered from its natural state and, when combined, do not add significantly more to the judicial exception (i.e., the natural phenomenon/natural product). Id. The Examiner finds that there is no indication in Appellant’s Specification that mixing the claimed combination in the recited ratios and dosages alters the function, or other properties, of vitamin D3 and 25- hydroxyvitamin D3 in any marked way. Final Act. 4. Instead, the Examiner finds, both chemicals retain their properties. Id. The Examiner also finds that there is no indication that mixing of these components changes the structure of the components, as no chemical reaction evidently occurs between the constituents. Id. In performing an analysis of patentability under Section 101, we follow the framework set forth by the Supreme Court in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). We are also mindful of, and guided by, the United States Patent and Trademark Office’s 2019 Revised Patent Subject Matter Eligibility Guidance, 84(4) Fed. Reg. 50–57 (January 7, 2019) (the “2019 Guidance”). Appellant’s claim 1 recites: “A pharmaceutical, nutraceutical, food supplement or food composition comprising….” Following the first step of the Mayo analysis, we find that the claims are directed to a composition of Appeal 2020-003673 Application 13/467,414 5 matter, and therefore fall into one of the broad statutory categories of patent- eligible subject matter under 35 U.S.C. § 101. In the next step of the Mayo analysis, we determine whether the claims at issue are directed to a nonstatutory, patent-ineligible concept, i.e., a law of nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S. at 70–71. If the claims are so directed, we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. Id. at 78–79; see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Specifically, the Supreme Court considered this second step as determining whether the claims recite 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.” Mayo, 566 U.S. at 72–73. More specifically, in this second step of the Mayo analysis, we look to whether the claim recites one of the judicially-created exceptions to Section 101, i.e., an abstract idea, a law of nature, or a natural phenomenon. See 2019 Guidance 54 (step 2A, prong 1). Claim 1 is directed to “A pharmaceutical, nutraceutical, food supplement or food composition comprising…,” and recites the following limitations: (1) 25-hydroxyvitamin D3 (25-OH D3); (2) Vitamin D3; (3) in a ratio of 1:6 to 6:1; (4) in an amount sufficient to increase or retain or prevent the loss of muscle function or muscle strength in a human; (5) wherein the amount of 25-OH D3 is selected from the group consisting of; (6) a weekly dose of 7 μg -350 μg; and (7) a monthly dose of 30 μg - 1500 μg. Appeal 2020-003673 Application 13/467,414 6 Put more succinctly, the claims are directed to a composition comprising a mixture of vitamin D3 and 25-OH D3 in a range of ratios and dosages sufficient to increase, maintain, or prevent the loss of muscle function. The Examiner finds that the claims thus recite a law, or phenomenon, of nature and, consequently, are directed to one of the judicially-created exceptions to article 1. We disagree. We concur with the Examiner’s finding that vitamin D3 and 25-OH D3 are, in themselves, naturally- occurring compositions. However, as our reviewing court has held that: “A claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and ‘the potential for significant utility.’” Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1348 (Fed. Cir. 2019) (citing Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980). In Natural Alternatives, one of the claims at issue recited: 1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine. 918 F.3d at 1348. The court held that: Although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine.… the Product Claims are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.… [T]he “dietary supplement” in claim 1 of the ’084 patent uses the product beta-alanine at a dosage of “between about 0.4 grams to 16 grams” to “effectively increase[] athletic performance.” In each case, the natural products have been Appeal 2020-003673 Application 13/467,414 7 isolated and then incorporated into a dosage form with particular characteristics. Id. at 1348–49. Similarly, in the claims before us, vitamin D3 and 25-OH D3 are constituents of the claimed composition and present in ratios between 1:6 and 6:1. The claimed composition is further constituted into dosages ranging between 7–350 μg for a weekly dosage, and 30–1500 μg for a monthly dosage, and that these amounts are “sufficient to increase or retain or prevent the loss of muscle function or muscle strength in a human,” as recited in claim 1. We conclude that, following the holding of our reviewing court in Natural Alternatives, Appellant’s claims are not directed to the natural products vitamin D3 and 25-OH D3, because the composition has different characteristics (i.e., the claimed ranges and dosages) and “potential for significant utility.” Natural Alternatives, 918 F.3d at 1348. And because we conclude that the claims are not directed to a natural product or phenomenon, our analysis ends at this point. We consequently reverse the Examiner’s rejection of claims 1 and 2 as unpatentable under 35 U.S.C. §101. CONCLUSION The rejection of claims 1 and 2 as unpatentable under 35 U.S.C. § 101 is reversed. The rejection of claims 1 and 2 as unpatentable under 35 U.S.C. § 102 is affirmed. Appeal 2020-003673 Application 13/467,414 8 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). AFFIRMED Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2 101 Nonstatutory subject matter 1, 2 1, 2 102 Krammer 1, 2 Overall Outcome 1, 2