Ex Parte Hamaura et alDownload PDFPatent Trial and Appeal BoardMay 31, 201613135961 (P.T.A.B. May. 31, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/135,961 07/19/2011 Takeshi Hamaura 1933 7590 06/02/2016 HOLTZ, HOLTZ & VOLEK PC 630 Ninth A venue Suite 1010 NEW YORK, NY 10036-3744 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. 07715Dl/RSB 6875 EXAMINER TOWNSLEY, SARA ELIZABETH ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 06/02/2016 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): USPTO@HHPATENT.COM pair_hhgc@cpaglobal.com rlevinsohn@hhpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TAKESHI HAMAURA and MITSURU KANN01 Appeal2013-003061 Application 13/135,961 Technology Center 1600 Before LORA M. GREEN, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a tablet comprising olmesartan medoxomil, amlodipine besylate, and polyvinyl alcohol. The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 According to Appellants, the Real Party in Interest is Daiichi Sankyo Company. (App. Br. 2.) Appeal2013-003061 Application 13/135,961 STATEMENT OF THE CASE Claims 1 and 18 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A tablet comprising a pharmacologically effective amount of a combination of active ingredients comprising olmesartan medoxomil, amlodipine besylate and a polyvinyl alcohol, wherein the polyvinyl alcohol is in an amount of 5 to 10% by weight of the total weight of the tablet, wherein the tablet is produced by direct tableting. Appellants request review of the Examiner's rejection2 of claims 1 and 18 under 35 U.S.C. § 103(a) as unpatentable over Kawamura3 and Grogan.4 The issues are: (1) Does the preponderance of evidence of record support the Examiner's conclusion that the claims are obvious; and if so (2) have Appellants provided sufficient evidence of secondary considerations, such as unexpected results, to overcome a finding of obviousness? 2 Appellants do not request review of the nonstatutory obviousness-type double patenting rejection over U.S. Patent Application No. 11/188,275, 12/074,779, 12/074,797,12/401,748 (see Final Act. 5-14 (mailed Mar. 1, 2012); Advisory Act. 2 (mailed May 23, 2012); Ans. 3.) We, therefore, summarily affirm those rejections. See MPEP § 1205.02 ("If a ground of rejection stated by the examiner is not addressed in the appellant's brief, that ground of rejection will be summarily sustained by the Board."). The failure to appeal is a waiver under Ex parte Frye, 2010 WL 889747 *4 (BPAI 2010) (precedential) ("If an appellant fails to present arguments on a particular issue--or, more broadly, on a particular rejection--the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection"). 3 Kawamura et al., US 2004/0219208 Al, published Nov. 4, 2004. 4 Grogan et al., US 2005/0187262 Al, published Aug. 25, 2005. 2 Appeal2013-003061 Application 13/135,961 Findings ofFact We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (see Final Act. 3-7, 14--17; Ans. 3-9). For emphasis only we highlight the following: FF 1. Grogan teaches the "co-administration of (S)-amlodipine malate and ... olmesartan" an angiotensin receptor blocker (ARB) also known as an angiotensin II antagonist. (See Grogan Fig. I, i-fi-123 and 25; see Ans. 4.) FF2. Grogan teaches that "[t]ablets are often a preferred dosage form because of the advantages afforded both to the patient (e.g., accuracy of dosage, compactness, portability, blandness of taste as well as ease of administration) and to the manufacturer." (Grogan i188; see Ans. 6.) Grogan teaches that "there are three general methods of tablet preparation: (1) the wet-granulation method; (2) the dry-granulation method; and (3) direct compression." (Grogan i189; see Ans. 7.) FF3. Grogan teaches the production of a compressed tablet containing (S)- amlodipine (L)-malate, Lorsartan, a known ARB, and microcrystalline cellulose, a plasticizer. (See Grogan i-f 185; i-fi-f 18 and 111.) FF4. Grogan teaches that "when combined with ARBs [(angiotensin receptor blocker, for example olmesartan or losartan)], a lower dose of (S)-amlodipine, as compared to the conventionally used dose, can be used for the treatment, prevention and management of cardiovascular diseases and disorders, which in tum can lower the incidence of side effects associated with (S) amlodipine." (Grogan i125; see Ans. 5.) 3 Appeal2013-003061 Application 13/135,961 FF5. Grogan teaches the production capsules containing "(S)-Amlodipine and Olmesartan." (Grogan i-f 181, table 4; Ans. 4--5.) FF6. The Examiner finds that capsules disclosed in Grogan contain "the angiotensin II receptor blocker, olmesartan, and the calcium channel blocker, amlodipine, are present in a ratio, e.g., 1: 1." (Ans. 4--5.) FF7. Grogan teaches that the "specific salts of (S)-amlodipine include, but are not limited to, the malate, besylate, maleate, camsylate, tosylate, nicotinate, L-hemitartrate, and D-hemitartrate salts." (Grogan i-f 30; see Ans. 5.) "The besylate salt of amlodipine is sold under the trade name NORVASC® (Pfizer, Inc.), and is indicated in the United States for the treatment of hypertension, chronic stable angina and vasospastic angina." (Grogan i-f 9; see Ans. 5.) FF8. Grogan teaches that "olmesartan medoxomil is sold in the United States under the trade name BENICAR® (Sankyo Pharmaceuticals, Inc.)." (Grogan i-f 40; see Ans. 5.) FF9. Grogan teaches that polyvinyl alcohol can be used as both a surfactant (Grogan i-f 104) and plasticizer (id. at i-f 111) in the production of oral dosage forms (see generally i-fi-182-121.) FFlO. Kawamura teaches [ s ]ustained-release medicines comprising (A) an angiotensin II antagonist combined with (B) one or more drugs selected from among remedies for hypertension. . . . Using these medicines, remarkably excellent effects can be achieved compared with the case of using each active ingredient alone, which makes it possible to lessen the administration dose and relieve side effects. (Kawamura, Abstract; claims 1, 3, 5, and 8; see Ans. 3) 4 Appeal2013-003061 Application 13/135,961 FF 11. Kawamura teaches that the angiotenins 11 antagonist may include "olmesartan medoxomil and their metabolic active substances." (Kawamura i-f 59, see i-f 120; Ans. 3.) FF12. Kawamura teaches the use "of a solid dosage form for oral administration include the aforementioned powders, granules, tablets, pills and capsules. . . . [A Jn active ingredient can be mixed with at least one additive." (Kawamura i-f 59, see i-f 120; Ans. 3.) FF 13. Kawamura teaches that the "active ingredients other than the All [ angiotensin II] antagonist ... may be any of a salt, a free compound, a prodrug, a hydrate, and a non-hydrate." (Kawamura i-f 107; see Ans. 3.) FF 14. Kawamura teaches "[ e ]xamples of the calcium antagonist include amlodipine, nitrendipine and manidipine." (Kawamura i-f 112; see Ans. 3.) FF15. Kawamura teaches that "[a]n emulsifier may be added to the aforementioned outer aqueous phase .... Specifically, for example ... polyvinyl alcohol ... The concentration upon use is preferably in a range of about 0.01 to about 10% by weight, more preferably in a range of about 0.05 to about 5% by weight." (Kawamura i-f 265, see i-f 326; Ans. 4.) Principle of Law "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability." Id. at 417. 5 Appeal2013-003061 Application 13/135,961 Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act 3-5; Ans. 3---6; see also FFl- FF 15) and agree that the claims are rendered obvious over Kawamura and Grogan. We address Appellants' arguments below. Appellants contend that the Examiner admitted that Kawamura "do[ es] not disclose the besylate salt of amlodipine, as recited in appellants' claim 1." (App. Br. 3.) "Claim 3 of Kawamura et al. recite olmesartan (not olmesartan medoxomil) along with nine other angiotensin II receptor antagonists; and claim 8 (which does not depend on claim 3) recites amlodipine (not amlodipine besylate) with two other drugs." (Id. at 5.) Appellants contend that "[t]he specific embodiments of Grogan et al. are directed to the co-administration of (S)-amlodipine malate (not amlodipine besylate) and olmesartan (not olmesartan medoxomil)." (Id. at 5.) We are not persuaded. Although neither Grogan nor Kawamura exemplify a composition containing both amlodipine besylate and olmesartan medoxomil, the references never the less suggest the use of these components in a combination product (see FF7, FF8, FFl 1, FF13). Kawamura teaches composition that contain an angiotensin II antagonist in conjunction with another drug, specifically with a drug that remedies hypertension (FFlO). Kawamura teaches that angiotensin II antagonist include olmesartan medoxomil (FFl 1) and suggests that the active may be in salt form (FF13), in addition Kawamura lists amlodipine as an example of a calcium antagonist that is a known remedy for hypertension (FF 13; see also FF4). Grogan teaches the co-administration of (S)-amlodipine malate and olmesartan (FF 1 ). Grogan suggests that the (S)-amlodipine salts can include 6 Appeal2013-003061 Application 13/135,961 besylate salts and also discloses that amlodipine besylate is a commercially available product (FF7). Grogan also teaches that olmesartan medoxomil is a commercially available product (FF8). Both Grogan and Kawamura recognize that the use of a combination product will result in lowering the dose of amlodipine when combined with angiotensin II antagonist (FF4 and FF 10). Based on the combination of Grogan and Kawamura we agree with the Examiner's conclusion that it would have been obvious to produce a combination product that contains olmesartan medoxomil and amlodipine besylate. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references .... [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981)). Because the Examiner presents a prima facie case of obviousness, we consider whether Appellants submits sufficient evidence or argument in rebuttal. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). Evidence rebutting a prima face case of obviousness may include "[ e ]vidence of unexpected results." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1369 (Fed. Cir. 2007). Appellants assert that the composition provides unexpected results as shown by Mituso Kanno Declaration5 (App. Br. 8). Appellants contend that the "the use of polyvinyl alcohol resulted in a 136.4% to 135.6% improvement in the dissolution of olmesartan medoxomil" when compared 5 Declaration ofMitsuru Kanno under 37 C.F.R. § 1.132, signed Feb. 9, 2011. ("Kanno Dec.".) 7 Appeal2013-003061 Application 13/135,961 to compared to "Polymer 0%." (App. Br. 9.) In other words, Appellants are relying on unexpected results to overcome the Examiner's prima facie case. We are not persuaded. We agree with the Examiner's conclusion that the results of the Kanno Dec. are not sufficient to show unexpected results based on a formulation containing polyvinyl alcohol (PVA). (Ans. 8-9.) As noted by the Examiner, "amlodipine dissolution with PVA did not achieve superior results; rather, of the seven polymers tested, amlodipine dissolution with CMC-Na (sodium carboxymethyl cellulose, Additional Example 1) showed results superior to PVA." (Ans. 8.) We also agree with the Examiner that Table 1 of the Kanno Dec. shows dissolution of tablets containing both olmesartan medoximil and amlodipine besylate, however, as noted by the Examiner the disclosed tablets do not show that the addition of polyvinyl alcohol produces a noted benefit. (Ans. 8.) See Galderma Labs., LP v. Tolmar, Inc., 737 F.3d 731, 739 (Fed Cir. 2013) (quoting Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) ("Unexpected results that are probative of nonobviousness are those that are 'different in kind and not merely in degree from the results of the prior art."'). Thus, Table 1 of the Kanno Dec. does not establish that the olmesartan medoximil, amlodipine besylate, and polyvinyl alcohol composition has any superior or unexpected effect on the dissolution of the tablets. The burden of demonstrating unexpected results rests on the party asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). That burden has not been carried here because Appellants have not established that the results achieved using polyvinyl alcohol in a composition containing olmesartan medoximil and amlodipine besylate compounds were 8 Appeal2013-003061 Application 13/135,961 unexpectedly superior compared to the closest prior art. See Jn re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Even if the Kanno Dec. had established, which it did not, that polyvinyl alcohol improves the dissolution rate of a tablet, the Examiner's position is that this effect was known in the art, citing Lee6 in support. (Ans. 8.) Therefore, the combination of olmesartan medoxomil, amlodipine besylate and polyvinyl alcohol as taught by the combination of Grogan and Kawamura would merely have provided the expected result of better dissolution. (Id.) See In re Skoner, 517 F .2d 94 7, 950 (CCP A 197 5) ("Expected beneficial results are evidence of obviousness of a claimed invention. Just as unexpected beneficial results are evidence of unobviousness. "). We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 1, and Appellants have not provided sufficient evidence of secondary considerations that outweighs the evidence supporting the prima facie case. As Appellants do not argue the claims separately, claim 18 falls with claim 1. 37 C.F.R. § 41.37 (c)(l)(iv). 6 Lee et al., WO 2004/010976 Al, published Feb. 5, 2004, identified by the Examiner as submitted by Appellants on the Information Disclosure Statement dated July 19, 2011. (See Final Act. 16, mailed March 1, 2012.) 9 Appeal2013-003061 Application 13/135,961 SUMMARY We affirm the rejection of claims 1and18 under 35 U.S.C. § 103(a) over Kawamura and Grogan. 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