DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 02/05/2024, are acknowledged. Claims 1-28 are pending in this action. Claims 1-27 have been amended. New claim 28 has been added. No new matter was added. Claims 1-28 are currently under consideration.
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 and now issued as U.S. Patent No. 8,758,805, which claims benefit of foreign priority to BR102021015486-1, filed August 5, 2021. No English translations of the certified copy of priority application has been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Inventorship
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.
Specification
The specification is objected to because of the following informalities:
The specification comprises multiple acronyms without proper definition (e.g., Para. 0027-0030, 0057, 0085, 0183-0184). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The specification comprises the typographic error, e.g., “30% medium chain triglycerides” (e.g., Para. 0061) that needs to be corrected to “30% of medium chain triglycerides”. Similar is applied to Para. 0062-0065. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Para. 0061-0065, 0087-0090, 0123, 0147, 0151, 0152, 0159-0163, 0166, 0171-0179). Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (Para. 0131, 0132, 0168-0170). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
Drawings
The drawings, filed 02/05/2024, are objected to because in Fig. 3 y-axis is not clearly identified. Further, the image scale labels in Figs. 4 and/or 6 are unreadable. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement, filed 06/20/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
The information disclosure statement fails to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
The information disclosure statement does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 5-7, 9-13, 15-18, 20, 28 are objected to because of the following informalities:
Claim 5 comprises the typographic error “comprises 0.1 to 3%” that needs to be corrected to “comprises from 0.1 to 3%” (see, e.g., claims 1, 2). Similar is applied to claims 7, 9, 11-13, 15, 17.
Claim 6 comprises the typographic error “consisting of:” that needs to be corrected to “consisting of”. Similar is applied to claim 10.
Claim 6 comprises acronyms “BHT”, “EDTA”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. Similar is applied to claims 11, 28.
Claim 7 comprises the typographic error “2% phenoxyethanol” that needs to be corrected to “2% of phenoxyethanol”. Similar is applied to other constituents recited in claim 7, as well as to claims 11-13.
Claim 10 comprises the typographic error “polypolylene glycol stearyl ester” that needs to be corrected to “polypropylene glycol stearyl ester” or clarified.
In claims 15-18 (dependent on claim 1) the term “particles” should be corrected to “nanoparticles” for clarity (see claim 1) or clarified.
Claim 20 recites the limitation “oxidative stress response/inflammation” that needs to be corrected to “oxidative stress response and inflammation” or clarified.
In claim 20 the terms “DNA repair” and/or “differentiation of keratinocytes” are recited twice that needs to be corrected or clarified.
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 1-28 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.
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.
Claim 7 recites the amount limitation “0.1 to 2%” that is unclear and indefinite, because the recited relative amounts are not clearly delineated (e.g., mol%, wt%, etc.). Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claims 8, 11-13. Clarification is required.
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.
Claim 11 recites the limitation “capric/caprylic acid triglyceride” that is not reasonably clear. Is it a mixture of compounds, OR a single compound? Clarification is required.
Claim 12 recites the limitation “selected from the group consisting of ethoxylated nonionic surfactant, poloxamer" that is unclear and indefinite. In the present case, it is noted that the members of the Markush group must belong to a recognized physical or chemical class or to an art-recognized class. MPEP §803.02. In the present case, some members of said group are defined by their functionality (i.e., surfactant), whereas other members are defined by their chemical properties (i.e., poloxamer). Clarification is required.
Claim 13 comprises parenthetical expressions, i.e., “steareth-2 (stearyl alcohol ethoxylate)”, “poloxamer 407 (polymer with oxirane)”, “steareth-21 (stearyl alcohol ethoxylate)” that do not clarify the scope of the claim. To this point, 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). In the present case, different constituents, e.g., steareth-2 and steareth-21, are “clarified” by the same parenthetical expression, i.e., (stearyl alcohol ethoxylate). Further, it is noted that “poloxamer 407” is a product name that does not clearly define the structure/composition of said triblock copolymer to be used in the instant invention. Clarification is required.
Claim 15 (dependent on claim 1) recites the limitation “the particles have an average diameter of 300 to 420 nm” that is unclear and indefinite. First, given that the ranges are shown with and without units of measurements, the metes and bounds of the claim are not reasonably clear. Second, where a claimed value (i.e., particle 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.
Claim 19 discloses “A method for preventing skin aging, 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 a method for preventing skin aging by providing antioxidation effect, anti-inflammatory effect, whitening effect, photoprotection, and by controlling skin permeation and gene modulation relation to skin aging? Clarification is required.
Claims 19, 20, 28 disclose a method for downregulating genes responsible for extracellular matrix synthesis, cellular and oxidative stress response, DNA repair, differentiation of keratinocytes, hydration, intercellular junctions and desquamation, and genes responsible for growth factors, extracellular matrix degradation, innate immunity, proliferation of keratinocytes, and inflammation by applying the composition of claim 1 to skin, i.e., the composition of lipid nanoparticles comprising 0.1-2 wt% of Vitis vinifera (see claim 1). To this point, it is noted that 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 (i.e., 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. Clarification is required.
Claims 2-6, 9, 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 1-28 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 (Title; Abstract; Para. 0019, 0022, 0055, 0055, 0066, 0071 as applied to claim 1). 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 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 5-8); and
(iii) nonionic surfactants, e.g., ethoxylated alkylphenols, poloxamer 407 (Para. 0044 as applied to claims 12, 13).
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. Applicant is advised to clarify the language and the scope of the claims, the structure of the claimed formulations/compositions 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.
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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615