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 .
Priority
The present application is a National Stage entry of International application PCT/EP2023/067109 filed 06/23/2023, which claims the benefit of Foreign application EP22181944.4 filed 06/29/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 12/17/2024, in the matter of Application N° 18/875,953. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-7, 9-13, 15-21 are pending.
Claims 1-7, 9-13, 15-21 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-13, and 15-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 6 recite “substantially free” which is a relative term. In Applicant’s Specification, “substantially free” is defined (pg 12, lines 24-29): “As used herein, substantially free refers less than 0.5% by weight of the composition, or less than 0.1% by weight of the composition, preferably 0% by weight of the composition. Applicant’s definition of ‘substantially free” contains broad and narrow ranges which is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the Examiner will examine based upon the scope of the broadest range (i.e., LT 0.5 wt%).
All other claims that depend from claim 1 are additionally rejected.
Claims 1, 4, 5, 15, 17 recite a “%” and/or “by weight” which is defined in Applicant’s Specification (pg 3, lines 24-26): “All amounts are by weight of any of the compositions or components thereof, unless otherwise specified. It should be noted that in specifying any ranges of values, any particular upper value can be associated with any particular lower value.” Thus, it is unclear whether by “by weight” used in the claim scope limitation, is in relation to the overall composition or another component. The Examiner recommends clarification in the claims (e.g., include “by weight in relation to the total weight of the composition” in claim 1” or something like this. For purpose of examination, the Examiner assumes the wt% is in relation to the overall composition.
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.
Claims 10, 12, 18, and 20 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.
Claims 10, 12, 18, and 20 do not further limit claim 1, because the additional skin benefit agent is “optionally” included, and therefore, the ingredient can be read as not being included.
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 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, 4-7, 9-13, 15, 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Klusiatis (GB2283421A, 1995).
Applicant’s claims are directed to a composition comprising: a) from 90% to 93% by weight water; b) from 1% to 3% by weight of a non-ionic surfactant having an HLB from 15.7 to 17.5; and c) from 0.75% to 2% by weight of an anti-acne agent, wherein the anti-acne agent is salicylic acid, wherein the composition is substantially free of thickeners and gelling agents: and wherein the composition is a stable continuous water phase. Claim 15 further describes a method of administering.
Klusiatis teaches anti-acne compositions, comprising an aqueous continuous phase and nonionic surfactants with an HLB from 12-19 (abstract). Klusiatis teaches the criticality of the surface-active solubilizer to solubilize the anti-acne active in water (i.e., especially nonionic surfactants with an HLB in the range of 12-19, such as polyethylene glycol based nonionic surfactants (pg 4-5)), because salicylic acid is virtually insoluble in water without the disclosed solution (pg 2).
Regarding claims 1-2, 4-5, 10, and 17: Klusiatis teaches a composition, comprising 80-95 wt% water (pg 11), 0.1-30 wt% nonionic surfactant with an HLB range from 12-19 (Klusiatis – claim 1), and 0.1-10 wt% anti-acne active that is salicylic acid (Klusiatis – claims 1-2), wherein there is no requirement for thickeners, gelling agents, parabens, silicones, sulfates, etc. (Klusiatis – claim 1), and the composition is a stable continuous water phase (abstract, Klusiatis – claim 11). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
Regarding claim 6: Klusiatis teaches a composition that incorporates multiple surfactants (reads on instant claim 10) (Klusiatis – claim 6).
Regarding claim 7: Klusiatis teaches a composition with a 2 wt% salicylic acid and 2 wt% nonionic surfactant Pareth 8 (Example II, pg 12; pg 6), as a demonstration of a 1:1 ratio of active to surfactant.
Regarding claim 9: Klusiatis teaches a solution (abstract), that is a single phase aqueous composition (Klusiatis – claim 11), and additionally, solubilized salicylic acid (pg 4-5).
Regarding claim 11 and 19: Klusiatis teaches compositions that additionally incorporate sorbitol, propylene glycol, glycerol, etc. (pg 9).
Regarding claim 12: Klusiatis teaches incorporation of moisturizing agents, vitamin B complex, etc. (pg 11).
Regarding claim 13: Klusiatis teaches incorporation of emollients, perfume oils, etc. (pg 7).
Regarding claim 15: Klusiatis teaches the compositions described above to be applied topically to the skin, for treatment of acne (pg 13).
Regarding claim 21: Klusiatis teaches a pH of 2-4.5 (abstract) (i.e., reads on the instant pH range of 3-7 by overlap.).
In summary, Klusiatis teaches the elements and desirability for the limitations of the instant claims, and thus, their obviousness. The instant composition claimed appears to be little more than the selection of art-known elements according to their known utility taught from within a single prior art reference, teaching the desirability of selecting such components, and obvious thereby, that the instant invention is obvious. Furthermore, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, Klusiatis renders the instant composition with soluble salicylic acid for acne treatment as obvious.
Claims 1-7, 9-13, and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Klusiatis (GB2283421A, 1995), as applied to claims 1-2, 4-7, 9-13, 15, 17, 19, and 21 above, and in further view Fleur & Bee (2021), Han (2020), and Kuehl (2003).
As discussed above, Klusiatis teaches compositions comprising salicylic acid that is solubilized by polyethylene glycol based nonionic surfactants in single continuous phase aqueous compositions, for acne treatment by topical administration. Klusiatis also teaches incorporations of additives such as vitamin B complex (pg 11). However, Klusiatis does not teach niacinamide (instant claim 20), polysorbate-20 (instant claims 3 and 16), or the additional cationic surfactant (instant claim 18).
Fleur & Bee teaches niacinamide (or vitamin B3) is used in many vitamin B complex supplements (i.e., Klusiatis already incorporates vitamin B complex) (pg2), in which niacinamide balances oils, protects skin from environmental stressors, and brightens and evens skin tone (pg 1).
Han teaches polysorbate-20 (aka, polyoxyethylene (20) sorbitan monolaurate, or Tween 20) as a polyethylene glycol based nonionic surfactant (pg 1-4) (i.e., Klusiatis teaches the value of polyethylene glycol based nonionic surfactants to solubilize salicylic acid), that is commonly used in skin care products of the cosmetics industry, as a strong solubilizing agent (pg 5-7).
Kuehl teaches anionic, nonionic, and cationic surfactants due to their detergent like effect (pg 1-2) are all generally beneficial for anti-acne formulations (pg 2-4 and 7).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Klusiatis to incorporate niacinamide, as taught by Fleur & Bee, because topical niacinamide improves the skin, and Klusiatis teaches compositions that treat acne. Furthermore, Klusiatis teaches incorporation of additives/vitamin B complex, and niacinamide is a form of vitamin B3 that is often found in vitamin B complex (pg 1-2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Klusiatis by specifying polysorbate-20 (as described by Han) as the polyethylene glycol based nonionic surfactant (as generally taught for incorporation in Klusiatis), because selecting polysorbate-20 is nothing more than the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Additionally, Han teaches nonionic surfactants as strong solubilizing agents, and Kuehl teaches nonionic surfactants as beneficial in anti-acne formulations for their detergent like effect.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Klusiatis by additional incorporation of cationic surfactants, as taught by Kuehl, because Kuehl teaches cationic surfactants to exhibit a detergent like effect in anti-acne formations, whereby Klusiatis is directed to anti-acne topical compositions for acne treatment, that rely on surfactant effects for solubilization and/or cleansing (abstract).
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 1-7, 9-13, 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent 9295625, and in further view of Klusiatis (GB2283421A), Fleur & Bee (2021), Han (2020), and Kuehl (2003):
claims 1-10 of Patent No. US9295625
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a topical cosmetic composition that comprises a nonionic surfactant with an HLB above 15 (‘625 – claim 1) and salicylic acid (‘625 – claim 7), where the claim scope of ‘625 infers a sizeable amount of water. Patent No. ‘625 differs only significantly by not explicitly naming water as part of the composition in certain amounts.
This is remedied by Klusiatis, who teaches similar compositions with high amounts of water, whereby the nonionic surfactant with an HLB between 12-19 solubilizes salicylic acid (see 103 rejection above for more detail). Kuehl, Fleur & Bee, and Han also teach the additional dependent limitations. One of ordinary skill in the art would have been motivated to modify the teachings of ’625 with the recited Art above, because ‘625 is direct toward topical cosmetic compositions that protect the skin from sun, to benefit skin, and instant claims are also directed to sunscreens designed to protect the skin (instant claim 12), that also generally benefits skin (all claims).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 8/10/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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