DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending and represent all claims currently under consideration.
Claims 13-20 are withdrawn.
Priority
This application is a 371 of PCT/US21/47941, which claims benefit to PRO 63/071,782.
Claims 1-20 are considered to have an effective filing date of 08/28/2020.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-12, drawn to an ultraviolet light-absorbing particle; and
Group II, claims 13-20, drawn to a method of protecting skin from ultraviolet light.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The groups lack unity of invention because even though the inventions of these groups require the technical feature of an ultraviolet light-absorbing particle comprising a biocompatible polymer and a UV absorber, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Willian (WO 2014009097 A1; IDS reference, 02/22/2023). Willien teaches a cosmetically acceptable composition comprising particles comprising a UV-screening agent (Willien, claim 1), which absorbs UV radiation (i.e., a UV absorber; Willien, page 9, lines 10-11), and a biocompatible material which can be polymers (Willien, page 4, lines 44-45).
During a telephone conversation with Geoffrey Lottenberg on 05/23/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statements filed 02/22/2023, 03/06/2023, and 09/13/2024 have been considered.
Regarding the information disclosure statement filed 03/06/2023, NPL citation 2 was not considered, because it does not include a date of the publication as required. See MPEP § 1.98.
Claim Objections
Claims 2, 10, and 12 are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 2, “Trolamine salicylate, and Zinc oxide” should read “Trolamine salicylate, Zinc oxide”.
Regarding claim 10, “polyvinyl alcohol surfactant” should read “a polyvinyl alcohol surfactant”, “thickener” should read “a thickener”, and “binder” should read “a binder”.
Regarding claim 12, “pigment” should read “a pigment”.
Specification
The use of the terms TWEEN, BASF, Branson, Nanotrac, Cary, Agilent, and Dragonhawk, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 2, 4, 6, and 10 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.
Regarding claim 2, the parenthetical recitations of “(Tinuvin® 400)”, “(Tinuvin® 405)”, “(Tinuvin® 460)”, “(Tinuvin® 479)”, “(Tinuvin® 900)”, and “(Tinuvin® 928)” render the claims indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d). Further, where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe UV absorbers and, accordingly, the identification/description is indefinite.
Regarding claim 4, the term “analog” is a relative term which renders the claim indefinite. The term “analog” is 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. It is unclear how far one can deviate from the parent compound without the “analog” being so far removed therefrom as to be considered a different compound.
Regarding claim 6, the parenthetical recitations of “(PMMA)”, “(PLA)”, “(PLGA)”, “(PDMS)”, and “(PEG)” render the claims indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d).
Regarding claim 10, the parenthetical recitations of “(v/v)” and “(molecular weight 1000)” render the claim indefinite because it is unclear whether the limitation in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Willien (WO 2014009097 A1; IDS reference, 02/22/2023).
Regarding claim 1, Willien teaches a cosmetically acceptable composition comprising particles comprising titanium dioxide (Willien, page 49, example 1), which absorbs UV radiation (Willien, page 9, lines 10-11) and PMMA (i.e., a biocompatible polymers; Willien, page 49, example 1). “Suitable for intradermal use” is a recitation of intended use. Patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure. See MPEP § 2111.02. Willien teaches the structure of the instant claim and teaches the composition can be used in a great number of treatments and as an anti-sun product (Willien, page 48, lines 23-28). Therefore, the composition of Willien is expected to be suitable for intradermal use absent evidence to the contrary.
Regarding claim 2, Willien teaches all the elements of the claimed invention as applied to claim 1. Willien teaches the UV screening agent is titanium dioxide (Willien, page 49, example 1).
Regarding claim 5, Willien teaches all the elements of the claimed invention as applied to claim 1. Willien teaches the particles A2 comprise the polymer PMMA (i.e., a polymer particle; Willien, page 49, example 1).
Regarding claim 6, Willien teaches all the elements of the claimed invention as applied to claim 1. Willien teaches the particles comprise PMMA (Willien, page 49, example 1).
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, 5-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Willien (WO 2014009097 A1; IDS reference, 02/22/2023), further in view of Piasecka-Zelga (J Occup Health, 2015; IDS reference, 02/22/2023).
Regarding claim 1, Willien teaches a cosmetically acceptable composition comprising particles comprising a UV-screening agent (Willien, claim 1), which absorbs UV radiation (i.e., a UV absorber; Willien, page 9, lines 10-11), and a biocompatible material which can be polymers (Willien, page 4, lines 44-45). Willian teaches the composition can be used in a great number of treatments and as an anti-sun product (Willien, page 48, lines 23-28), but does not specifically state the suitability for intradermal use as stated in the instant claim. Piasecka-Zelga teaches a sensitization study of UV absorbers (Piasecka-Zelga, abstract), such as zinc oxide (Piasecka-Zelga, page 277, “Z11 modifier”) and polymers (Piasecka-Zelga, page 281, table 1, “paste”), in which dispersions are injected into animals to test for irritation (i.e., the ingredients are suitable for intradermal use; Piasecka-Zelga, page 278, “Research method”).
Willien and Piasecka-Zelga are considered to be analogous to the claimed invention, because both are in the same field of UV-absorbing cosmetics. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed particle based on the teachings of Willien and it would have been obvious to have utilized the particle intradermally, because Piasecka-Zelga teaches injection as a method of assessing acute dermal irritation for cosmetics (Piasecka-Zelga, page 275, “objectives”).
Regarding claim 2, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the UV screening agent can be titanium or zinc oxide (Willien, page 5, lines 38-41).
Regarding claim 5, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the particles A2 comprise the polymer PMMA (i.e., a polymer particle; Willien, page 49, examples 1-4).
Regarding claim 6, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the particles comprise PMMA (Willien, page 49, examples 1-4).
Regarding claim 7, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the composition comprises an active agent such as vitamins or antioxidants (Willien, page 47, lines 30-36).
Regarding claim 8, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the particles can be in the form of an oily dispersion in an oil such as triglycerides (i.e., the particle is suspended in a biocompatible oil; Willien, claim 18).
Regarding claim 9, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the composition further comprises additives such as thickeners and surfactants (Willien, page 46, lines 41-47).
Regarding claim 12, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the particle further comprises an optional colouring pigment (Willien, page 37, line 44).
Claims 3-4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Willien (WO 2014009097 A1; IDS reference, 02/22/2023) and Piasecka-Zelga (J Occup Health, 2015; IDS reference, 02/22/2023) as applied to claims 1-2, 5-9, and 12, further in view of Gupta (US 6348591 B1).
Regarding claim 3, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the composition further comprises additives such as stabilizers (Willien, page 46, lines 41-46) but does not specifically teach a photo-stabilizer. Gupta teaches ultraviolet light absorbers and stabilizers for inhibiting degradation from sunlight (i.e., photodegradation; Gupta, column 1, lines 23-24) and teaches these additives can be used in a wide variety of materials including cosmetics (Gupta, column 7, lines 43-45).
Willien, Piasecka-Zelga, and Gupta are considered to be analogous to the claimed invention, because both are in the same field of UV-absorbing cosmetics. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Willien and Piasecka-Zelga to have included a stabilizer as taught by Gupta, because Gupta teaches sunlight causes degradation of various materials and stabilizers can inhibit degradation from sunlight (Gupta, column 1, lines 16-24).
Regarding claim 4, Willien, Piasecka-Zelga, and Gupta together teach all the elements of the claimed invention as applied to claim 3. Gupta further teaches a preferable stabilizer is a 2,2,6,6-tetraalkylpiperidine derivative of the following formula wherein J is an alkyl (i.e., an alkylated analog of 2,2,6,6,-tetramethylpiperidine):
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(Gupta, column 47, lines 45-58). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Willien and Piasecka-Zelga to have included a preferred stabilizer as taught by Gupta, because Gupta teaches sunlight causes degradation of various materials and such stabilizers can inhibit degradation from sunlight (Gupta, column 1, lines 16-24).
Regarding claim 10, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches the aqueous phase comprises 1-30% of a water-soluble organic solvent which can be glycerol (Willian, page 40, lines 9-17), which overlaps the claimed range of 10-30% of glycerol. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). Willien further teaches the use of hydrophilic thickeners (i.e., thickeners that would be in the aqueous layer with the glycerol; Willien, page 47, line 8).
Willien teaches the composition further comprises additives such as stabilizers and surfactants (Willien, page 46, lines 41-47) and teaches surfactants including polyols (Willien, page 46, line 12) in a concentration of 1-50% by weight (Willien, page 28, line 20), but does not specifically teach a polyvinyl alcohol surfactant to stabilize the particle and does not teach a (v/v) amount. Gupta teaches polymeric materials for stabilizing against degradation from UV radiation (Gupta, column 27, lines 54-57) to include polyvinyl alcohol (Gupta, column 28, line 7), but does not teach a (v/v) amount. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Willien and Piasecka-Zelga to have included a stabilizer as taught by Gupta, because Gupta teaches sunlight causes degradation of various materials (Gupta, column 1, lines 16-24) and stabilizers such as polyvinyl alcohol (Gupta, column 28, line 7) can inhibit degradation from sunlight (Gupta, column 1, lines 16-24).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Willien (WO 2014009097 A1; IDS reference, 02/22/2023) and Piasecka-Zelga (J Occup Health, 2015; IDS reference, 02/22/2023) as applied to claims 1-2, 5-9, and 12, further in view of Tibbits (US 20160339120 A1; IDS reference, 02/22/2023).
Regarding claim 11, Willien and Piasecka-Zelga together teach all the elements of the claimed invention as applied to claim 1. Willien teaches a cosmetically acceptable composition comprising particles comprising a UV-screening agent (Willien, claim 1), which absorbs UV radiation (i.e., a UV absorber; Willien, page 9, lines 10-11), but does not specifically state the UV-screening agent is a tattooable sensor. Tibbits teaches a programmable bacterial tattoo (i.e., the bacteria is tattooable; Tibbits, claim 1) wherein the bacteria is programmed to sense ultraviolet radiation (i.e., the bacteria is a UV sensor; Tibbits, claim 10).
Willien, Piasecka-Zelga, and Tibbits are considered to be analogous to the claimed invention, because both are in the same field of UV-absorbing cosmetics. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Willien and Piasecka-Zelga with a sensor as taught by Tibbits, because Willien teaches the use of UV screening agents for protection from UV radiation (Willien, page 3, lines 16-18)) and Tibbits teaches the use of such sensors for UV radiation (Tibbits, page 2, paragraph 0028).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613