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 (i.e., changing from AIA to pre-AIA ) 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.
Current Status of 18/942,389
This Office Action is in response to the amended claims of 11/09/2024.
Claims 1-20 are new and examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 11/09/2024 and 12/13/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 09/15/2022.
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 1-20 rejected on the ground of obviousness-type nonstatutory double patenting as being obvious unpatentable over claims 1-2 and 7-20 of U.S. Patent No. 12,144,802. Instant claims of 05/31/2024 were used for writing this rejection.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1 and 11-20 disclose composition of roflumilast, water, and a pharmaceutically acceptable solvent selected from the group consisting of 1,3-butylene glycol, 1,2-hexanediol, 1,3-propanediol, 1,2-pentanediol, dipropylene glycol, 2-(2-butoxy-ethoxy)ethanol, 1,6-hexanediol, propylene glycol methyl ethyl acetate, 5-methyloxolan-2-one, pantolactone, and combinations thereof same as composition of instant claims 1 and 11-20. Reference claim 2 recites roflumilast is present in amount 0.005% to about 2% w/w, same as instant claim 2. Reference claims 7 recites solvent and water are present in an approximately equal molar blend same as instant claim 7. Reference claim 8 recites wherein said solvent and water are present in an approximately 1:2 solvent to water blend (weight:weight) same as instant claim 8. Reference claim 9 recites pharmaceutical composition is selected from the group consisting of an emulsion, a gel, and an ointment same as instant claim 9. Reference claim 10 recites pharmaceutical composition further comprises at least one additional component selected from the group consisting of a moisturizer, a surfactant or emulsifier, a polymer or thickener, an antifoaming agent, a preservative, an antioxidant, a sequestering agent, a stabilizer, a buffer, a pH adjusting agent, a skin penetration enhancer, a film former, a dye, a pigment, and a fragrance, same as instant claim 10.
The specification of the reference claims discloses treatment of allergic or inflammatory dermatosis such as psoriasis, eczema, atopic dermatitis, and seborrheic (claims 1, 3-6) (column 14, lines 25-50), which is the objective of the instantly claimed method.
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference claims composition of roflumilast, reference claim does not teach a method of treating inflammation or allergic dermatosis.
3. Resolving the level of ordinary skill in the pertinent art.
A person skilled in the art is an artisan who is knowledgeable in using roflumilast for treating different diseases.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop a method of treating inflammation or allergic dermatosis because specification of reference claims state roflumilast is used for allergic or inflammatory dermatosis such as psoriasis, eczema, atopic dermatitis, and seborrheic (claims 3-6) (column 14, lines 25-50). Therefore, formulation of instant claims 1-2 and 7-20 are also expected to treat allergic or inflammatory dermatosis such as psoriasis, eczema, atopic dermatitis, and seborrheic (claims 3-6). Therefore, it would be obvious for a person skilled in the art to develop a method of treating allergic or inflammatory dermatosis such as psoriasis, eczema, atopic dermatitis, and seborrheic (claims 3-6 with the composition of instant claims 1-2 and 7-20.
Put another way, although the claims at issue are not identical since the instant application (“instant”) is drawn to a method of use of the compound of the reference patent (“reference”), see analysis, above, they are not patentably distinct from each other because both instant and reference are drawn to the same underlying compound. See analysis, above.
Moreover, the reference patent (column 14, lines 25-50), teaches the instantly claimed method of treating an inflammatory or allergic dermatosis.
Conclusion
No claims are allowed as written.
Osbourne (US 9,895,359 B1) teaches a topical composition comprising roflumilast with hexylene glycol in water. Osbourne does not teach topical composition comprising roflumilast with solvents in independent claim 1.
Moreover, the reference OSBOURNE was the subject of an obviousness rejection in the parent application (now U.S. Patent 12,144,802) in which Examiner argued the instantly claimed solvents and roflumilast was obvious in light of OSBOURNE’s teaching of hexylene glycol and roflumilast. However, Applicants’ persuasively traversed disclosing where in their Specification the instantly claimed invention has surprising/unexpected results (see pages 3-4 of the Notice of Allowance of 12 September 2024 in the parent application).
Thus, Osbourne is close art but not a prior art.
Osbourne (US 9,895,359 B1) is not a double patent reference because it teaches topical composition comprising roflumilast with hexylene glycol in water.
Applicants are encouraged to file terminal disclaimer to overcome the double patenting rejection, above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
