DETAILED ACTION
AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of Group I (claims 1-11 and 18-22) and the species of the non-steroidal anti-inflammatory drug (ketoprofen) and the co-agent (ketotifen) in the reply filed on 26 May 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 3-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of NSAID, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bosse (US Patent Application Publication 2010/0143469).
Bosse discloses pharmaceutical compositions which comprise an opioid analgesic, a non-opioid analgesic, and an agent which reduces or eliminates an adverse effect of said analgesic (claim 1). The non-opioid analgesic can be naproxen (paragraph [33]). And the agent which reduces or eliminates an adverse effect of said analgesic can be ketotifen (paragraph [77]). Bosse further states that the use of the pharmaceutical compositions can be used in a way to inhibit tolerance of the opioid (paragraph [46]).
Bosse thus discloses compositions and methods comprising the individual elements of the instantly recited combination (ibuprofen and ketotifen) and together these would provide a method as instantly claimed. However, Bosse is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Instant claim 18 and 22 further limit the non-steroidal anti-inflammatory drug and the co-agent, and are read upon by the above cited combination.
Instant claims 19-21 further limit the amounts of the non-steroidal anti-inflammatory drug and the co-agent. Bosse does not expressly state amounts for these agents. Bosse does state that the amount can be adjusted according to the particular analgesics used (paragraph [90]). Generally, differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A). Given the general conditions are taught for the composition by Bosse, and the amounts are suggested to be a feature which can be adjusted, the amounts instantly recited are considered prima facie obvious.
Nonstatutory 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,675,261.
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite a method of inhibiting dependence to an opioid by a human subject in need thereof comprising administering an effective amount of an ibuprofen NSAID and a ketotifen co-agent. They differ in that the issued claims recite limitations to the opioid as well.
Claims 1-2 and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,129,803.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are narrower and read upon the instantly recited claims. In particular, the issued claims are limited by “consisting of” language, whereas the instant claims are broader in scope as they recite “comprising” language.
Claims 1-2 and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,911,355.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are narrower and read upon the instantly recited claims. In particular, the issued claims are limited by “consisting of” language, whereas the instant claims are broader in scope as they recite “comprising” language.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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