Ex Parte Bhalani et alDownload PDFBoard of Patent Appeals and InterferencesFeb 14, 201110207146 (B.P.A.I. Feb. 14, 2011) 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. 10/207,146 07/30/2002 Vinayak T. Bhalani 70164.0005USC2 9006 23552 7590 02/14/2011 MERCHANT & GOULD PC P.O. BOX 2903 MINNEAPOLIS, MN 55402-0903 EXAMINER TRAN, SUSAN T ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 02/14/2011 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte VINAYAK T. BHALANI and SATISHCHANDRA P. PATEL __________ Appeal 2010-000803 Application 10/207,146 Technology Center 1600 __________ Before DONALD E. ADAMS, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a pharmaceutical composition. The Patent Examiner rejected the claims on the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-000803 Application 10/207,146 2 STATEMENT OF THE CASE Claims 57, 61, 69, 143, 156 and 166, which are all the pending claims, are on appeal.2 Claim 143 is representative and reads as follows: 143. A pharmaceutical composition comprising: a) at least one cyclosporin; b) a surfactant component; c) a polar lipid component comprising at least one fatty acid partial glyceride comprising at least 50 weight percent monoglycerides of C6-C12 fatty acids; d) at least one triglyceride; e) said pharmaceutical composition does not contain a hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1-(-O- (CH2))X-OR2, wherein R1 is alkyl or tetrahydrofurfuryl, R2 is alkyl, tetrahydrofurfuryl, or hydrogen, and x is an integer of 1 to 6; and wherein said at least one cyclosporin, said surfactant component, and said polar lipid component are present in effective amounts relative to each other so that the composition, on contact with an aqueous phase, is capable of spontaneously forming a fine emulsion; and wherein said pharmaceutical composition does not contain a hydrophilic component. The Examiner rejected the claims as follows: • claim 143 under 35 U.S.C. § 103(a) as unpatentable over Hauer;3 and 2 When this appeal began, Appellants identified the appealed claims as 1- 18, 21, 22, 26, 33-44, 47-57, 60-64, 67-69, 72-83, 86-88, 89-110, 115-126, 128-132, 134-143, 146-147, 149-156, 159, 161-164, 166, 169 and 170. (App. Br. 3.) After briefing was complete, Appellants cancelled most of the claims and amended the remaining claims. The Examiner then advised Appellants that “Claims 57, 61, 69, 143, 156 and 166 stay rejected over the prior [art] of record. See Examiner’s Answer dated 04/04/08.” (Advisory Action mailed Oct. 7, 2009.) 3 Birgit Hauer et al., US 5,342,625, issued Aug. 30, 1994. Appeal 2010-000803 Application 10/207,146 3 • claims 57, 61, 69, 156, and 166 under 35 U.S.C. § 103(a) as unpatentable over Hauer and Lacy.4 OBVIOUSNESS The Issue The Examiner found that Hauer taught a composition comprising the ingredients recited in Appellants claims and comprising a hydrophilic phase “which is a 1,2-propylene glycol or an ether of formula R1-(O-(CH2))x-OR2.” (Ans. 4.) According to the Examiner, “[t]here is nothing in the record establishing the detrimental effect in the use of 1,2-propylene glycol or an ether of formula R1-(O-(CH2))x-OR2.” (Id. at 4-5.) Notwithstanding the proviso in the appealed claims excluding a hydrophilic phase having that formula, the Examiner concluded that it would have been obvious “to combine the cyclosporine with hydrophilic/lipophilic surfactants (b), and mono/di-glycerides (c) to obtain a pharmaceutical composition, which capable [sic] of forming a micro-emulsion with or without the use for the hydrophilic phase, because the pharmaceutical composition of the claimed invention permits other components including the hydrophilic component in the use of the transitional phrase ‘comprising.’” (Id. at 5.) Appellants point out that “[a]ll the claims pending in this application call for a composition that: does not contain a hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1-(O-(CH2))x-OR2, wherein R1 is an alkyl or tetrahydrofuryl, R2 is alkyl, tetrahydrofuryl, or hydrogen, and x is an integer of 1 to 6.” 4 Jonathan Ernest Lacy et al., US 5,645,856, issued Jul. 8, 1997. Appeal 2010-000803 Application 10/207,146 4 (App. Br. 9-10.) Appellants contend that the rejection is based on the idea that it would have been obvious to eliminate the hydrophilic phase from the Hauer composition, but that is incorrect because “the hydrophilic phase is not only desired in the Hauer composition, it is required.” (Id. at 10, emphasis deleted.) The issues are: does the transitional term “comprising” override the proviso excluding a hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1-(O-(CH2))x-OR2; did the rejection reasonably explain why it would have been obvious to remove Hauer’s hydrophilic phase from Hauer’s composition? Principles of Law “Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007). Analysis The appealed claims define compositions that do not comprise a hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1- (O-(CH2))x-OR2. The Examiner provided no logical explanation for interpreting the transitional phrase “comprising” to contradict a defining clause in the claim. We cannot agree that a person of ordinary skill in the art would interpret a claim that reads “said pharmaceutical composition does not contain a hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1-(-O-(CH2))X-OR2” to mean the opposite. To the extent the Appeal 2010-000803 Application 10/207,146 5 rejection relies on the incorrect and internally contradictory claim interpretation, it must be reversed. The rejection gives one possible reason to remove the hydrophilic phase from Hauer’s composition: that there is no evidence it has a detrimental effect, and so it would have been obvious to make the composition with or without it. We are not persuaded that this explanation has a rational underpinning. See Kahn, 441 F.3d at 988. We conclude that the rejection did not state a prima facie case of obviousness. CONCLUSIONS The rejection did not articulate reasoning with rational underpinning sufficient to state a prima facie case of obviousness. SUMMARY We reverse the rejection of claim 143 under 35 U.S.C. § 103(a) as unpatentable over Hauer. We reverse the rejection of claims 57, 61, 69, 156, and 166 under 35 U.S.C. § 103(a) as unpatentable over Hauer and Lacy. REVERSED lp Appeal 2010-000803 Application 10/207,146 6 MERCHANT & GOULD PC P.O. BOX 2903 MINNEAPOLIS MN 55402-0903 Copy with citationCopy as parenthetical citation