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 .
DETAILED ACTION
This action is in response to a Request for Continued Examination received July 13th, 2026.
Status of Claims
Claims 1-3 and 10-21 are pending in the instant application.
Claims 4-9 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-3, 5, and 10-21 under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Applicant’s cancellation of Claim 5 renders the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejections of Claims 1-3, 5, and 10-21 under 35 U.S.C. 103. Applicant’s cancellation of Claim 5 renders the rejection thereof moot. These rejections are hereby withdrawn.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
The sixth line of Claim 1 reads, in part, “… present in an amount from about 0.001 wt. % to less than 1.0…”. 1.0 is missing a unit. For clarity, the Examiner suggests amending the claim to read, “… present in an amount from about 0.001 wt. % to less than 1.0 wt. %”.
Claim 15 recites “10-hycroxydecanoic acid”. The examiner has interpreted this as a misspelling of “10-hydroxydecanoic acid”.
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.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a skin care composition further including at least one auxiliary skin benefit agent wherein the auxiliary skin benefit agent comprises Curcuma longa (turmeric) root extrac, Ganoderma lucidum (mushroom) extract, Astragalus membraceus root extract, Aloe barbadensis, Camelia sinensis leaf extract, hydroxycinnamic acid, rutin, sodium hyaluronate, lysine, bisabolol, 10-hydroxydecanoic acid, does not reasonably provide enablement for a skin care composition comprising any auxiliary skin benefit agent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a skin care composition comprising an anti-acne active ingredient, an odor neutralizer, and further comprising at least one auxiliary skin benefit agent.
Breadth of the invention:
The scope of the claimed invention is broad. Auxiliary skin benefit agent encompasses a myriad of known compounds and compositions linked to providing a benefit to skin. This limitation also encompasses auxiliary skin benefit agents that are not yet known, but later discovered, or presently known compounds later associated with a skin benefit. Can Applicant simply “reach through” and obtain patent protection for compositions including agents that are either not yet known, or those presently known, but later are classified as providing a skin benefit?
State of the prior art and predictability in the art:
With respect to auxiliary skin benefit agents, Mohiuddin (“Skin Care Creams: Formulation and Use”, Dermatology Clinics & Research, 2019; hereinafter referred to as Mohiuddin) represents the state of the prior art.
Speaking to the breadth of compounds reading on the limitation of auxiliary skin benefit agent, Mohiuddin states at the Abstract, “The cosmetic and pharmaceutical industry offers a vast armamentarium of skin care products and procedures to clean, soothe, restore, reinforce, protect and to treat our skin and hence to keep it in ‘good condition’. Skin care products are readily in daily life and they play a major role in health and nursing care.” Further, at Page 239, First Column, Mohiuddin teaches efficacy of dermatological and cosmetic products are influenced by the vehicle and active ingredients of skin care compositions, and that cosmetic formulations serve a purpose of helping skin homeostasis and preventing degenerative processes. At Page 240, First Paragraph, Mohiuddin states, “Now, a variety of skincare products are available for almost any beauty concern one can have, including body washes, gels, lotions, exfoliants, moisturizers, toners and sun protection.”
Taken together, in view of Mohiuddin, products that read on the instantly recited limitation of “auxiliary skin benefit agent” are wide-ranging, far beyond those that are positively recited in the instant application.
Level of ordinary skill in the art:
An ordinary artisan in the area of the development of a skin care composition includes synthetic chemists, formulation chemists, and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in bioaffecting compositions, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compositions are suitable in the context of the instant invention.
The amount of direction provided and working examples:
Beginning at Page 18 of the instant specification, several exemplary embodiments of compositions of the instant invention are disclosed. These limited examples, however, are insufficient to provide enabling disclosure for compositions comprising the breadth of auxiliary skin benefits that read on the instant Claim 14, as noted above. In other words, the instant application is not enabled for compositions comprising auxiliary skin benefit agents beyond those positively recited, for example, at instant Claim 15.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for compositions including any auxiliary skin benefit agent, as broadly as is recited.
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 11-13 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.
Claim 11 recites the limitation "… wherein the AHA consists of…" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 2, from which Claim 11 depends, does not recite “AHA.”
Claim 12 recites the limitation “… wherein the AHA comprises…” in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 2, from which Claim 12 depends, does not recite “AHA.”
Claim 13 recites the limitation “a mixture of AHAs…” in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 2, from which Claim 13 depends does not recite “AHA.”
Claim 18 recites the limitation “wherein the AHA consists of…” at the third line of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 2, from which Claim 18 depends, does not recite “AHA.”
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 18 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 18 depends from Claim 2, which ultimately depends from Claim 1. Claim 1 recites the limitation “an anti-acne active ingredient consisting of a sulfur ingredient…”. Per MPEP 2111.03, II., “The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948)”. Claim 18 recites the limitation “wherein the anti-acne active ingredient further comprises salicylic acid…” This improperly expands the scope of Claims 1 and 2, from which it depends, as the limitation recited at Claim 1 excludes salicylic acid, as it is drawn to an anti-acne active ingredient consisting of a sulfur ingredient. Salicylic acid is not a sulfur ingredient.
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 § 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 1-3, 10-13, 16, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et. al. (US2021/0093724; initially cited in the non-final rejection mailed September 24th, 2024; hereinafter referred to as LaRosa) in view of Zouboulis et. al. (Pathogenesis and Treatment of Acne and Rosacea, 2014; initially cited in the non-final rejection mailed September 24th, 2024; hereinafter referred to as Zouboulis), Delvalle et. al. (WO 2012/027143 A1; initially cited in the non-final rejection mailed September 24th, 2024), in further view of Velafresh (Velafresh ZP30, Safety Data Sheet Revised January 9th, 2020, Itaconix Corporation; initially cited in non-final rejection mailed September 24th, 2020; hereinafter referred to as Velafrash) as evidenced by the Government of Canada (Government of Canada Chemical Substance Information, Modified June 6th, 2024; initially cited in non-final rejection mailed September 24th, 2020; hereinafter referred to as Government of Canada).
Regarding Claim 1, LaRosa teaches at Page 1, Paragraph [006] that the disclosed compositions are useful in preventing, treating, managing, and/or ameliorating dermal diseases or disorders including acne, and that the compositions are additionally beneficial in cleansing the skin, and providing smooth skin, among other skin benefits.
LaRosa provides several compositions in which sulfur is the active ingredient. At Page 33, Production Example 265 teaches a sulfur lotion with sulfur present in an amount of 10%, at Page 35, Production Example 276 teaches a sulfur gel with sulfur present in an amount of 6%, production example 277 teaches a sulfur lotion with sulfur present in an amount of 8%, and several other compositions teach lotions with sulfur as an active ingredient. Gels and lotions are instantly recited at Claim 16. The active ingredient is elemental sulfur, reading on the limitations of Claims 2-3, and the amounts are within the recited range of 0.5 wt. % to about 10.0 wt. %. Per MPEP 2131.03, I., “"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”.
Further, at Page 35, LaRosa teaches Production Example 276 as a sulfur gel containing 6% sulfur and a fragrance. At Page 8, Paragraph [0030], LaRosa defines a fragrance as ingredients that can add or mask a scent. An ingredient that masks a scent can be interpreted as an ingredient that is an odor neutralizer.
Further, regarding Claims 11-12 and 21, LaRosa teaches at Page 33 Production Example 265 a sulfur lotion with 10% sulfur and glycolic acid. At Page 42, Table 3, LaRosa teaches glycolic acid is included at 4 wt. %, 7 wt. % or 10 wt. %. At Pages 1-2, Paragraph [0015], LaRosa teaches glycolic acid is an external anti-acne agent.
LaRosa does not teach a composition comprising an odor neutralizer consisting of sodium/zinc acryloyldimethyltaurate/itaconate copolymer.
At Page 409, First Paragraph under “54.10 Sulfur”, Zouboulis teaches sulfur is a common ingredient in acne treatments that has fallen out of favor due to its pungent odor.
At Pages 41-42, Paragraph [00167], Delvalle teaches the use of the polymer polyethylene glycol as a deodorant agent. Further, at Page 50, Table 2, Delvalle teaches inclusion of the copolymer in amounts of either 1 or 2%.
At Page 1, Section 1.2, Velafresh teaches the use of sodium/zinc acryloyldimethyltaurate/itaconate copolymer as an odor absorbing agent in personal care products. While this name is not provided in Velafresh, it is reported as a common name by the Government of Canada, and the CAS registry number is the same.
Taken together, LaRosa teaches a composition comprising sulfur and a fragrance. Based on the definition provided by LaRosa, fragrance includes an odor absorbing agent. Delvalle teaches the inclusion of copolymers as deodorant agents in amounts of either 1% or 2%, and Velafresh teaches the specifically recited odor neutralizer.
Regarding Claim 20, at Page 1, Paragraphs [0002]-[0003], LaRosa teaches the compositions disclosed are suitable for topical administration to provide an anti-acne benefit. Applying KSR exemplary rationale C, a person having ordinary skill in the art would have been motivated to modify the sulfur containing compositions taught by LaRosa with the sodium/zinc acryloyldimethyltaurate/itaconate copolymer taught by Velafresh as an odor neutralizing agent, motivated by the teachings of Zouboulis that inclusion of sulfur in skin care compositions is associated with a pungent odor. With respects to the recited ranges of the sodium/zinc acryloyldimethyltaurate/itaconate copolymer, Delvalle provides the basis at which to start optimizing formulations. Though the amounts Delvalle teaches is just outside the instantly recited range, per MPEP 2144.05, II., A., “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Taken together, this would result in the practice of Claims 1-3, 10-13, 16, and 20-21 with reasonable expectation of success.
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa in view of Zouboulis, Delvalle, Velafresh as evidenced by the Government of Canada, in further view of Yin et. al., (“Chapter 14 Preventive and Therapeutic Effect of Ganoderma (Lingzhi) on Skin Diseases and Care”, Ganoderma and Health Pharmacology and Clinical Application, 2019; initially cited in non-final rejection mailed September 24th, 2024; hereinafter referred to as Yin).
As noted above, LaRosa in view of Zouboulis, Delvalle, and Velafresh as evidenced by the Government of Canada obviates Claim 1, from which Claims 14-15 and 17 depend. Zouboulis, Delvalle, and Velafresh as evidenced by the Government of Canada do not obviate the inclusion of at least one auxiliary skin benefit agent wherein the at least one auxiliary skin benefit comprisies Ganoderma lucidum (mushroom) extract.
At Page 311, at the Abstract, Yin teaches Ganoderma lucidum is known to improve skin quality and treat skin diseases. Further, Ganoderma extracts are known to promote skin wound healing and have been used in skin care because of their roles in skin photoaging and skin whitening.
Applying KSR exemplary rationale A, it would have been prima facie obvious to a person having ordinary skill in the art to include Ganoderma lucidum in the composition obviated by LaRosa in view of Zouboulis, Delvalle, and Velafresh as evidenced by the Government of Canada, motivated by the knowledge in the art that Ganoderma lucidum is known to have beneficial properties when applied to the skin.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zouboulis, Delvalle, Velafresh as evidenced by the Government of Canda, in further view of www.lovelyskin.com (June 25, 2014 capture obtained from Internet Archive via https://web.archive.org/web/20140625043842/https://www.lovelyskin.com/c/claritymd-acne-solution#expand capturing https://www.lovelyskin.com/c/claritymd-acne-solution; initially cited in non-final rejection mailed September 24th, 2024; hereinafter referred to as Lovely Skin).
As noted above, LaRosa in view of Zouboulis, Delvalle, and Velafresh as evidenced by the Government of Canada obviates Claim 1, from which Claims 14-15 and 17 depend. Zouboulis, Delvalle, and Velafresh as evidenced by the Government of Canada do not obviate a packaged product comprising a container and the skin care composition of Claim 1 housed in the container.
Lovely Skin teaches the sale of Clarity MD Acne Solution Clarifying Gel in a consumer-packaged product containing the skin care composition housed in the container. Applying KSR exemplary rationale D, a person having ordinary skill in the art would find it prima facie obvious to utilize a container to house the skin care composition of claim 1 in a consumer-packaged product, motivated by other skin care compositions known in the art being packaged in the same way.
Taken together, this results in the practice of Claim 19 with reasonable expectation of success.
Conclusion
Claims 1-3 and 10-21 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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