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 .
DETAILED ACTION
Claims 1, 2, 5, 9, 15, 20, 23, 26, 33-35, 38, 41, 44, 46, 48, 50, 54, 65 and 73 are currently pending and a preliminary amendment to the claims filed on 06/16/2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2025 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Allowable Subject Matter
Claim 65 is 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. It would be hindsight after exhausting all the other rationales to combine, to specifically select the components and arrange them in specific ranges as applicant has claimed.
Claim Objections
Claims 1, 2, 15, 20, 26, and 34 are objected to a minor informality.
Each of claims 62, 15 and 34 are not written in a proper Markush-type claim format. Each of them recites type “selected from A, B, and C”. However, the Markush-type claim should recite alternatives in a format such as "selected or chosen from the group consisting of A, B, and C." Alternatively, “selected or chosen from A, B or C” can be used. (see MPEP 2111.03 –II and 2117 and MPEP 2173.05(h)). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 26 recites “dimethyl isosorbide” as the non-aqueous solvent in line 4. However, it appears that the said limitation is outside scope of instant claim 1 because the non-aqueous solvent of claim 1 is limited to polyol, C1-6 alkanediol, glycol ether, dimethyl ether and a combination thereof . However, it appears that “dimethyl isosorbide” does not belong to the genus of solvent recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 9, 15, 20, 23, 26, 33-35, 38, 41, 44, 46, 48, 50, 54 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Baek (WO2020/081868A1, published on 04/23/2020, citation is obtained from its corresponding US publication no. 2021/0228467A1, both references are IDS documents of 06/13/2025) in view of Jackson (US2019/0290639A1, IDS of 06/13/2025).
Applicant claims the below claim 1 filed on 06/16/2025:
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Regarding claim 1, Baek discloses topical storage stable formulations comprising an urea agent, an ascorbic acid and a non-aqueous skin-compatible solvent in the form of emulsion wherein the non-aqueous liquid composition containing ascorbic acid can be combined with an immiscible phase or oil ingredient to produce emulsion composition (e.g., abstract and [0066]); the emulsion comprises dispersed phase and continuous phase (e.g., [0068]) wherein the dispersed phase (=discontinuous phase) contains 1-20% or 5-20% urea agent (e.g., [0081] and claim 1 of prior art) that is within the instant range of 1-30%, MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), and the urea agent is dissolved in non-aqueous solvent (e.g., [0026] and [0059]) and the solvent includes polyols, C(1-6) alkanediols, glycol ethers, dimethyl ethers, and combinations thereof (e.g., [0042]-[0043], [0060]-[0064] and the Examples), which reads on the claimed dispersed phase containing urea and non-aqueous solvent; the oil phase (=continuous phase) contains 30% silicone polymer such as dimethicone which also can be as emulsifiers and/or acts as the continuous/dispersed phase of the emulsion (e.g., [0068] and [0200]-Table 3) wherein the amount 30% of dimethicone overlaps the instant range of 10% or more. As one of optional ingredients, e.g., retinoid including all-trans-retinoic acid, adapalene and tazarotene can be contained in the emulsion composition (e.g., [0055]) which reads on the claimed retinoid. The formulations are storage stable (e.g., abstract and claim 1-4 of prior art).
However, Baek does not expressly disclose “0.01 to 1.5%” of the retinoid agent in a continuous phase of instant claim 1. The deficiency is cured by Jackson.
Jackson discloses compositions for treating skin conditions comprising an imidazoquinoline compound and a retinoid agent (e.g., abstract); the retinoid is selected from the group consisting of: retinol, retinal, retinyl acetate, retinaldehyde, retinyl palmitate, retinoic acid, retinyl propionate, retinyl linoleate, dehydroretinol, eretinate, eretrin, motretinide, tazarotene, isotretinoin, tretinoin, adapalene, bexarotene, fenretinide, and alitretinoin (e.g., [0013]) in an amount of between about 0.001 to about 1% (e.g., [0023]-[0024]) that overlaps the instant range of 0.01 to 1.5% and gives benefits of treating or improving skin condition. MPEP 2144.05 noted above.
It would have been obvious to modify the composition of Baek with certain amount of retinoid of Jackson as a continuous oil phase component as taught by Baek in order to enhance the benefits of treating or improving skin condition.
Regarding instant claims 2 and 5, Baek discloses the emulsion composition further comprises antioxidant such as vitamin C (e.g., [0051]) and azelaic acid ([0045], [0055], etc.) (instant claim 2) wherein vitamin C is used in an amount of e.g., 5-28% (e.g., claim 1 of prior art) that overlaps the instant range of 5 to 15% or 5% (instant claim 5). MPEP 2144.05 noted above.
Regarding instant claim 9, Baek discloses azelaic acid in an amount of 3-10% (e.g., [0086]) that overlaps the instant range of 5 to 15% or 5%. MPEP 2144.05 noted above.
Regarding instant claim 15, Baek discloses retinoids including all-trans-retinoic acid, adapalene and tazarotene (e.g., [0055]) and Jackson discloses retinol, retinal, retinyl acetate, retinaldehyde, retinyl palmitate, retinoic acid, retinyl propionate, retinyl linoleate, dehydroretinol, eretinate, eretrin, motretinide, tazarotene, isotretinoin, tretinoin, adapalene, bexarotene, fenretinide, and alitretinoin (e.g., [0013]). It would have been obvious to further define the retinoid with species of Jackson and such definition would have yielded no more than the predictable results of retinoid.
Regarding instant claim 20, Baek discloses the continuous (oily) phase contains dimethicone (e.g., the Examples) and the claimed other species are obvious variation due to equivalent function of silicone polymer.
Regarding instant claims 23 and 35, Baek discloses urea agent includes hydroxyalkyl urea (e.g., hydroxyethyl urea) or combination of urea and/or substituted urea (e.g., [0035]) (instant claim 23) in an amount of e.g., 1-20% or 5-20% urea agent (e.g., [0081] and claim 1 of prior art) that is within the instant range of 5-20%, or 5% ([0049]) which is identical to the claimed range of 5% (instant claim 35). MPEP 2144.05
Regarding instant claim 26, Baek discloses non-aqueous solvent includes glycerol (1,2,3-propanetriol); diglycerol; propylene glycol (1,2-propanediol); dipropylene glycol; 1,3-propanediol; butylene glycol (1,3-butanediol); 1,2-butanediol; pentylene glycol (1,2-pentanediol); 1,5-pentanediol; 1,2-hexanediol; 1,6-hexanediol; 1,2,3-hexanetriol, 1,2,6-hexanetriol; ethoxydiglycol; and dimethyl isosorbide (e.g., [0043]).
Regarding instant claims 33, 34, 48 and 50, Baek discloses one or more optional ingredients in an amount of 9% or less (e.g., [0046]) that is within the claimed range of 10% or less (instant claim 33) such as tocopherol (e.g., [0048]), tocotrinol (e.g., [0049]), cinnamic acid, ferulic acid, hydroxy acid (e.g., [0052]), panthenol (e.g., [0064]). pinus pinaster bark extract (e.., [0045]), hyaluronic acid complex (e.g., [0064]), cholesterol (e.g., [0069]), free fatty acid, linoleic acid, linolenic acid (e.g., [0069]), glycyrrhizic acid (e.g., [0055]), madecassoside (e.g., [0058]), acetyl zingerone (e.g., [0060]), bakuchol (e.g., [0053]), and/or bis-ethylhexylhydroxydimthoxyl bezylmalonate (e.g., claim 11 of prior art) (instant claims 34 and 50). Although Baek discloses cholesterol ([e.g., [0069] ], it does not discloses a cholesterol/lanosterol esters, but it would be obvious variation of optional additive. Further, the claimed amount of “5% or less” also embraces absence of those esters (instant claim 48).
Regarding instant claims 38, 41, 44, 46, and 54, Baek discloses ferulic acid in an amount of 2% or less that overlaps the instant rage of 0.1 to 2% or 0.5% (instant clam 38); tocopherol (=vitamin E) is present in an amount of 2% or less that is identical to the claimed range (instant claim 41); as the secondar antixodant, bis-ethylhexyl hydroxydimethoxy benzylmalonate (HDBM) or bakuchiol is used in an amount of 0.1 to 3% that overlaps the instant range of 2% or less (instant claims 44 and 46); and pinus pinaster bark extract is present in an amount of 1.5% or less (e.g., [0062]) that overlaps the instant rage of 0.5 to 2% (instant claim 54).
Regarding instant clam 73, Baek discloses the preparation process includes combining 1% to 20% by weight urea agent selected from urea, hydroxyethyl urea, and combination thereof; then 10% to 94% by weight of a non-aqueous skin-compatible solvent comprising C(3-6)polyol, ethoxydiglycol, dimethyl ether, or a combination thereof; and then, optionally one or more additional agents; with 5% to 28% by weight ascorbic acid, thereby dissolving the urea agent, and one or more additional agents in the said non-aqueous solvent; suspending the disperse phase in a continuous phase comprising 30% by weight of silicone compound dissolved in an oil-phase solution (e.g., [0080]-[0081], Table 3) to produce the composition, that is storage stable (e.g., [0199], Example 3 and Table 3).
However, Baek does not expressly disclose 0.01 to 1.5% retinoid agent in a continuous phase of instant claim 73. The deficiency is cured by Jackson.
Jackson discloses compositions for treating skin conditions comprising an imidazoquinoline compound and a retinoid agent (e.g., abstract); the retinoid is selected from the group consisting of: retinol, retinal, retinyl acetate, retinaldehyde, retinyl palmitate, retinoic acid, retinyl propionate, retinyl linoleate, dehydroretinol, eretinate, eretrin, motretinide, tazarotene, isotretinoin, tretinoin, adapalene, bexarotene, fenretinide, and alitretinoin (e.g., [0013]) in an amount of between about 0.001 to about 1% (e.g., [0023]-[0024]) that overlaps the instant range of 0.01 to 1.5% and gives benefits of treating or improving skin condition.
It would have been obvious to modify the composition of Baek with addition of retinoid (oily compound) of Jackson as a continuous oil phase component as taught by Baek in order to enhance the benefits of treating or improving skin condition.
In light of the foregoing, instant claims 1, 2, 5, 9, 15, 20, 23, 26, 33-35, 38, 41, 44, 46, 50, 54, and 73 are obvious over Baek in view of Jackson.
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, 2, 5, 9, 15, 20, 23, 26, 33-35, 38, 41, 44, 46, 48, 50, 54 and 73 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 9, 11, 12 and 14-27 of copending Application No. 17/918823 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require storage stable topical emulsion comprising internal phase (=dispersed phase) urea agent in non-aqueous skin compatible solvent and its species, and external phase (=continuous phase=oil phase) comprising silicone/its species, and additional ingredients of retinol, tocopherol, tocotrienols, ferulic acid, ascorbic acid, vitamin E ... titanium dioxide, and overlapping amounts thereof. Both compositions do not contain salicylic acid or ammonium lactate. The difference between them is that reference application requires value of storage stability, but this property would also be implicit in the claimed invention. Therefore, the claimed invention is obvious over reference application ‘823.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The instant case is not allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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