Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
The Remarks, Amendments, and Request for Continued Examination filed on 04/09/26 are acknowledged.
Claims 1-61 were previously cancelled.
Claim 62 was amended.
Claims 62-69 are pending and included in the prosecution.
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/09/26 has been entered.
Response to Amendments & Arguments
Rejection of claims under 35 USC § 103(a)
Applicant amended claim 62 to recite that the renally impaired patient has moderate to severe renal impairment and wherein a log transformed AUC of oxymorphone is about 1 to about 2.5 times greater than a log transformed AUC of a healthy patient administered the same dose. In light of this amendment, Applicant’s arguments (Pages 5-7, filed 04/09/26) regarding the rejection of claims 62-69 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baichwal et al. (US 2003/0129234 A1), or alternatively over Sackler et al. (US 5,478,577), or Maloney (WO 01/08661 A2), each in view of Reitberg (US 2002/0032581 A1) have been fully considered and are persuasive. Since none of the cited references teach or suggest a log transformed AUC of oxymorphone is about 1 to about 2.5 times greater than a log transformed AUC of a healthy patient administered the same dose as recited in amended claim 62, the rejection of 12/16/24 is withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,808,737 B2 (“the ‘737 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
The difference is that instant claims recite that the renally impaired patient is administered a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment, whereas claims of the ‘737 Patent do not recite this limitation.
Claims of the ‘737 Patent specifically recite measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief; wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 ng·hr/mL, whereas instant claims recite that the renally impaired patient has a creatinine clearance rate of less than about 80 mL/min.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of treating pain in a renally impaired patient of the ‘737 Patent, and arrive at the instant invention. One of ordinary skill in the art would have found it obvious to do so because one of ordinary skill in the art would recognize that the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘737 Patent and they are not patentably distinct over each other.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of U.S. Patent No. 9,789,103 B2 (“the ‘103 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
Claim 1 of the ‘103 Patent recites that the log transformed AUC of oxymorphone is about 1.05 to about 2.45 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose, whereas instant claim 62 recites that the log transformed AUC of oxymorphone is about 1 to about 2.5 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose. One of ordinary skill in the art would have considered the ranges obvious since they are so close and are preceded by the term “about.”
Claim 2 of the ‘103 Patent specifically recites that the creatinine clearance rate of the patient is determined to be about 51 mL/min to about 80 mL/min, whereas instant claims recite that the renally impaired patient has a creatinine clearance rate of less than about 80 mL/min.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of treating pain in a renally impaired patient of the ‘103 Patent, and arrive at the instant invention. One of ordinary skill in the art would have found it obvious to do so because one of ordinary skill in the art would recognize that the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘103 Patent and they are not patentably distinct over each other.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,389,443 B2 (“the ‘443 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
Claim 1 of the ‘443 Patent recites that the log transformed AUC of oxymorphone is about 1.05 to about 2.45 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose, whereas instant claim 62 recites that the log transformed AUC of oxymorphone is about 1 to about 2.5 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose. One of ordinary skill in the art would have considered the ranges obvious since they are so close and are preceded by the term “about.”
Moreover, one of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘443 Patent and they are not patentably distinct over each other.
Response to Arguments
Applicant’s arguments (Page 7, filed 04/09/26) with respect to the double patenting rejections over the ‘737 Patent; the ‘103 Patent; and the ‘443 Patent have been fully considered but are not persuasive.
Applicant requests that these rejections be held in abeyance until all other rejections have been overcome, and at that time Applicant will consider a terminal disclaimer if appropriate.
Until such time that terminal disclaimer(s) are filed, the double patenting rejections will be maintained for the reasons provided above.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
