DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 107-129 are pending and under current examination in this application.
Amendment to Claims and Applicant Arguments/Remarks Made in an Amendment filed 25 March 2025, are acknowledged. Claims 1-106 have been canceled and claims 107-129 are new. Remarks provide common inventor or assignee disclosure.
Specification Objections
The title of the invention is objected to under 37 CFR § 1.72(a) as not being specific. The title of the invention, "Skin and hair care formulations", is misleading and overly broad and not commensurate with the scope of the claims. The claims are narrowly directed to specific chemical formulations with precise compositional ranges. The title, however, suggests a much broader invention encompassing any formulation for skin or hair care, which is not what is claimed, and the title inappropriately emphasizes the intended use over the structural invention.
According to USPTO guidelines (MPEP § 606), the title of the invention should be a short and specific description of the subject matter of the invention. It must be commensurate in scope with the claims and technically accurate. The claims are the measure of what the inventor has invented and wishes to protect.
A new title is required that is clearly indicative of the invention to which the claims are directed. A more appropriate title to inform the public of the invention would be more specific and directly reference the key novel components disclosed, such as the following suggested titles:
Topical Formulations Comprising Ethylhexyl Olivate and a Saturated Hydrocarbon;
Topical compositions of Ethylhexyl Olivate, Squalane, and C13-C15 Alkanes; or
Topical Serum Formulations with Specific Emollient and Hydrocarbon Content.
The Abstract is objected to as failing to comply with the requirements of 37 CFR 1.72(b) and MPEP 608.01(b). 37 CFR 1.72(b) states that the abstract must "be in such form as to be usable as an indexing and searching tool and shall be a concise summary of the disclosure as a whole." It must "set forth the technical subject matter of the invention in a manner which will enable the USPTO and the public to determine quickly from a cursory inspection the nature and gist of the technical disclosure."
The present Abstract is deficient because it is overly broad, vague, and does not accurately reflect the specific invention disclosed in the specification and defined by the claims. The Abstract describes the invention generically as "skin and/or hair cleansing and... treatment formulations" that provide a wide range of benefits such as reducing hair loss, promoting hair growth, repairing skin, and improving texture without clogging pores. However, the claims describe a much more specific and limited invention. The independent claims are directed to specific topical formulations defined by their precise chemical composition and concentration ranges, not general cleansing or treatment systems (e.g., a formulation comprising ethylhexyl olivate in a specific range (30-70%), a formulation comprising squalane or squalene in a specific range (1-15%), and a formulation comprising a saturated hydrocarbon with a chain length of C10-C20 (e.g., C13-15 alkane) in a specific range (30-60%)). The Abstract fails to mention any of these specific, essential components that are the core of the claimed invention. Instead, it uses functional and result-oriented language ("reduce hair loss," "improve the overall look") that is not commensurate in scope with the structural and compositional limitations of the claims. This lack of specificity renders the Abstract ineffective as a searching and indexing tool, as a searcher would not be able to discern the novel aspects of the invention—namely, the specific combination of ingredients—from the Abstract alone. Accordingly, the Abstract is objected to.
Applicant is required to provide a new Abstract that concisely and accurately summarizes the invention by, at a minimum, identifying it as a topical formulation and reciting the key, specific compositional elements (e.g., ethylhexyl olivate, a saturated hydrocarbon such as C13-15 alkane, and optionally squalane/squalene) that distinguish it over the prior art and complies with 37 CFR 1.72(b).
Applicant is reminded of the proper content of an abstract of the disclosure:
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which Applicant regards as his invention.
Claims 117-120 and 129 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, regards as the invention.
Claims 117, 118, and 119 further limit the formulation of claim 107 by stating it is "safe for application to eczema-prone skin," "sensitive skin," and "acne-prone skin," respectively.
The term "safe" is a term of degree that lacks objective boundaries. The Specification provides no standard or definition for determining what is considered "safe" for these specific skin types (e.g., does it mean non-irritating or non-comedogenic and by what objective criteria (e.g., passes a repeat insult patch test (RIPT) on a panel of at least 50 human subjects with clinically diagnosed eczema or some other result in an in vitro assay measurement)). Safety is not an inherent property but a risk assessment based on a multitude of factors including individual allergic responses, severity of the condition, concentration of actives, frequency of use, and the subjective tolerance of the user. A person skilled in the art cannot determine the boundaries of the claim because they cannot know if any given formulation meets the undefined "safe" standard, rendering the claims indefinite.
Claims 120 and 129 are directed to a method comprising two alternative steps: (1) "applying the formulation" or (2) "instructing the application of a formulation." The second step, "instructing the application," is indefinite. The claim language does not specify the method or manner of instruction (e.g., a medical prescription, a marketing advertisement, a kit insert) and the breadth creates uncertainty as to what specific actions would constitute infringement of the method claim. The step "instructing" is nebulous and could encompass a wide range of activities making it impossible to determine the precise boundaries of the claim (see Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008), "If a claim is insolubly ambiguous, and no narrowing construction can be determined, the claim is invalid for indefiniteness."). Therefore, the scope of the "instructing" step in claims 120 and 129 is unclear, rendering these claims indefinite.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 107-112, 116, 121-123, 125, 126, and 128 are rejected under 35 U.S.C. § 103 as being unpatentable over Bacchini et al. (WO2019008116A1; published 10 January 2019; IDS reference).
Regarding instant claims 107-112, Bacchini teaches a topical composition (page 13, line 4-13), wherein the formulation comprises a carrier oil including 50-75% ethylhexyl olivate (page 40, clause 219 and 220), 5-20% squalane (page 45, clause 268), and further comprises 50-75% at least one carrier selected from saturated hydrocarbons including C13-C15 alkane (page 40, clause 219). MPEP 2144.05(I) states that “[i] n the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” In the instant case, the reference discloses ranges that significantly overlap with the instant claimed ranges, rendering the claims obvious as adjusting the percentages of components in a formulation is considered routine optimization for a person of ordinary skill in the art. One would be motivated to adjust component percentages to achieve desired physical properties (e.g., spreadability, viscosity) or provide more flexibility to add other beneficial ingredients, as is a well-known and routine practice in the art of formulation.
It also would have been obvious to one of ordinary skill in the art to modify the composition of the Bacchini to include ethylhexyl olivate as a further emollient with squalane and saturated hydrocarbons including C13-C15 alkane carrier. Bacchini explicitly encourages the use of additional emollients, stating: "said composition further comprises at least a further emollient. Said further emollient is preferably a fatty acid ester... decyl olivate, ethylhexyl olivate, octyldodecyl olivate, stearyl olivate and any mixture thereof." (page 23, clauses 20 and 21). Emollients are routinely combined in cosmetics to achieve desired textures, spreadability, or stability. KSR International Co. v. Teleflex Inc. (550 U.S. 398 (2007)) supports that combining known elements in a predictable way is obvious. One skilled in the art would be motivated to combine ethylhexyl olivate with the disclosed squalane-alkane base to improve spreadability, as ethylhexyl olivate is an emollient is known for its light texture, and improved consumer acceptance (e.g., cosmetic feel; see evidentiary reference: Personal Care Magazine, Biomimetic ingredient offers formulation benefits, story 8731; published 07 September 2011) is expected from combining these known emollients. The claimed formulation is a predictable variation Bacchini 's teaching of siloxane-free compositions (Example 6).
Regarding instant claims 113 and 124, Bacchini is silent as to the presence or absence of fragrance. It does not disclose compositions containing fragrance, thus meeting the limitation of the instant claims. One would be motivated to use fragrance-free formulations, as it is well known in the art to prepare fragrance-free cosmetic compositions for use on sensitive skin to reduce irritation or, one could also be motivated to use fragrances in formulations, as fragrance is a common additive in topical and cosmetic formulations to enhance consumer appeal.
Regarding instant claim 116, Bacchini explicitly teaches formulations configured for application to the hair as, “The compositions as herein disclosed offer the surprising and highly desirable combination of benefits of being highly effective, spreading evenly, drying quickly, having low mammalian toxicity, and being hair and skin compatible by not having a significantly greasy or oily texture.” (page 5, lines 13-15) and “By the term "topical application", it is meant that the composition is applied to the exterior of the treated subject, e.g. to the exterior skin, hair, fur, or foliage.” (page 13, lines7-8).
Regarding instant claims 121-123, instant claim 121 is read on by Bacchini's disclosure of a composition comprising the emollient squalane and a C13-C15 alkane saturated hydrocarbon. The broad term "one or more emollients" is read on by "squalane." Claims 122-123 are rejected for reasons as stated above for routine optimization of amounts.
Regarding instant claims 125, 126, and 128, instant claims 125 and 126 are directed to a formulation comprising 30-70% ethylhexyl olivate and 30-60% or 30-50% C13-15 alkane, respectively. As previously discussed for instant claim 107, Bacchini discloses the C13-15 alkane and explicitly teaches ethylhexyl olivate as a suitable emollient to add to such formulations. Combining them is thus obvious and routine optimization of amounts is obvious as discussed above for instant claim 107. The addition of 1-15% squalene as specified by the limitation of instant claim 128, is also addressed in the rejection of instant claim 107 above.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to combine squalane with ethylhexyl olivate as suitable emollients and at the claimed concentrations as taught by Bacchini as a matter of routine formulation optimization with a reasonable expectation of success based on the combination of teachings of Bacchini that explicitly discloses all the components of the instant claimed invention and provides motivation to combine them. The specific percentage ranges and intended uses represent the predictable use of prior art elements according to their established functions and routine optimization in the cosmetic formulation art.
Claims 107, 113 and 114 are rejected under 35 U.S.C. § 103 as being unpatentable over Bacchini et al. (WO2019008116A1; published 10 January 2019; IDS reference), and in further view of Rughani et al. (US20180280269A1; published 4 October 2018).
Bacchini teaches the limitations of instant claims 107 and 113, as described above, from which instant claim 114 depends, however does not teach specific limitations of instant claim 114, as Bacchini is silent as to the presence or absence of fragrance. It does not expressly limit the compositions to being fragrance-free or containing fragrance.
Rughani teaches methods for treating hair comprising applying hair-treatment compositions for repairing, strengthening, and protecting hair from damage including components that result in the hair exhibiting improved properties such as smoothness, gloss, combability, strength, and elasticity (¶ [0002]) in which fragrance(s) are an optional component in such preferred embodiments as Examples 1-4(¶ [0390]-[0393]), thus disclosing the addition of fragrances in similar formulations.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the missing limitation of adding fragrances to the invention of Bacchini, as taught as an optional ingredient in similar formulations by Rughani, with a reasonable expectation of success, given it was known in the art at the time of the invention to formulate topical hair application compositions with the addition of fragrance as a conventional option. The choice between including or omitting fragrance is a predictable matter of design choice (see In re Leshin, 227 F.2d 197, 199 (CCPA 1960) and MPEP §2144.04). As held in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980), “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose.” Here, including a fragrance in a hair care product to meet consumer demand for “fragrant” products would have been a prima facie obvious design choice as supported by the modification disclosed by Rughani.
Claims 107, 115, 117-120, 125, 127, and 129 are rejected under 35 U.S.C. § 103 as being unpatentable over Bacchini et al. (WO2019008116A1; published 10 January 2019; IDS reference), and in further view of SEEN Magic Serum, Fragrance Free consumer hair product (www.helloseen.com/products/seen-magic-serum-ff-1oz; commercially available prior to 23 March 2022 (see product review comments published 23 March 2022)), hereinafter referred to “SEEN” product).
Bacchini teaches the limitations of instant claims 107 and 125, as described above, from which instant claims 115, 117-120, and 127 and 129, respectively, depend, however does not teach specific limitations of instant claims 115, 117-120, and 127 and 129.
Regarding instant claim 115 and 127, Bacchini does not explicitly teach the composition as a serum and fragrance-free. The SEEN product discloses a fragrance-free serum formulation (see product name) including ethylhexyl olivate, C13-15 alkane and squalane (Full Ingredients list).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to formulate the Bacchini composition as a serum as a matter of routine formulation choice, since serum is merely one of several predictable dosage forms for topical cosmetic application, chosen based on consumer preference (see KSR v. Teleflex, 550 U.S. 398, 417 (2007)), which was known to be used in the art at the time of the invention (as evidence by the SEEN product). One would be motivated to use fragrance-free formulations as it is well known in the art to prepare fragrance-free cosmetic compositions for use on sensitive skin to reduce irritation. Here, omitting fragrance to meet consumer demand for “fragrance-free” products would have been a matter of obvious design choice and is not inventive. As held in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980), “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose.”
Regarding instant claims 117-119, reciting, “…wherein the formulation is safe for application to…”, the Examiner notes that none of the claims add compositional or structural limitations to the composition already recited by claim 107. Instead, the claims are broadly and reasonably considered to recite limitations of intended use which do not contribute to the overall patentability of the claimed composition. Thus, where the limitations of claim 107 are met, so too will the limitations of claims 117-119. In addition, the SEEN product discloses a serum formulation including ethylhexyl olivate, C13-15 alkane and squalane (Full Ingredients list). The formulation is disclosed to be “Non-comedogenic (won’t clog pores); Non-irritating; Safe for sensitive, acne-prone, and eczema-prone skin” (Skin Benefits section). A person of ordinary skill in the art would have reasonably expected that the compositions taught by Bacchini and the instant claimed invention to be safe for sensitive, acne-prone, and eczema-prone skin, as they contain the same ingredients as the SEEN product disclosed to be non-irritating, dermatologically tested to be safe for sensitive, acne-prone, and eczema-prone skin.
Regarding instant claims 120 and 129, the claims are rejected as being unpatentable over Bacchini in view of the knowledge of one of ordinary skill in the art and The SEEN product. The claimed method of "improving or maintaining the health, shine, strength..." of hair is an expected and obvious result of applying a composition comprising high levels of emollients (oils and alkanes) to hair. Emollients are well known to impart shine and improve the feel of hair. The step of "instructing the application" is a routine and obvious method of disseminating information regarding the use of a known product. Additionally, the SEEN product discloses a serum formulation that “Reduces frizz; Reduces breakage; Adds shine; Nourishes; Strengthens; Heat Protection (up to 450°F); Color-Safe; Keratin-Safe” (Hair Benefits section) and, “All SEEN products are clinically proven to be safe for sensitive skin and non-comedogenic (won’t clog pores) and designed to help you achieve stronger, smoother, healthier hair.” (Our Mission section). Thus, explicitly disclosing improvement of shine and strength and inherently hair health.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to use the Bacchini compositions for safe application to eczema-prone skin, sensitive skin and acne-prone skin, as the same ingredients formulated in the SEEN product are disclosed to be used as such. In addition, it would be obvious to use the Bacchini compositions applied to the hair as a method for improving or maintaining the health, shine and strength since the same ingredients formulated in the SEEN product are disclosed to be used as such and known in the art to be used for the same purpose. A person of ordinary skill in the art would have been motivated to apply the known composition of Bacchini to hair in order to achieve predictable cosmetic benefits (shine, strength, volume) taught in the art and as evidence by the SEEN product.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RL Scotland/
Examiner, Art Unit 1615
/Jeffrey T. Palenik/Primary Examiner, Art Unit 1615