Ex Parte Halliday et alDownload PDFPatent Trial and Appeal BoardJan 11, 201814099663 (P.T.A.B. Jan. 11, 2018) 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. 14/099,663 12/06/2013 Janet Anne Halliday 27521-0046004 6022 26211 7590 01/16/2018 FISH & RICHARDSON P.C. (NY) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER SASAN, ARADHANA ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 01/16/2018 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): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JANET ANNE HALLIDAY, JUKKA TUOMINEN, MARK ALEXANDER LIVINGSTONE, FRANK KOPPENHAGEN, LILIAS MORTON CURRIE, and SARAH STEWART Appeal 2017-001431 Application 14/099,663 Technology Center 3700 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a controlled release composition comprising a cross-linked polyurethane polymer loaded with misoprostol. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm a double patenting rejection but reverse the other rejections. 1 Appellants identify the real party in interest as Ferring B.V. (see App. Br. 1). 2 We refer to the Specification filed Dec. 6, 2013 (“Spec.”); Final Rejection mailed May 12, 2015 (“Final Act.”); Appeal Brief filed June 9, 2016 (“Appeal Br.”); Examiner’s Answer mailed Sept. 9, 2016 (“Ans.”). [It is noted that a Reply Brief was filed on Nov. 4, 2016.] Appeal 2017-001431 Application 14/099,663 Statement of the Case Background A prior art “polyurethane polymer is the reaction product of polyethylene glycol 8000, Desmodur (DMDI i.e. dicyclohexylmethane-4,4- diisocyanate) and 1,2,6-hexane triol and which has been used commercially for vaginal delivery of prostaglandins” (Spec. 1:26 to 2:6). “[Sjince the conventional cross-linked polyurethane polymer is essentially insoluble in both water and organic solvents, processing of the formed polymer into other solid forms, such as films or coatings, is not possible” (id. at 2:24—28). “The object of the present invention is to provide a polyurethane polymer of the aforementioned type which is not cross-linked but is linear but which still possesses the desirable properties of reproducible swellability found in the prior cross-linked polyurethanes” (Spec. 2:29-33). The Claims Claims 21—30 are on appeal. Claim 21 is representative and reads as follows: 21. A controlled release composition, comprising a cross- linked polyurethane polymer loaded with misoprostol; wherein the cross-linked polyurethane polymer is formed from a polyethylene glycol, a triol and a diisocyanate, and at least about 80% of the misoprostol is released when the composition is immersed in water at 37°C for 480 minutes. The issues A. The Examiner rejected claims 21—30 under 35 U.S.C. § 103(a) as obvious over Embrey3 and Schaub4 (Final Act. 3—9). 3 Embrey et al., US 4,931,288, issued June 5, 1990 (“Embrey”). 2 Appeal 2017-001431 Application 14/099,663 B. The Examiner rejected claims 21—30 on the ground of nonstatutory double patenting as being unpatentable over claims 1—9 of U.S. Patent No. 8,628,798 B2 (Final Act. 12-13). C. The Examiner rejected claims 21—30 on the ground of nonstatutory double patenting as being unpatentable over claims 1—23 of U.S. Patent No. 8,557,281 B2 (Final Act. 13-14). A. 35 U.S.C. § 103(a) over Embrey and Schaub The Examiner finds Embrey teaches “a controlled release composition comprising a prostaglandin and a crosslinked polymeric carrier . . . prepared by the reaction of a polyethylene glycol (a polyethylene oxide of equivalent weight greater than 1,000), diisocyanate, and a triol” (Final Act. 3). The Examiner acknowledges Embrey does “not expressly teach misoprostol or that at least about 80% of the misoprostol is released when the composition is immersed in water at 37°C for 480 minutes” (id. at 4). The Examiner finds Schaub teaches “misoprostol (a prostaglandin PGEi analogue) is a labor-inducing substance . . . [and] may comprise 0.0001 wt% to 10 wt% of the total dosage form” (Final Act. 4). The Examiner finds “it obvious to use various PGEi analogues for inducing labor, including the misoprostol recognized for inducing labor” (id. at 5). The Examiner finds the “limitation of at least about 80% of the misoprostol released when the composition is immersed in water at 37°C for 480 minutes is a property associated with the controlled release composition and inseparable from it” (Final Act. 6). The Examiner also finds “it obvious 4 Schaub, US 2005/0053670 Al, published Mar. 10, 2005. 3 Appeal 2017-001431 Application 14/099,663 to modify the release rate of the misoprostol based on the desired induction of labor” (id. at 10). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the release rate of 80% at 37-C for 480 minutes is either inherent in, or obvious over, the teachings of Embrey and Schaub? Findings of Fact 1. Embrey teaches “a controlled release composition comprises a prostaglandin and a polymeric carrier therefor comprising . . . polyethylene oxide and are cross-linked through urethane groups” (Embrey 1:29-34). 2. Embrey teaches: “When reacting a di-isocyanate with a polyethylene oxide it is preferred to incorporate an additional polyfimctional compound in the reactants to give the desired cross-linking. Tri- or higher functional amines and particularly hydroxy compounds are conveniently used, including aliphatic triols” (Embrey 3:46—51). 3. Embrey teaches: “In vitro studies on the release of the prostaglandin from the dry cylinders into pH 7.4 phosphate buffer through measurement of the 3H activity typically show a half life of the order of 95 hours” (Embrey 15:34—37). 4. Embrey teaches “a release of 60—70% of the prostaglandin content of the release composition can be achieved and in appropriate circumstances in a manner approximating to a linear release rate, over a period of 24 hours” (Embrey 7:58—62). 5. Embrey teaches the “pattern of release is very largely controlled by the nature of the polymeric carrier rather than the nature of the entire 4 Appeal 2017-001431 Application 14/099,663 release composition, providing the active substance has a good water solubility, so that the formulation of such release compositions to give a particular release rate is considerably simpified” (Embrey 8:16—22). 6. Schaub teaches a “lubricant in vaginal child birthing by women” (Schaub 11) that “may additionally comprise an active pharmaceutical ingredient or a combination of at least two active pharmaceutical ingredients which serve as medicaments for certain indications occurring during delivery” (Schab 136). 7. Schaub teaches “examples of labor-inducing substances are oxytocin, dinoprostone, sulprostone, misoprostol, and hyaluronidase.” (Schaub 137; emphasis added). 8. Table 21 of the Specifciation is reproduced below: rahle 21 Bate of drug release jk. of drug- candidates from cross-linked and .linear polymer pessaries Drug Kate of drug release, k Copy with citationCopy as parenthetical citation