Ex Parte Wang et alDownload PDFPatent Trial and Appeal BoardDec 17, 201312076294 (P.T.A.B. Dec. 17, 2013) 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. 12/076,294 03/17/2008 Ae-June Wang WANG3284C/REF/LES 4072 23364 7590 12/18/2013 BACON & THOMAS, PLLC 625 SLATERS LANE FOURTH FLOOR ALEXANDRIA, VA 22314-1176 EXAMINER KISHORE, GOLLAMUDI S ART UNIT PAPER NUMBER 1612 MAIL DATE DELIVERY MODE 12/18/2013 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte AE-JUNE WANG, PEI-LIN WANG, and SHIN-JR LU __________ Appeal 2012-003334 Application 12/076,294 Technology Center 1600 __________ Before DONALD E. ADAMS, ERICA A. FRANKLIN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a stabilized liposome and a stabilized drug delivery system comprising at least one liposome. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Industrial Technology Research Institute of Hsinchu, Taiwan. (See App. Br.1.) Appeal 2012-003334 Application 12/076,294 2 STATEMENT OF THE CASE Claims 1-19 are on appeal. Claim 1 is representative and reads as follows: 1. A stabilized liposome, comprising a phospholipid bilayer and a hydrophilic core and being injectable, wherein the phospholipid bilayer contains an amount of vitamin E derivative (D-alpha tocopheryl polyethylene glycol 1000 succinate, TPGS) being used for increasing stability of said liposome in circulating blood of a patient. The Examiner rejected the claims as follows:2 I. claims 1-3, 10-12 and 19 under 35 U.S.C. §103(a) as unpatentable over Sonne3 by itself or in combination with Ghyczy4 and/or Edgar;5 II. claims 1-3 and 10-12 under 35 U.S.C. § 103(a) as unpatentable over Constantinides6 in combination with Sonne, Ghyczy, and Edgar by themselves or in combination; III. claims 4-8 and 13-19 under 35 U.S.C. §103(a) as unpatentable over Sonne by itself or in view of with Ghyczy, Edgar by themselves or in combination , further in view of Woodle7 and Munechika;8 2 We vacate rejections I. and III. as cumulative to rejections II. and IV. and we will not discuss these vacated rejections further. 3 Patent Application Publication No. WO 95/31217 A1 by Matte Sonne, published Nov. 23, 1995. 4 US Patent No. 5,741,513 issued to Miklos Ghyczy et al., Apr. 21, 1998. 5 US Patent No. 5,498,420 issued to Mentrup Edgar et al., Mar. 12, 1996. 6 Patent No. US 6,479,540 B1 issued to Panayiotis P. Constantinides et al., Nov. 12, 2002. 7 US Patent No. 5,356,633 issued to Martin C. Woodle et al., Oct. 18, 1994. 8 US Patent No. 5,662,931 issued to Koji Munechika et al., Sep. 2, 1997. Appeal 2012-003334 Application 12/076,294 3 IV. claims 4-8 and 13-19 under 35 U.S.C. § 103(a) as unpatentable over Constantinides in combination with Sonne, Ghyczy, and Edgar by themselves or in combination, further in view of Woodle and Munechika; and V. claims 1-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 18-26 of Application No. 12/076,295. OBVIOUSNESS The Examiner’s findings regarding rejection II. are set forth in the Answer. In particular, the Examiner found that Constantinides disclosed tocopherol and its derivatives, including TPGS, for solubilizing active agents such as vitamin A and retinoids in systems such as liposomes. (Ans. 6.) Appellants contend that Constantinides “does mention liposomes as an example of a ‘multiphase system’…but does not provide any further explanation of how liposomes may be relevant to the invention.” (App. Br. 5.) Appellants assert that Constantinides “does not teach or suggest using tocols such as TPGS as components of liposomal phospholipid bilayer,” or “that such liposomes would be injectable and demonstrate increased stability as recited in the present claims.” (Id.) After considering the evidence and arguments, we conclude that the record supports a conclusion of prima facie obviousness. In particular, Constantinides expressly discloses: The invention is directed to compositions having an oil phase that contains pharmaceutically active ingredients that are charged amphiphilic or water soluble. The compositions generally comprise tocol-soluble ion pairs in a tocol-based oil Appeal 2012-003334 Application 12/076,294 4 of a multiphasic system or a precursor of such a system. The compositions of the invention can be in the form of an emulsion, liquid crystalline gel, self-emulsifying drug delivery system, or a liposomal or niosomal dispersion for oral or parenteral administration, which term is meant to include, for instance, intravenous, subcutaneous, intraperitoneal, intramuscular, pulmonary, intranasal, and topical administration such as transdermal and ocular. (Constantinides col. 1, ll. 7-19) (emphasis added). Further, Constantinides’ claim 52 discloses a composition comprising liposomes. (Id. at col. 16, ll. 39-41.) Therefore, we find that, contrary to Appellants’ assertion, Constantinides disclosed the relevance of liposomes to its invention, and that such liposomes can be injectable. Additionally, Constantinides explained that it uses of the term “tocols” in “a broad sense to indicate the family of tocopherols and tocotrienols and derivatives thereof,” which includes TPGS, as evidenced by its Examples. (Id. at col. 3, ll. 19-50; see also, e.g., Example 3.) We remain unpersuaded of nonobviousness by Appellants’ assertion that Constantinides “does not teach or suggest using tocols such as TPGS as components of liposomal phospholipid bilayer,” or “that such liposomes would be injectable and demonstrate increased stability as recited in the present claims.” (App. Br. 5.) The Examiner has provided sound reasoning that one of ordinary skill in the art would expect TPGS to sequester in the phospholipid bilayers when used in conjunction with phospholipids and formulated as a liposome. (Ans. 13.) As Constantinides is directed to an injectable liposome composition comprising components substantially identical to the claimed invention, i.e., a phospholipid bilayer, a hydrophilic core, and TPGS, it is proper for the Examiner to require Appellants to prove Appeal 2012-003334 Application 12/076,294 5 that the prior art product does not necessarily or inherently posses the characteristics of the instantly claimed product. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). When weighed against the evidence of record, Appellants have not met this burden by asserting that “a person of ordinary skill in the art would not have reasonably predicted that such an ion-pair would form liposomes.” (Reply Br. 4.) Accordingly, we affirm the obviousness rejection of claim 1. Appellants have not argued claims 2, 3, and 10-12 separately. Therefore, these claims fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). Regarding rejection IV., Appellants assert that the combined references fail to render claims 4-8 and claims 13-19 obvious for at least the reasons asserted with regard to claims 1 and 10. (App. Br. 6.) Further, Appellants assert that “Woodle et al. and Munechika et al. fail to remedy the serious deficiencies of Constantinides et al., Sonne, Ghyczy et al. and Edger et al.” (Id.) We affirm this rejection for the reasons discussed regarding the rejection of claims 1-3 and 10-12. DOUBLE PATENING Appellants include the non-statutory obviousness-type double patenting rejection in their statement of Grounds of Rejection to be Reviewed on Appeal, but do not present any argument relating to the rejection. (See App. Br. 2-3.) Instead, Appellants request the rejection to “be held in abeyance until at least claims in one of the applications are allowed.” (Id. at 3.) We summarily sustain this rejection. 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.”). Appeal 2012-003334 Application 12/076,294 6 SUMMARY We affirm rejections II., IV. and V. 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 lp Copy with citationCopy as parenthetical citation