Ex Parte PakDownload PDFPatent Trial and Appeal BoardSep 25, 201811673497 (P.T.A.B. Sep. 25, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/673,497 02/09/2007 32425 7590 09/27/2018 NORTON ROSE FULBRIGHT US LLP 98 SAN JACINTO BOULEVARD SUITE 1100 AUSTIN, TX 78701-4255 FIRST NAMED INVENTOR Charles Y.C. Pak 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. UTSD.Pl831US/l ll 13030 2807 EXAMINER SPRINGER, STEPHANIE K ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 09/27/2018 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): aoipdocket@nortonrosefulbright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte CHARLES Y.C. PAK Appeal2017-009636 Application 11/673,497 1 Technology Center 1600 Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3-6, 13-17, 19-21, 23-25, 27, 30, and 32 (Final Act. 2). 2 Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellant identifies "BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM" as the real party in interest (Br. 2). 2 Office Action mailed April 21, 2016. Appeal2017-009636 Application 11/673,497 STATEMENT OF THE CASE Appellant's disclosure relates "to the field of treatments for hypertension, and more particularly, to compositions and methods for supplementing a Dietary Approaches to Stop Hypertension (DASH) diet" (Spec. ,r 1). Claims 1, 13, and 30 are representative and reproduced below: 1. A method for treating essential hypertension in a patient in need thereof comprising administering to the patient an effective amount of a dietary supplement consisting essentially of a potassium-magnesium citrate preparation. (Br. 8.) (Id.) 13. A method for ameliorating or correcting one or more metabolic disturbances in a patient having one or more metabolic disturbances and essential hypertension, wherein the one or more metabolic disturbances are selected from the group consisting of: salt retention, insulin resistance, unusually acid urine, low serum magnesium, or renal hypercalciuria, the method comprising providing to the patient a composition comprising a pharmaceutically effective amount of potassium, magnesium, and citrate. 30. The method of claim 13, wherein the metabolic disturbance is insulin resistance. (Id. at9.) 2 Appeal2017-009636 Application 11/673,497 The claims stand rejected as follows: Claims 1, 3-6, 19-21, 23-25, and 27 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Morris, 3 Szelenyi, 4 Derrien, 5 and W alsdorf. 6 Claims 13-17, 30, and 32 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Morris, Szelenyi, Derrien, Walsdorf, and F errannini. 7 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS The combination of Morris, Szelenyi, Derrien, and Walsdorf Examiner finds that "Morris discloses the treatment of hypertension using non-halide potassium salts, particularly potassium citrate, and teaches the use of compositions which have an alkalinizing effect" (Ans. 3--4). Specifically, Examiner finds that "Morris teaches the need for 'an effective method for treating essential hypertension which utilizes a potassium compound[']" and discloses that Morris' "[']invention fulfills these and 3 Morris, Jr. et al., US 5,804,204, issued Sept. 8, 1998. 4 Szelenyi et al., Effect of magnesium orotate and orotic acid on experimental hypertension and cardiopathogenic changes in heart muscle," 21 Deutsches Medizinisches Journal 1405-1412 (1970) (Examiner relied upon CAPLUS, Abstract, Accession Number: 1971:74795, CAN 74:74795 (2014)). 5 Derrien et al., US 2004/0224076 Al, published Nov. 11, 2004. 6 Walsdorfetal., US 5,219,889, issued June 15, 1993. 7 Ferrannini et al., Insulin Resistance in Essential Hypertension, 317 N. Engl. J. Med. 350-357 (1987). 3 Appeal2017-009636 Application 11/673,497 other related needs'" (id. at 17; see Morris 3: 4--11). In addition, Examiner finds that "Morris discloses a working embodiment directed towards the treatment of subjects afflicted with essential hypertension, using a non- halide salt of potassium to lower blood pressure ([Morris,] Example 1, column 7)" (Ans. 17; see Morris 7: 5-8 ("Studies were performed in two men (ages 55 and 57) with essential hypertension to demonstrate that a non- halide salt of potassium, potassium bicarbonate, lowered blood pressure")). For the foregoing reasons, we are not persuaded by Appellant's contention that Examiner improperly relied upon inherency to establish that "essential hypertension-is 'necessarily present' in the cited references" (Br. 4; cf Ans. 16 ("Appellant's arguments are misplaced, and are an incorrect interpretation of[] Examiner's position")). Examiner finds that "Morris is silent with regard[] to magnesium citrate" and relies on Szelenyi, Derrien, and Walsdorf to make up for this deficiency in Morris (see Ans. 4---6). We find no error in Examiner's prima facie case of obviousness (see id. at 3-7). In this regard, we note that Appellant does not contest Examiner's combination of Morris with Szelenyi, Derrien, and Walsdorf (see Br. 3--4 ). The combination of Morris, Szelenyi, Derrien, Walsdorf, and Ferrannini: Examiner relies on the combination of Morris, Szelenyi, Derrien, and W alsdorf to suggest the administration of a single formulation of magnesium, potassium, and citrate to treat essential hypertension (see Ans. 9-12). Examiner finds, however, that the combination of Morris, Szelenyi, Derrien, and W alsdorf fails to disclose "metabo lie disturbances that [] accompany essential hypertension" (id. at 12). Examiner, therefore, relies 4 Appeal2017-009636 Application 11/673,497 on Ferrannini to disclose, inter alia, that "essential hypertension is itself an insulin-resistant state" (id. at 13; see Ferrannini, Abstract; see generally Ferrannini 354 ("essential hypertension may be an insulin-resistant state in itself'). Thus, based on the combination of Morris, Szelenyi, Derrien, Walsdorf, and Ferrannini, Examiner concludes that, at the time Appellant's invention was made, it would have been "prima facie obvious to administer potassium, magnesium, and citrate to a patient afflicted with hypertension who is also afflicted with insulin resistance, as the administration of potassium, magnesium, and citrate to a patient afflicted with hypertension is obvious, regardless of whether that patient also has insulin resistance" (Ans. 14 ( emphasis omitted)). In this regard, Examiner reasons that one having ordinary skill in the art would have a reasonable expectation of success in using the composition disclosed by W alsdorf in the methods for treating hypertension, as taught by Morris, Derrien, and Szelenyi, and one would further recognize that treating hypertension in a subject would also provide a therapeutic benefit for insulin resistance in the subject. (Id. (emphasis added)) We are not persuaded. Appellant's independent claim 13, from which claims 14--17, 30, and 32 depend, is directed to a method of ameliorating or correcting one or more metabolic disturbances in a patient having one or more specifically recited metabolic disturbances, such as insulin resistance, and essential hypertension (see Br. 8). Although, Examiner asserts that the administration of a composition, suggested by the combination of prior art relied upon by Examiner, to an individual experiencing essential hypertension may provide some therapeutic benefit with regard to insulin resistance, Examiner failed to establish that such a composition would necessarily be effective in 5 Appeal2017-009636 Application 11/673,497 ameliorating or correcting the metabolic disturbance, i.e., insulin resistance, as is required by Appellant's claimed invention (see Ans. 14; cf Br. 8; see Br. 5 ("none of the cited references suggest amelioration or correction of [the claimed] metabolic disturbances")). We recognize Examiner's reliance on Ferrannini to teach that insulin resistance is "directly correlated with the severity of hypertension" and conclusion, from this teaching, that "[t]he ordinarily skilled artisan would reasonably expect that the treatment of hypertension would also have a therapeutic effect on insulin resistance" (Final Act. 6). We acknowledge Ferannini's teaching of a correlation between insulin resistance and hypertension. Ferannini, however, ultimately leaves open the question of whether hypertension causes insulin resistance (see Ferrannini 355 ("The obvious question that the present studies present is whether there is a causal relation between hypertension and insulin resistance"). Accordingly, the record does not provide a persuasive basis on which to conclude that the skilled artisan would reasonably have expected that a composition taught to treat essential hypertension would also be effective in the amelioration or correction of insulin resistance as required by Appellant's claimed invention. CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness with respect to Appellant's claim 1. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris, Szelenyi, Derrien, and Walsdorf is affirmed. Claims 3-6, 19-21, 23-25, and 27 are not separately argued and fall together with Appellant's claim 1. 6 Appeal2017-009636 Application 11/673,497 The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness with respect to Appellant's claims 13- 17, 30, and 32. The rejection of claims 13-17, 30, and 32 under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris, Szelenyi, Derrien, W alsdorf, and F errannini is reversed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a). AFFIRMED-IN-PART 7 Copy with citationCopy as parenthetical citation