Ex Parte Carty et alDownload PDFBoard of Patent Appeals and InterferencesJul 20, 201211775002 (B.P.A.I. Jul. 20, 2012) 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. 11/775,002 07/09/2007 Sarah Carty 029318-1492 4268 31049 7590 07/20/2012 Elan Drug Delivery, Inc. c/o Foley & Lardner 3000 K Street, N.W. Suite 500 Washington, DC 20007-5109 EXAMINER KASSA, TIGABU ART UNIT PAPER NUMBER 1619 MAIL DATE DELIVERY MODE 07/20/2012 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 SARAH CARTY, SCOTT JENKINS, and GARY LIVERSIDGE __________ Appeal 2011-007536 Application 11/775,002 Technology Center 1600 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a nanoparticulate composition, which the Examiner has rejected on the grounds of obviousness and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm the rejections based on obviousness. Appeal 2011-007536 Application 11/775,002 2 STATEMENT OF THE CASE Sorafenib tosylate is a known compound (Spec. 2, ¶ 6) that “acts as a multi-kinase inhibitor, targeting several serine/threonine and receptor tyrosine kinases, and has been shown to both inhibit tumor cell proliferation and tumor angiogenesis” (id. at 2, ¶ 7). Claims 1-21 are on appeal. Claim 1 is representative and reads as follows: 1. A stable nanoparticulate sorafenib composition comprising: (a) particles of sorafenib or a salt thereof having an average effective particle size of less than about 2000 nm; and (b) at least one surface stabilizer. The claims stand rejected as follows: • Claims 1-21 under 35 U.S.C. § 103(a) based on Bosch1 and Biggs2 (Answer 4); • Claims 1-21 under 35 U.S.C. § 103(a) based on Ryde3 and Biggs (Answer 9); • Claims 1-3 and 9-12 for obviousness-type double patenting based on claims 1-13 and 16 of Ryde, in view of Biggs (Answer 27); • Claims 1-3 and 9-12 for obviousness-type double patenting based on claims 1-13 of the ‘986 patent4 in view of Biggs (Answer 28-29); and 1 Bosch et al., Patent Application Publication US 2003/0181411 A1, Sept. 25, 2003. 2 Biggs et al., WO 2005/009367 A2, Feb. 3, 2005. 3 Ryde et al., US 6,592,903 B2, July 15, 2003. 4 Ryde et al., US 6,375,986 B1, Apr. 23, 2002. Appeal 2011-007536 Application 11/775,002 3 • Claims 1-21, provisionally, for obviousness-type double patenting based on claims 1-24 of the ‘427 application5 in view of Biggs (Answer 30).6 I. Issue The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) based on either Bosch or Ryde, combined with Biggs (Answer 4, 9). The Examiner finds that Bosch and Ryde both disclose nanoparticulate compositions that contain a mitogen-activated protein (MAP) kinase inhibitor as the active agent (id. at 5, 10) and that Biggs discloses that sorafenib (also known as BAY 43-9006) is a MAP kinase inhibitor (id. at 7, 12). The Examiner concludes that it would have been obvious to include sorafenib as the MAP kinase inhibitor in the nanoparticulate compositions of Bosch or Ryde (id. at 8, 12-13). Appellants contend that each of the cited references provides only a generic disclosure that would not provide a reason to make the specific, claimed composition (Appeal Br. 7-10). Appellants also contend that the 5 Jenkins et al., US Patent Application 11/802,427, filed May 22, 2007. 6 In the Answer, the Examiner states that “[f]or exactly the same reasons” as the provisional rejection based on the ‘427 application, forty-two other “copending applications merit provisional obviousness-type double patenting rejections in view of Biggs” (Answer 33). No actual rejections have been made based on any of those other applications, however. To the extent that the Examiner intended the statement on page 33 of the Answer to constitute forty-two additional grounds of rejection, the rejections are vacated because the Examiner has not provided an adequate basis on which to conclude that any such rejections would be proper. Appeal 2011-007536 Application 11/775,002 4 references fail to enable the claimed compositions, especially given the structural diversity among MAP kinase inhibitors (id. at 10-14). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that both of the cited combinations of references would have provided a reason to combine their teachings with a reasonable expectation of success? Findings of Fact 1. Bosch discloses “nanoparticulate formulations of Mitogen- Activated Protein (MAP) kinase inhibitors” (Bosch 1, ¶ 1). 2. Bosch discloses that its “nanoparticulate compositions compris[e] at least one poorly soluble MAP kinase inhibitor and at least one surface stabilizer associated with the surface of the MAP kinase inhibitor” (id. at 4, ¶ 30). 3. Bosch discloses that the “pivotal role of the MAP kinase pathway and enhanced expression of its essential components in tumor cells, suggests that the inhibition of the pathway represents an important route to both radio- and chemo-sensitization of tumor cells and a likely target for pharmacological intervention in proliferative diseases” (id. at 3, ¶ 13). 4. Bosch discloses that any of a variety of MAP kinase inhibitors can be included in its nanoparticulate formulations (id. at 7, ¶¶ 80-81). 5. Bosch discloses that its nanoparticulate formulations have a number of advantages, including faster onset of action and increased bioavailability (id. at 4, ¶ 37). Appeal 2011-007536 Application 11/775,002 5 6. Bosch discloses that the “nanoparticulate MAP kinase inhibitor compositions of the invention have an effective average particle size of less than about 2 microns” (id. at 10, ¶ 114). 7. Ryde discloses “solid dose nanoparticulate compositions having a synergistic combination of at least one polymeric surface stabilizer and dioctyl sodium sulfosuccinate (DOSS)” (Ryde, col. 1, ll. 11-13). 8. Ryde discloses that its nanoparticulate composition can comprise a drug “selected from a variety of known classes of drugs” (id. at col. 7, ll. 6- 7; see also col. 7, ll. 7-28 (listing drug classes)). 9. Ryde discloses that its compositions “exhibit dramatically superior redispersion of the nanoparticulate composition upon administration to a mammal” (id. at col. 5, ll. 21-25). 10. Ryde discloses that the “combination of DOSS and a polymeric surface stabilizer was tested on a wide variety of drugs, including Mitogen- Activated protein (MAP) kinase inhibitor, an analgesic, and an angiogenesis inhibitor. Thus, the phenomenon of high redispersibility is not limited to a specific drug or drug class.” (Id. at col. 6, ll. 16-21.) 11. Ryde exemplifies a composition comprising a MAP kinase inhibitor (id. at col. 14, l. 25 to col. 15, l. 35). 12. Ryde discloses that its nanoparticulate composition comprises particles with an average particle size of less than 2000 nm (id. at col. 6, ll. 29-56). 13. Sorafenib tosylate is also known as BAY 43-9006 (Spec. 1, ¶ 4). 14. Biggs discloses that “BAY 43-9006 . . . is an inhibitor of Raf kinases which function in the Ras signaling pathway in many cancers. BAY Appeal 2011-007536 Application 11/775,002 6 43-9006 has been observed to be effective against liver cancer (hepato- cellular carcinoma) and kidney cancer.” (Biggs 1, ¶ 6.) 15. Biggs discloses “the discovery of additional cellular targets for particular protein kinase inhibitors,” including BAY 43-9006 (id. at 2, ¶ 11). 16. Biggs discloses that “[s]ome of the additional cellular targets of BAY 43-9006 are p38 mitogen-activated protein (MAP) kinase (p38/MAPK14) [and] Gleevec resistant and sensitive Abl kinases” (id. at 3, ¶ 14). 17. Biggs discloses that “BAY 43-9006 may be used for the inhibition or prevention of diseases mediated by p38/MAPK14 [or] Gleevec resistant and sensitive Abl kinases” (id.). 18. Biggs discloses that the “target protein binding compounds of the invention are preferably used to prepare a medicament, such as by formulation into pharmaceutical compositions for administration to a subject using techniques generally known in the art” (id. at 14, ¶ 63). 19. Biggs discloses that the compounds can be formulated as solid or liquid compositions, including nanoparticles (id. at 15, ¶ 66). Analysis Both Bosch and Ryde disclose nanoparticulate compositions having the size and surface stabilizer recited in the claims on appeal (FFs 2, 6, 7, 12), in combination with a MAP kinase inhibitor (FFs 1, 4, 10), although not specifically sorafenib. Biggs discloses that sorafenib (BAY 43-9006) is a MAP kinase inhibitor, that it can be used for inhibition or prevention of diseases, and that it can be formulated as nanoparticles. We agree with the Examiner that it would have been obvious to substitute sorafenib for the Appeal 2011-007536 Application 11/775,002 7 other MAP kinase inhibitors specifically disclosed by Bosch and Ryde in their nanoparticulate compositions, in order to produce a sorafenib composition having the beneficial properties disclosed by Bosch and Ryde (FFs 5, 9). Appellants argue that “each of Biggs, Ryde and Bosch provide only generic disclosures that fail to provide the reason or motivation to make Appellants’ specific, claimed composition - e.g., a stable nanoparticulate sorafenib composition” (Appeal Br. 9). This argument is unpersuasive. Bosch and Ryde disclose that their nanoparticulate composition provides beneficial properties to a wide variety of drugs (FF 8), and specifically MAP kinase inhibitors (FFs 1, 4, 10). Thus, the disclosure in Biggs that sorafenib (BAY 43-9006) is a MAP kinase inhibitor would have provided a reason to make a nanoparticulate composition like that of Bosch or Ryde, containing sorafenib. Appellants also argue that Biggs “only mentions nanoparticles” and the “mere recitation of nanoparticles in the same specification does not provide any reason of suggestion to select nanoparticulate sorafenib from Biggs, with any reasonable expectation of success” (Appeal Br. 10). As discussed above, however, both Bosch and Ryde provide ample reason to formulate sorafenib as a nanoparticulate composition. Finally, Appellants argue that the references fail to enable the claimed composition. Appellants argue that “Ryde, at Example 4, for example, shows that not all formulations are equally efficacious,” which is evidence of unpredictability in the art (Appeal Br. 11). Appellants argue that “[t]his unpredictability is magnified when applying the teachings of Bosch or Ryde Appeal 2011-007536 Application 11/775,002 8 to other MAP kinase inhibitors, such as sorafenib” (id.) because MAP kinase inhibitors have “great variation in chemical structure and physical properties” (id.; see also id. at 11-13 (showing exemplary structures)). This argument is also unpersuasive. “[A] presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). The applicant bears the burden of “proving that the relevant disclosures of the prior art patent are not enabled.” Id. Bosch discloses that its nanoparticulate composition can be formulated with any of a variety of MAP kinase inhibitors. See Bosch 7, ¶ 80 (“[a] useful MAP kinase inhibitor according to the invention can inhibit any MAP kinase factor”). Ryde discloses that its nanoparticulate composition can be formulated with any of a variety of drugs (see Ryde, col. 7, ll. 6-28). Those disclosures are entitled to a presumption of enablement. Appellants have pointed to no disclosure in either Bosch or Ryde that would lead a skilled worker to doubt that sorafenib would work in the prior art nanoparticulate compositions. Although Appellants argue that “it is well known that the manufacture of stable nanoparticulate formulations of active agents is not routine or predictable” (Appeal Br. 14), they have provided no persuasive evidence or technical reasoning to show that a skilled worker would not have reasonably expected to be successful in combining Biggs’ sorafenib with the nanoparticulate composition of Bosch or Ryde. “For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Appeal 2011-007536 Application 11/775,002 9 Conclusion of Law The evidence of record supports the Examiner’s conclusion that both of the cited combinations of references would have provided a reason to combine their teachings with a reasonable expectation of success. We therefore affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on either Bosch or Ryde, combined with Biggs. Claims 2-21 fall with claim 1 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii). II. The Examiner has rejected claims 1-3 and 9-12 for obviousness-type double patenting based on the claims of either Ryde or the ‘986 patent, combined with Biggs (Answer 27-29). The Examiner has also provisionally rejected all of the claims on appeal for obviousness-type double patenting based on the claims of the ‘427 application, combined with Biggs (Answer 30). Appellants argue that the nonprovisional rejections are improper because the claims of Ryde and the ‘986 patent are generic and do not “provide the necessary specificity or direction to use sorafenib when combined with Biggs” (Appeal Br. 18). Appellants argue that the provisional rejection is improper because the claims of the ‘427 application “recite the antifungal active agent posacanazole, which is unrelated functionally and structurally to sorafenib” (id.). We agree with Appellants that the Examiner has not established that the claims on appeal would result in an unjustified timewise extension of the right to exclude granted in the Ryde or ‘986 patents, or potentially granted in the ‘427 application. See In re Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998) Appeal 2011-007536 Application 11/775,002 10 (“Obviousness-type double patenting is a judge-made doctrine that prevents an extension of the patent right beyond the statutory time limit. . . . Its purpose is to prevent an unjustified extension of the term of the right to exclude granted by a patent by allowing a second patent claiming an obvious variant of the same invention to issue to the same owner later.”). The Ryde patent claims are directed to a nanoparticulate dispersion comprising “a poorly soluble active agent” (Ryde, col. 18, ll. 4-5). The ‘986 patent claims are directed to a solid dose nanoparticulate composition comprising “an active agent which has a solubility in a liquid dispersion medium of less than about 10 mg/mL” (‘986 patent, col. 18, ll. 3-4). The Examiner has not pointed to evidence or provided any persuasive reasoning to show that those skilled in the art would have recognized sorafenib as a poorly soluble active agent, as required by Ryde’s claims, or that it would have been recognized as having the specific solubility required by the claims of the ‘986 patent. Thus, the Examiner has not shown that sorafenib would have been an obvious species within the genera claimed in Ryde and the ‘986 patent, based on the claims of those patents combined with Biggs. The claims of the ‘427 application are directed to “a stable nanoparticulate posaconazole composition” (Answer 30). As Appellants have pointed out, the claims in the ‘427 application require a different active agent than the claims on appeal. The Examiner has not persuasively explained why the grant of claims to a composition comprising posaconazole would result in an unjustified timewise extension of claims to a composition comprising sorafenib, or vice versa. Appeal 2011-007536 Application 11/775,002 11 SUMMARY We reverse the rejections on appeal based on obviousness-type double patenting. We affirm the rejections of claims 1-21 under 35 U.S.C. § 103(a) based on either Bosch or Ryde, combined with Biggs. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp Copy with citationCopy as parenthetical citation