DETAILED ACTION
Notice of Pre-AIA or 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.
Claim Status
Claims 1-33 are cancelled.
Claims 34-46 are newly added and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Nonstatutory Double Patenting Rejections
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 34-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,973,787.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference patent always recite a composition comprising ibuprofen or a salt thereof, in a concentration within the instantly claimed range, and further comprising a hypertonic saline solution within the instantly claimed range. Therefore, the copending claims read upon the instantly recited composition.
Regarding claims 38 and 42-46 regarding a salt form of ibuprofen, the ‘787 patent recites the sodium form in claims 3 and 11.
2) Claims 34-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 U.S. Patent No. 11,925,612.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference patent always recite a composition comprising ibuprofen or a salt thereof, in a concentration within the instantly claimed range, and further comprising a hypertonic saline solution within the instantly claimed range. Therefore, the copending claims read upon the instantly recited composition.
Regarding claims 38 and 42-46 regarding a salt form of ibuprofen, the ‘612 patent recites the sodium form in claims 7-8 and 14.
Technical Background Material
The following prior art is made of record and not relied upon is considered pertinent to applicant's disclosure. Munoz (“High Concentrations of Sodium Chloride Improve Microbicidal Activity of Ibuprofen against Common Cystic Fibrosis Pathogens,” Pharmaceuticals 2018, 11, 47), an inventor of the instant invention, provides further insight regarding the instantly claimed invention, as well as penetration studies of the claimed composition.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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