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
This action is in response to Applicant’s amendment filed June 24, 2026 in reply to the First Office Action on the Merits mailed March 27, 2026. Claims 42, 46, and 53-59 have been amended; claims 1-41 and 47-51 have been canceled; and claims 60-64 have been newly added. Claims 44, 46, 52, 53, and 59 have previously been withdrawn. Newly added claims 61-64 are hereby also withdrawn as being directed to non-elected subject matter. Claims 42, 43, 45, 54-58, and 60 are under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Neither Beyer et al., Murad, nor El-Maghraby et al. explicitly disclose polysorbate-20, as now stipulated in newly amended claim 42. Therefore, the 35 USC 103 rejection presented in the Non-final Office Action mailed March 27, 2026 is hereby withdrawn. Upon further search and consideration, however, new prior art has been procured, and new ground of rejection has been formulated that addresses the pending claim limitations, and is presented herein below.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The phrase “a positively charged molecules” is in improper English grammatical form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 42 and 54-58 are objected to because of the following:
i) In claim 42, there is an extraneous comma between “a skin-penetrating” and “composition”.
ii) In claims 54-58, there should be a comma between the recitation of the weight percent value and the phrase “based on the total weight of the composition. For example, in claim 54, the phrase “comprises 1-20 wt% based on the total weight of the composition, of the at least one sugar-based emulsifier” should be “comprises 1-20 wt%, based on the total weight of the composition, of the at least one sugar-based emulsifier”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 43 is 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.
Claim 43, which depends from claim 42, stipulates that the composition “further comprises a coemulsifier having a…HLB…of about 1 to about 20, and being nonionic, cationic, anionic, amphoteric, or a combination thereof in nature”, which renders the claim indefinite for the following reasons:
1. The composition of claim 42 already necessarily contains a coemulsifier, and the coemulsifier is necessarily polysorbate 20, which has an HLB of about 1 to about 20, and is nonionic.
2. Claim 42 further provides that the composition can optionally contain a second coemulsifier, and this second coemulsifier is sucrose laurate, which also has an HLB of about 1 to about 20, and is nonionic.
3. One of ordinary skill in the art thus cannot make heads or tails out of the limitation of claim 43. Does claim 43 mean that the composition necessarily contains the sucrose laurate? Does claim 43 mean that the composition necessarily contains another coemulsifier that is not sucrose laurate, and need not contain sucrose laurate at all? Does claim 43 mean that the composition necessarily contains sucrose laurate and also necessarily contains another comulsifier that is not sucrose laurate? Or what?
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 42, 43, 45, 54-58, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. (U.S. Patent Application Pub. No. 2014/0134221), in view of Murad (Happi [online]; 2012) and Barathur et al. (U.S. Patent Application Pub. No. 2014/0234428).
Applicant Claims
Applicant’s elected subject matter is directed to a skin-penetrating composition comprising positively-charged vesicles comprising inulin lauryl carbamate, a coemulsifier comprising polysorbate 20 and sucrose laurate, behentrimonium chloride, water, and retinol (i.e. vitamin active), in the amounts of 1-20 wt%, 0.1-20 wt%, 0.1-10 wt%, 1-30 wt%, and 1-50 wt%, respectively; wherein the vesicles have a particle size of 50-1000 nm, and a zeta potential of 1-150 mV.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Beyer et al. disclose a skin-penetrating composition comprising positively-charged vesicles with good adhesion to the skin comprising e.g. phospholipids in which at least one antioxidant is encapsulated therein; wherein said antioxidant can be present in the amount of 0.01-20 wt% and can be e.g. a vitamin, and wherein the lipid vesicle has a particle size of 10-1000 nm and a zeta potential of 1-100 mV, and comprises 5-25 wt% of e.g. inulin lauryl carbamate having a degree of modification most preferably of 0.03-0.15, and 0.1-10 wt% of a positively charged molecule, e.g. C12-C22 alkyltrimethylammonium salt, in which the C22 form, i.e. behentrimonium salt is most preferred, and can be e.g. behentrimonium chloride; wherein the positive surface charge affords the advantages that it permits stable incorporation of large amounts of lipophilic active in the vesicle, permits good adhesion to the skin surviving several washings, and permits incorporation of the encapsulated lipophilic active in a hydrophilic (e.g. water-based, i.e. water solvent) cosmetic formulation product (abstract; paragraphs 0009, 0010, 0034, 0037-0039, 0041, 0044, 0050, 0054, 0057, 0059, 0067, 0069-0071, 0074, 0081; claims 19-21, 25).
Murad discloses that retinol is a vitamin (i.e. Vitamin A) and a potent antioxidant, and that micro-encapsulated retinol applied to skin can help reduce the appearance of deep wrinkles.
Barathur et al. disclose a skin-penetrating composition comprising e.g. positively-charged lipid vesicles in which at least one vitamin is encapsulated therein for delivery, and a polar solvent; wherein the lipid vesicles have a particle size of 30-5000 nm and a zeta potential of e.g. 20-100 mV, and wherein the lipid vesicles comprise 1-10 wt% surfactants, e.g. polysorbate-20 and sucrose laurate, which serve as interfacing agents with the polar solvent and also as skin penetration enhancers (abstract; paragraphs 0044, 0045, 0067, 0071; claims 1-7, 14).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Beyer et al. do not explicitly disclose that the antioxidant vitamin active is retinol, and that the lipid vesicle further contains 0.1-10 wt% of polysorbate-20. These deficiencies are cured by the teachings of Murad and Barathur et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Beyer et al., Murad, and Barathur et al., outlined supra, to devise Applicant's instantly claimed skin penetrating composition.
Beyer et al. disclose a skin penetrating “variant” of a UV protective lipid vesicle carrier with good adhesion to the skin comprising a liposomal carrier system that penetrates the skin comprising e.g. phospholipids in which at least one antioxidant is encapsulated therein; wherein said antioxidant can be present in the amount of 0.01-20 wt% and can be a vitamin, and wherein the lipid vesicle has a particle size of 10-1000 nm. Since anyone of ordinary skill in the art would know that good skin adhesion is the first requisite step to successful skin penetration, since Beyer et al. disclose that their lipid vesicle carrier system affords good skin adhesion surviving several washings, can include e.g. oils and antioxidants, and further provides via the positive surface charge of 1-150 mV the advantages of permitting large amounts of lipophilic actives to be stably encapsulated therein and permits incorporation of the encapsulated lipophilic active in hydrophilic (e.g. water-based) cosmetic and pharmaceutical formulations; since Murad discloses that retinol (i.e. Vitamin A) is a potent antioxidant, and that micro-encapsulated retinol applied to skin can help reduce the appearance of deep wrinkles; and since Barathur et al. disclose a skin-penetrating composition comprising e.g. positively-charged lipid vesicles in which at least one vitamin is encapsulated therein for delivery, and a polar solvent; wherein the lipid vesicles have a particle size of 30-5000 nm and a zeta potential of e.g. 20-100 mV, and wherein the lipid vesicles comprise 1-10 wt% surfactants, e.g. polysorbate-20 and sucrose laurate, which serve as interfacing agents with the polar solvent and also as skin penetration enhancers; one of ordinary skill in the art would be motivated to formulate the Beyer et al. skin penetrating “variant” lipid vesicle carrier by combining e.g. inulin lauryl carbamate, behentrimonium chloride, polysorbate-20, and phospholipids, with e.g. 0.01-20 wt% retinol incorporated therein, wherein the composition has a positive surface charge of 1-150 mV; with the reasonable expectation that the resulting composition will adhere to and successfully penetrate the skin, and permit stable incorporation of large amounts of lipophilic retinol oil in the particle and stable incorporation of the particle with encapsulated lipophilic active in water-based cosmetic and pharmaceutical formulations.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed June 24, 2026 have been fully considered but are moot in view of the new grounds of rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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