Ex Parte Berner et al

Patent Trials and Appeals BoardAug 28, 2013

11322448 - (D) (P.T.A.B. Aug. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte BRET BERNER, SUI YUEN EDDIE HOU and GLORIA M. GUSLER __________ Appeal 2012-003377 Application 11/322,448 Technology Center 1600 __________ Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134(a) involving claims to methods of treating pain by administering gabapentin. The Patent Examiner rejected the claims as obvious and on the ground of non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is Depomed, Inc. (App. Br. 2.) Appeal 2012-003377 Application 11/322,448 2 STATEMENT OF THE CASE Claims 69-81 are on appeal. Claim 69 is representative and reads as follows: 69. A method for treating pain, comprising: administering to a subject a daily dose of between about 1800 to about 2400 mg of gabapentin, wherein the daily dose is administered from a gastric retentive dosage form as an evening dose to the subject in a fed mode; wherein the pain is post-herpetic neuralgia; and wherein bioavailability of gabapentin from the gastric retentive dosage form, as measured by area under the curve, is between about 70-130% of the bioavailability of a comparable gabapentin dose in an immediate release dosage form. (Emphasis added.) The Examiner rejected the claims 69-81 under 35 U.S.C. § 103(a) as unpatentable over Berner2 and Wheeler.3 The Examiner also rejected claims 69-81 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 17-19, 22-35, 39-64 and 66-67 of US Patent 7,438, 927 in view of Wheeler. OBVIOUSNESS The Examiner found that Berner taught a method for treating neuropathic pain, comprising administering to a subject a daily dose of about 900-2400 mg of gabapentin, wherein the daily dose is administered from a 2 Patent Application Publication No. WO 03/035040 A1 by Bret Berner et al., published May 1, 2003. 3 Glen Wheeler, Gabapentin Pfizer, 3 CURRENT OPINION IN INVESTIGATIONAL DRUGS 470-477 (2002). Appeal 2012-003377 Application 11/322,448 3 gastric retentive dosage form as an evening dose to the subject in a fed mode. (Ans. 5.) The Examiner found that Berner taught that the bioavailability of gabapentin is greater or equal to 80% relative to an equal dose of an immediate release dosage form. (Id.) Additionally, the Examiner found that Berner taught that the benefit of a gastric retained dosage form of gabapentin is that it reduces the incidence and/or severity of CNS side effects of the drug. (Id. at 6.) However, the Examiner found that Berner did not explicitly teach that its treatment of neuropathic pain included post- herpetic neuralgia. (Id.) The Examiner found that Wheeler taught the administration of gabapentin for the treatment of neuropathic pain, specifically including post- herpetic neuralgia. (Id. at 7.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have applied Berner’s method of treating neuropathic pain to specifically treat post-herpetic neuralgia, because Wheeler taught that post- herpetic neuralgia is a syndrome of neuropathic pain which is effectively treated with gabapentin. (Id. at 8.) The Examiner found that the person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to treat post-herpetic neuralgia pain with gabapentin from a gastric retentive dosage form because Berner taught that such a dosage form of gabapentin reduced CNS side effects of the drug. (Id.) Appellants contend that “the Examiner has failed to clearly articulate a rationale supporting the obviousness rejection.” (App. Br. 9.) According to Appellants “the finding that dosing of about 1800 mg to 2400 mg gabapentin once per day using a gastric retained dosage form in the evening produced an efficiency that would not have been predicted at the time of Appeal 2012-003377 Application 11/322,448 4 filing.” (Id. at 10.) In support of this contention, Appellants refer to the declaration of Dr. Verne Cowles.4 (Id.) Based upon known pharmacokinetics for gabapentin, Dr. Cowles explains that he did not expect gabapentin administered as a once-daily evening dose of the gastric retentive dosage form to provide effective relief for post-herpetic neuralgia. (Decl. ¶ 11; App. Br. 11.) However, Dr. Cowles’ human studies comparing pain management using various dosing schedules and dosage forms revealed that the once daily dosing regimen of the gabapentin gastric retentive dosage form “provided (i) effective pain relief for the full 24 hour period and (ii) more effective pain relief than the twice daily dosing regimen.” (Id. at ¶ 14.) According to Dr. Cowles, “[t]his was surprising in view of the blood concentration profiles ….” (Id.) Appellants assert that Dr. Cowles’ declaration provided evidence that an ordinarily skilled artisan would have had no reasonable expectation of success in treating post-herpetic neuralgia by the claimed methods. After considering all the evidence and arguments, we conclude that the record supports a conclusion of prima facie obviousness. We do not agree with Appellants that a skilled artisan at the time of the invention would not have been motivated to treat post-herpetic neuralgia by using Berner’s method of administering a daily dose of a gastric retentive dosage form as an evening dose of about 900-2400 mg. As the Examiner found, and Appellants do not dispute, Berner taught that its method provided an effective treatment for neuropathic pain, and Wheeler taught that post- herpetic neuralgia is a syndrome of neuropathic pain that is also effectively 4 Declaration of Verne Cowles, submitted June 15, 2010. Appeal 2012-003377 Application 11/322,448 5 treated with gabapentin. (Ans. 5-8.) Thus, we agree with the Examiner that a person of ordinary skill in the art at the time the invention was made would have been motivated, with a reasonable expectation of success, to treat post- herpetic neuralgia with a daily evening dose of gastric retentive gabapentin based upon the teachings of Berner and Wheeler. This result is unchanged by Appellants’ declaratory evidence. While we recognize Dr. Cowles’ apparent expertise in the field of biology and gastrointestinal physiology (see Cowles Decl. ¶¶ 1-3) we do not find that his statements and conclusions carry persuasive weight when considered in light of the prior art cited by the Examiner. Although Dr. Cowles did not expect gabapentin administered as a once-daily evening dose of the gastric retentive dosage form to provide effective relief for post-herpetic neuralgia based upon the pharmacokinetics of gabapentin (see Decl. ¶ 11; App. Br. 11) we agree with the Examiner that such effectiveness would have been expected by a skilled artisan at the time of the invention from the cited prior art, which Dr. Cowles did not discuss. As we have discussed, Berner explicitly taught that administering the gastric retentive dosage form of gabapentin once daily in the evening provided effective pain relief for neuropathic pain, which pain Wheeler taught is associated with post-herpetic neuralgia. Thus, while the claimed method may have been unexpectedly successful based upon the pharmacokinetic profile of gabapentin, such method was reasonably expected to be successful based upon the teachings of the combined prior art. Accordingly, we affirm the obviousness rejection. Appeal 2012-003377 Application 11/322,448 6 OBVIOUSNESS-TYPE DOUBLE PATENTING Appellants do not contest the obviousness-type double patenting rejection. (See App. Br. 8-12.) Therefore, we summarily affirm the rejection. See MANUAL OF PATENT EXAMINING PROCEDURE § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant's brief, that ground of rejection will be summarily sustained by the Board.”). SUMMARY We affirm the obviousness rejection of claims 69-81. We summarily affirm the obviousness-type double patenting rejection of claims 69-81. 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 cdc