Ex Parte Henke et alDownload PDFPatent Trial and Appeal BoardDec 23, 201613604266 (P.T.A.B. Dec. 23, 2016) 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. 13/604,266 09/05/2012 Stefan HENKE 01-1405-US-3 6970 28515 7590 12/28/2016 MICHAEL P. MORRIS BOEHRINGERINGELHEIM USA CORPORATION 900 RIDGEBURY RD P. O. BOX 3686 RIDGEFIELD, CT 06877-0368 EXAMINER PURDY, KYLE A ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 12/28/2016 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): US PTO.e-Office. rdg@ boehringer-ingelheim .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEFAN HENKE, MARTIN ANDREAS FOLGER, JENS SCHMALZ, DIANA KEILHOFER, HANS-JUERGEN KROFF, and NINA HERZ1 Appeal 2015-007110 Application 13/604,266 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and TAWEN CHANG, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL appellants state the real party-in-interest is Boehringer Ingelheim Vetmedica GmbH. App. Br. 3. Appeal 2015-007110 Application 13/604,266 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1—20. Specifically, claims 1—8 and 13—20 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Chen et al. (US 6,106,862, August 22, 2000) (“Chen”), Fuisz et al. (US 5,654,003, August 5, 1997) (“Fuisz”), Uhrich et al. (US 2002/0106345 Al, August 8, 2002) (“Uhrich”), and Bock et al. (US 6,869,948 Bl, March 22, 2005) (“Bock”). Claims 9—12 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Chen, Fuisz, Uhrich, Bock, and Robinson et al. (US 6,071,539, June 6, 2000) (“Robinson”) We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CFAIMED INVENTION Appellants’ invention is directed to water-soluble meloxicam granules. Abstract. REPRESENTATIVE CLAIM Independent claim 1 is representative of the claims on appeal and recites: 1. Water soluble meloxicam granules comprising: (a) meloxicam; (b) a salt forming agent which forms the meglumine, sodium, potassium, or ammonium salt of meloxicam; (c) a binder; 2 Appeal 2015-007110 Application 13/604,266 (d) a sugar or sweetener; and (e) a carrier, and optionally a flavoring agent and optionally other excipients; wherein the granules have a particle size distribution of 125 pm to 500 pm. App. Br. 16. 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 below the arguments raised by Appellants. A. Independent claims 1 and 20 Issue Appellants argue that the Examiner erred because no combination of the cited prior art references teaches or suggests the features of each of claims 1 and 20. App. Br. 10. Analysis Appellants argue Chen teaches an analgesic tablet comprising a nonsteroidal anti-inflammatory drug (NS AID) such as salicyclic acid, indomethacin, ibuprofen, naproxen, naproxen sodium, flubiprofen, indoprofen, ketoprofen, piroxicam, diclofenac, etodolac, and ketorolac, but neither teaches nor suggests the anti-inflammatory meloxicam or meloxicam granules. App. Br. 10. Furthermore, Appellants contend, Chen teaches that the granules are micronized and preferably should have a particle size of less 3 Appeal 2015-007110 Application 13/604,266 than 20 microns. Id. (citing Chen col. 3,11. 23—24). Furthermore, Appellants assert Chen teaches the granules are formed only as an intermediate product and are subsequently compressed into a tablet which is then coated with an external seal. Id. (citing Chen col. 4,11. 31—35). Appellants contend Fuisz teaches making a solid tablet which can be compressed directly after flash-flow processing. App. Br. 11 (citing Fuisz col. 3,11. 10—13, 48—50). According to Appellants, Fuisz teaches that “the majority of particles resulting from the flash flow process pass through the first screen, which has a mesh size of 2000 microns and are retained on screens which have a mesh size of 420 microns and 250 microns and that “[tjhese particles are ideal for feeding into tableting dies.” Id. at 11—12 (quoting Fuisz col. 13,11. 23—27, emphasis omitted). Appellants argue there is no teaching or suggestion by Fuisz of ensuring that the particles have a particle size distribution of 125—500 microns as recited in claims 1 and 20. Id. Appellants next discuss Uhrich. The Examiner relies upon Uhrich as teaching the substitution of etodolac, one of the preferred analgesics taught by Chen, with meloxicam, since “both are known to have analgesic activity through similar biological pathways.” App. Br. 13 (quoting Final Act. 6). Appellants argue that if, in fact, etodolac could be readily substituted with meloxicam, as suggested by the Final Office Action, and provide the same desired analgesic effect, the question becomes why would Chen not have listed meloxicam in the first place? Id. Finally, Appellants argue that, while Bock teaches oral meloxicam compositions in which a meglumine salt of meloxicam may be used, Bock fails to cure the alleged deficiencies of Chen, Fuisz and Uhrich. App. Br. 4 Appeal 2015-007110 Application 13/604,266 13. Appellants contend that, absent improper hindsight and reliance upon the claimed invention, there is no reasonable motivational or predictable rationale for obtaining the combination of features of claims 1 and 20 based upon the teachings of the Examiner’s cited references. Id. at 14. The Examiner responds that term “micronized,” as taught by Chen, does not teach away from the range recited by Appellants’ claims. Indeed, the Examiner finds the claimed range of 125—500 microns is also “micronized” as their size dimensions are in microns. Ans. 7. The Examiner also finds Chen’s teaching of a particle of less than 20 microns is simply a preference and, although preferred, should not be construed as a requirement. Id. The Examiner finds further that Fuisz teaches that particles “having a size greater than 150 microns (e.g., those retained on 150, 180, 250 and 420 micron mesh), are preferable as they are ideal for feeding into tabletting [sic] dies, exhibit optimum flowability and are easily moved by machine.” Ans. 8 (citing Fuisz col. 13,11. 22—27, Table 8). The Examiner finds Fuisz teaches that this preferred range, i.e., 250-2540 microns, overlaps with Appellants’ recited range of 125—500 microns. Id. The Examiner therefore concludes it would have been obvious to a person of ordinary skill to: “(1) adjust and optimize the size of Chen’s analgesic particle so as to achieve a particle size distribution ideal for feeding into tabletting [sic] dies, exhibit optimum flowability and being easily moved by machine; and (2) apply the technique of isolating particles which are retained on the 250 microns mesh after passing through the 420 micron mesh to use in a tabletting [sic] process. Id. The Examiner finds that applying such a technique would include particles between 250 and 420 5 Appeal 2015-007110 Application 13/604,266 microns in size (i.e., those retained on the 250 micron mesh) which would possess the favorable properties taught by Fuisz. Id. at 8—9. The Examiner also finds, although as Appellants argue Fuisz does not teach granules explicitly in the final product, a tablet is comprised of compressed granules, and therefore that final composition still comprises granules. Id. at 9. The Examiner next finds that Chen teaches that its anti-inflammatory analgesics may be preferably selected from etodolac, naproxen, ibuprofen, piroxicam, amongst others. Ans. 10. The Examiner finds Uhrich also teaches anti-inflammatory analgesics, including etodolac, piroxicam and meloxicam, which overlap with the teachings of Chen. Id. The Examiner concludes it would be obvious to a person of ordinary skill in the art to substitute anti-inflammatory analgesic actives (e.g., etodolac or piroxicam) for other known anti-inflammatory analgesics (e.g., meloxicam), all of which are well-known in the art and which would have led to predictable results (i.e., an analgesic composition). Id. We are not persuaded by Appellants’ arguments. We agree with Appellants that Chen teaches that particles of 20 microns or less are preferable in the compositions taught therein, but Fuisz articulates a rational motivation to select, by meshing, larger granules, including those between 240 and 420 microns in diameter, which have improved properties in the formulation of compressed pills. See Chen col. 3,11. 22—23; see also Fuisz, col. 2,11. 27—30 (stating that “very tiny particles on the order of 150 micron . . . can interfere with operation of apparatus feeding tabletting [sic] machines as well as the operation of the tabletting [sic] machines”); see also id. at col. 13,11. 22—27. 6 Appeal 2015-007110 Application 13/604,266 Furthermore, we are not persuaded by Appellants’ arguments that Chen must either teach or suggest a granule as the final product, instead of an intermediate product. Such a requirement is not a limitation of Appellants’ claims. Moreover, we agree with the Examiner that it would have been obvious to substitute the anti-inflammatory analgesic meloxicam, taught by Uhrich, for the non-steroidal anti-inflammatory analgesics taught by Chen. Chen teaches a range of preferred analgesics (i.e., salicylic acid, indomethacin, ibuprofen, naproxen, naproxen sodium, flubiprofen, indoprofen, ketoprofen, piroxicam, diclofenac, etodolac, ketorolac or their pharmaceutically acceptable derivatives). See Chen col. 1,11.8—12. Uhrich also teaches a number of non-steroidal anti-inflammatory analgesics, with similar mechanisms (i.e., COX inhibitors) that overlaps with those taught by Chen (i.e., etodolac, celebrex, meloxicam, piroxicam, nimesulide, nabumetone, and rofecoxib). Uhrich 138 (emphasis added). Appellants ask why, if the substitution of meloxicam for the analgesics taught by Chen is obvious, then why did not Chen include meloxicam in its teachings? Such is not the test of obviousness; rather, “the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). In the appeal before us, we agree with the Examiner that it would have been obvious to a person of ordinary skill to substitute one well-known non steroidal anti-inflammatory analgesic for another, also well known the art. See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”). Furthermore, 7 Appeal 2015-007110 Application 13/604,266 “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Appellants make no argument that the substitution of meloxicam for the other non-steroidal anti-inflammatory analgesics taught by Chen would not yield predictable results. We consequently affirm the Examiner’s rejection of independent claims 1 and 20. Moreover, because Appellants rely upon the same arguments for the remaining claims on appeal (see Appeal Br. 14—15), we affirm the Examiner’s rejection of those claims for the same reason. DECISION The Examiner’s rejection of claims 1—20 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)(1). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 8 Copy with citationCopy as parenthetical citation