DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 02/27/2025, are acknowledged.
Claims 21-39 are pending in this action. Claims 1-20 have been cancelled. New claims 21-39 have been added. No new matter was added. Claims 21-39 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/US2022/075796, filed August 31, 2022.
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 lengthy specification (54 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Para. 0019, 0020, 0061, 0064, 0066, 0085, 0139). Appropriate correction is required.
The specification comprises multiple acronyms without proper definition (e.g., Para. 0047, 0097-0100, 0119-0120, 0149). 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 references on publications (e.g., Para. 0063, 0068, 0118). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0069, 0077, 0082-0083, 0111, 0114, 0133, 0141, 0149). 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.
The specification comprises typographic errors that need to be corrected. For instance, the names of the recited chemical compounds should be written in small letters (Para. 0107).
Drawings
The drawings, filed 02/27/2025, are objected to because in Figs, 3-8 x-axis and/or y-axis are not clearly identified. 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 03/18/2025, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
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).
Claim Objections
Claims 21-24, 29-33 are objected to because of the following informalities:
Claims 21 and/or 22 comprise acronym “UVB”. 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.
Claim 23 recites the limitation “wherein the amount of gadusol is present at from about 0.25 to about 2.0 % by weight” that needs to be corrected to “wherein gadusol is present in an amount of from about 0.25 to about 2.0 % by weight” for clarity. Similar is applied to claim 24, as well as to claim 31.
Claims 29-31 comprise the typographic error “the ZnO” that needs to be corrected to “ZnO”.
Claim 32 recites the limitation “composition is spread on a person's skin at from about 1 to about 3 mg/cm3” that needs to be corrected to “composition is spread on a person's skin in an amount of from about 1 to about 3 mg/cm3” for clarity.
Claim 33 discloses “The method of claim 12”. To this point, it is noted that claim 12 has been cancelled.
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 21-39 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 21 is unclear and indefinite, because the structure of the claimed composition is not clearly delineated. Claim 21 attempts to define the subject-matter in terms of the result to be achieved (i.e., variation of sun protection factors, increased UVB absorbance), which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. The claim language does not set forth well-defined boundaries of the invention, but only states a problem to be solved and/or a result to be obtained. 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 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. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Similar is applied to claims 22, 25, 35, 37, 38. Clarification is required.
Claim 23 recites the term "about” that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, but teaches that “about” can change from ±20% to ±5% of the specified value (Specification, Para. 0036). Therefore, the scope of the claim is not reasonably clear. Similar is applied to claims 23, 24, 29, 30, 31, and also to claim 32 regarding the limitation “minimal residual whitening effect”, to claim 34 regarding the term “negligible”, and to claim 39 regarding the term “substantially”. Clarification is required.
Claim 26 recites the limitation “the photoprotective material comprises zinc oxide (ZnO) or titanium dioxide (TiO2)” that is not reasonably clear. In the present case, it is unclear what is claimed as “photoprotective material” – a mixture of compounds (i.e., comprising), or recited compounds (i.e., ZnO or TiO2). Similar is applied to claims 27, 36, 37. Clarification is required.
Claim 29 recites the limitation “ZnO has an average particle size of less than about 100 nm” that is unclear and indefinite. First, it is unclear what particle size should be measured – radius, diameter. Second, it is noted that where a claimed value (i.e., particle size) 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 it is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size 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 cannot be determined. Similar is applied to claim 30, and to claim 31 regarding the limitation “SPF of 30 or greater”. Clarification is required.
Claim 33 discloses “The method of claim 12” that is unclear, because claim 12 has been cancelled, and the instant claims do not disclose “a method”. Clarification is required.
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 21-32, 34-39 are rejected under 35 U.S.C. 103 as being unpatentable over Qvit-Raz et al., US 2016/0000701A1 (cited in IDS, hereinafter referred to as Qvit-Raz), Mahmud et al., US 2021/0071184A1 (cited in IDS; hereinafter referred to as Mahmud).
Qvit-Raz teaches compositions for protection of the skin from ultraviolet rays (UV), wherein said compositions comprise/include a compound(s) that can absorb or reflect UVA (320-400 nm), UVB (315-280 nm), or both (Abstract; Para. 0006, 0015, 0098, 0215 as applied to claims 21, 22). Qvit-Raz teaches that said compositions may include: (i) gradusol (Claim 10; Para. 0016, 0097, 0099 as applied to claim 21); in combination with such sunscreen products/compounds as (ii) zinc oxide, titanium dioxide (Claims 5, 9; Para. 0127, 0215 as applied to claims 21, 26, 28); (iii) avobenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, sulisobenzone, benzophenone-4, padimate-O, cinoxate, dioxybenzone (Claim 5; Para. 0127, 0215 as applied to claim 27); and further may include (iv) other additives, e.g., stabilizers (Para. 0195-0201 as applied to claim 37).
Qvit-Raz does not teach compositions that may include gadusporine A, gadusporine B or gadusporine C (claim 36).
Mahmud teaches sunscreen compositions that include naturally produced sunscreen compounds such as mycosporine-like amino acids (MAAs; Para. 0036-0038), e.g., in combination with gradusol (Para. 0040-0043). Mahmud teaches that said sunscreen compositions may include such sunscreen agents as: (i) gradusol in combination with gadusporine A, gadusporine B and gadusporine C (Para. 0126-0128 as applied to claims 21, 35, 36); (ii) zinc oxide, titanium dioxide (Para. 0130 as applied to claims 21, 26, 28); (iii) homosalate, octocrylene (Para. 0141 as applied to claims 21, 27); in combination with (iv) other additives, e.g., antioxidants, scavengers (Para. 0131 as applied to claims 21, 37). Mahmud teaches that said sunscreen agents can be present in amounts to achieve a SPF of from 2 to 60 (Para. 0142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify photoprotective compositions as taught by Qvit-Raz by including mycosporine-like amino acids as taught by Mahmud, because it is prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. (MPEP 2144.06). One would do so with expectation of beneficial results, because the cited prior art teaches that said natural sunscreen products/compounds can be used as a replacement for synthetic compounds, e.g., oxybenzone and octinoxate, to minimize toxicity of synthetic compositions.
With regard to the concentrations as instantly claimed (claims 23, 24, 31), it is noted that differences in experimental parameters such as concentration of compounds in a solution/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 comprising the same components. The determination of suitable or effective concentration/composition can be 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 (claims 25, 32, 38), 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.
Claims 29, 30 are rejected as being dependent upon rejected base claims. Applicant is advised to clarify the claimed language, the structure of the claimed 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 references cited, to place the application in condition for allowance.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2013/0115180A1 - teaches compositions for administering a specific wavelength phototherapy by administering compositions that may include and gadusol, avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octocrylene, octinoxate, octisalate, oxybenzone, padimate O, sulisobenzone, (Claims 10, 11; Abstract; Para. 0031).
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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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