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 .
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
The instant application 18/533,442, filed 12/08/2023, claims domestic benefit to U.S. provisional patent application 63/477,913, filed 12/30/2022, and claims foreign priority to French patent application FR 2303024, filed 03/29/2023.
Status of Application and Claims
No preliminary amendment has been filed. Claims 1-20 are currently pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/08/2023 and 01/17/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner except where noted. In the IDS submitted 12/08/2023, NPL documents “L’Oreal Paris – Miracle Blur” and “L’Oreal Paris – Pore Vanisher” are not considered because the copies provided are illegible. In the IDS submitted 01/17/2024, the NPL document “Preliminary Search Report and Written Opinion issued…” is not considered because neither an English translation nor a concise summary of the relevance has been provided in English, as is required in 37 CFR 1.98.
Claim Objections
Claims 3-5 and 11 are objected to because of the following informalities:
Terms and limitations placed in parenthesis are not considered part of the claim. Only reference characters and abbreviations are placed in parenthesis.
Claim 3 should have the word “from” or “from the group consisting of” inserted between the words “selected” and “polysaccharides” in line 2.
Claim 4 recites duplicate recitations of montmorillonite(s), saponite(s), and hectorite(s) in lines 2-3.
Claim 5 recites duplicate recitations of cellulose (lines 3 and 7), perlite (line 3) and nylon-12 (lines 6 and 7).
Claim 11 should recite “sodium alginate fibers” instead of “sodium alginate fivers” in line 8.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification, while being enabling for providing improvement to the appearance of skin, e.g., by reducing the appearance of wrinkles, eye bags, pores, and skin imperfections such as scarring, dark spots (and uneven skin tone), dark circles, and roughness, does not reasonably provide enablement for all treatments of the skin, such as acne, rosacea, cancer, etc. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, relative skill level, and breadth of the claims
The instant invention is directed to a method of treating skin.
The complex nature of the claims is greatly exacerbated by the breath of the claims. The claims encompass broad ways that application of the composition of claim 1 to the skin treats the skin. The relative skill of those in the art is high, that of an MD or PhD.
The state and predictability of the art
The state of the art recognizes that topical application of a composition comprising pullulan, hydrophilic non-acrylate film-forming polymers, mineral clays, water-soluble organic solvents, and water provides a long-lasting skin-tightening effect and a mattifying finishing effect. As illustrative of the state of the art, the examiner cites US 2020/0345596 A1 (Montoya, M. et al) published 11/05/2020 (cited in IDS 01/17/2024).
The lack of significant guidance from the specification or the prior art with regard to treating the skin makes practicing the scope of the invention unpredictable. Since the instant specification provides no limiting definition of the term “treatment”, the examiner will adopt the broadest reasonable interpretation for it. The Merriam-Webster’s Online Dictionary defines “treatment” as “management and care to prevent, cure, ameliorate, or slow progression of a medical condition.”
The claim is thus very broad insofar as it recites treatment of the skin. While such “treatment” of a medical condition of the skin might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live; complications such as allergy, inflammation, or inability to treat a condition, such as acne, rosacea, cancer, etc., is always a risk.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for treating the skin. The specification only states that the composition of the invention provides improvement to the appearance of skin, e.g., by reducing the appearance of wrinkles, eye bags, pores, and skin imperfections such as scarring, dark spots (and uneven skin tone), dark circles, and roughness (p. 1 “Field of the Disclosure”). This guidance fails to address the treatment of any/all medical skin condition(s). Due to the limited guidance in the art surrounding treatment of the skin by applying a composition comprising pullulan, hydrophilic non-acrylate film-forming polymers, mineral clays, water-soluble organic solvents, and water to skin, one of ordinary skill would undergo undue experimentation in deducing which medical conditions of the skin can be effectively treated by this method, and which components are responsible for said treatment.
There are no provided working examples of the specification directed towards treating skin. The principles, preferred embodiments, and modes of operation described in the specification fail to enable treatment of any condition of the skin.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed method could be predictably used to treat all conditions of the skin as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 1-5, 10, 13-14 and 18 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 claims 1 (lines 14-16), 3 (line 3), 13 (line 2), and 18 (lines 18-20), the phrase "for example" (or in this case, “e.g.”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1-4 and 18, any recitation of the phrase “preferably” or “more preferably” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are requirements of the claimed invention, or are merely optional. For the purposes of compact prosecution, the limitations following any recitation of “preferably” or “more preferably” are considered to be optional.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “hectorites”, and the claim also recites “including disteardimonium hectorite” which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation “silica” and the claim also recites “silica which may or may not be coated.” The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 recites the limitation “the one or more fibers.” There is insufficient antecedent basis for this limitation in the claim or the claims upon which it depends (claim 8, which depends on claim 6, which depends on claim 1). For the purposes of compact prosecution, claim 10 will be interpreted as instead depending upon claim 9, which introduces the limitation of one or more fibers.
Regarding claim 14, the phrase “and/or” renders the claims indefinite because it is unclear if the limitations following the phrase should be considered as optional, or part of the claimed invention. Any claimed limitations following recitation of the phrase “and/or” will be interpreted as being optional limitations recited in the alternative, and not required for the claimed invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends upon claim 2. Claim 2 narrows the scope of the “one or more hydrophilic non-acrylate film-forming polymers” of claim 1 by stating these polymers are selected from “polyurethanes, vinyl polymers, natural polymers, latex or pseudolatex polymers, vinylpyrrolidone-based polymers, amphoteric polymers or a combination thereof.” However, claim 3 appears to broaden the narrowed scope of claim 2 by instead reciting that the one or more hydrophilic non-acrylate film-forming polymers are selected from the comparatively broader group of “polysaccharides and polysaccharide derivatives (e.g., carrageenan and dehydroxyxanthan gum), polyurethanes, polyvinyl alcohol, sodium hyaluronate, vinyl polymers, natural polymers, copolymers derived from C4-C monounsaturated carboxylic acids or anhydrides, methyl vinyl ether/butyl monomaleate copolymers, polyvinyl pyrollidone, polyvinyl acetate, water soluble gums, water soluble celluloses, dextrans, hyaluronic acid, cyclodextrins, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymers, or a mixture thereof.” Thus, claim 3 fails to further limit the subject matter of the claim upon which it depends, because it instead broadens the scope of claim 2. For the purposes of compact prosecution, claim 3 is being interpreted as instead depending upon claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3-8, 12-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2020/0345596 A1 (Montoya, M. et al) published 11/05/2020 (cited in IDS 01/17/2024).
Montoya teaches skin-tightening compositions which provide a long-lasting skin-tightening effect and mattifying finishing effect (Abstract). Montoya exemplifies a skin tightening composition in the form of a stable oil-in-water emulsion which comprises, in % weight of the total weight of the composition: (a) 5 wt. % magnesium aluminum silicate; (b) 2 wt. % hydroxypropylcellulose; (c) 3 wt. % stearalkonium hectorite; (d) 1 wt. % pullulan and/or galactoarabinan; (e) either 13.6 or 5.6 wt. % of pentylene glycol, glycerin, propylene glycol, and/or caprylyl glycol; (f) 0.8 wt. % sodium acrylates copolymer and/or acrylates copolymer; (g) either 69 or 78 wt. % water; (h) 2 wt. % caprylic/capric triglyceride; (i) 1.2 wt. % polyglyceryl-3 methylglucose distearate steareth-20, and/or lecithin acrylates/polytrimethylsiloxymethacrylate copolymer, either 1.2 or 1.1 wt % licorice root extract, caffeine, biotin and/or adenosine, and ≤1 wt. % preservatives, chelating agents, pH adjusters, etc. (Table 1 “H” and “I”). Montoya teaches that hydroxypropyl cellulose is a water soluble cellulose derivative ([0124]).
Component (a) reads on the one or more particulate fillers and the concentration range thereof recited in instant claims 1, 5, and 18, because magnesium aluminum silicate is a species of the claimed genus of aluminum siliacate recited in instant claim 5. Component (b) reads on the optional one or more hydrophilic non-acrylate film-forming polymers other than pullulan and the concentration range thereof recited in instant claims 1, 3, and 18, because hydroxypropyl cellulose is a species of the claimed genus of water-soluble celluloses recited in instant claim 3. Component (c) reads on the one or more mineral clays and the concentration range thereof recited in instant claims 1, 4, and 18, because stearalkonium hectorite is a species of the claimed genus of hectorites recited in instant claim 4. Component (d) reads on the pullulan and concentration range thereof recited in instant claims 1 and 18. Component (e) reads on the one or more water-soluble organic solvents and concentration range thereof, as recited in instant claims 1, 6-8, and 18. The concentration of water reads on the water claimed in instant claims 1 and 18. The presence of caffeine in the composition read on the one or more skin active agents recited in instant claims 12, 13 and 18. The presence of ≤1 wt. % of preservatives, chelating agents, and pH adjusters reads on the miscellaneous ingredients and concentration range thereof, as recited in instant claims 14 and 18, respectively. The composition being in the form of an oil-in-water emulsion satisfies the limitation of instant claim 15.
The instant specification defines “essentially free” as meaning “less than about 2% by weight of the specific material based on the total weight of the composition” (see instant specification p. 51 2nd para). The instant specification further defines “about” as within +/- 5% of the indicated number (see instant specification p. 50 4th para). Therefore, the instant specification is inferring that “essentially free” means less than 1.9-2.1% by weight of the composition, because +/- 5% of 2 = the range of 1.9-2.1 (2*0.05 = 0.1). Montoya teaches a total content of sodium acrylates copolymer and/or acrylates copolymer (component (f)) and polyglyceryl-3 methylglucose distearate steareth-20, and/or lecithin acrylates/polytrimethylsiloxymethacrylate copolymer (one of the components in (i)) to equal exactly 2% by weight of the composition (0.8 wt. % + 1.2 wt. % = 2 wt. %). Therefore, Montoya teaches an emulsion composition where, as defined by the instant specification, the composition is essentially free from acrylate and/or methacrylate polymers and copolymers regardless of what other monomer units appear in the polymer and copolymer (and crosspolymer). Therefore, Montoya’s composition reads on the optional limitation regarding acrylate and/or methacrylate polymers and copolymers recited in instant claims 1 and 18, and Montoya also reads on the limitation of claim 17.
Montoya teaches methods for improving the appearance of skin by applying the aforementioned skin-tightening compositions to the skin; the methods improve the appearance of the skin by treating or reducing the appearance of wrinkles, blemishes, dryness, roughness, dullness, age spots, sagging, eye bags, and/or puffy skin ([0025]). Montoya teaches the composition may be applied with the hands and simply spread or rubbed into the skin of the face and/or neck, especially the skin around the eye ([0154]). These teachings read on the method of instant claims 19 and 20.
Pertaining specifically to instant claim 18, because the presence of fibers is considered optional in the claimed composition, the teachings of Montoya satisfy the limitations of the composition claimed in claim 18 despite not specifically incorporating fibers into the composition. Therefore, all required limitations of claim 18 are read upon by Montoya, as addressed supra.
Montoya does not explicitly state that its skin tightening composition is also skin perfecting, as is recited in the preambles of the instant claims. However, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) and Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). The intended use of the instantly claimed composition (to be skin perfecting) is not considered a limitation and is of no significance to claim construction because the bodies of the instant claims addressed herein intrinsically set forth all of the limitations of the claimed invention. Montoya teaches all of the limitations of the instant claims addressed herein, and the preamble of the instant claims does not distinguish the instantly claimed invention from the invention of Montoya.
Therefore, Montoya anticipates instant claims 1, 3-8, 12-15 and 17-20.
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.
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.
Claims 1-8 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0345596 A1 (Montoya, M. et al) published 11/05/2020 (cited in IDS 01/17/2024) in view of Behrens, M. (2021). “Covestro’s Baycusan Eco E 1001 Enables High Natural Content, Wear Resistance.” Cosmetics & Toiletries, https://www.cosmeticsandtoiletries.com/cosmetic-ingredients/news/21846631/covestro-llc-covestros-baycusan-eco-e-1001-enables-high-natural-content-wear-resistance (cited in PTO-892) and “Baycusan® eco E 1001” Information Sheet. Covestro. Available online on 10/26/2021. Accessed via WebArchive.org. https://solutions.covestro.com/-/media/covestro/solution-center/brands/downloads/imported/1634108475.pdf (hereinafter “Covestro;” cited PTO-892).
The teachings of Montoya as they pertain to instant claims 1, 3-8, 12-15 and 17-20 are addressed in the 35 U.S.C. 102 rejection supra.
Montoya differs from the instantly claimed invention in that it fails to teach that the composition’s one or more hydrophilic non-acrylate film-forming polymers are selected from a group including polyurethanes, as recited in instant claim 2. Montoya fails to teach that one of the one or more hydrophilic non-acrylate film-forming polymers is polyurethane-99, as recited in instant claim 16.
Behrens teaches that Covestro’s Baycusan eco E 1001 is a naturally derived polymer that acts as a film former and is suitable for water-based products (1st para). Behrens teaches that Baycusan eco E 1001 is a partially bio-based alternative to synthetic film formers and imparts wear resistance for cosmetics that lasts all day (2nd para). Behrens teaches the chemistry of the liquid polymer allows for the introduction of high amounts of renewable materials into polymers without losing the key benefits of synthetics; e.g., water resistance, rub-off resistance and anti-smudge effects; furthermore, the natural content of the active is above 50% which fulfills the bio-based content criteria for a naturally derived ingredient (3rd para).
Covestro teaches that the INCI name for Baycusan® eco E 1001 is Polyurethane-99 (“General information”). Covestro recommends a formulating use level of 3-10% when formulating with Baycusan® eco E 1001 (“Use level”). Covestro suggests addition of Baycusan® eco E 1001 at the end of the formulation process after homogenization with pH adjustments as necessary (“Process”).
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add Baycusan® eco E 1001 (INCI name polyurethane-99) to the skin tightening composition of Montoya, at the recommended formulation use level of 3-10% by weight of the composition, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Baycusan® eco E 1001 is a desirable, bio-derived film former which imparts water resistance, rub-off resistance and anti-smudge effects for long-lasting wear-resistance in water-based cosmetic formulations. The formulation of Montoya is intended to be a long-lasting skin tightening composition, and thus would benefit from the long-wear properties of the film former Baycusan® eco E 1001. The ordinarily skilled artisan would have a reasonable expectation of success adding Baycusan® eco E 1001 to the water-based oil-in-water emulsion formulation of Montoya at a concentration of 3-10% by weight of the composition because Behrens teaches that Baycusan® eco E 1001 is suitable for water-based skin products, and Covestro teaches addition of Baycusan® eco E 1001 to formulations at this concentration range is suitable at the end of the formulation process.
Claims 1, 3-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0345596 A1 (Montoya, M. et al) published 11/05/2020 (cited in IDS 01/17/2024) in view of Lubart, R. et al. (May 2022). “A Novel Facial Cream Based on Skin-penetrable Fibrillar Collagen Microparticles.” J. Clin. Aesthet. Dermatol., 15(5), 59-64 (cited PTO-892).
The teachings of Montoya as they pertain to instant claims 1, 3-8, 12-15 and 17-20 are addressed in the 35 U.S.C. 102 rejection supra. Montoya also teaches inclusion of skin-tightening active ingredients into its compositions, such as a humectant and moisturizing ingredients from a group which includes collagen ([0139]-[0140]).
Montoya differs from the instantly claimed invention in that it fails to teach that its composition further comprises one or more fibers, particularly about 0.01 to about 15 wt. % of the one or more fibers as recited in instant claims 9 and 10. Furthermore, Montoya fails to teach that the one or more fibers are selected from the list of fibers recited in instant claim 11.
Lubart teaches that collagen protein plays a key role maintaining skin firmness; topical creams containing collagen fibers are widely available, but their usefulness is questionable due to the limited skin penetration of collagen (p. 59 “Background”). Lubart teaches the preparation of micronized marine collagen (m-collagen) -fibers and subsequent insertion into a cream; the micronized collagen fibers in the cream is found to penetrate the stratum corneum (SC) barrier (p. 60 L. Col. 2nd para). Lubart teaches the m-collagen is inserted, at a 0.2% concentration, into a basic cream consisting of aqua (water) and other basic ingredients (p. 60 “Preparation of a cream with micronized collagen”). Lubarts demonstrates that the resulting facial collagen cream allows for fully functional collagen fibers to penetrate deeper layers of human skin samples (p. 63 “Conclusion”).
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to insert micronized marine collagen fibers into the skin-tightening composition of Montoya at a 0.2% concentration relative to the total weight of the composition, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because collagen protein plays a key role in mainlining skin firmness, and micronized marine collagen fibers are shown by Lubart to penetrate the stratum corneum when added to a basic facial cream. The formulation of Montoya is intended to be a skin tightening composition for use on the face, and Montoya specifically teaches the incorporation of collagen into its composition; thus, the facial composition of Montoya would benefit from the enhanced penetration of the micronized marine collagen fibers taught by Lubart. The ordinarily skilled artisan would have a reasonable expectation of success adding micronized marine collagen fibers to the composition of Montoya at a concentration of 0.2% by weight of the composition because Lubart demonstrates that simple insertion of the micronized marine collagen fibers into a basic facial cream in this manner results in a functional cream which demonstrates the desirable deep-penetration effects of the incorporated collagen. Thus, the ordinarily skilled artisan would reasonably expect that simple insertion of the micronized marine collagen into the facial composition of Montoya would be comparably successful, especially since Montoya teaches collagen is appropriate for use in its compositions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 14-15 and 18 of U.S. Patent No. US 10,799,435 B1 in view of US 2020/0345596 A1 (Montoya, M. et al) published 11/05/2020 (cited in IDS 01/17/2024; PGPub is prior art which corresponds to US 10,799,435 B1), Behrens, M. (2021). “Covestro’s Baycusan Eco E 1001 Enables High Natural Content, Wear Resistance.” Cosmetics & Toiletries, https://www.cosmeticsandtoiletries.com/cosmetic-ingredients/news/21846631/covestro-llc-covestros-baycusan-eco-e-1001-enables-high-natural-content-wear-resistance (cited in PTO-892), “Baycusan® eco E 1001” Information Sheet. Covestro. Available online on 10/26/2021. Accessed via WebArchive.org. https://solutions.covestro.com/-/media/covestro/solution-center/brands/downloads/imported/1634108475.pdf (hereinafter “Covestro;” cited PTO-892) and Lubart, R. et al. (May 2022). “A Novel Facial Cream Based on Skin-penetrable Fibrillar Collagen Microparticles.” J. Clin. Aesthet. Dermatol., 15(5), 59-64 (cited PTO-892).
US’435 claims a skin-tightening composition in the form of an oil-in-water emulsion comprising:
(a) at least 1 to about 15 wt. % of montmorillonite;
(b) about 1 to about 10 wt. % of one or more cellulose thickeners;
(c) about 1 to about 10 wt. % of one or more clays selected from hectorite and organically modified hectorites;
(d) about 0.1 to about 10 wt. % of one or more polysaccharide film forming agents;
(e) about 1 to about 25 wt. % of one or more polyols;
(f) about 0.1 to about 10 wt. % of one or more acrylate polymers; and
(g) about 50 to about 90 wt. % of water,
wherein the weight percentages are based on the total weight of the composition (claim 1).
US’435 claims the montmorillonite is a magnesium aluminum silicate, an aluminum silicate, or a mixture thereof (claim 2), more specifically magnesium aluminum silicate (claim 3). US’435 claims the one or more cellulose thickeners are selected from hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, methylcellulose, ethylhydroxyethylcellulose, carboxymethylcellulose, and a mixture thereof (claim 4). US’435 claims the one or more organically modified hectorites selected from disteardimonium hectorite, stearalkonium hectorite, and a mixture thereof (claim 5). US’435 claims wherein the one or more polysaccharide film forming agents are selected from pullulan, galactoarabinan, xanthan gum, cellulose, cellulose derivatives, gellan gum, guars, carrageenan, pectin, and a mixture thereof (claim 6). US’435 claims the one or more polysaccharide film forming agents comprise at least one of pullulan and galactoarabinan (claim 7). US’435 claims the one or more polyols are selected from polyols having from 2 to 15 carbon atoms and at least two hydroxyl groups (claim 8). More specifically the polyols are selected from ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, pentylene glycol, 1,3-propanediol, diethylene glycol, dipropylene glycol, caprylyl glycol, glycerin, and a mixture thereof (claim 9).
US’435 claims a method for improving the appearance of skin, and a method for firming and/or tightening the skin comprising applying the skin-tightening composition to the skin (claims 14 and 15).
18. A skin-tightening composition comprising:
(a) at least 1 to about 15 wt. % of magnesium aluminum silicate;
(b) about 1 to about 10 wt. % of one or more cellulose thickeners;
(c) about 1 to about 10 wt. % of one or more clays selected from hectorite and organically modified hectorites;
(d) about 0.1 to about 10 wt. % of pullulan, galactoarabinan, or a mixture thereof;
(e) about 1 to about 25 wt. % of one or more polyols;
(f) about 0.1 to about 10 wt. % of one or more acrylate polymer;
(g) about 50 to about 90 wt. % of water;
(h) one or more fatty compounds; and
(i) about 0.1 to about 20 wt. % of one or more emulsifiers,
wherein the weight percentages are based on the total weight of the composition (claim 18).
Component (a) of the claims reads on and renders obvious the one or more particulate fillers and the concentration range thereof recited in instant claims 1, 5, and 18, because magnesium aluminum silicate is a species of the claimed genus of aluminum silicate recited in instant claim 5. Component (b) of the claims reads on and renders obvious the optional one or more hydrophilic non-acrylate film-forming polymers other than pullulan and the concentration range thereof recited in instant claims 1, 3, and 18, because hydroxypropyl cellulose is a species of the claimed genus of water-soluble celluloses recited in instant claim 3. Component (c) reads on the one or more mineral clays and the concentration range thereof recited in instant claims 1, 4, and 18, because stearalkonium hectorite is a species of the claimed genus of hectorites recited in instant claim 4. Component (d) reads on the pullulan and concentration range thereof recited in instant claims 1 and 18. Component (e) reads on the one or more water-soluble organic solvents and concentration range thereof, as recited in instant claims 1, 6-8, and 18. The concentration of water reads on the water claimed in instant claims 1 and 18. The composition being in the form of an oil-in-water emulsion satisfies the limitation of instant claim 15.
The claims of US’435 differ from the instantly claimed invention because US’435 fails to claim the skin active agents and miscellaneous ingredients recited in instant claims 12-14 and 18. However, in instant claim 18, these are considered optional components. Additionally, US’435 fails to claim that the composition further comprises one or more fiber as recited in instant claims 9-11. US’435 also fails to claim that the optional component (b) is polyurethane-99 as recited in instant claim 16, and that the composition is free or essentially free from acrylate and methacrylate polymers and copolymers as recited in instant claim 17. Finally, US’435 fails to claim the method of treating skin comprises the specific step of applying the composition to the face of an individual using the individual's hands as recited in instant claim 20.
Montoya teaches the same claimed composition as what is claimed in US’435, since Montoya is the PGPub which corresponds to US’435 and contains the same subject matter in the disclosure. Montoya exemplifies the use of caffeine and ≤1 wt. % of preservatives, chelating agents, and pH adjusters (Table 1 “H” and “I”).
The instant specification defines “essentially free” as meaning “less than about 2% by weight of the specific material based on the total weight of the composition” (see instant specification p. 51 2nd para). The instant specification further defines “about” as within +/- 5% of the indicated number (see instant specification p. 50 4th para). Therefore, the instant specification is inferring that “essentially free” means less than 1.9-2.1% by weight of the composition, because +/- 5% of 2 = the range of 1.9-2.1 (2*0.05 = 0.1). Montoya teaches a total content of sodium acrylates copolymer and/or acrylates copolymer (component (f)) and polyglyceryl-3 methylglucose distearate steareth-20, and/or lecithin acrylates/polytrimethylsiloxymethacrylate copolymer (one of the components in (i)) to equal exactly 2% by weight of the composition (0.8 wt. % + 1.2 wt. % = 2 wt. %). Therefore, Montoya teaches an emulsion composition where, as defined by the instant specification, the composition is essentially free from acrylate and/or methacrylate polymers and copolymers regardless of what other monomer units appear in the polymer and copolymer (and crosspolymer).
Montoya teaches methods for improving the appearance of skin by applying the aforementioned skin-tightening compositions to the skin; the methods improve the appearance of the skin by treating or reducing the appearance of wrinkles, blemishes, dryness, roughness, dullness, age spots, sagging, eye bags, and/or puffy skin ([0025]). Montoya teaches the composition may be applied with the hands and simply spread or rubbed into the skin of the face and/or neck, especially the skin around the eye ([0154]).
Behrens teaches that Covestro’s Baycusan eco E 1001 is a naturally derived polymer that acts as a film former and is suitable for water-based products (1st para). Behrens teaches that Baycusan eco E 1001 is a partially bio-based alternative to synthetic film formers and imparts wear resistance for cosmetics that lasts all day (2nd para). Behrens teaches the chemistry of the liquid polymer allows for the introduction of high amounts of renewable materials into polymers without losing the key benefits of synthetics; e.g., water resistance, rub-off resistance and anti-smudge effects; furthermore, the natural content of the active is above 50% which fulfills the bio-based content criteria for a naturally derived ingredient (3rd para).
Covestro teaches that the INCI name for Baycusan® eco E 1001 is Polyurethane-99 (“General information”). Covestro recommends a formulating use level of 3-10% when formulating with Baycusan® eco E 1001 (“Use level”). Covestro suggests addition of Baycusan® eco E 1001 at the end of the formulation process after homogenization with pH adjustments as necessary (“Process”).
Lubart teaches that collagen protein plays a key role maintaining skin firmness; topical creams containing collagen fibers are widely available, but their usefulness is questionable due to the limited skin penetration of collagen (p. 59 “Background”). Lubart teaches the preparation of micronized marine collagen (m-collagen) -fibers and subsequent insertion into a cream; the micronized collagen fibers in the cream are found to penetrate the stratum corneum (SC) barrier (p. 60 L. Col. 2nd para). Lubart teaches the m-collagen is inserted, at a 0.2% concentration, into a basic cream consisting of aqua (water) and other basic ingredients (p. 60 “Preparation of a cream with micronized collagen”). Lubarts demonstrates that the resulting facial collagen cream allows for fully functional collagen fibers to penetrate deeper layers of human skin samples (p. 63 “Conclusion”).
Regarding instant claims 12-14, 17-18 and 20, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to (1) add the caffeine and ≤1 wt. % of preservatives, chelating agents, and pH adjusters as exemplified by Montoya to the composition of US’435, (2) include acrylate polymers and copolymers in the composition of US’435 at the concentration of 2 wt % exemplified by Montoya, thus satisfying the ”essentially free” limitation, and (3) use the composition of US’435 in the method via application onto the face/neck using the hands, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have performed all three modifications to the claimed invention of US’435 because Montoya is the disclosure associated with the claimed invention of US’435, and per MPEP 2143 I(A), the simple combination of prior art elements according to known methods to yield predictable results is prima facie obvious. US’435 and Montoya contain each element claimed, with the only difference being the combination of the elements together into the claims of US’435. One of ordinary skill in the art could have combined the elements by the known methods demonstrated by examples H and I in Table 1 of Montoya, and in combination the elements would perform the same function as done separately based on the example of Montoya. One of ordinary skill in the art would have recognized these results to be predictable because Montoya teaches the full disclosure of the claimed invention of US’435, and thus further extrapolates on the elements of the claimed invention of US’435; therefore, performing these modifications would not appear to impart any deleterious effects to the claimed composition and method of US’435.
Regarding instant claim 16, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to add Baycusan® eco E 1001 (INCI name polyurethane-99) to the skin tightening composition of US’435, at the recommended formulation use level of 3-10% by weight of the composition, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because Baycusan® eco E 1001 is a desirable, bio-derived film former which imparts water resistance, rub-off resistance and anti-smudge effects for long-lasting wear-resistance in water-based cosmetic formulations. The formulation of US’435/Montoya is intended to be a long-lasting skin tightening composition, and thus would benefit from the long-wear properties of the film former Baycusan® eco E 1001. The ordinarily skilled artisan would have a reasonable expectation of success adding Baycusan® eco E 1001 to the water-based oil-in-water emulsion formulation of US’435/Montoya at a concentration of 3-10% by weight of the composition because Behrens teaches that Baycusan® eco E 1001 is suitable for water-based skin products, and Covestro teaches addition of Baycusan® eco E 1001 to formulations at this concentration range is suitable at the end of the formulation process.
Regarding instant claims 9-11, it would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to insert micronized marine collagen fibers into the skin-tightening composition of US’435 at a 0.2% concentration relative to the total weight of the composition, and arrive at the instantly claimed invention. The ordinarily skilled artisan would have been motivated to do so because collagen protein plays a key role in mainlining skin firmness, and micronized marine collagen fibers are shown by Lubart to penetrate the stratum corneum when added to a basic facial cream. The formulation of US’435 is intended to be a skin tightening composition for use on the face, and Montoya specifically teaches the incorporation of collagen into its composition; thus, the facial composition of US’435/Montoya would benefit from the enhanced penetration of the micronized marine collagen fibers taught by Lubart. The ordinarily skilled artisan would have a reasonable expectation of success adding micronized marine collagen fibers to the composition of US’435/Montoya at a concentration of 0.2% by weight of the composition because Lubart demonstrates that simple insertion of the micronized marine collagen fibers into a basic facial cream in this manner results in a functional cream which demonstrates the desirable deep-penetration effects of the incorporated collagen. Thus, th