Ex Parte Altenschopfer et alDownload PDFPatent Trial and Appeal BoardJan 21, 201612508522 (P.T.A.B. Jan. 21, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/508,522 07/23/2009 20350 7590 01/25/2016 KILPATRICK TOWNSEND & STOCKTON LLP TWO EMBARCADERO CENTER EIGHTH FLOOR SAN FRANCISCO, CA 94111-3834 Peter Altenschopfer 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. 95069-000200US-857422 8176 EXAMINER TRAN, SUSAN T ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 01125/2016 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): ipefiling@kilpatricktownsend.com j lhice@kilpatrick.foundationip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER AL TENSCHOPFER and ADAM CHARLES WATKINSON Appeal2013-007331 Application 12/508,522 Technology Center 1600 Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC B. GRIMES, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. § 134(a) involves claims 1-32 (Reply Br. 3). 2 Examiner entered rejections under the enablement provision of 35 U.S.C. § 112, first paragraph, 35 U.S.C. § 102(b), 35 U.S.C. § 103(a), and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the Real Party in Interest as "Strakan International Limited" (App. Br. 3). 2 Pending claims 33-35 stand withdrawn from consideration (Reply Br. 3). Appeal2013-007331 Application 12/508,522 STATEMENT OF THE CASE The claims are directed "to transdermal patches comprising granisetron" (Spec. 1). Claims 1, 20-23, and 31 are representative and reproduced in the Claims Appendix of Appellants' Brief. Claim 31 stands rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. Claims 1-32 stand rejected under 35 U.S.C. § 102(b) as anticipated by Effing. 3 Claim 31 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Effing and Sanger. 4 Claims 1-32 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claim of Altenschopfer. 5 Obviousness-type Double Patenting: Appellants acknowledge the obviousness-type double patenting rejection and contend that they "will file a terminal disclaimer upon resolution of all other issues in this case" (Reply Br. 5; see App. Br. 6; Ans. 10). In sum, Appellants waived appeal of this rejection. Accordingly, we decline to address the merits of the obviousness-type double patenting rejection. 3 Effing, WO 98/53815, published Dec. 3, 1998. 4 Sanger et al., WO 94/01095, published Jan. 20, 1994. 5 Altenschopfer et al., US 7,608,282 B2, issued Oct. 27, 2009. 2 Appeal2013-007331 Application 12/508,522 Enablement: ISSUE Does the evidence of record support Examiner's conclusion that undue experimentation would be required to practice the claimed invention? ANALYSIS Appellants' claim 31 is directed to a patch (see Appellants' claim 31). We note that Appellants' claim 31 recites a number of conditions for which the claimed patch is intended to treat or provide prophylaxis (id.). The intended use of the patch, however, does not limit Appellants' claimed patch. Therefore, we are not persuaded by Examiner's assertion that Appellants' Specification "does not reasonably provide enablement for a method for the treatment and/or prophylaxis of a patient having, or susceptible to, a condition" set forth in Appellants' claim 31 (Ans. 5; see Reply Br. 6 ("If the patch is acknowledged to be enabled, how can the use of such patch for the treatment of conditions which are known in the art to be responsive to the same active ingredient, granisetron, not also be enabled?"); see App. Br. 7). CONCLUSION OF LAW The evidence of record fails to support Examiner's conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claim 31 under the enablement provision of 35 U.S.C. § 112, first paragraph is reversed. 3 Appeal2013-007331 Application 12/508,522 Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner's finding that Effing teaches Appellants' claimed invention? FACTUAL FINDINGS (FF) FF 1. Effing "relates to a transdermal drug delivery device for the delivery of tropisetron or granisetron" (Effing 1: 5---6; see Ans. 8). FF 2. Effing teaches that "the drug is present[] in an amount by weight of about 1 to about 25 percent, preferably about 4 to 15 percent, by weight based on the total weight of the adhesive layer" (Effing 5: 28-30; Ans. 8; cf Spec. 9 ("Levels of granisetron may be up to about 10% by weight")). FF 3. Effing exemplifies a transdermal patch comprising hydroxyethyl acrylate (HEA) and tropisetron (Effing 13: 16-28; id. at 9: 13; Ans. 12; Spec. 6: 3--4 ("Particularly preferred acrylates are ... , especially hydroxyethylacrylate (HEA)")). FF 4. "Stability testing of [Effing' s] formulation [comprising HEA] revealed [] a decrease in the drug content of more than 10% within 4 weeks of storage" (Effing 13: 27-28). FF 5. Effing's examples 1 and 2 relate to a patch comprising tropisetron, iso-octylacrylate (IOA) and N-vinyl-2-pyrrolidone (NVP), with or without ELVACITE™, see Effing's examples 2 and 1 respectively (Effing 11: 1- 27). 4 Appeal2013-007331 Application 12/508,522 Claim 1: ANALYSIS Effing teaches and exemplifies an adhesive patch suitable for the transdermal administration of granisetron to a subject in need thereof, that comprises: (1) HEA, an acrylic adhesive containing non-acidic hydroxyl moieties, and (2) a physiologically effective amount of granisetron loaded in the acrylic adhesive (FF 1-3). In this regard, Appellants recognize that a person of ordinary skill in this art would have realized that because Effing teaches "adhesive patches containing either tropisetron or granisetron [] observations made with respect to tropisetron [] would be equally applicable to granisetron" (App. Br. 8). Thus, an exemplification of a patch containing tropisetron is also an exemplification of a patch containing granisetron. For the foregoing reason we are not persuaded by Appellants' contention that Effing fails to disclose an "acrylic adhesive contain[ing] 'non-acidic hydroxyl moieties"' (App. Br. 8; cf FF 3). Appellants' claim 1 does not require a particular level of stability, therefore, we are not persuaded by Appellants' contentions regarding Effing's stability results for the patch exemplified in Effing's Example 7 (see App. Br. 8-9; Reply Br. 7-8; FF 4). Claim 20: Appellants' claim 20 depends from and further limits the patch of claim 1 to require that no crystallization is observed after one month storage at room temperature and pressure (see Appellants' claim 20). Appellants failed to present persuasive evidence or argument to support a finding that Effing' s patch, comprising granisetron and HEA, will 5 Appeal2013-007331 Application 12/508,522 not inherently exhibit the absence of crystallization after one month storage at room temperature and pressure (cf App. Br. 9 ("claim 20, further distinguishes over Effing by requiring that 'no crystallization is observed after one month storage at room temperature and pressure"')). Claims 21and22: Appellants' claims 21 and 22 depend from and further limit the patch of claim 1 to require that the granisetron content of the patch remains substantially unchanged when stored at 25°C or 40°C, respectively, for at least six weeks (see Appellants' claims 21 and 22). We recognize, but are not persuaded by, Examiner's reliance on Effing's Examples 1 and 2 to support a finding that Effing's "device shows stability at storage conditions under 25°C and 40°C after 4 weeks" (Ans. 8; see generally FF 5). Examiner failed to establish an evidentiary basis on this record to support a conclusion that the adhesive of Effing's Examples 1 and 2 contain non-acidic hydroxyl moieties, as required by Appellants' claims 21 and 22 (see Ans. 8; FF 5; cf App. Br. 8; Ans. 12). Therefore, Examiner failed to establish a factual basis on this record to support a finding that the stability of the products disclosed in Effing' s Examples 1 and 2 are within the scope of Appellants' claimed invention. Examiner did, however, establish that the product of Effing's Example 7 is within the scope of Appellants' claimed invention. The stability of the product disclosed in Effing's Example 7, however, is outside the scope of the stability requirements set forth in Appellants' claims 21 and 22 (see Appellants' claims 21 and 22; see Reply Br. 7-8; cf FF 4). 6 Appeal2013-007331 Application 12/508,522 Claims 23 and 31: Appellants' claims 23 and 31 are directed the patch of claim 1. Claims 23 and 31 additionally recite various intended uses for the claimed patch. The intended uses recited in claims 23 and 31 are "for the treatment of conditions which are known in the art to be responsive to [] granisetron" (Reply Br. 6). Having found that Effing anticipates the patch of Appellants' claim 1, we are not persuaded by Appellants' contention and/ or intimation that a recitation of the intended use of the claimed patch, which does not place additional structural limitations on the claimed patch, renders the patch set forth in Appellants' claims 23 and 31 novel in view of Effing. CONCLUSION OF LAW The preponderance of evidence on this record supports Examiner's finding that Effing teaches Appellants' claimed invention as it relates to claims 1, 20, 23, and 31. The rejection of claims 1, 20, 23, and 31 under 35 U.S.C. § 102(b) as being anticipated by Effing is affirmed. Claims 2-19 and 32 are not separately argued and fall with claim 1. Claims 24--30 are not separately argued and fall with claim 23. The preponderance of evidence on this record fails to support Examiner's finding that Effing teaches Appellants' claimed invention as it relates to claims 21 and 22. The rejection of claims 21 and 22 under 35 U.S.C. § 102(b) as being anticipated by Effing is reversed. 7 Appeal2013-007331 Application 12/508,522 Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 6. Examiner relies on Effing as set forth above (Ans. 10). FF 7. Examiner relies on Sanger to disclose "the use of 5-HT 3 receptor antagonist[, which include granisetron,] for the treatment of visceral pain and migraine (abstract)" (id.). ANALYSIS Based on the combination of Effing and Sanger, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to modify the teaching of Effing for the treatment of migraine to obtain the claimed invention" (Ans. 10). Having found that Effing anticipates the subject matter of Appellants' claim 31, we find that Effing makes obvious the subject matter of Appellants' claim 31. Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) ("anticipation is the epitome of obviousness"). For the foregoing reasons we are not persuaded by Appellants' contention that "Sanger is unable to cure the deficiencies of Effing" (App. Br. 1 O; Reply Br. 8). Appellants' claim 31 does not require a particular level of stability, therefore, we are not persuaded by Appellants' contentions regarding Effing's stability results for the patch exemplified in Effing's Example 7 (see App. Br. 11; see Reply Br. 8-9; FF 4). 8 Appeal2013-007331 Application 12/508,522 CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 31 under 35 U.S.C. § 103(a) as unpatentable over the combination of Effing and Sanger is affirmed. 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-IN-PART cdc 9 Copy with citationCopy as parenthetical citation