Brian D. Scherzer et al.Download PDFPatent Trials and Appeals BoardJul 23, 201914861046 - (D) (P.T.A.B. Jul. 23, 2019) 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. 14/861,046 09/22/2015 Brian D. SCHERZER UTSB.P1060US.D1 3541 108197 7590 07/23/2019 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 Austin, TX 78746 EXAMINER SOROUSH, ALI ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 07/23/2019 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): docket@phiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BRIAN D. SCHERZER, JONATHAN C. EVANS, and JAMES E. HITT ____________ Appeal 2019-001013 Application 14/861,046 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appeal 2019-001013 Application 14/861,046 2 Introduction Appellants1 seek our review, under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 5, 6, 11–13, 15, 18, 20, and 21. (Appeal Brief filed September 4, 2018 (“App. Br.”) 4.) We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appellants’ Specification is directed to particles of poorly water soluble drugs prepared by freezing a solution of the drug in an organic solvent onto cold solid surfaces. (Specification dated September 22, 2015 (“Spec.”) ¶ 10.) The Specification discloses that decreasing particle size is known to increase the rate of dissolution of a particulate drug. (Spec. ¶ 5.) However, Appellants assert that milling drug particles may cause the drug to change forms (e.g., from crystalline to amorphous) or otherwise lose activity after being exposed to excessive mechanical shear. (Id.) By rapidly freezing a solution of drug and organic solvent and then removing the organic solvent, Appellants assert that the process results in drug particles with a high surface area and enhanced dissolution rates as compared to unprocessed drug particles. (See Spec. ¶¶ 10, 39, 41.) Appellants’ claim 15 recites: Drug particles produced by a method which comprises: (a) cooling a cold solid surface to less than 5°C; (b) selecting a freezable organic solvent with a freezing point not higher than the temperature of the cold surface and into which a poorly water soluble drug substance dissolves; 1 Appellants report that the real party in interest is Board of Regents, The University of Texas System. Appeal 2019-001013 Application 14/861,046 3 (c) dissolving the poorly water soluble drug substance in the freezable organic solvent into a solution; (d) contacting the solution with the cold solid surface so as to freeze the solution, wherein the rate of freezing of the solution is determined by the difference between the freezing point of the freezable organic solvent and the temperature to which the cold solid surface is cooled in step (a); and (e) removing the organic solvent, wherein the resulting particles have a mean volume average particle size from less than 0.05 microns to 24 microns, a surface area of at least 2 m2/g and exhibit an in vitro dissolution rate of at least 2 times better than that of the unprocessed drug when measured at a 2 minute time point. (App. Br. 11–12.) Our analysis focuses on claim 15, as Appellants do not argue the claims separately. See 37 C.F.R. § 41.37(c)(iv). The Examiner rejects the claims under 35 U.S.C. § 102(b) as anticipated by Mosharraf.2 Analysis The Examiner finds the claims recite a product-by-process. (Final Act. 3.) Therefore, the Examiner determines that the patentability of the product does not depend on the process by which it is made. (Id.) The Examiner finds Mosharraf teaches milling a poorly water soluble drug (e.g., oxazepam), resulting in particles having an average particle mean volume size of 3.99 μm and a surface area of 4.05 m2/g. (Id., citing Mosharraf p. 39, Table 1; p. 41.) Because Mosharraf teaches a poorly water soluble drug 2 Mosharraf, M. and Nyström, C., The effect of particle size and shape on the surface specific dissolution rate of microsized practically insoluble drugs, 122 Int’l J. Pharmaceutics 35–47 (1995). Appeal 2019-001013 Application 14/861,046 4 having the same particle size and surface area as the claimed product resulting from the recited process, the Examiner finds Mosharraf anticipates the claims. (Id.) Appellants contend that the process of the pending product-by-process claims results in a different product than the prior art Mosharraf particles. (Reply Brief filed November 15, 2018 (“Reply Br.”) 2.) Appellants support their contention with the Declaration of Dr. Williams.3 Dr. Williams refers to the claimed technique as “thin-film freezing” or “ultra-rapid freezing” (“TFF/URF”). (Williams Decl. ¶ 2.) Dr. Williams declares that Mosharraf’s mechanical milling produces discrete particles as opposed to TFF/URF which produces aggregates of high porosity. (Reply Br. 2, citing Williams Decl. ¶ 4.) Dr. Williams also declares that sublimation of the frozen solvent results in “interconnected/matrix particle morphology/geometries” which is distinct from breaking a single particle in multiple subdivided particles by mechanical shearing. (Reply Br. 2–3, citing Williams Decl. ¶ 5.) Dr. Williams declares “[a]s a result of the completely different techniques, immunosuppressive drugs and excipient(s) produced by TFF/URF are always amorphous.” (Id.) Appellants contend that process limitations in the claims connote structure, and therefore may be used to distinguish the invention from the prior art. (Reply Br. 4.) In particular, Appellants support their arguments by citing In re Nordt Devel. Co., 881 F.3d 1371, 1374 (Fed. Cir. 2018), as 3 Declaration of Robert O. Williams III, PhD., filed October 25, 2017 (“Williams Decl.”). Appeal 2019-001013 Application 14/861,046 5 applied by the Board in Ex Parte Williams, No. 2017-003283 (PTAB October 26, 2018). (Reply Br. 4–6.) In re Nordt states that when considering the patentability of product claims that contain process limitations, claim scope is generally based on the product itself, not the process. 881 F.3d at 1374. However, if the process limitation connotes specific structure and may be considered a structural limitation, that structure should be considered. (Id.) In In re Nordt, the Court of Appeals for the Federal Circuit found that the process claim terms “injection molded” connoted structure that was distinguishable from the prior art. See 881 F.3d at 1375. Applying In re Nordt in Ex Parte Williams, the Board found that “ultra-freezing connotes a structural limitation,” and thus considered that structure as a limitation of the product itself. See Ex Parte Williams, slip op. 6. Unlike In re Nordt and Ex Parte Williams, Appellants do not direct us to any process limitation that connotes specific structure. (See Reply Br. 4– 6.) For example, Appellants refer to particles prepared by “ultra-freezing” or “thin-film freezing” as having a different structure than the prior art particles. (See Reply Br. 4.) Unlike the claims in Ex Parte Williams, the claims here do not recite “ultra-freezing,” or any similar limitation. (See Ex Parte Williams, slip op. 2.) Moreover, Appellants’ claims do not include any of the type of process limitations that have been previously found to connote structure, e.g., “injection molded,” “chemically engraved,” “integral,” or “superimposed.” See 881 F.3d at 1376. Because, Appellants do not direct us to any process limitation that connotes specific structure, we Appeal 2019-001013 Application 14/861,046 6 conclude that the claim scope is based on the product itself and not the process. 881 F.3d at 1374. Appellants contend that Mosharraf’s mechanically milled particles will necessarily have totally different morphology and physical properties as compared to drug particles prepared by thin-film freezing. (App. Br. 6.) Appellants cite to Dr. Williams’s declaration, arguing that thin-film freezing results in an aggregate matrix of high porosity, containing drugs and excipients that are always amorphous. (See App. Br. 8–9.) However, this description contradicts the specification, which states that “[s]urprisingly, the resulting drug particles are substantially crystalline in nature, despite the fact that the present invention involves rapid freezing.” (Spec. ¶ 42.) We are not persuaded by Appellants’ arguments, because, as noted by the Examiner, none of these argued features are recited by the claims. (See Final Act. 4.) Rather the claims recite particles defined in terms of mean volume average particle size and surface area. (Id.) Because the Examiner has identified particles with the same morphology in the prior art, we are not persuaded that the Examiner erred. Appellants contend that the claimed improvement of in vitro dissolution rate distinguishes the claimed particles from Mosharraf’s micronized drug. (App. Br. 5.) Appellants cite to Table B of the Specification for showing a “dramatic improvement” in dissolution that was not related to size reduction as the particle size of the processed drug did not decrease. (App. Br. 6.) Appellants contend the bulk drugs listed in Table B are similar to the Mosharraf’s micronized product and thus Mosharraf is distinguishable by comparison. (See App. Br. 6.) Appeal 2019-001013 Application 14/861,046 7 The Examiner finds that improved dissolution is an inherent property of the product. (Final Act. 4.) The Examiner finds that Table B does not list oxazepam, and Appellants do not compare the structure of oxazepam to the drugs listed in Table B. (Examiner’s Answer dated October 19, 2018 (“Ans.”) 3.) The Examiner thus finds that Appellants have not established that Mosharraf’s particles would not have the same claimed dissolution profile. (Ans. 4.) We are not persuaded by Appellants’ arguments. Where the claimed and prior art products are identical, the PTO can require an applicant to prove that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The fairness of the burden-shifting is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. (Id.) Here, the Examiner has established a prima facie case of anticipation. Appellants have not met their burden to “prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.” In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Because Appellants have not provided persuasive evidence that the prior art does not inherently possess the characteristics of the claimed particles, we are not persuaded that the Examiner erred. After consideration of Appellants’ evidence and arguments, we are not persuaded that the Examiner erred in finding the prior art anticipates Appellants’ pending claims 5, 6, 11–13, 15, 18, 20, and 21. Appeal 2019-001013 Application 14/861,046 8 Conclusion Upon consideration of the record and the reasons given, the rejection of claims 5, 6, 11–13, 15, 18, 20, and 21 is sustained. Therefore, we affirm the decision of the Examiner. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136. AFFIRMED Copy with citationCopy as parenthetical citation