DETAILED ACTION
Claims 38, 39, and 54-65 are currently pending in the instant application. Claims 62 and 63 are rejected. Claims 64 and 65 are objected. Claims 38, 39, and 54-61 are allowed.
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 .
Terminal Disclaimer
The terminal disclaimer filed on 24 February 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,691,946 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 24 February 2026 have been fully considered and entered into the instant application. The objection to claims 59-61 is overcome as claims 38, 39, and 54-58 are allowable. Therefore, claims 59-61 are also allowable. As claim 64 is still dependent upon a rejected claim, the objection to claim 64 is maintained. The 35 USC 112(b) rejection of claim 65 is overcome as claim 65 has been amended to be dependent upon claim 64. As claim 65 is dependent upon a rejected claim, claim 65 is now objected. In regards to the 35 USC 112(a) rejection of claim 62, Applicant’s representative argues that:
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. This argument is not persuasive as formulation (f) on page 80, which discloses a formulation for topical application with 1.000g active compound in 100g total formulation does not correspond to 0.1% (w/w) active compound. 1.000g active compound in a formulation with a total weight of 100g, is a formulation with 1% (w/w) active compound, not 0.1% (w/w) active compound as 1g/100g is 0.01, which is equivalent to 1% (w/w). Therefore WO 2006/066978 does not provide support for 0.1% (w/w). Additionally, even if the formulation (f) on page 80 had 0.1% (w/w) of Frome E polymorph, this formulation (f) is a specific formulation with specific other ingredients in the composition which does not provide written description for a broader claim to any composition comprising 0.1% (w/w). The 35 USC 112(a) rejection of claim 62 is therefore maintained.
In regard to the 35 USC 112(a) rejection of claim 63, Applicant’s representative argues that
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. This argument is not persuasive. While WO 2006/066978 provides multiple examples of varying specific skin disorders, the ‘978 WO does not provide written description of any and all “skin disorders” as found in instant claim 63. Pages 14, Field 4 does not provide “skin disorders” as described above in applicant’s arguments, but provides specific “skin disorders caused by exposure to UV radiation.” The varying specific skin disorders provided in the ‘978 WO do not provide written description to a claim to any and all “skin disorders”. The 35 USC 112(a) rejection of claim 63 is therefore maintained.
Claim Objections
Claims 64 and 65 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 62 and 63 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claims 62 and 63 in the amendment filed 8/31/2023 are as follows:
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Claims 62 and 63 in the amendment filed 24 February 2026 are as previously presented
in the 8/31/2023 amendment.
In regards to claim 62, page 16 of the WO provides concentrations between 0.001% and 10% by weight and preferably between 0.01% and 1% by weight. Page 17 provides 3% by weight. There is no mention in the instant specification or WO 2006/066978 for 0.1% by weight. Therefore, as neither the instant specification or WO 2006/066978 provides the composition comprising 0.1%w/w, claim 62 is considered new matter.
In regards to claim 63, the term “skin” is only found in the specification on page 1 in the background section discussing that Trifarotene is a topical retinoid that can selectively target retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. The treatment of acne vulgaris is also provided in the background section. WO 2006/066978, which is incorporated by reference, see page 1 of the specification and page 35 of the specification, while providing the treatment of certain skin disorders, for example, on page 14, such as skin disorders caused by exposure of UV radiation, repairing or combating ageing of the skin, and precancerous skin lesions, does not provide the treatment of any and/or all skin disorders. Pages 16 and 17 of the ’978 WO provides treating acne-prone skin, greasy appearance of the skin, treating physiologically dry skin, ageing and/or dry skin. Page 19 of the WO provides enhancing appearance of the skin. Claims 13, 20 and 23 of the WO provides specific skin disorders. Page 1 of the WO provides that the compounds of the invention modulate retinoic acid receptors and page 1 of the instant specification provides that Trifarotene is a topical retinoid that can selectively target retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Therefore, as neither the instant specification or WO 2006/066978 provides the treatment of any and all skin disorders in a subject, claim 63 is considered new matter.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 26 March 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600