Ex Parte Perricone

Patent Trial and Appeal BoardSep 18, 2012

10448632 (P.T.A.B. Sep. 18, 2012)

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. 10/448,632 05/30/2003 Nicholas V. Perricone 01961-P0210B 5476 24126 7590 09/18/2012 ST. ONGE STEWARD JOHNSTON & REENS, LLC 986 BEDFORD STREET STAMFORD, CT 06905-5619 EXAMINER ARNOLD, ERNST V ART UNIT PAPER NUMBER 1613 MAIL DATE DELIVERY MODE 09/18/2012 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 NICHOLAS V. PERRICONE __________ Appeal 2011-006705 Application 10/448,632 Technology Center 1600 __________ Before DEMETRA J. MILLS, ERIC GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for anticipation, obviousness and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2010-006705 Application 10/448,632 2 STATEMENT OF THE CASE The following claims are representative of the claims on appeal: 8. A method for topically administering a macromolecular drug comprising formulating a composition containing a polyenylphosphatidylcholine- enriched phosphatidylcholine multilamellar liquid crystal carrier entrapping a polypeptide, and applying the composition to the skin for delivery of the polypeptide to the dermal vasculature. 14. A method according to claim 12 wherein the polypeptide is somatotropin. Cited References The Examiner relies on the following prior art references: Praveen Tyle, Liquid Crystals and Their Applications in Drug Delivery; Chapter 4, pp. 125-162, in Controlled Release of Drugs: Polymers and Aggregate Systems, Morton Rosoff (ed.), VCH Publishers, New York (1989). Weiner et al., Liposome-Collagen Gel Matrix: A Novel Sustained Drug Delivery System, 74(9) Journal of Pharmaceutical Sciences (1985). Cevc „500 US 6,165,500 Dec. 26, 2000 Spicer et al. US 2002/0160040 A1 Oct. 31, 2002 Popescu et al. US 4,708,861 Nov. 24, 1987 The Appellant relies on the following prior art references: Esposito et al., Lipid-Based Supramolecular Systems for Topical Application: A Preformulatory Study, AAPS PharmaSci 5(4) Article 30 (2003). Cevc 1998 et al., Ultraflexible vesicles, Transfersomes, have an extremely low pore penetration resistance and transport therapeutic amounts of Appeal 2011-006705 Application 10/448,632 3 insulin across the intact mammalian skin, 1368 Biochimica et Biophysica Acta 201-215 (1998). Grounds of Rejection 1. Claims 8-10, 12, 13, and 15-18 are rejected under 35 U.S.C. § 102(b) as being anticipated by Cevc „500 as evidenced by Spicer and Praveen Tyle. 2. Claims 8, 10, 12, 13, 15, 16 and 18 are rejected under 35 U.S.C. § 102(b) as being anticipated by Popescu as evidenced by Spicer and Praveen Tyle. 3. Claims 8 and 14 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Cevc „500 and Weiner as evidenced by Spicer and Praveen Tyle. 4. Claims 8, 13 and 16 provisionally rejected on the ground of nonstatutory obviousness type double patenting as being unpatentable over claims 1 and 13 of copending Application No. 11/344,442. FINDINGS OF FACT The Examiner‟s findings of fact are set forth in the Answer at pages 4- 11. The following facts are highlighted. 1. Spicer teaches that “[c]urrently, vesicles or liposomes (dispersed lamellar liquid crystalline particles) can be used to contain and deliver active materials.” (Spicer, ¶ [0003].) 2. Spicer discloses that “[l]amellar phases have a bilayer sheet structure.” (Id. at ¶ [0022.]) Discussion 1. Claims 8-10, 12, 13, and 15-18 are rejected under 35 U.S.C. §102(b) as being anticipated by Cevc „500 as evidenced by Spicer and Praveen Tyle. Appeal 2011-006705 Application 10/448,632 4 3. Claims 8 and 14 are rejected under 35 U.S.C. §103(a) as being unpatentable over Cevc „500 and Weiner as evidenced by Spicer and Praveen Tyle. ISSUE The Examiner finds that Cevc „500 discloses each element claimed, as evidenced by Spicer and Praveen. In particular Cevc „500 “discloses methods of transporting medical agents through the skin” with lipid transfersomes which are vesicles which include a lipid such as phosphatidylcholine and polyenyl phosphatidylcholine from soybeans. (Cevc „500 claims 18, 19; Col. 54, l. 13; Ans. 4-5.) Spicer evidences that „“vesicles or liposomes (dispersed lamellar liquid crystalline particles) can be used to contain and deliver active materials.‟ ([003].)” (Ans. 5. (emphasis omitted).) Praveen teaches on page 127, that “lipophilic chains are transformed into a disordered, liquid state and the water penetrates between the polar hydrophilic layers to form a lyotropic lamellar liquid crystalline structure.” (Praveen, p. 127 (emphasis added); Ans. 5.) Appellant argues that “Cevc's[„500] flexible transfersomes are large vesicles, e.g. liposomes, not a liquid crystal. See e.g. Cevc., col. 4, lines 37- 46).” (App. Br. 6.) The transfersomes of Cevc „500 are generally spherical structures (See e.g., Cevc, col. 55-56 [measurements of vesicle diameters]). (App. Br. 6.) Cevc „500 “discloses a different physical structure - a vesicle structure - which is not the same as the multilamellar liquid crystal claimed in the present application.” (App. Br. 6.) The issue is: Does the cited prior art teach a multilamellar liquid crystal carrier, as claimed? Appeal 2011-006705 Application 10/448,632 5 PRINCIPLES OF LAW In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477(Fed. Cir. 1997). To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). Where . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product…. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO‟s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at Appeal 2011-006705 Application 10/448,632 6 issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Our mandate is to give claims their broadest reasonable interpretation. In re American Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). “An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). ANALYSIS We agree with the Examiner‟s fact finding, statement of the rejection and responses to Appellant‟s arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of anticipation. We provide the following additional comment. Appellant argues that “[t]o interpret „multilamellar liquid crystal carrier‟ as reading on liposome structures is an unreasonably broad interpretation.” (Reply Br. 3.) Appellant further argues that “Cevc discloses a different physical structure - a vesicle structure - which is not the same as the multilamellar liquid crystal claimed in the present application.” (App. Br. 6.) We are not persuaded. Spicer evidences that “vesicles or liposomes [are] (dispersed lamellar liquid crystalline particles) [and] can be used to contain and deliver active materials.” (Spicer ¶ [0003]; (FF1.) Appellant Appeal 2011-006705 Application 10/448,632 7 argues that Spicer discloses that “precursor, bulk, and particulate liquid crystals are distinct crystal forms which are not the same as liposomes). [0004].” (Reply Br. 4.) However, Spicer is distinguishing liposomes from “cubic” liquid crystalline forms, and does not disavow its previous statement indicating that liposomes are “lamellar” liquid crystalline particles. To the extent that Appellant is arguing that Cevc‟s transfersomes are not multilamellar, Cevc expressly states that they “consist of one or several layers of amphiphilic molecules” (Cevc, abstract (emphasis added)). Cevc therefore discloses multilamellar vesicles. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, at 322. Appellant is in the better position to remove claim uncertainties. We do not find based on the evidence before us that the claim language “multilamellar liquid crystal carrier” distinguishes from prior art, Cevc‟s, disclosure of transfersome vesicles which Spicer establishes are liquid crystal lamellar particles. Finally, Appellant refers to a publication of Cevc, Biochemica et Biophysica Acta 1368 (1998) (pp. 201-215) (in Appellant‟s Evidence Appendix) providing additional information regarding Cevc‟s transfersomes. Appellant argues that “Cevc's [1998] article confirms that the highly ordered transfersomes of the patent are not the same as the invention claimed in the present application.” (App. Br. 12-13.) However, Appellant has failed to provide evidence that the transfersomes of Cevc [1998] are not multilamellar liquid crystal carriers. In particular, Appellant has not pointed to any Appeal 2011-006705 Application 10/448,632 8 specific disclosure in Cevc‟s 1998 journal article in which the authors teach that the transfersomes are not multilamellar liquid crystal carriers as claimed. The anticipation rejection is affirmed for the reasons of record. With respect to the obviousness rejection of claims 8 and 14, Appellant argues that “[f]or the same reasons stated above with respect to the rejection under §102 based on Cevc, namely that Cevc describes a liposome, not a multilamellar liquid crystal carrier, the combination of Cevc and Weiner does not make claims 8 and 14 unpatentable.” (App. Br. 11.) Having found no deficiency in the anticipation rejection over Cevc, we also affirm the obviousness rejection over Cevc, Weiner, Praveen and Spicer. Discussion 2. Claims 8, 10, 12, 13, 15, 16 and 18 are rejected under 35 U.S.C. §102(b) as being anticipated by Popescu et al. as evidenced by Spicer and Praveen Tyle. The Examiner finds that Popescu et al. disclose methods of topical (claim 77) delivery of a bioactive agent by administering a liposome composition with a bioactive agent entrappped [sic] in the liposomes (claims 66-68). Topical delivery inherently reads on the skin and delivery of the active agent to the dermal vasculature. Popescu et al. disclose a finite number of phospholipids to make the plurilamellar liposomes which include: 1) egg lecithin or soy lecithin; 2) saturated synthetic lecithins such as dimyristoylphosphatidylcholine or dipalmitoyl- phosphatidylcholine or distearolyl-phsophatidylcholine; and 3) unsaturated synthetic lecithins, such as dioloyl- phosphatidylcholine or dilinoleoylphosphatidylcholine (column 5, Appeal 2011-006705 Application 10/448,632 9 lines 5-30). The active agent can be insulin or hormones or growth factors (claims 40-46). The liposome-gel composition (claims 1-65) is multilamellar vesicles (claims 28 and 32) or reverse phase evaporated vesicles (claim 30). (Ans. 6-7.) Appellant argues that the Examiner “equates the plurilamellar liposomes [of Popescu] with the multilamellar liquid crystal carrier of the present invention, but these are different structures.” (App. Br. 10.) Appellant further argues that, “[f]or the same reasons stated above with respect to Cevc, namely that Popescu describes a liposome, not a multilamellar liquid crystal carrier, Popescu does not anticipate the claims of the present invention.” (Id.) Having found no deficiency in the anticipation rejection over Cevc with respect to arguments concerning a multilamellar liquid crystal carrier, we also affirm the anticipation rejection over the plurilamellar liposomes of Popescu in combination with Praveen and Spicer for the same reasons. 4. Claims 8, 13 and 16 provisionally rejected on the ground of nonstatutory obviousness type double patenting as being unpatentable over claims 1 and 13 of copending Application No. 11/344,442. We have confirmed that copending Application No. 11/344,442 of the obviousness type double patenting rejection is abandoned. Therefore, the rejection is vacated. Appeal 2011-006705 Application 10/448,632 10 CONCLUSION OF LAW The cited references support the Examiner‟s anticipation and obviousness rejections. The obviousness-type double patenting rejection is vacated. TIME PERIOD 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 alw