Ex Parte Oshlack et alDownload PDFPatent Trial and Appeal BoardAug 22, 201610389238 (P.T.A.B. Aug. 22, 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. 10/389,238 03/14/2003 Benjamin Oshlack 200.1155US 9647 7590 08/22/2016 DAVIDSON, DAVIDSON & KAPPEL, LLC 14th Floor 485 Seventh Avenue New York, NY 10018 EXAMINER CARTER, KENDRA D ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 08/22/2016 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte BENJAMIN OSHLACK, HUA-PIN HUANG, PHILIP GOLIBER, and RICHARD MANNION1 __________ Appeal 2014-006770 Application 10/389,238 Technology Center 1600 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to naltrexone hydrochloride compositions, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Naltrexone is an opioid antagonist which, when co-administered with opioids, may reduce the incidence of dependence on opioids. Spec. ¶ 2. It 1 Appellants identify the real party-in-interest as Purdue Pharma L.P. Appeal Br. 2. Appeal 2014-006770 Application 10/389,238 2 has been discovered that naltrexone hydrochloride may degrade upon storage, adversely impacting drug efficacy. Spec. ¶ 8. The present invention is a pharmaceutical composition comprising naltrexone hydrochloride and a stabilizer. Spec. ¶ 1. By incorporating a stabilizer in the composition, the naltrexone retains greater than 90% of its labeled strength after a year’s storage. Spec. ¶ 48. Claims 4, 5, 15–21, 44, 45, 48–57, 59–70, 74–76, and 79–81 are on appeal. Claim 4 is illustrative and reads as follows: Claim 4: A pharmaceutical composition comprising: naltrexone hydrochloride in an amount of greater than 0.001 mg and less than 20 mg; a degradation product of the naltrexone hydrochloride formed in said composition; and a stabilizer in an effective amount to inhibit the formation of the degradation product such that at least about 95% of the naltrexone hydrochloride remains in undegraded form after storage for 1 month at 40±2° C and 75±5% relative humidity, wherein the degradation product is 10-ketonaltrexone, the pharmaceutically acceptable stabilizer is selected from the group consisting of sodium thiosulfite, sodium ascorbate, succinic acid, acid salts of amino acids, sodium metabisulphite, malic acid, isoascorbic acid, citric acid, sodium carbonate, sodium hydrogen carbonate, calcium carbonate, calcium hydrogen phosphate, sodium sulphite, sodium bisulphate, sulphites, bisulphites, hydrogen sulphites, PHB esters, 2,6-di-t-butyl-alpha-dimethylamino-p- cresol, t-butylhydroquinone, di-t-amylhydroquinone, di-t- butylhydroquinone, pyrocatechol, pyrogallol, nordihydroguaiaretic acid, lower fatty acids, phosphoric acids, sorbic and benzoic acids, lecithins, citraconic acid, conidendrine, diethyl carbonate, methylenedioxyphenols, kephalines, β,β’-dithiopropionic acid, biphenyl, pharmaceutically acceptable salts thereof, and mixtures thereof, and the pharmaceutical composition is a solid pharmaceutical composition. Appeal 2014-006770 Application 10/389,238 3 The claims stand rejected as follows: Claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 have been rejected on the grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 5, 6, 8, and 13 of Oshlack ‘0882 in view of Sackler3, in view of Cain4, Archer5, Raffelsberger6, and Eichman7. Claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 have been rejected on the grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1–6, 9–11, and 18 of Oshlack ‘9398, in view of Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. Claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 have been rejected under 35 U.S.C. § 103(a) as obvious over Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. 2 Oshlack et al., US 6,696,088 (issued Feb. 24, 2004) (“Oshlack ‘088”). 3 Sackler, US 2003/0068391 A1 (published Apr. 10, 2003) (“Sackler”). 4 Cain et al, US 6,166,211 (issued Dec. 26, 2000) (“Cain”). 5 Archer et al., 10-Ketonaltrexone and 10-Ketooxymorphone, 28 J. MED. CHEM. 974 (1985) (“Archer”). 6 Raffelsberger, EP 0880352 B1 (published Feb. 12, 1998) (“Raffelsberger”). 7 Eichman, US 5,980,882 (issued Nov. 9, 1999) (“Eichman”). 8 Oshlack et al., US 7,658,939 B2 (issued Feb. 9, 2010) (“Oshlack ‘939”). Appeal 2014-006770 Application 10/389,238 4 THE REJECTION UNDER 35 U.S.C. § 103(a) Issue The Examiner has rejected claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 as obvious over the combination of Sackler, Cain, Archer, Raffelsberger, and Eichman. The Examiner finds that Sackler teaches a tablet containing naltrexone and an antioxidant. Final Act. 14–15. The Examiner also finds that Sackler teaches that the use of accelerated storage conditions of 40° C and 75% relative humidity to determine the effectiveness of the tablet. Final Act. 15. The Examiner finds that Cain teaches that 10-keto analogs of morphinans, including 10-ketonaltrexone, are the degradation products of morphinans and may be related to the age and storage conditions of the original morphinans. Final Act. 16. The Examiner also finds that Archer teaches that 10-ketonaltrexone has diminished effects as compared to naltrexone. Id. The Examiner finds that Raffelsberger and Eichman teach the use of various antioxidants and chelating agents to stabilize various drug compositions. Id. The Examiner concludes that To one of ordinary skill in the art at the time of the invention would have found it obvious and motivated to provide the degradation product 10-keto naltrexone hydrochloride in the composition of Sackler because of the following reasons: 1) Cain et al. teach that the 10-keto morphinan compounds such as 10-keto naltrexone are the degradation products of morphinans and may therefore be related to the age and condition of the original morphinan (see column 1, lines 49-53; claim 1; column 2, formula I and line 58); 2) Sackler teaches that the formulations are cured by comparing the dissolution profile of the dosage form Appeal 2014-006770 Application 10/389,238 5 immediately after curing to the dissolution profile of the dosage form after exposure to accelerated storage conditions of at least one month at a temperature of 40 °C and a relative humidity of 75% (see paragraph 167); 3) where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case or either anticipation or obviousness has been established; thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254 (CCPA 1977); and 4) “Products of identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709 (Fed. Cir. 1990). To one of ordinary skill in the art at the time of the invention would have found it obvious and motivated to optimize the amount of naltrexone hydrochloride versus the degradation product 10-keto naltrexone because hydrochloride in the composition of Sackler because Archer et al. teach that 10-Ketonaltrexone diminished opioid effects compared to naltrexone (see abstract). Final Act. 17–18. Appellants contend that the invention addresses a previously unknown problem, oxidative degradation of solid naltrexone Appeal Br. 24. Since degradation of naltrexone was not known to be a problem, there was no reason to add a stabilizer to a solid composition naltrexone. Appeal Br. 24– 25, Reply Br. 3. Appellants contend that none of the references teach that 10-ketonaltrexone is formed in solid compositions containing naltrexone and therefore there is no motivation to combine the references. Appeal Br. 26– 29. Appellants go on to argue that the Examiner has not articulated a reason Appeal 2014-006770 Application 10/389,238 6 to combine the references. Appeal Br. 30. Appellants also argue that the references do not teach all the elements of the claims. Appeal Br. 30–32. Appellants next argue that the references do not teach that the amount of antioxidant has an effect on the amount of 10-ketonaltrexone formed in the product. Appeal Br. 32-35. With respect to the claims 5, 44, 45, 48, 49, 51, 52, 56, 61–709, and 76, Appellants argue that the Examiner has failed to point out the specific portions of the references teach the limitations in the claims. Appeal Br. 35- 36, Reply Br. 7-10. Appellants also argue that not all of the teachings of Sackler are prior art to the instant application as the utility application was filed after the date of the present application and contains disclosures not found in the Sackler provisional application10. Appeal Br. 36–37. Appellants argue that the Sackler provisional application only teaches use of an antioxidant in the push layer of the composition and not elsewhere. Id. Finally, with respect to claim 75, Appellants argue that none of the references teach that 10-ketonaltrexone may form in a solid composition containing naltrexone or that the use of a stabilizer can inhibit the formation of 10-ketonaltrexone. Appeal Br. 38. In addition, Appellants argue that none of the references teach using the antioxidants recited in claim 75. Id. The issue with respect to this rejection is whether the Examiner has established that the claims would have been obvious over the combination of Sackler, Archer, Raffelsberger, and Eichman under 35 U.S.C. § 103(a). 9 Appellants Appeal brief lists claim 71 as being argued separately. Appeal Br. 35. Claim 71 was cancelled in in amendment filed May 17, 2010. 10 US 60/310,515, filed Aug. 6, 2001. (“Sacker ‘515”) Appeal 2014-006770 Application 10/389,238 7 Findings of Fact We adopt as our own the Examiner’s findings and analysis. The following findings are included for emphasis and reference convenience. FF1. Sackler teaches a composition comprising an opioid analgesic and an opioid antagonist. Sackler ¶ 46. FF2. The antagonist of Sackler can be naltrexone. Sackler ¶ 58. FF3. The composition of Sackler can be in the form of a tablet. Sackler, ¶100. FF4. In one embodiment Sackler teaches that the antagonist can be in a “push layer” which is separate from the opioid. Sackler ¶¶ 171 and 173. FF5. Sackler teaches that the “push layer” can also contain an antioxidant “to inhibit the oxidation of ingredients.” Sackler ¶ 177. FF6. Sackler teaches the use of accelerated storage at 40° C and 75% relative humidity to determine when the product is fully cured. Sackler ¶ 167. FF7. Cain teaches that 10-keto morphinans are the degradation products of morphinans and may be related to the age and condition of the original morphinan compounds. Cain col.1, ll. 49–53. FF8. Naltrexone is a morphinan compound. Cain, col. 2, ll. 17–58. FF9. Archer teaches that 10-ketonaltrexone exhibits reduced antagonist potency. Archer 975. FF10. Raffelsberger teaches that naloxone (a morphinan) can be stabilized from oxidation using antioxidants such as ascorbic acid, tocopherol, BHA, BHT, fruit acids, sulfites, bisulphites, hydrogen sulfites, PHB esters, phosphoric acids, sorbic acid, benzoic acid, EDTA, Appeal 2014-006770 Application 10/389,238 8 conidenrines, diethyl carbonates, and methylene dioxyphenols. Raffelsberger ¶¶ 15 and 18. FF11. Eichman discloses the use of chelating agents to stabilize drug agents. Eichman col. 2, ll. 40–61. FF12. Eichman use of a stabilizer in a dry drug composition. Eichman col. 3, l. 67 to col. 4, l. 3. Principles of Law “The factual predicates underlying an obviousness determination include the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the art.” In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998). A claim can be obvious even where all of the claimed features are not found in specific prior art references, where ‘there is a showing of a suggestion or motivation to modify the teachings of [the prior art] to the claimed invention.’ SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000) (concluding that patent would have been obvious in light of teachings in prior art which provided motivation and suggestion to modify existing techniques to arrive at method in question).” Ormco Corp. v. Align Technology Inc., 463 F.3d 1299, 1307 (Fed. Cir. 2006). To show criticality of a claimed range, “‘it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454 (CCPA 1955). Only if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical Appeal 2014-006770 Application 10/389,238 9 range. In re Antonie, 559 F.2d 618, 620 (CCPA 1977).” In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997). “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). “[T]he PTO carries its procedural burden of establishing a prima facie case when its rejection satisfying 35 U.S.C. § 132, ‘notifying the applicant . . .[by] stating the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging the propriety of continuing the prosecution of [the] application.’ 35 U.S.C. § 132. That Section ‘is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.’” In re Jung, 637 F.3d. 1356, 1362 (Fed. Cir. 2011) (citing Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990). Appeal 2014-006770 Application 10/389,238 10 Analysis Claim 4 Claim 4 relates to solid pharmaceutical compositions comprising naltrexone hydrochloride, a stabilizer and 10-ketonaltroxone. Sackler teaches the preparation of tablets comprising an opioid, an opioid antagonist such as naltrexone and an antioxidant. FF1–3. The efficacy of the composition in Sackler is determined by storing the composition at 40° C and 75% humidity for one month. FF6. Cain teaches that 10-ketonaltrexone is the degradation product of naltrexone and may be related to the age and condition of naltrexone. FF7–8. Archer teaches that 10-ketonaltrexone is less potent than naltrexone. FF9. Raffelsberger and Eichman teach various antioxidants and chelating agents that inhibit oxidation in pharmaceutical products. FF10 and 11. We agree with the Examiner’s conclusion that claim 4 would have been obvious over Sackler in view of Cain, Archer, Rafflesberger and Eichman because the ordinary artisan, concerned over naltrexone degradation to a less effective form as taught by Cain and Archer would have reasonably incorporated the stabilizing agents of Raffelsberger and Eichman in the tablet of Sackler to mitigate this degradation concern. See Final Act. 8. Appellants contend that the problem of oxidative degradation of naltrexone in solid compositions was unknown and that there would be no motivation to add an antioxidant to compositions containing naltrexone. Appeal Br. 24–25. We are unpersuaded. Although none of the individual references specifically teach that naltrexone degrades to 10-ketonaltrexone in solid tablets, Sackler teaches combining naltrexone with an antioxidant to Appeal 2014-006770 Application 10/389,238 11 inhibit oxidation of ingredients in solid compositions, thereby recognizing concerns regarding degradation of active ingredients in the treatment composition. FF5. Cain teaches that the degradation product of naltrexone is 10-ketonaltrexone and Archer teaches that 10-ketonaltrexone is less potent that naltrexone. FF7 and 8. Raffelsberger teaches adding an antioxidant to another morphinan, naltrexone, to prevent degradation including naltrexone in solid mixtures. FF9 and 10. We agree with the Examiner that one skilled in the art “would be look for ways to stabilize the formulation of Sackler from such degradation with what is known in the art to inhibit degradation of drugs, particularly via oxidation, such as antioxidants and stabilizing agents as taught by Sackler, Raffelsberger, and Eichman.” Ans. 22. Appellants argue that Cain does not teach that 10-ketonaltrexone would be present in a solid composition because Cain only addresses forming 10-ketonaltrexone in solution. Appeal Br. 31, Reply Br. 3. We remain unpersuaded. Cain is cited for the general proposition that 10- ketonaltrexone is the degradation product of naltrexone and may be the result of age or product condition. FF7. Sackler teaches the preparation of solid compositions comprising naltrexone and an antioxidant. FF1–3. The antioxidant is added to “inhibit the oxidation of the ingredients” which includes naltrexone. FF4 and 5. From the combined teachings of the references one skilled in the art would understand that oxidation can occur in solid compositions and would add an antioxidant to prevent oxidation and the resultant degradation from occurring. Appellants next argue that the references do not teach what would have been an effective amount of stabilizer to use in the composition. Appeal 2014-006770 Application 10/389,238 12 Appeal Br. 33. Again, we are unpersuaded. As the Examiner points out, from the teachings of Cain, Archer, and Sackler, one skilled in the art would have found it obvious to vary and/or optimize the amount of antagonist, stabilizer and degradation product to develop a product with the desired properties. “[W]here the general conditions are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation.” In re Aller, 20 F.2d 454, 456 (CCPA 1955). Appellants do not identify any secondary consideration regarding this value. Claims 5, 44, 45, 48, 49, 51, 52, 56, 61–70, and 76. Appellants have argued that claims 5, 44, 45, 48, 49, 51, 52, 56, 61– 70, and 76 are separately patentable. Appeal Br. 35–37. Appellants argue that the Examiner failed to recite which part of the different references teach or suggest a pharmaceutically acceptable bead coated with a mixture of naltrexone hydrochloride and a stabilizer as recited in instant claims 5, 68 and 76; a plurality of substrates coated with a mixture of naltrexone hydrochloride and a stabilizer as recited in claims 44, 45, 51, 52, and 70; a solid pharmaceutical composition comprising an inert core and a layer comprising a mixture of naltrexone hydrochloride, a degradation product of naltrexone hydrochloride formed in said composition and a stabilizer as recited in claims 48 and 49; a solid pharmaceutical composition comprising an inert bead and a layer comprising a mixture of naltrexone hydrochloride and a stabilizer as recited in claims 56 and 57; a solid pharmaceutical composition comprising a mixture of naltrexone hydrochloride and a stabilizer coated over a plurality of pharmaceutically acceptable beads as recited in claims 61-62; and a solid pharmaceutical composition comprising a mixture of naltrexone hydrochloride and a stabilizer coated over a plurality of pharmaceutically acceptable inert beads as recited in claim 65. Appeal 2014-006770 Application 10/389,238 13 Appeal Br. 36. We are not persuaded. In the Final Action, the Examiner discussed the various teachings of Sackler and references that claims that are addressed by this limitations. Final Act. 4-5. For example, at page 5 of the Final Action it states “[t]he formulation may be formulated as a tablet (i.e. solid; addresses claims 4, 5, 45, 48-55, 76 and 78) or capsules that can be coated (see paragraph 156), coated on a bead (i.e. solid; see paragraphs 107 and 109), or osmatic dosage forms (see paragraph 171).” Final Act. 4. We find that the Examiner has provided sufficient information to allow appellants to recognize and address the rejection as presented by the Examiner. In re Jung, 637 F.3d at 1362. Appellants also argue that only the portions of Sackler that appear in the Sackler provisional application (Sackler ’515) can be properly considered as prior art as Sackler was filed after the filing date of the instant application. Appeal Br. 36–37. Appellants argue that the Sackler ’515 only teaches use of a stabilizer in one embodiment on the invention, an osmotic dosage form. Appeal Br. 37. Appellants go on to argue that that in the osmotic dosage example, the antioxidant is only in the “push” layer and does not teach the inclusion of an antioxidant with the drug component. Id. We are unpersuaded. As the Examiner points out, although Sackler ’515 only teaches inclusion of an antioxidant in the “push layer”, Sackler ’515 also teaches inclusion of the antagonist in the push layer. Sackler ’515 at 41. The provisional application also include the same teaching that the antioxidant inhibits the oxidation of the ingredients of the push layer. Sackler ’515 at 42. We agree with the Examiner that Sackler ’515 renders Appeal 2014-006770 Application 10/389,238 14 obvious the combination of naltrexone and an antioxidant in combination with the other prior art references. Ans. 24–25. Claim 75 Appellants have argued that claim 75 is separately patentable. Appeal Br. 38. Appellants contend that the references do not explain 10- ketonaltrexone may form from naltrexone in a solid form or that a stabilizer might limit the formation of 10-ketonaltrexone in solid form. Id. Appellants also argue that the references do not suggest selection a stabilizer from the group cite in claim 75. We are unpersuaded. We agree with the Examiner’s conclusion that One of ordinary skill in the art at the time of the invention would have found it obvious and motivated to provide the stabilizing agents of claims 75 because of the following teachings: 1) naltrexone is known to degrade by oxidation to 10-keto naltrexone, which is less active as taught by Cain (see column 1, lines 49-53; claim 1; column 2, formula I and line 58) and Archer et al (see abstract).; 2) antioxidants are known to be added to stabilize the composition from oxidation as taught by Sackler (see paragraph 177) and Eichman (see column 2, lines 40-61); 3) effective antioxidants included in claim 75 are taught by Raffelsberger (fruit acids, EDTA, conidenrines, diethyl carbonates, and methylene dioxyphenols for example; see page 13, claims 1-4; page 2, paragraph 1; and page 3, paragraph 4) between the amounts of 0.001 to 5% by weight (see page 14, claims 6-8); and 4) Sackler teaches that the formulation can include and antioxidant. Therefore, one would be motivated to include the stabilizers in claim 75 in order to reduce decomposition of the naltrexone by oxidation. Ans. 25. Appeal 2014-006770 Application 10/389,238 15 Conclusion of Law We conclude that the Examiner has established by a preponderance of the evidence that claims 4, 5, 44, 45, 48, 49, 51, 52, 56, 61–70, 75, and 76 would have been obvious over Sackler, in view of Cain, Archer, Raffelsberger, and Eichman under 35 U.S.C. § 103(a). Claims 15-21, 50, 53–55, 57, 59, 60, 74, and 79–81 have not been argued separately and therefore fall with claim 4. 37 C.F.R. § 41.37(c)(1)(iv). THE OBVIOUSNESS-TYPE DOUBLE PATENTING REJECTIONS The Examiner has rejected claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79-81 have been rejected on the grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 5, 6, 8, and 13 of Oshlack ‘088 in view of Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. The Examiner also rejected claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79-81 grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1–6, 9–11, and 18 of Oshlack ‘939, in view of Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. With respect to both rejections on the grounds of obviousness-type double patenting, Appellants argue that the Oshlack ‘088 and ‘939 patents do not teach the presence of 10-ketonaltrexone. Appeal Br. 39 and 40. Appellants go on to argue that For the reasons discussed above, the Sackler reference, the Cain reference, the Archer reference, the Raffelsberger reference, and the Eichman reference are not properly combinable and, even if, arguendo, the references were properly combinable, the Appeal 2014-006770 Application 10/389,238 16 combination of the Sackler reference, the Cain reference, the Archer reference, the Raffelsberger reference, and the Eichman reference does not teach or suggest a solid pharmaceutical composition comprising naltrexone hydrochloride and 10- ketonaltrexone as recited in the instant claims for the reasons articulated above. Appeal Br. 39 and 40. Appellants conclude by arguing that the combination of references cannot cure the deficiencies of Oshlack ‘088 or “939 patents. Appeal Br. 39 and 40. While we agree with Appellants that the Oshlack patents may not refer to 10-ketonaltrexone, for the reasons stated above we find that the cited references are properly combinable and collectively teach a solid pharmaceutical product comprising naltrexone and 10-ketonaltrexone as recited in the rejected claims. We, therefore, affirm the rejections based on obviousness-type double patenting. SUMMARY We affirm the rejection of claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 on the grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 5, 6, 8, and 13 of Oshlack ‘088 in view of Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. We affirm the rejection of claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 on the grounds of non-statutory obviousness-type double patenting as being unpatentable over claims 1–6, 9–11, and 18 of Oshlack ‘939, in view of Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. Appeal 2014-006770 Application 10/389,238 17 We affirm the rejection of claims 4, 5, 15–21, 44, 45, 48–57, 61–70, 74–76, and 79–81 under 35 U.S.C. § 103(a) as obvious over Sackler, in view of Cain, Archer, Raffelsberger, and Eichman. 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 Copy with citationCopy as parenthetical citation