DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification, drawings and claims as well as applicant arguments/remarks, filed 06/22/2026, is acknowledged. Amendments to the specification and drawings have been entered.
Claims 1-4, 7-29 are pending in this action. Claims 5 and 6 have been cancelled. Claims 1, 7-13, 15, 17-20, 27-28 have been amended. New claim 29 has been added. No new matter was added. Claims 1-4, 7-29 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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 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.
Priority
This application is a 371 of PCT/BR2022/050269, filed July 20, 2022, which claims benefit of foreign priority to BR102021015486-1, filed August 5, 2021.
Claim Objections
Claims 15, 17, 28 are objected to because of the following informalities:
Claim 15 comprises the typographic error “diameter from 300 nm to” that needs to be corrected to “diameter of from 300 nm to”. Similar is applied to claim 17.
The acronyms recited in claim 28 should be removed, because said acronyms are not used in subsequent claims.
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.
Claims 1-4, 7-28 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 pre-AIA the applicant regards as the invention.
As stated previously, claim 1 recites the limitation “physical delimitation of the nanoparticles is a lipid matrix” that is not reasonably clear. To this point, it is noted that nether the claims nor the instant specification provides the clear definition for the term “physical delimitation”. Therefore, the scope of the claim is not clear. Clarification is required.
In response to the applicant’s argument that said limitation was introduced during international examination, it is noted that said limitation does not clearly define the structure of the disclosed composition. If applicant implies that disclosed lipid nanoparticles encapsulate claimed ingredients within the lipid matrix (see Specification; Detailed Description Of The Invention) that should be clearly stated/defined. Clarification is required.
Claim 7 (dependent on claim 1) recites the limitation “composition comprises from 0.1 to 2% by weight of phenoxyethanol and from 0.1 to 2% by weight of caprylyl glycol” that is not reasonably clear. To this point, it is noted that newly amended claim 1 discloses the composition comprising “from 0.1 to 2% by weight of preservatives comprising a combination of phenoxyethanol and caprylyl glycol”. Therefore, the amounts of recited compounds to be present in the claimed composition are not clearly delineated. Clarification is required.
As stated previously, claim 8 recites the limitation “preservative comprises a 1:1 combination of phenoxyethanol and caprylyl glycol” that is not reasonably clear, because the recited numerical limitation, i.e., “1:1”, is shown without units of measurements. Is it a molar ratio, OR weight ratio, etc.? Clarification is required.
As stated previously, claim 10 recites the terms “simple”, “complex”, “long”, “medium”, “short” that are relative terms, which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claim 14 regarding the limitation “soft color”. Clarification is required.
In response to the applicant’s argument, that said terms are well known in the field, it is noted that the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear, so the public is informed of the boundaries of what constitutes infringement of the patent. In the present case, the definitions for said claimed adjectives are not provided in the instant specification. Therefore, clarification is required.
Newly amended claim 11 recites the limitations “capric/caprylic acid triglyceride”, “polypropylene glycol (15) stearyl ether” that are not reasonably clear, because the structures of disclosed compounds/constituents are not clearly delineated. First, regarding the limitation “capric/caprylic acid triglyceride” it is noted that that it is unclear (i) if it is a mixture of recited compounds or a single compound; and/or (ii) what triglyceride should be used – long, medium, short. Second, regarding the limitation “polypropylene glycol (15) stearyl ether”, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). Similar is applied to claim 13 regarding the limitations “steareth-2” and/or “steareth-21”, because the structures of said recited compounds are not clearly deliniated. Clarification is required.
Claim 15 (dependent on claim 1) recites the limitation “the nanoparticles have an average diameter of from 300 to 420 nm” that is unclear and indefinite. As stated previously, where a claimed value (i.e., nanoparticle diameter) varies with its method of measurement and several alternative methods of measurement are available, the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). To this point, it is noted that there is no a comprehensive standard for particle size measurements, and different methods of particle size/diameter analysis yield different estimates of particle size/diameter for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to claim 16, as well as to claims 17, 18 regarding particle surface charge measurements. Clarification is required.
In response to the applicant’s argument that the methods of measurement are well recognized in the state of the art and one skilled in the art would recognize and understand the limits defined in said claim, it is noted that one skilled in the art would also know that particle size experimental estimates depended on the method chosen to measure a physical property of the system, based on which the particles size characteristics will be recalculated. Therefore, clarification of method of measurement of nanoparticle diameters is required.
Newly amended claim 19 (dependent on claim 1) discloses “A method for preventing skin aging, comprising applying a cosmetic product with antioxidant, anti-aging, anti-inflammatory, whitening, photoprotective, skin permeation and gene modulation related to skin aging effects” that is not clear. Does this claim disclose the use of a cosmetic product that includes recited functional agents in combination with the composition recited in claim 1? To this point, as stated previously, it is well known in the field that properties of multicomponent systems (e.g., compositions/products) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/product. Claiming a result (e.g., gene regulations) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Similar is applied to claim 20. Clarification is required.
Claim 28 recites the limitation “wherein the downregulated genes responsible for extracellular matrix synthesis comprise Collagen Type I Alpha 1 Chain (COL1A1), Collagen Type III Alpha 1 Chain (COL3A1), elastin (ELN), fibronectin 1 (FN1), and fibrillin 1 (FBN1)” that is unclear, because genes (i.e., sequences of nucleotides) are defined as proteins (i.e., sequences of amino acid residues). Similar is applied to other downregulated genes limitations recited in claim 28. Clarification is required.
Claims 2-4, 12, 21-27 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-4, 7-28 are rejected under 35 U.S.C. 103 as being unpatentable over Viladot Petit et al., US 2013/0017239 (hereinafter referred to as Viladot Petit).
Viladot Petit teaches a delivery system for active ingredients, wherein said delivery systems comprise lipid nanoparticles, such as solid lipid nanoparticles or nanostructured lipid carriers, that include such anti-wrinkle and/or anti-aging active agent as Vitis vinifera extract, e.g., in an amount of 0.001-30 wt% (Title; Abstract; Para. 0019, 0022, 0052-0057, 0066, 0071 as applied to claims 1-3). Viladot Petit teaches that said delivery systems may include:
(i) lipids, e.g., medium-chain triglycerides such as capric and caprylic triglycerides; medium and/or long-chain fatty acids (Para. 0040, 0041 as applied to claims 1, 9, 10);
(ii) caprylyl glycol, phenoxyethanol, imidazolidinyl urea, 1,2-hexanediol, 1,2-octanediol, pentylene glycol as bactericidal/antimicrobial/germicidal agent (Para. 0065, 0067); disodium EDTA as a whitening/depigmenting agent (Para. 0069); butylhydroxytoluene (BHT) as an antioxidant (i.e., preservatives; Para, 0077 as applied to claims 1, 7-8); and
(iii) nonionic surfactants, e.g., ethoxylated alkylphenols, poloxamer 407 (Para. 0044 as applied to claims 12, 13, 29).
Viladot Petit provides examples of preparing composition comprising 0.5 wt% of caprylyl glycol in combination with 0.7 wt% of phenoxyethanol (Para. 0197, 0198 as applied to claim 1).
Viladot Petit teaches that the size of the nanoparticles ranges from 10 nm to 500 nm (Para. 0032 as applied to claims 15, 16); and also teaches that said nanoparticles in combination with suitable excipients can be included into cosmetic compositions/products to be used for the treatment and/or care of the skin, wherein said compositions/products can be solid, liquid or semi-solid, e.g., as creams, oil in water emulsions, water-in-oil emulsions, lotions, gels, cream-gels, etc. (Abstract; Para. 0001, 0021, 0089, 0090 as applied to claims 19, 21-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions comprising lipid nanoparticles and Vitis vinifera extract as taught by Viladot Petit to be used for skin treatment. One would do so with expectation of beneficial results, because Viladot Petit teaches that said compositions comprising Vitis vinifera (grape) extract can be used to inhibit elastin degradation (Para. 0054); for providing anti-wrinkle and/or anti-aging treatment (Para. 0068); to stimulate heat shock protein synthesis (Para. 0070); for healing of the skin, dermatological treatment of skin diseases, treatment and/or prevention of cellulitis, skin tanning, skin lightening or whitening (Para. 0089).
With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a composition/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations/compositions comprising the same components. The determination of suitable or effective concentration/composition can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding the properties of the disclosed formulations/compositions (claim 17-20, 28), it is noted that the cited prior art teaches formulations that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Further, it is noted that the fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Claim 4, 11, 13-14 are rejected as being dependent on rejected base claim.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2016/0263014 A1 - teaches lipid nanoparticles that may include extract of Vitis vinifera as anti-wrinkle and/or antiaging agent and also may include phenoxyethanol and caprylyl glycol, caprylic/capric triglyceride, steareth-2, and other additives (Para. 0044, 0053, 0058, 0061, Examples).
US 2015/0342852 A1 - teaches lipid nanoparticles that may include extract of Vitis vinifera as anti-wrinkle and/or antiaging agent and also may include phenoxyethanol and caprylyl glycol, caprylic/capric triglyceride, and other additives (Para. 0095, 0106, 0108-0110, Examples).
Response to Arguments
Applicant's arguments, filed 06/22/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language and scope, the chemical structure of the compounds to be included into the claimed compositions/products, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the reference cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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