10392342 (B.P.A.I. Aug. 24, 2010)

Ex Parte Jackson et al

Board of Patent Appeals and InterferencesAug 24, 2010

10392342 (B.P.A.I. Aug. 24, 2010)

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. 10/392,342 03/19/2003 Blair Jackson 2685.2044 US1 7537 38421 7590 08/24/2010 ELMORE PATENT LAW GROUP, PC 515 Groton Road Unit 1R Westford, MA 01886 EXAMINER FISHER, ABIGAIL L ART UNIT PAPER NUMBER 1616 MAIL DATE DELIVERY MODE 08/24/2010 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 BLAIR JACKSON, DAVID J. BENNETT, RAYMOND T. BARTUS, and DWAINE F. EMERICH __________ Appeal 2009-013843 Application 10/392,342 Technology Center 1600 __________ Before CAROL A. SPIEGEL, LORA M. GREEN, and MELANIE L. McCOLLUM, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL1 This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1, 3-9, 11, and 29. 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 2009-013843 Application 10/392,342 2 We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE Claim 1 is representative of the claims on appeal, and read as follows: 1. A method of treating a patient with Parkinson’s disease, that comprises: administering to the respiratory tract of the patient particles that include more than about 90 weight percent levodopa, and a salt wherein the formulation contains less than 10% by weight of a salt, and a nonreducing sugar, wherein the particles are delivered to the pulmonary system. Claims 1, 3-9, 11, and 29 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Burns,2 Edwards,3 and Dunn.4 We reverse. ISSUE Has the Examiner established by a preponderance of the evidence that the combination of Burns, Edwards, and Dunn renders the claimed methods of treating Parkinson’s disease or delivering L-Dopa to the pulmonary system obvious? FINDINGS OF FACT FF1 The Examiner’s rejection may be found at pages 3-5 of the Answer. 2 Burns U.S. 5,284,133 Feb. 8, 1994 3 Edwards WO 98/31346 Jul. 23, 1998 4 Dunn US 6,461,631 B1 Oct. 8, 2002 Appeal 2009-013843 Application 10/392,342 3 FF2 The Examiner notes that Edwards discloses porosity (Ans. 4 (citing Edwards, pp. 26-27)), finding that Edwards teaches “that porosity affects the tap density of the product and that diminishment of the tap density by increasing porosity permits the delivery of larger particle volumes to the lung” (Ans. 7.) FF3 While we cannot find a discussion of porosity at pages 26-27 of Edwards, Edwards teaches at page 18, ll. 21-24, that “diminishing the tap density by increasing particle surface irregularities and particle porosity permits the delivery of larger particle envelope volumes into the lungs, all other physical parameters being equal.” FF4 The Examiner cites Dunn for teaching that “it is well-known in the art to include pore forming additives, such as sodium chloride, in microparticles to create pores.” (Ans. 4 (citing Dunn, col. 3, l. 9, and col. 13, l. 28).) FF5 Dunn is drawn to “a flowable composition suitable for use in medical applications.” (Dunn, col. 1, ll. 42-43.) The flowable composition is used to produce, by solidification of the composition, in situ and ex vivo implants, wherein the solidification is achieved through contact with an aqueous medium, a body fluid, or water. (Id. at col. 1, ll. 46-49.) FF6 Dunn teaches that the composition may be used in producing microparticles that have a dimension of 10 to 400 microns, and are composed “of a porous matrix of the thermoplastic, branched polymer and bioactive agent.” (Id. at col. 3, ll. 15-28.) FF7 Dunn teaches that a pore-forming agent may be added to the composition, wherein the pore-forming agent may be any biocompatible, water-soluble material, such as a salt. (Id. at col. 13, ll. 2-10 and l. 28.) Appeal 2009-013843 Application 10/392,342 4 According to Dunn, upon contact with a body fluid, the pore-forming agent dissipates into the surrounding body tissue, which causes the formation of microporous channels in the coagulating polymer matrix. (Id. at col. 13, ll. 35-38.) FF8 The Examiner concludes that Edwards’ teachings regarding porosity “provides motivation to one of ordinary skill in the art to manipulate the tap density via porosity in order to deliver large volumes to the lung.” (Ans. 7.) PRINCIPLES OF LAW As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). “We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed Appeal 2009-013843 Application 10/392,342 5 invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008). ANALYSIS Appellants assert that Dunn “is directed to a substantially unrelated technology, [that is,] implantable sustained release devices where the sodium chloride will dissolve and form pores on implantation.” (App. Br. 7 (emphasis in original).) Appellants argue that the Examiner has not provided a reason as to “why the skilled practitioner would turn to teachings related to implantable devices and select a component which must dissolve on implantation to form those pores.” (Id. (emphasis in original).) As taught by Edwards, Appellants assert, the pores need be present in the drug product when it is loaded into the inhaler. (Id. at 7-8.) We agree with Appellants. Specifically, Edwards discusses porosity in the context of tap density, which allows the delivery of larger particle envelope volumes into the lungs. Thus, as argued by Appellants, the pores need to be present before loading the particles into the inhaler. Dunn is drawn to a flowable composition which may be used to form an ex vivo or in situ implant. While Dunn teaches a pore forming agent, Dunn teaches the use of a water-soluble biocompatible material, such as a salt, which dissolves upon contact with body fluids. Thus, the pore is formed after delivery of the implant, not before. We therefore agree with Appellants that the Examiner has not explained why the ordinary artisan would have used the pore-forming agent of Dunn to form pores in the inhalable particle taught by Edwards. Appeal 2009-013843 Application 10/392,342 6 CONCLUSION OF LAW We conclude that the Examiner has not established by a preponderance of the evidence that the combination of Burns, Edwards, and Dunn renders the claimed methods of treating Parkinson’s disease or delivering L-Dopa to the pulmonary system obvious. We thus reverse the rejection of claims 1, 3-9, 11, and 29 under 35 U.S.C. § 103(a). REVERSED alw ELMORE PATENT LAW GROUP, PC 515 GROTON ROAD UNIT 1R WESTFORD, MA 01886