DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 04/25/2024, 02/02/2026 and 04/14/2026 is/are acknowledged. The submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner. See attached copy(ies) of PTO-1449.
Response to Restriction
Applicants' election with traverse of Group I (claims 1-12) in the reply filed on 06/02/2026 is acknowledged. The traversal is on the grounds that Group I is drawn to a composition (cosmetic), and Group II is drawn to method of making a cosmetic as provided at 37 C.F.R. § l.475(b), a national stage application containing claims to different categories of invention can be considered to have unity of invention if the claims distinguishable over prior art are drawn only to a product and a process specially adapted for the manufacture of said product. Accordingly, the claims satisfy unity of invention. Also, it is noted the Written Opinion had indicated novelty with respect to claims 1-16, inventive step with respect to claims 3-16, and industrial applicability with respect to claims 1-16.
This is not found persuasive. The groups lack unity of invention because even though the inventions of these groups require the composition of comprising nanoparticles of simonkolleite crystals, which is zinc chloride hydroxide hydrate composed of zinc, a hydroxy group, and chlorine and is a compound represented by the chemical formula Zn5(OH)8Cl2·(H2O)n, as an active ingredient for hair growth, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Schwartz et al. (US 20040213751A1), who teach zinc pyrithione (ZPT) is used as the anti-microbial particulate in the anti-microbial compositions herein, that an additional benefit of hair growth or re-growth may be stimulated or regulated, or both, or that hair loss may be reduced or inhibited, or that hair may appear thicker or fuller, (0037), and Zinc-Containing Layered Material (ZLM), naturally as minerals, that Zinc, the formula simplifies to Zn1+x(OH)22+x2A-.nH2O. (0024-0030). When x = 0.25, n = 0.25, and A- = Cl-, the specific crystal structure matches the overarching mathematical model for these types of layered materials, Simonkolleite a rare zinc chloride hydroxide mineral Zn5(OH)8Cl2. H2O.
In accordance with 37 CPR 1.499, the claims must be restricted.
I. Claims 1-12, drawn to a composition.
II. Claim 13-16, drawn to methods
The requirement is still proper and is therefore made FINAL. For examining purpose Claims 1-12 of Group I are examined in this office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefore, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 1 recites a cosmetic for hair growth comprising simonkolleite crystals as an active ingredient.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 1-12 is drawn to a composition of matter, in this case a composition of simonkolleite crystals as an active ingredient. Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirement set forth in the composition comprises simonkolleite crystals as an active ingredient.
The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 2-12, the answer is no. There is not a practical application of the law of nature. Claim 5 is same as claim 1; Claims 2 and 11 recite a specific amount of simonkolleite crystals; Claims 3, 6-7 recite further some excipients like polyethylene glycol, polypropylene glycol, an ethylene oxide-propylene oxide copolymer, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and hydroxyethyl cellulose and solvent for cosmetic application. Claim 12 recites the intended use. These claims do not impart "markedly different characteristics" or integrate the natural product into a practical application that provides "significantly more" under MPEP 2106 guidelines.
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use of a natural product (for hair growth) does not amount to significantly more than the judicial exception. The composition contains naturally occurring ingredients that do not have markedly different characteristics from what occurs in nature.
The composition as claimed is composed of all naturally occurring ingredients. The recitation of a coloring agent is not enough to overcome the 101 rejection because this reads on naturally occurring simonkolleite. The claims encompass ingredients polyethylene glycol, polypropylene glycol, an ethylene oxide-propylene oxide copolymer, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and hydroxyethyl cellulose and specific sizes. Recitation of intended use hair growth does not amount to significantly more than the judicial exception. The composition contains naturally ingredients that do not have markedly different characteristics from the natural components that occurs in nature. The recitation of the amounts of ingredients do not arrive at any change in the characteristics (structural or functional) of the naturally occurring ingredients. Claims 1 and 5 are a nature-based product. In the instant case, the claim encompasses ingredients that exist in nature thus the composition is formed of naturally occurring ingredients. It does not have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. For example, gunpowder comprising a finely ground mixture of 75 % potassium nitrate, 15 % charcoal and 10 % sulfur. The three counterparts occur naturally in nature. None of them are explosive in nature. When the substances are finely ground and intimately nixed in the claimed ratio, the claimed combination is explosive upon ignition. The explosive property of the claimed combination is markedly different from the nonexplosive properties of the substances by themselves in nature and thus the claimed combination has markedly different characteristics. In the instant case, there is no evidence that the combination has any markedly different characteristics. There is no indication that the claimed ingredients have any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. Another example involves an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacterial of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific. Here, there is no indication that the claimed mixture of bacteria has any characteristics (structural, functional or otherwise) that are different from the naturally occurring bacteria. Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. The test is not whether the ingredients all occur naturally together in nature. There is no indication that the claimed ingredients have any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients.
As such, the claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception.
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.
Claim(s) 1-2, 4-5 and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz et al. (US 20040213751A1).
Claims 1, 5 and 12,
Schwartz et al. teach a composition comprising an effective amount of metal salts of pyrithione and an effective amount of a zinc containing layered material which provides an augmentation factor greater than 1. More particularly, the present invention relates to personal care compositions and methods of treating microbial and fungal infections on the skin or scalp. (0002). Zinc pyrithione (ZPT), (0013), has an additional benefit of hair growth or re-growth may be stimulated or regulated, or both, or that hair loss may be reduced or inhibited, or that hair may appear thicker or fuller. (0037). Another class of ZLM's can be prepared called Hydroxy double salts, which can be represented by the general formula [M2+1-xM2+1+x (OH)3(1-y)]+An-(1-3y)/n.nH2O where the two metal ion may be different; if they are the same and represented by Zinc, the formula simplifies to [Zn1+x(OH)2]2x+2A-.nH2O. This latter formula represents (where x=0.4) common materials such as Zinc hydroxy chloride and Zinc hydroxynitrate, (0030), where A is Choride. When x = 0.25, n = 0.25, and A- = Cl-, the specific crystal structure matches the overarching mathematical model for these types of layered materials, Simonkolleite a rare zinc chloride hydroxide mineral Zn5(OH)8Cl2. H2O.
Claims 1 and 12 are composition claims and claim 1 with the intended use for hair growth; claim 12 with the intended use for hair growth or scalp care, and the intended uses have no patentable weight.
With regard to claim 2,
Schwartz et al. teach the composition of the present invention may include dispersed particles. In the compositions of the present invention, it is preferable to incorporate at least 0.025% by weight of the dispersed particles, more preferably at least 0.05%, no more than about 20% by weight of the dispersed particles. (0061).
With regard to claim 4,
Schwartz et al. teach the compositions of the present invention may further comprise one or more optional components known for use in hair care or personal care products, provided that the optional components are physically and chemically compatible with the essential components described herein, or do not, otherwise unduly impair product stability, aesthetics or performance. (0065). Other components include Nonionic Polymers, (0080), such as polyalkylene glycols or polyethylene glycols. (0081-0083).
With regard to claim 8,
Schwartz et al. teach the composition of the present invention may include dispersed particles. (0061). In a preferred embodiment, the carrier is water. (0043). The compositions of the present invention are typically in the form of pourable liquids (under ambient conditions). The compositions will therefore typically comprise an aqueous carrier. The aqueous carrier may comprise water, or a miscible mixture of water and organic solvent. (0063).
With regard to claim 9,
Schwartz et al. teach and could be added to the main mix, final mix, or both. Basic Zinc Carbonate or other Zinc-containing layered material could be added to a premix of Surfactants or water with or without the aid of a dispersing agent via conventional powder incorporation and mixing techniques into the final mix. (0205).
With regard to claim 10,
Schwartz et al. teach the compositions of the present invention may further comprise one or more optional components known for use in hair care or personal care products, provided that the optional components are physically and chemically compatible with the essential components described herein, or do not otherwise unduly impair product stability, aesthetics or performance. (0065). Other components include Nonionic Polymers, (0080), such as polyalkylene glycols or polyethylene glycols, (0081-0083), which frequently function as dispersant agents because they dissolve well in water and keep particles separated to stop clumping.
With regard to claim 11,
Schwartz et al. teach the composition of the present invention may include dispersed particles. In the compositions of the present invention, it is preferable to incorporate at least 0.025% by weight of the dispersed particles, more preferably at least 0.05%, no more than about 20% by weight of the dispersed particles. (0061).
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 non-obviousness.
Claim(s) 1 and 3 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US 20040213751A1), in view of Landa et al. (US 20190105249 A1).
The teachings of Schwartz et al. are described in claims 1 and 5 above.
Claim(s) 3 and 6-7,
Schwartz et al. do not teach the cosmetic according to claim 1, wherein the simonkolleite crystals are nanoparticles having a 90% cumulative particle size (D90) of 800 nm or smaller in a volume-based particle size distribution obtained by a laser diffraction scattering method.
Landa et al. teach compositions including zinc titanate crystals for cosmetic purposes. (0025). Nanoparticles of doped or undoped zinc titanate crystals, having at least one dimension or a hydrodynamic diameter not exceeding 500 nm. (0085). The nanoparticles of the disclosure have a cumulative particle size distribution of D90 of 500 nm or less. (0100). In some embodiments, at least 50%, at least 60%, at least 75%, or at least 90% of the nanoparticles embedded in the matrix elements or matrix flakes have a cumulative particle size (D50, D60, D75, and D90, accordingly) of at most 100 nm. (0140).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have a composition comprising Simonkolleite a rare zinc chloride hydroxide mineral Zn5(OH)8Cl2. H2O, taught by Schwartz et al., and the Simonkolleite can be crystals like undoped zinc titanate nanoparticles with D90 of 500 nm or less, and D50 of 100nm or less, taught by Landa et al. since these zinc particle sizes are the appropriate sizes for cosmetic compositions.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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