Ex Parte Andersen et al

Patent Trial and Appeal BoardMar 22, 2018

13928190 (P.T.A.B. Mar. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/928,190 06/26/2013 Christine Andersen 22428 7590 03/26/2018 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 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. 108221-0123 6116 EXAMINER FALKOWITZ, ANNA R ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 03/26/2018 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTINE ANDERSEN, KARSTEN LINDHARDT, JAN MARTIN OEVERGAARD, LOUISE INOKA LYHNE-IVERSEN, MARTIN REX OLSEN, ANNE-METTE HAAHR, and PERNILLE KRISTINE HOEYRUP HEMMINGSEN Appeal2016-002887 Application 13/928, 190 Technology Center 1600 Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. Â§ 134(a) involving claims to a tablet for oral delivery of an analgesic. The Examiner rejected the claims as obvious and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellants identify Egalet Ltd. as the real party in interest. App. Br. 3. Appeal2016-002887 Application 13/928,190 STATEMENT OF THE CASE Appellants' invention relates to formulations for the controlled release of active drug substances (e.g., analgesics for pain to be administered once daily). Spec. i-fi-12, 4, 10. According to the Specification, "controlled release formulations allowing less frequent administration, but still having clinical efficacy over the entire time interval between administrations, are desirable." Id. i-f 3. Claims 59--95 are on appeal. Claim 59, the only independent claim, is illustrative: 59. A tablet for oral delivery of an analgesic selected from at least one of oxycodone and hydrocodone, the tablet comprising: a) a matrix composition having a cylindrical shape with two ends, wherein each of the two ends is optionally tapered, and the length of the matrix is shorter than 8 mm, wherein the matrix composition comprises (i) an analgesic selected from at least one of oxycodone and hydrocodone and (ii) at least one polyglycol, wherein the matrix composition exhibits a release rate of the analgesic from the matrix in ethanol that is equal to or lower than the release rate of the analgesic from the matrix in water; and b) a coating substantially surrounding the matrix composition and having one or two openings exposing at least one surface of the matrix composition, the coating being substantially impermeable to an aqueous medium, wherein the tablet provides controlled release of the analgesic over an interval of 5 to 20 hours, wherein the tablet is resistant to isolation of the analgesic by any of crushing of the tablet, melting of the tablet, and ethanol extraction, and wherein the tablet exhibits a mean protraction index of at least 0.45 in a 24 hour dosing interval. App. Br. 15 (Claims App.). 2 Appeal2016-002887 Application 13/928,190 Issue The claims stand rejected as follows: I. Claims 59, 62---65, 69, 70-72, 74--89, and 91-95 under 35 U.S.C. Â§ 103(a) over Fischer2 and Haahr. 3 II. Claims 60, 61, 66-68, and 73 under 35 U.S.C. Â§ 103(a) over Fischer, Haahr, and Fischer '429. 4 III. Claims 90 and 92 under 35 U.S.C. Â§ 103(a) over Fischer, Haahr, and Katikaneni. 5 IV. Claims 59-95 for provisional obviousness-type double patenting over claims 59---67 and 69-96 of US Application No. 13/928, 135. 6 REJECTION I Has the Examiner established by a preponderance of the evidence that claims 59, 62---65, 69, 70-72, 74--89, and 91-95 would have been obvious over Fischer and Haahr? 2 Fischer et al., US 2007/0003617 Al, publ. Jan. 4, 2007 ("Fischer"). 3 Haahr et al., Drug abuse resistant controlled release using EgaletÂ® dosage units, Proceedings of the 34th Annual Meeting Exposition of the Controlled Release Society (July 7-11, 2007) ("Haahr"). We attach to this Decision a more legible version of this reference. 4 Fischer et al., WO 03/024429 Al, publ. Mar. 27, 2003 ("Fischer '429"). 5 Katikaneni et al., Ethylcellulose matrix controlled release tablets of a water-soluble drug, 123 INT'L J. OF PHARMACEUTICS 119-25 (1995) ("Katikaneni"). 6 This application issued as US Patent No. 9,023,394 on May 5, 2015. The double-patenting rejection is, thus, no longer "provisional." 3 Appeal2016-002887 Application 13/928,190 Findings of Fact The Examiner's findings of fact and statement of the rejection are provided at pages 2-12 of the Examiner's Answer (Nov. 12, 2015). See also Final Act. (Nov. 7, 2014) 2-12; Ans. 22-28. The following findings are provided for emphasis and convenient reference. FF 1. Fischer teaches pharmaceutical compositions for the controlled release of an opioid. Fischer, Abstract. The compositions comprise a matrix of a polymer or mixture of polymers, an opioid, and, optionally one or more pharmaceutically acceptable excipients. Id. The compositions also include a coating providing an opening to the matrix material that provides for controlled release of the opioid to obtain a delayed peak concentration and prolonged, therapeutically-effective plasma concentration, making once or twice daily administrations possible. Id.; see also id. i-fi-153-54 (describing, inter alia, "a coating having at least one opening exposing at the one surface of said matrix," and disclosing that the coating comprises "a first cellulose derivative which has thermoplastic properties and which is substantially insoluble in the aqueous medium.") and i1262 (example of a coating composition). FF 2. Fischer teaches "[t]he compositions employed are coated in such a manner that at least one surface is exposed to the aqueous medium and this surface has a substantially constant or controlled surface area during erosion." Id. i1 51. Fischer teaches the pharmaceutical composition "may have a simple uniform cylindrical shape or the cylindrical form can have one or more tapered ends in order to decrease (or increase) the initial release period." Id. Fischer describes embodiments with a cylinder length of 6 mm, 4 Appeal2016-002887 Application 13/928,190 7.5 mm, and 9 mm. Id. i-f 73 (also disclosing diameter and volume dimensions); see also id. Fig. 1 B (cylinder shaped composition) and i-f 226. FF 3. Fischer teaches polymers for use in the matrix comprise "a polyglycol, e.g. in the form of a homopolymer and/or a copolymer." Id. i-f 108. More specifically, Fischer teaches suitable polymers for use in the matrix composition include polyethylene oxides, particularly those having molecular weights of from about 20,000 to about 700,000 daltons. Id.; see also id. i-f 265 (describing an example matrix composition comprising polyethylene oxide 200,000 and morphine as active agent) and i-fi-1270-275. FF 4. Fischer teaches the active drug substance is an opioid, and preferably includes morphine, oxycodone, or hydrocodone. Id. i-fi-126-28; see also id., claim 13. See, e.g., id. i-fi-1301-306 (describing testing with Morphine Sulphate EgaletÂ® 30mg tablets versus a reference product). FF 5. Fischer teaches controlled release formulations, for controlled administration of the active drug over an interval of between 6 to 24 hours. Id. i-fi-1221-222, Abstract; see also id. i-f 12 ("The optimised effect is only obtained when the right balance is obtained between the maximum concentration, the duration of the time where the plasma concentration is above the minimum therapeutic level and the administered dosage") and i-fi-1 13-16 (describing optimizing formulations for prolonged plasma concentration and pain relief while balancing against concentrations that are too high, which risk inducing drug resistance and addiction). FF 6. Haahr relates to abuse-resistant controlled-release EgaletÂ® dosage units. Haahr, passim. Haahr teaches "[i]n its basic shape EgaletÂ® dosage units comprise a matrix partly covered by a bio-degradable shell 5 Appeal2016-002887 Application 13/928,190 exposing a constant surface area to dissolution." Id., Introduction. Haahr teaches "EgaletÂ® dosage units containing Morphine sulphate were prepared by two component injection molding ... [and] both shell and matrix are formulated using thermoplastic polymers which are melted and shaped into EgaletÂ® dosage units followed by cooling." Id., Materials and Methods. FF 7. Haahr teaches "[t]he inability ofEgaletÂ® units to dose dump is based on the composition having solubility in water that is higher than that in Ethanol." Id., Discussion. Haahr teaches "[i]n this way EgaletÂ® units possess inherent properties that facilitate a lower solubility in ethanol." Id. ("Accordingly, EgaletÂ® release technology is designed to encompass a large range of drug substances with diverse chemical properties."). FF 8. Haahr teaches "it was impossible to extract the drug substance powder either by crushing or by melting EgaletÂ® units" and "[ e ]xtraction with different solvents did not lead to a solution useful for injection." Id., Conclusion. Principles of Law Where ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. Â§ 102, on "prima facie obviousness" under 35 U.S.C. Â§ 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted)). 6 Appeal2016-002887 Application 13/928,190 More recently, the Federal Circuit has further "recognized that inherency may supply a missing claim limitation in an obviousness analysis." PAR Pharma., Inc. v. TWI Pharmas., Inc., 773 F.3d 1186, 1194-- 95 (Fed. Cir. 2014 ). The "concept of inherency" is, however, limited in respects when applied in an obviousness analysis, "and is present only when the limitation at issue is the 'natural result' of the combination of prior art elements." Id. at 1195; see also id. at 1195-96 (explaining that a limitation "necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art"). Analysis Claim 59 The Examiner finds that Fischer teaches controlled-release tablets having the features recited in claim 59, including, inter alia, a matrix comprising a polyglycol, an opioid such as oxycodone or hydrocodone, and a substantially water-insoluble coating with an opening that partially exposes the matrix material. Ans. 3. The Examiner further finds that Fischer teaches the tablet that is cylindrical in shape and has a length of 6-9 mm, thus overlapping the claimed range of less than 8 mm. Id. Also, according to the Examiner, Fischer teaches prolonged treatment of pain via controlled administration of the active agent over an interval of 6 to 24 hours, thus overlapping with the claimed interval of 5 to 20 hours. Id. The Examiner also finds that the time of administration (i.e., 5 to 20 hours as claimed) of the active drug is a result effective parameter that the skilled artisan would routinely optimize absent evidence to the contrary. Id. at 3--4 ("optimization of time for drug release would have been obvious ... 7 Appeal2016-002887 Application 13/928,190 in view of the teachings of[] Fischer."). With regard to the property of a "mean protraction index" recited in claim 59, the Examiner notes that "Fischer does not specify [a] protraction index," but the Examiner reasons that "since Fischer teach[ es] the structure claimed, this product would have had the instantly claimed function." Id. at 4 (citing in re Best). The Examiner also finds that Fischer is silent regarding two other properties recited in claim 59 - a release rate of the drug in ethanol that is less than or equal to the release rate in water, and the formulation's resistance to isolation of the drug by crushing, melting, or ethanol extraction. Id. at 5. The Examiner, thus, turns to Haahr as teaching EgaletÂ® dosage units similar to the dosage units in Fischer, and the Examiner cites Haahr's express teaching that the EgaletÂ® dosage units have the release rate and resistance to crushing, etc. properties like the tablet of claim 59. Id. The Examiner concludes it would have been obvious to combine the teachings of Fischer and Haahr to arrive at a tablet with the structural features and properties recited in claim 59. Id. at 10. According to the Examiner, it would have been obvious to design a composition that is resistant to drug extraction (by crushing, ethanol extraction, etc.) in view of Haahr and Fischer. Id. The Examiner reasons the skilled person would have been motivated to make this design to mitigate narcotic (e.g., oxycodone) abuse. Id. The Examiner further reasons it would have been obvious to design prolonged release oxycodone or hydrocodone tablets in view of Fischer's teachings, as prolonged release formulations would have been expected to provide longer-lasting pain treatment while avoiding a high drug 8 Appeal2016-002887 Application 13/928,190 burst, and therefore decreasing the chances of the patient becoming addicted to the narcotic/opioid. Id. at 11 (citing Fischer i-fi-f 12-13). Appellants argue the Examiner's rejection is "based on legal error" for "improperly invoking the doctrine of inherency in the context of obviousness." App. Br. 7. According to Appellants, the "Examiner assumes that the recited protraction index property is inherent in the compositions of G. Fischer," yet the Examiner is "rely[ing] on the alleged inherent properties of a composition that did not exist in the prior art." Id. at 9. Appellants contend, "because the cited references do not discuss protraction index, or describe hydrocodone or oxycodone compositions that inherently exhibit the recited protraction index property, the doctrine of inherency does not support the instant rejections." Id. at 10. Appellants further contend the combination of Fischer and Haahr fails to disclose all the limitations in claim 59, and fails to provide a reasonable expectation of success in arriving at a composition with the mean protraction index and abuse-resistance properties. Id. at 7. Here again, Appellants note that the references do not discuss a protraction index. Id. at 8. As to the abuse-resistance properties, Appellants contend "Haahr reports the testing of a morphine composition, not an oxycodone or hydrocodone tablet as recited in the instant claims." Id. at 10. Further, Appellants contend, "the use of the term 'EgaletÂ® dosage units' in the cited references does not necessarily designate the same tablet or matrix composition." Id. The evidence of record on appeal favors the Examiner. Fischer teaches extended-release opioid formulations with the structural features recited in claim 59. FF 1-5; Ans. 23 ("Fischer discloses all the structural 9 Appeal2016-002887 Application 13/928,190 elements and chemical elements in the base claim."). Fischer also expressly teaches several of claim 59's tablet properties, such having a controlled release of between 6 to 24 hours (overlapping the claimed 5-20 hour range) and a coating that is substantially impermeable in the aqueous environment. FF 1-2, 5. Appellants provide no persuasive evidence to the contrary. Although Fischer's working examples use morphine (or salts thereof) as the opioid, the prior art's teachings are not limited to working examples or preferred embodiments when obviousness is the issue. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that preferred and unpreferred embodiments must be considered). And here, Fischer identifies the analgesics of claim 59 - hydrocodone or oxycodone - as other "preferred" opioids. FF 4. Fischer (like Appellants' Specification) acknowledges that the skilled person knows of and is able to routinely modify the dosages depending on the active substance and condition being treated. See Fischer i-f 188; Spec. i-f l 09. Accordingly, we are persuaded the skilled person would modify Fischer's examples, to the extent necessary, to use effective amounts of oxycodone or hydrocodone and provide long-lasting, controlled-release formulations with the claimed opioids consistent with Fischer's other teachings. FF 1-5. Regarding the other properties recited in claim 59 (e.g., "mean protraction index"), we agree with the Examiner on this record that those properties would be inherent and "naturally flow [from] both the chemical and structural makeup of the tablet." Ans. 25. As explained above, the structural elements of claim 59 and those taught in Fischer are the same or substantially so. Under these circumstances, in recognition of the fact that 10 Appeal2016-002887 Application 13/928,190 the Patent Office lacks testing facilities to prove whether a particular property inheres to a known or obvious structure, it is appropriate for the Examiner to require Appellants to provide evidence that the claimed properties are not present in the prior art formulations. In re Best, 562 F.2d at 1255; Ans. 24. Moreover, if the "abuse-resistance properties" of claim 59 are not inherent based on Fischer's teachings alone, 7 those properties are expressly disclosed in connection with the similar dosage units of Haahr. FF 6-8. Absent evidence to the contrary, these properties would, thus, be the "natural result" of combining Fischer and Haahr. PAR Pharma, 773 F .3d at 1195. And the Examiner has provided a persuasive, evidence-backed rationale explaining why the skilled artisan would have designed a tablet with these properties - to avoid removal of the drug and its misuse. Ans. 10-11. Accordingly, the Examiner has met the burden to show that claim 59 would have been prima facie obvious over Fischer and Haahr. Appellants' arguments are unpersuasive. Inasmuch as the Appellants argue inherency cannot support a rejection underÂ§ 103, the Federal Circuit 7 In terms of the tablet being resistant to isolation of the drug by crushing, melting, or ethanol extraction, we note that the components of the matrix and coating in examples from Fischer and Appellants' Specification are substantially the same. See, e.g., Spec. i-fi-1386-387 (describing injection- molded formulations) (Table 14 (formulation A)); see Fischer i-fi-1258-264, 270-271 (describing illustrative injection-molded matrix and coating compositions). Other formulations in Appellants' Specification use the same coating components and further add to the matrix, , for example, a co- carrier/plasticizer like Poloxamer 188. Spec. i1389 (Table 16). Although Poloxamer 188 (or other plasticizers) are not used in Fischer's working examples, they are expressly disclosed as suitable additives for Fischer's matrix. Fischer i-f 113. 11 Appeal2016-002887 Application 13/928,190 has rejected that position. PAR Pharma., 773 F.3d at 1194--95. Appellants contend the Examiner erred by "rely[ing] on the alleged inherent properties of a composition that did not exist in the prior art." App. Br. 9. But the prior art composition need not have actually been made to invoke inherency. If that was the rule, and if inherency was appropriate only for a composition that "existed" in the prior art, then the doctrine would be limited to anticipation under Â§ 102. It is not. And here, the only apparent structural difference between the compositions that Fischer did make and claim 59 is that Fischer used a different opioid - morphine rather than another "preferred" opioid like oxycodone or hydrocodone. FF 4. Yet the skilled artisan, following Fischer's teachings, would have predictably prepared such an oxycodone or hydrocodone composition. The Examiner, relying on Best, invited Appellants to cite evidence showing that the claimed properties are not present in a composition designed according to Fischer's (and Haahr's) teachings. Final Act. 5; Adv. Act. (Mar. 25, 2015) 2; Ans. 4, 21. Appellants responded, however, with legal argument and no such evidence. 8 8 At oral hearing, Appellants pointed to Table 14 (a morphine sulfate pentahydrate composition) in the Specification, which Appellants suggested was comparable to Fischer's exemplified morphine compositions, and Table 21 of the Specification as allegedly demonstrating that the formulation from Table 14 exhibited a mean protraction index of 0.37 (below the claimed range). Mar. 6, 2018 Hr'g Tr. 4: 16-5: 11. When asked whether Appellants cited these tables or raised these contentions with the Examiner, however, Appellants were unable to identify clearly any portion of the record where they did so. Id. at 11: 12-12:4. Generally arguments and evidence not raised before the Examiner are waived on appeal to the Board. 37 C.F.R. Â§ 41.37(c)(l)(iv) (2015); Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative). In any event, even if a morphine composition had a 12 Appeal2016-002887 Application 13/928,190 Appellants' contention that the rejection is flawed because neither Fischer nor Haahr describes the "mean protraction index" property is also unpersuasive. App. Br. 7-8. The issue here is whether a composition made according to Fischer and Haahr, which undisputedly teaches the structural elements recited in the claim, would provide that property. The Examiner has made a prima facie showing that it would, and Appellants have provided no persuasive evidence or argument demonstrating otherwise. Neither are we persuaded that the Examiner erred by citing Haahr, which Appellants emphasize "reports the testing of a morphine composition, not an oxycodone or hydrocodone tablet." Id. at 10. The skilled artisan would not read Haahr so narrowly, particularly when Haahr describes abuse of narcotic drugs more generally and specifically states that the "EgaletÂ® release technology is designed to encompass a large range of drug substances with diverse chemical properties." FF 7; see also Haahr, Introduction. Moreover, even if the EgaletÂ® dosage units in Haahr are not the same as the dosage units in Fischer, as Appellants suggest (App. Br. 10), that does not demonstrate error by the Examiner. The rejection is based on the combination of Fischer and mean protraction index below the claimed range, the appropriate composition for testing the presence or absence of the property would be one including oxycodone or hydrocodone, both of which are taught as preferred opioids in Fischer. FF 4. Appellants have not provided such evidence. Further to this point, although we do not rely on the following for purposes of this appeal, we observe that the Specification describes hydrocodone formulations that include matrix and shell components that are substantially the same as those disclosed in Fischer. Spec. i-fi-1388-389 (Table 16); see, e.g., Fischer i-fi-f 108, 113, 262, 270-275. And these hydrocodone formulations (at lengths of 6 mm, 7 .5 mm, and 9 mm) all exhibited a mean protraction index within the claimed range. Spec. i1 334 (Table 5). 13 Appeal2016-002887 Application 13/928,190 Haahr's teachings, and Appellants have provided insufficient argument or evidence to show that such combination would not result in a tablet with all the claimed features. For the above reasons, the preponderance of the evidence on this record supports the Examiner's conclusion that claim 59 would have been obvious over Fischer and Haahr. Claims 62-65, 71, 72, 74--89, and 91-95 have not been argued separately and fall with claim 59. 37 C.F.R. Â§ 41.37(c)(l)(iv). Claims 69 and 70 Appellants contend claims 69 and 70, which each depend from claim 59, are separately patentable. App. Br. 11-12. Claim 69 recites that the tablet "results in a mean residence time (MRT) [of] 8 to 15 hours," and claim 7 0 recites that the tablet "results in a T max of 3 to 6 hours after last administration to a steady state individual." App. Br. 16 (Claims App.). Appellants do not dispute that the teachings cited by the Examiner in Fischer disclose MRT and Tmax values that overlap with the claimed range. Ans. 6, 27; App. Br. 11-12. Instead, Appellants contend those disclosures "relate[] to specific morphine compositions having a specific shape and size." App. Br. 11-12. We agree with and adopt the Examiner's findings, reasoning, and conclusion that claims 69 and 70 would have been obvious, and we find Appellants' contentions unpersuasive. Here too, Appellants have provided no evidence that modifying Fischer's formulations to include oxycodone or hydrocodone rather than morphine would have resulted in a tablet with an MR T or T max outside the claimed range. In addition, we agree with the 14 Appeal2016-002887 Application 13/928,190 Examiner that MRT and Tmax are well-known pharmacokinetic properties and result-effective parameters that it would have been obvious to optimize. Ans. 27-28. Indeed, Fischer, which discloses formulations designed and optimizable for controlled release of opioids over 6-24 hours, supports the Examiner on this point. FF 1, 5; see, e.g., Fischer i-f 222 (describing the design of formulations to reach maximal concentration within 1 to 10 hours, and even more preferred within hour 2.5 to 5). 9 REJECTION II The Examiner has rejected claims 60, 61, 66-68, and 73 over Fischer, Haahr, and Fischer '429. As an initial matter, Appellants contend these claims are patentable for the same reasons advanced with respect to claim 59 and that the Examiner has failed to show how the combination of references "would have rendered obvious the claimed tablet as a whole." App. Br. 12. These contentions are unpersuasive for the reasons explained above and we otherwise adopt the Examiner's fact finding, reasoning and conclusion of obviousness with respect to these claims. Ans. 12-17, 27-28. Appellants contend claims 67 and 68, which both depend from claim 59, are separately patentable. App. Br. 12-13. Claim 67 recites "the tablet provides a steady state trough of the analgesic that is in the range of 5 to 40% of steady state Cmax" and claim 68 recites that the tablet provides "a 2nd point where plasma concentration of the analgesic of 50% of steady state Cmax occurs in the range of 4 to 6 hours." App. Br. 16 (Claims App.). Like 9 The Specification defines "T max" as the "average time lapsing between administration of a pharmaceutical composition and arrival at Cmax [i.e., the maximum plasma concentration]." Spec. i-f 3 8. 15 Appeal2016-002887 Application 13/928,190 argued above concerning claims 69 and 70, Appellants contend the Examiner erred in citing data in the art that "relates to specific morphine compositions having specific shapes and sizes." Id. at 12-13. Appellants' contentions related to the patentability of claims 67 and 68 are unpersuasive for the reasons given by the Examiner and as explained above related to claims 69 and 70. See Ans. 27-28. REJECTION III Appellants refer to their arguments related to the rejection of claim 59, and further state that the Examiner has failed to show how combining the references "would have rendered obvious the claimed tablets as a whole." App. Br. 13-14. We agree with and adopt the Examiner's fact finding, reasoning and conclusion of obviousness with respect to the rejection of claims 90 and 92 (Ans. 17-19, 27-29), and are unpersuaded by Appellants' contentions for reasons already explained above. REJECTION IV Appellants provided no argument in the Appeal Brief responsive to the obviousness-type double patenting rejection. In the Reply Brief, Appellants contend a terminal disclaimer has been filed that allegedly obviates the double patenting rejection. Reply Br. 2. The sufficiency of a terminal disclaimer to overcome the double patenting rejection is a petitionable matter. Because Appellants did not argue the merits of the double patenting rejection, it is summarily affirmed. 16 Appeal2016-002887 Application 13/928,190 SUMMARY We affirm the rejections for obviousness and obviousness-type double patenting on appeal. 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. Â§ 1.136(a). AFFIRMED 17 Application/Control No. Applicant(s)/Patent Under Reexamination 13/928, 190 Christine Andersen et al. Notice of References Cited Examiner Art Unit 1600 Anna Falkowitz U.S. PATENT DOCUMENTS * DOCUMENT NO. DATE NAME CLASS SUBCLASS D A D B D c D D D E D F D G D H D I D J D K D L D M FOREIGN PATENT DOCUMENTS * DOCUMENT NO. DATE COUNTRY NAME CLASS SUBCLASS D N D 0 D p D Q D R D s D T NON-PATENT DOCUMENTS * DOCUMENT (Including Author, Title Date, Source, and Pertinent Pages) HAAHR ET AL., Drug Abuse Resistant Controlled Release using EgaletÂ® Dosage Units. D u Proceedings of the 34th Annual Meeting Exposition of the Controlled Release Society July 7-11 2007. D v D w D x .. *A copy of this reference 1s not being furnished with this Office action. 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