Ex Parte Zhang et alDownload PDFPatent Trial and Appeal BoardJul 8, 201612702846 (P.T.A.B. Jul. 8, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 121702,846 02/09/2010 48219 7590 07112/2016 PATENT DEPT FMC CORPORATION 2929 WALNUT STREET PHILADELPHIA, PA 19104 FIRST NAMED INVENTOR Yeli Zhang 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 60769-USA 2891 EXAMINER CHOI, FRANK I ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 07/12/2016 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): patents@fmc.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YELI ZHANG and BRIAN CARLIN1 Appeal2014-005563 Application 12/702,846 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and TIMOTHY G. MAJORS, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants state the real party-in-interest is FMC Corporation. App. Br. 2. Appeal2014-005563 Application 12/702,846 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner's Final Rejection of claims 17-21 and 23-292 which stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over Pruss et al. (US 2003/0215502 Al, November 20, 2003) ("Pruss"), Masaki Sugimoto et al., Effect of Formulated Ingredients on Rapidly Disintegrating Oral Tablets Prepared by the Crystalline Transition Method, 54(2) CHEM. PHARM. BULL. 175-80 (2006) ("Sugimoto"), Yourong Fu et al., Orally Fast Disintegrating Tablets: Developments, Technologies, Taste-Masking and Clinical Studies' 21 ( 6) CRITICAL REVIEWS™ IN THERAPEUTIC DRUG CARRIER SYSTEMS, 433-75 (2004) ("Fu"), and Jae Han Park et al., An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets, 1-9 (August 2, 2008), available at http://www.pharmtech.com/altemative- usp-disintegration-test-orally-disintegrating-tablets (last visited June 28, We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to the functionality and performance of superdisintegrants in orally disintegrating tablets (ODT). Abstract. 2 Claims 1-16 and 22 are canceled. App. Br. 12-13. 2 Appeal2014-005563 Application 12/702,846 REPRESENTATIVE CLAIM Appellants argue all of the claims on appeal together. Independent claim 17 is representative and recites: 17. A direct compression ODT, consisting essentially of about 0.5 % (wt/wt) to 2.0 % (wt/wt) sodium croscarmellose relative to the total weight of the ODT, from 0.1 % (wt/wt) to 2.0 % (wt/wt) magnesium stearate, up to about 20 % (wt/wt) of an API, optionally from 0.1 % to less than 10 % (wt/wt) microcrystalline cellulose, optionally one or more colorants, sweeteners, fragrances, flavor compounds, and/or flavor blockers, and the balance spray-dried mannitol, App. Br. 12. a) wherein the dry ODT has a tensile strength from 0.5 to 1.7 MPa, b) wherein the disintegration time using an excess water test is less than 3 0 seconds, and c) wherein the friability is less than 0.5%. ISSUES AND ANALYSES We agree with, and adopt, the Examiner's findings and conclusion that the appealed claims are prima facie obvious over the cited prior art references. We address the arguments raised by Appellants below. Issue 1 Appellants argue the Examiner erred in finding that the combination of references teaches or suggests, with a reasonable expectation of success, the specific oral disintegrating tablet ("ODT") of the claimed invention. App. Br. 6. 3 Appeal2014-005563 Application 12/702,846 Analysis Appellants argue that, although Pruss teaches the use of a diluent (such as microcrystalline cellulose ("MCC")) in an amount of 90% to 10% w/w, Pruss neither teaches nor suggests a desired concentration of MCC when used specifically with sodium croscarmellose. App. Br. 6. Moreover, Appellants argue, Pruss teaches concentrations of MCC of less than 10% are not typical. Id. Therefore, Appellants contend, even though Pruss does not teach that MCC is required, Pruss teaches that, if MCC is used, it would not be typical to use it in a concentration of less than 10%. Id. Appellants next point to another piece of prior art, Ferran (US 2006/0165781 Al, July 27, 2006) ("Ferran") which, Appellants argue, teaches its ODTs contain MCC in concentrations of 10-18% based on the total weight of the tablet. App. Br. 6 (citing Ferran, all claims, examples, i-f 35). Appellants argue that Ferran explicitly warns against using lower concentrations because "lower quantities worsen the capacity of the disintegration promoter." Id. (quoting Ferran i-f 35). Appellants contend Ferran thus teaches away from their claimed invention teaching, supporting the patentability of their claims. Id. at 7. The Examiner responds that Ferran was not cited as prior art in the rejection and none of the prior art cited by the Examiner requires the use of MCC. Ans. 2 (citing, e.g., Pruss i-f 94). The Examiner finds the fact that Ferran required microcrystalline cellulose in an amount of 10% to 18% in his invention and indicated that lesser amounts worsened the capacity of his disintegration promotor is not sufficient evidence to overcome the Examiner's prima facie conclusion of obviousness. Id. The Examiner quotes the Federal Circuit's holding in In re Gurley that: "[a] known or 4 Appeal2014-005563 Application 12/702,846 obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." Id. (quoting 27 F.3d 551, 553 (Fed. Cir. 1994)). The Examiner also finds Pruss teaches sodium croscarmellose can be used in concentrations of about 1 % (w/w). Id. at 3. The Examiner notes Appellants provide no evidence that one of ordinary skill in the art would not expect a concentration of about 1 % (w/w) of sodium croscarmellose to be suitable as a disintegrant. Id. We are not persuaded by Appellants' arguments. Microcrystalline cellulose is an optional limitation of both independent claims 17 and 21. Claim 17 expressly recites: "optionally from 0.1 % to less than 10 % (wt/wt) microcrystalline cellulose" (emphasis added) indicating that the invention may be practiced without any MCC being added to the composition. Claim 21 recites: "O % (w/w) to less than 10 % (w/w) microcrystalline cellulose," which also indicates that the invention may be practiced without any (i.e., 0%) MCC in the composition. As optional limitations, neither can act to limit the scope of the claimed invention. See In re Johnston, 435 F.3d 1381, 1384 (Fed. Cir. 2006) ("[O]ptional elements do not narrow the claim because they can always be omitted"). We acknowledge, but do not agree with, Appellants' contention that Ferran teaches that, in its disintegration promoter system, concentrations of MCC lower than 10% "worsen the capacity of the disintegration promoter system." Ferran ,-r 35. However, we do not agree that Ferran thus "teaches away" from Appellants' claims. A reference "teaches away" from a combination when using it in that combination would produce an inoperative result. McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1354 (Fed. Cir. 5 Appeal2014-005563 Application 12/702,846 2001 ). Pruss teaches the use of MCC is optional as an excipient and may be used in a very wide range of concentrations, and although Ferran teaches that concentrations of less than 10% of MCC "worsen the capacity" of the disintegration promoter system, it does not teach that it renders the promoter system inoperative, i.e., incapable of disintegration. Nor does Ferran's teaching that concentrations of less than 10% of MCC "worsen the capacity" of the disintegrator necessarily differ significantly from the concentrations recited in independent claims 17 and 21. 3 For example, Appellants have not pointed to evidence that a concentration of 9 .9% MCC, which satisfies the requirements of Appellants' claims, would significantly worsen the capacity of Appellants' claimed invention. Finally, within the context of an obviousness analysis, "all disclosures of the prior art, including unpreferred embodiments, must be considered." Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)). We consequently agree with the Examiner on this ground. Issue 2 Appellants argue the Examiner erred because the cited combined prior art references neither teach nor suggest the unexpected results obtained from Appellants' claimed invention. App. Br. 7. 3 None of the dependent claims on appeal further limit the concentration of, or even address, MCC as a constituent. 6 Appeal2014-005563 Application 12/702,846 Analysis Appellants point to Example 4 of their Specification, in which a comparison is made between ODTs containing sodium croscarmellose as the disintegrant with ODTs containing one of three commercial superdisintegrants (i.e., two different types of crospovidone (Polyplasdone XL-10 and Kollidon CL-SF) and sodium starch glycolate ("SSG") at five different compaction pressures and ranging in superdisintegrant concentration from 0.5% to 2%. Ans. 7 (citing Spec. Tables 2-5; see also Spec. Table 1 ). Appellants contend that the results indicate that ODTs containing sodium croscarmellose disintegrated "much faster" than crospovidone and SSG at low use levels and that this result is not suggested by the references. Id. (citing Spec. i-f 83). Appellants also point to Example 6 which, they contend, compares ODTs containing five different active pharmaceutical ingredients ("API") with varying superdisintegrants and superdisintegrant use levels. App. Br. 8 (citing Spec. Figs. 1-5). Appellants argue the results indicate that, for APis possessing different drug solubilities, acidity, and dose levels, 2% sodium croscarmellose was superior in certain physical qualities when compared to 6% crospovidone and was equal in rate of dissolution. Id. (citing Spec. i-f 110). Similarly, Appellants argue, Example 7 of the Specification demonstrates that ODTs made with 1%and2% croscarmellose had better disintegration times throughout a wider range of compaction pressures than those ODTs made with either crospovidone or SSG when studied over 2- week and four-month storage intervals. App. Br. 8-9 (citing Spec. Tables 7-10). 7 Appeal2014-005563 Application 12/702,846 The Examiner finds Appellants' evidence of unexpected results is not commensurate in scope with the claimed invention. The Examiner finds Examples 4, 6, and 7 include specific amounts of various APis, sodium croscarmellose, magnesium stearate and spray dried mannitol, whereas the claims require no API, 0.1 to 2.0% magnesium stearate or any amount of any lubricant, zero to less than 10% MCC, and zero or any concentration of colorants, sweeteners, fragrances, flavor compounds and/or flavor blockers, up to the balance of the composition of a spray dried mannitol or spray dried sorbitol or any spray dried polyol. Ans. 3. The Examiner also finds the various Examples taught by Ferran demonstrate that factors other than the superdisintegrant, such as shape, size, APis, and other excipients can influence the rate of disintegration, contrary to Appellants' assertions with respect to their Specification. Ans. 4. We are not persuaded by Appellants' arguments. Appellants contend that sodium croscarmellose is superior in certain respects to other superdisintegrants, i.e., crospovidone and SSG. But that evidence is not persuasive that Appellants' claimed invention is superior to the teachings of the cited prior art, which already recognizes that sodium croscarmellose, in concentrations within the ranges recited in Appellants' claims, is an excellent disintegrating agent. See Ferran i-f 22. Appellants adduce no evidence that their claimed composition is unexpectedly superior to the sodium croscarmellose-based compositions taught in the prior art by Pruss or Ferran. See In re Clemens, 622 F.2d 1029, 1036, (C.C.P.A. 1980) ("In order to establish unexpected results for a claimed invention, objective evidence of non-obviousness must be commensurate in scope with the 8 Appeal2014-005563 Application 12/702,846 claims which the evidence is offered to support"); see also Manual of Patent Examining Procedure§ 716.02(d)-§ 716.02(e) (9th Ed., Nov. 2015). Indeed, the results concerning rates of disintegration presented by Appellants in their Specification do not appear to differ significantly from those presented by the prior art. Tables 2-5 of Appellants' Specification show that formulations containing concentrations of croscarmellose (i.e., Ac-Di-Sol®; see Table 1) of 0.5%- 2.0% have disintegration times of between approximately 11 and 45 seconds. See Spec i-fi-178-81. Ferran teaches that its ODT compositions containing concentrations of croscarmellose between 1%and4% "disintegrate in less than 30 seconds, preferably in less than 20 seconds, once they come into contact with the saliva of the oral cavity." Ferran i-fi-122, 36; see also Ferran claims 1, 11. We therefore find that a person of ordinary skill in the art, having learned the teachings of Ferran, would reasonably expect disintegration times within the ranges disclosed by Appellants' Specification for the corresponding croscarmellose concentrations. In re Skoner, 517 F.2d at 950 ("Expected beneficial results are evidence of obviousness of a claimed invention.") Because Appellants fail to produce persuasive evidence demonstrating that their compositions exhibit unexpected results in comparison to similar prior art compositions, we cannot agree that the data presented by Appellants overcomes the Examiner's prima facie conclusion of obviousness. We consequently affirm the Examiner's rejection of claims 17-21 and 23-29. 9 Appeal2014-005563 Application 12/702,846 DECISION The Examiner's rejection of claims 17-21 and 23-29 as unpatentable under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation