Ex Parte Moreyra et alDownload PDFPatent Trial and Appeal BoardMar 14, 201713455595 (P.T.A.B. Mar. 14, 2017) 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. 13/455,595 04/25/2012 Abel Ennio Moreyra 9428C 9276 27752 7590 03/16/2017 THE PROCTER & GAMBLE COMPANY Global IP Services Central Building, C9 One Procter and Gamble Plaza CINCINNATI, OH 45202 EXAMINER HENRY, MICHAEL C ART UNIT PAPER NUMBER 1673 NOTIFICATION DATE DELIVERY MODE 03/16/2017 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): centraldocket. im @ pg. com pair_pg @ firsttofile. com mayer.jk @ pg. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ABEL ENNIO MOREYRA, ASHRAF M. KORAYM, ALAN CHANEY WILSON, and OWEN RICKFORD CARRYL1 Appeal 2015-005966 Application 13/455,595 Technology Center 1600 Before MELANIE L. McCOLLUM, ULRIKE W. JENKS, and DAVID COTTA, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a method for lowering total cholesterol. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1—4 and 6—21 are on appeal (Br. 3 & 6). Claims 1, 14, and 21 are representative and read as follows: 1 Appellants identify the real party in interest as The Procter & Gamble Company (Br. 1). Appeal 2015-005966 Application 13/455,595 1. A method of lowering the total cholesterol level in a human comprising administering to a human a. at least one unit dose of cholesterol biosynthesis inhibitor selected from the group consisting of HMG CoA reductase inhibitors, HMG Co A synthase inhibitors, and mixtures thereof; b. a first unit dose of soluble fiber; c. a second unit dose of soluble fiber; and d. a third unit dose of soluble fiber; wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose are selected from the group consisting of fructooligosaccharides, psyllium, oat fiber, and combinations thereof and wherein the total cholesterol level is lowered. 14. The method according to Claim 1 wherein the cholesterol is reduced by at least 25%. 21. A method of lowering the total cholesterol level in a human comprising administering to a human a. from 5 milligrams to 80 milligrams of a HMG CoA reductase inhibitor selected from the group consisting of lovastatin, pravastatin, simvastatin, atorvastatin, and mixtures thereof; b. a unit dose of psyllium; wherein the unit dose of psyllium is administered concurrently with the HMG CoA reductase inhibitor during the evening hours. Claims 1—4 and 6—21 stand rejected under 35 U.S.C. § 103(a) as obvious over Broaddus2 (Ans. 5). Claims 1—4 and 6—21 also stand rejected under 35 U.S.C. § 103(a) as obvious over Schectman3 (Ans. 2). 2 Broaddus, WO 93/13801 Al, July 22, 1993. 3 Gordon Schectman et al., Evaluation of the Effectiveness of Lipid- Lowering Therapy (Bile Acid Sequestrants, Niacin, Psyllium and Lovastatin) for Treating Hypercholesterolemia in Veterans, 71 Am. J. Cardiology 759— 65 (1993). 2 Appeal 2015-005966 Application 13/455,595 I The Examiner relies on Broaddus for disclosing “that cholesterol- reducing agents such as lovastatin (a HMG CoA reductase inhibitor), psyllium, cholestyramine and gemfibrozil (a HMG CoA reductase inhibitor) can be used to treat atherosclerosis” (Ans. 6). The Examiner finds that Broaddus discloses “that kits comprising individual primary agent (cholesterol-reducing agents) can be used” (id.). The Examiner also finds that Broaddus discloses “the use of 5g of psyllium and 40 mg of lovastatin (a HMG CoA reductase inhibitor) for oral ingestion” (id.). The Examiner concludes: It would have been obvious ... to lower cholesterol in a human [by] administering to a human an effective amount of a cholesterol biosynthesis inhibitor such as Lovastatin and a soluble fiber... and to administer [the] composition in a specific manner or dose schedule in order to optimize the effect of said composition or active ingredients and based on factors such as the severity of the condition or disease and the type, age and weight [of the] individual that is being treated. (Id.) Broaddus discloses: Analysis [a] method for reducing atherosclerotic plaque build-up in the blood vessels of a human or animal patient in need of such treatment, comprising administering to said patient one or more primary agents which safely and effectively reduce a plaque- producing member selected from the group consisting of cholesterol, LDL triglycerides, total plasma triglycerides, or mixtures thereof, in said patient, the improvement which comprises additionally administering to said patient an amount of an auxiliary agent which wholly or partially decalcifies said plaque. 3 Appeal 2015-005966 Application 13/455,595 (Broaddus 4—5.) In particular, Broaddus discloses that “cholesterol-reducing agents such as lovastatin, psyllium, cholestyramine and gemfibrozil are used with agents such as the diphosphonates and polycarboxylates” (id. at Abstract). Specifically, Broaddus discloses mixtures containing both psyllium and cholestyramine (id. at 18, 20, & 21). We agree with the Examiner that it would have been prima facie obvious to administer both psyllium (a soluble fiber (see claim 6)) and lovastatin (a HMG CoA reductase inhibitor (see claim 2)). Appellants argue, however, that “Broaddus provides no motivation to put two primary agents in a single kit, let alone administering at least one unit dose of cholesterol biosynthesis inhibitor and three unit doses of soluble fiber as claimed” (Br. 6). We are not persuaded. Broaddus discloses a method “comprising administering to said patient one or more primary agents” (Broaddus 4—5 (emphasis added)). In addition, as noted by the Examiner (Ans. 8), Broaddus does disclose kits, and in fact mixtures, containing more than one primary agent —psyllium and cholestyramine (Broaddus 18, 20, & 21). With regard to the three unit doses of soluble fiber, we note that claim 1 does not require that these doses be administered at different times (see claim 10, which depends from claim 1 and recites that they are administered concurrently). Moreover, we agree with the Examiner that it would have been prima facie obvious “to administer [the] composition in a specific manner or dose schedule in order to optimize the effect of said composition or active ingredients and based on factors such as the severity 4 Appeal 2015-005966 Application 13/455,595 of the condition or disease and the type, age and weight [of the] individual that is being treated” (Ans. 6). Appellants also argue: there is no motivation to administer a third unit dose of psyllium concurrently with the cholesterol biosynthesis inhibitor during the evening hours, as recited in claims 13, 19, and 21 or combine the unit dose of cholesterol biosynthesis inhibitor with the third unit dose of soluble fiber in a single composition, as recited in claim 18. (Br. 7.) In support of this position, Appellants point to the 2002 Label for Metamucil® (id.). We are not persuaded. The 2002 Label for Metamucil® states: “Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.” However, as noted by the Examiner, this is a very general statement (Ans. 9). In addition, we agree with the Examiner that use of the term “may” suggests that, although “laxatives, including bulk fibers[,] may affect how well other medicines work[,] . . . they also may not affect how well other medicines work” (id. at 8). Furthermore, Broaddus specifically teaches a mixture of psyllium with another cholesterol-reducing agent, cholestyramine (Broaddus 18, 20, & 21). Thus, in the absence of a more specific teaching away, we conclude that the evidence supports the Examiner’s conclusion that it would have been obvious to administer psyllium and lovastatin concurrently. Conclusion The evidence supports the Examiner’s conclusion that Broaddus suggests the method of claim 1. We therefore affirm the obviousness 5 Appeal 2015-005966 Application 13/455,595 rejection, over Broaddus, of claim 1. Claims 2—4, 6—12, 14—17, and 20 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). The evidence also supports the Examiner’s conclusion that Broaddus suggests the method of claim 21. We therefore affirm the obviousness rejection, over Broaddus, of claim 21. Claims 13, 18, and 19 are argued with that therefore fall with claim 21. Id. II The Examiner relies on Schectman for disclosing “a method of treating a condition associated with elevated cholesterol levels (hypercholesterolemia) by lowering cholesterol comprising administering to a mammal in need of such treatment an effective amount of a cholesterol biosynthesis inhibitor (lovastatin)” (Ans. 3). The Examiner finds that Schectman “treats said condition associated with elevated cholesterol levels (hypercholesterolemia) by administering to a mammal the soluble fiber, psyllium” (id.). The Examiner concludes: It would have been obvious ... to lower cholesterol in a human [by] administering to a human an effective amount of a cholesterol biosynthesis inhibitor such as Lovastatin and a soluble fiber such as psyllium and to administer [the] composition in a specific manner or dose schedule in order to optimize the effect of said composition or active ingredients and based on factors such as the severity of the condition or disease and the type, age and weight [of the] individual that is being treated. (Id. at 4.) 6 Appeal 2015-005966 Application 13/455,595 Analysis Schectman discloses treating hypercholesterolemia using bile acid sequestrants, niacin, psyllium, or lovastatin (Schectman 759). We agree with the Examiner that it would have been prima facie obvious to treat hypercholesterolemia with two or more of these agents. In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”). Thus, we agree with the Examiner that it would have been prima facie obvious to administer both psyllium and lovastatin. Appellants argue, however, that “[sjince Schectman discloses that only minimal LDL cholesterol reductions were achieved with psyllium, Schectman does not motivate one skilled in the art to administer both a cholesterol biosynthesis inhibitor and soluble fiber” (Br. 5). We are not persuaded. We understand that Schectman teaches that psyllium had only a relatively small effect on total cholesterol and LDL cholesterol (Schectman 762: Table IV). Nevertheless, it did reduce both (id.). Thus, we do not agree that Appellants have demonstrated that one of ordinary skill in the art would not have used psyllium together with lovastatin. Appellants also argue that “Schectman provides no motivation for lowering the total cholesterol by at least 25% (claim[] 14 . . .) or 30% (claim 15)” (Br. 5). We are not persuaded. As noted by Appellants, “Schectman discloses that lovastatin produced the largest reductions in total cholesterol (-21%), while, psyllium 7 Appeal 2015-005966 Application 13/455,595 had the least decline (-2%)” (id. (citing Schectman 762: Table IV)). However, we agree with the Examiner that it would have been obvious to further reduce total cholesterol through, for example, higher doses (Ans. 17; see also Schectman 762: Table V, where high-dose lovastatin alone provided a reduction in total cholesterol of -22.7 ±2.1). In this regard, we note that Appellants have not provided persuasive evidence that the methods of claims 14 and 15, which do not require administration of the cholesterol biosynthesis inhibitor within 2 hours of the soluble fibers, provide a “surprising” result (Br. 5). In addition, Appellants argue: [Tjhere is no motivation to administer a unit dose of psyllium concurrently with the cholesterol biosynthesis inhibitor during the evening hours, as recited in claims 10, 13, 19, and 21, or to combine the unit dose of cholesterol biosynthesis inhibitor with the third unit dose of soluble fiber in a single composition, as recited in claim 18. (Br. 3 4.) As with the above rejection, Appellants point to the 2002 Label for Metamucil® to support their position (id. at 3). We conclude that Appellants have the better position. In this case, the Examiner has pointed to nothing in Schectman that points towards concurrent administration. However, Appellants have pointed to something that, albeit generally, teaches away from doing so. The Examiner may be relying on Broaddus to provide support for concurrent administration (Ans. 8 (“It should be noted that the rejections set forth above were made by applying Schectman et al. and also applying Broaddus”). However, given the Metamucil® Label and that Broaddus was not included in this rejection, we conclude that the Examiner has not adequately 8 Appeal 2015-005966 Application 13/455,595 explained why it would have been obvious to administer the psyllium concurrently with the lovastatin. Conclusion The evidence supports the Examiner’s conclusion that Schectman suggests the methods of claims 1, 14, and 15. We therefore affirm the obviousness rejection, over Schectman, of claims 1,14, and 15. Claims 2-4, 6—9, 11, 12, 16, and 17 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). However, the evidence does not support the Examiner’s conclusion that Schectman suggests the methods of claims 10,4 13, 18, 19, and 21. We therefore reverse the obviousness rejection, over Schectman, of claims 10, 13, 18, 19, and 21. Because claim 20 depends from claim 19, we also reverse this rejection of claim 20. SUMMARY We affirm the obviousness rejection of claims 1—4 and 6—21 over Broaddus. We also affirm the obviousness rejection of claims 1—4, 6—9, 11, 12, and 14—17 over Schectman. However, we reverse the obviousness rejection of claims 10, 13, and 18—21 over Schectman. 4 We note that claim 10 does not recite that the administration is during the evening hours, as argued by Appellants (Br. 3—4). However, because the basis of our reversal does not depend on the administration being during the evening hours, we have included claim 10 in the group of reversed claimed. 9 Appeal 2015-005966 Application 13/455,595 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. § 1.136(a). AFFIRMED 10 Copy with citationCopy as parenthetical citation