Ex Parte Krammer-Lukas et al

Patent Trial and Appeal BoardOct 27, 2016

13990569 (P.T.A.B. Oct. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/990,569 05/30/2013 23117 7590 10/31/2016 NIXON & V ANDERHYE, PC 901 NORTH GLEBE ROAD, 11 TH FLOOR ARLINGTON, VA 22203 FIRST NAMED INVENTOR Stephanie Krammer-Lukas 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 ATTORNEY DOCKET NO. CONFIRMATION NO. BHD-4662-2802 6426 EXAMINER CALVILLO, Y JEANMARIE Z ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 10/31/2016 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 STEPHANIE KRAMMER-LUKAS, ELISABETH STOECKLIN, JOSEPH SCHWAGER, and SWEN WOLFRAM Appeal2015-004491 Application 13/990,569 Technology Center 1600 Before DONALD E. ADAMS, RICHARD J. SMITH, and TA WEN CHANG, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. Â§ 134(a) involves claims 1--4 and 13-16 (App. Br. 1). Examiner entered rejection under 35 U.S.C. Â§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. STATEMENT OF THE CASE Appellants' Specification "relates to treating/preventing conditions associated with an increased level of eotaxin in a human with 25- 1 Appellants identify "[t]he real party in interest [as] DSM IP Assets, B.V." (Br. 2). Appeal2015-004491 Application 13/990,569 hydroxyvitamin D3 [(25-0H D3)] (calcifediol)" (Spec. 1: 11-12). Claim 1 is representative and reproduced below: 1. A method of decreasing eotaxin levels in a human at risk for or experiencing symptoms of a disease or condition characterized by increased levels of eotaxin comprising administering, to a human patient at risk of or experiencing increased levels of eotaxin from a disease or condition selected from the group consisting of allergic rhinitis, sinusitis, nasal polyps, eosinophilic esophagitis, ulcerative colitis, gastric symptoms due to food allergies, gastric parasitic infections, and gastro-esophageal reflux, an eotaxin lowering effective amount of 25-0H D3, and observing or appreciating a lessening of the eotaxin levels of the patient. (Br. 9.) The claims stand rejected as follows: Claims 1--4 and 13-16 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of Buck2 and Bikle. 3 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Appellants disclose that [e]otaxins (also called CCL-11, CCL-24, and CCL-26) are three proteins which belong to the CC family of chemokines. They are selective recruiters of eosinophils, and also induce the aggregation of eosinophils. Eosinophils play an important beneficial role in killing some invasive microbes and helminths, 2 Buck et al., US 2011/0052707 Al, published Mar. 3, 2011. 3 Daniel D Bikle, Vitamin D Insufficiency/Deficiency in Gastrointestinal Disorders, 22 Journal of Bone and Mineral Research V50-V54 (2007). 2 Appeal2015-004491 Application 13/990,569 especially in the gut. Recent studies also suggest a role m organogenesis, tissue repair, and immune regulation. (Spec. 6:8-12.) FF 2. Buck "relates to a composition comprising Vitamin D (cholecalciferol/and/or ergocalciferol) and 25-hydroxyVitamin D3 (calcifediol), and [the] use of that composition to affect at least concentration, bioavailability, metabolism, or efficacy of vitamin D" (Buck iT 1 ). FF 3. Buck discloses a composition that "comprises a combination of Vitamin D ( cholecalciferol and/or ergocalciferol) and 25-0H D3 ( calcifediol) for use as a pharmaceutical in a human," which "is suitable for any indication where a Vitamin D[]or 25-0H D deficiency is implicated" (Buck iT 14; Ans. 2 and 3). FF 4. Buck discloses that "[a] single weekly dosage may contain both Vitamin D and 25-0H D3 each in an amount from about 7 Âµg to about 350 Âµg" (Buck il 60; Ans. 2-3; cf Spec. 13:8-9 ("A single weekly dosage may contain both Vitamin D and 25-0H D3 each in an amount of from about 7 Âµg to about 350 Âµg.")). FF 5. Examiner finds that Buck fails to disclose the administration of 25- 0H D3 to patients with "a disease or condition selected from the group consisting of allergic rhinitis, sinusitis, nasal polyps, eosinophilic esophagitis, ulcerative colitis, gastric symptoms due to food allergies, gastric parasitic infections, and gastro-esophageal reflux" (Ans. 3; see also Br. 9). FF 6. Examiner finds that Bikle discloses, inter alia, that "celiac disease ([a gastrointestinal] disorder related to an allergic response to food) ... cause[s] [a] deficiency in vitamin D and 25(0H) D and should be treated with vitamin D" (Ans. 3, citing Bikle, Abstract and V50-V52). 3 Appeal2015-004491 Application 13/990,569 ANALYSIS Based on the combination of Buck and Bikle, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to administer a single weekly dosage of a composition comprising about 7-350 Âµg each of Vitamin D and 25-0H D3 for the treatment of a disease associated with a Vitamin D or 25-0H D deficiency, such as celiac disease (see Ans. 4; FF 2-6). Because the dosage suggest by the combination of Buck and Bikle is the same as Appellants' effective dosage, the dosage suggested by the combination of Buck and Bikle is necessarily an eotaxin-lowering effective amount of 25-0H D3 as required by Appellants' claimed invention (see FF 4). Therefore, we agree with Examiner's conclusion that Appellants' discovery of a new benefit (i.e., the lowering of eotaxin levels) of an old process (i.e., the administration of, inter alia, about 7-350 Âµg of 25-0H D3 to a subject experiencing a Vitamin Dor 25-0H D deficiency, such as celiac disease) cannot render the old process patentable (see Ans. 5---6; FF 2---6). See In re Huai-Hung Kao, 639 F.3d 1057, 1071 (Fed. Cir. 2011); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). For the foregoing reasons, we are not persuaded by Appellants' contentions that Buck "does not disclose[] the use [of 25-0H D3] for decreasing eotaxin, or for diseases/ conditions associated with eotaxin" and Bikle "is [] completely silent as to reducing eotaxin levels by administering 25-0H D3" (Br. 5 (emphasis removed); id. at 6-8). Buck discloses that 25-0H D3 "affect[s] at least [the] concentration, bioavailability, metabolism, or efficacy of vitamin D" (FF 2). Thus, Buck suggests that when vitamin D therapy is indicated, 25-0H D3 will facilitate 4 Appeal2015-004491 Application 13/990,569 that vitamin D therapy and vitamin D and 25-0H D3 are to be administered together (FF 2--4). Therefore, we are not persuaded by Appellants' contention that Bikle suggests "Vitamin D therapy- significantly not 25-0H D3" and "only describes administering vitamin D3 for bone health" (Br 6; id. at 7). For the reasons discussed above, the combination of Buck and Bikle suggest Appellant's claim 1. Appellant's claim 1 does not require an underlying disease be corrected (see Br. 9). Therefore, we are not persuaded by Appellant's contention that while Bikle discloses the administration of vitamin D therapy for an individual experiencing, inter alia, a vitamin D deficiency due to a condition such as celiac disease, Bikle does not "correct the underlying disease" (Br. 6). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of Buck and Bikle is affirmed. Claims 2--4 and 13-16 are not separately argued and fall with claim 1. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 5