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 .
Election/Restriction
Applicant’s election without traverse of group I, claim(s) 1-5 and 8-9 and the addition of claim 13 to the claim set in the reply filed on May 13, 2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-5, 8-9 and 13 are examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on April 23, 2024 and May 13, 2026 are being considered by the examiner. The signed IDS forms are attached with the instant office action. However, the non-patent literature document #1 (France Application Serial No. 201880073911.3, Search Report mailed 02-27-24) from April 23, 2024 were lined through and not considered. The information disclosure statement filed April 23, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably
within the range of 50 to 150 words in length. The abstract of the disclosure is less than 10 words. A corrected abstract of the disclosure within the preferred ranges disclosed is
required. See MPEP § 608.01(b).
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(s) 4-5 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 claim(s) contains 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.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Claim 5, which is dependent upon claim 4 states that the composition taught within claim 4 has the ability in “ameliorating, treating and/or preventing fine lines and wrinkles”. More specifically, applicant claims that the composition can “prevent” fine lines and wrinkles. It is noted that applicant’s specification discusses figure 1 that displays that a “composition of creatine, palmitoylTripeptide-5 and bifida ferment lysate significantly increased fibronectin levels” (towards the beginning of page 15 of the specification) along with additional knowledge that “creatine plus Bifida lysate tripeptide-5 shows an 82% increase in fibronectin over control, a 46% increase over tripeptide-5 alone and a 35% increase over tripeptide plus Bifida lysate. Neither creatine alone nor Bifida lysate alone were shown to have a measurable positive effect; creatine did not boost tripeptide 5’s effect; and Bifida lysate only boosted tripeptide-5’s performance by 11%” (towards the bottom of page 15 and towards the beginning of page 16 of the specification). Based on the information provided within figure 1, applicant does indeed show each of the ingredient results on the impact of fibronectin levels along with a section that shows the three combined ingredients (creatine, palmitoyltripeptide-5 and Bifida ferment lysate) result on fibronectin which does illustrate that the ingredients combined demonstrate exceeding levels of fibronectin. However, it is unclear based on the information provided within the specification combined with figure 1 how the composition that is taught in the claims of the present invention are able to “prevent” fine lines or wrinkles (as stated within claim 5 of the present invention). Thus, the data presented in the specification and the drawings/figures are not considered to support the claim limitation that the composition can “prevent” fine lines and wrinkles (as stated within claim 5 of the present invention). Given that prevention is unpredictable, in order to determine if the claimed composition is actually capable of “preventing” fine lines and wrinkles, the artisan would be forced to focus in on particular sections of the skin such as the epidermis, dermis and subcutaneous tissue. Based on a supporting reference by Shin et al (International Journal of Molecular Sciences, (Year: 2019), vol. 20, issue. 09, pp. 1-16), Shin et al discusses that the epidermis is made up of keratinocytes, the dermis is comprised of mainly the extracellular matrix (ECM) and the subcutaneous tissue [is comprised of mainly fat cells and connective tissue], and [in addition, at the very least, one or more of the three structures (epidermis, dermis and subcutaneous tissue) also comprises molecules such as collagen, glycosaminoglycans and keratinocytes (the cells that produce keratin)]. Based on the information provided by the Shin et al reference, applicant would have to demonstrate the effect of the composition across multiple areas of the skin and not only focus on fibronectin. Fibronectin is one of many molecules present within the ECM, thus, applicant should also focus in on other molecules that would have an impact on skin structure and function at the cellular and molecular level in order to further demonstrate that the composition of the present invention is capable of “preventing” fine lines and wrinkles in a subject. Thus, the Shin et al reference further demonstrates that the art shows that there is a very high bar to accomplish in order to effectively prove the “prevention” of fine lines and wrinkles using the present inventions composition. Applicant’s specification does not necessarily prove that the composition engages in preventative efforts in order to prevent a subject from obtaining fine lines and wrinkles but more so provides an example of one of many molecules involved in the skin (such as fibronectin) and how the fibronectin molecule alone, reacts to the ingredients present within the composition. Proof of prevention of fine lines and wrinkles will greatly exceed beyond applicant’s current data because one could consider (at the very least) the effects of the composition on a variety of pathways and molecules at the molecular and cellular level and not only focus on one molecule itself. This is clearly a burden of undue experimentation. Thus, the claims are not considered to be enabled for prevention of fine lines and wrinkles.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3 and 9 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 3 is indefinite because it is unclear what “wound healing” entails; it is unclear if the term encompasses burns (minor or major), puncture wounds, abrasions, or lacerations; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 9 is indefinite because it is unclear what “color cosmetic” means; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
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.
Claim(s) 1-5, 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Van Dan Nest (U.S. Pub. No. 20200046625 A1) in view of Marchant (WO 2017079248 A1).
Van Dan Nest teaches [that] the compounds are useful in therapeutic and non-therapeutic treatments and/or care of the skin, hair, nails and/or mucous membranes (paragraph 0002). Van Dan Nest teaches [that] the invention relates to use of the compound of the invention in the treatment of the symptoms of skin aging (paragraph 0029). Van Dan Nest teaches [that] the compositions for topical or transdermal application can be produced in any solid, liquid or semisolid formulation, such as and not restricted to, creams, foundations, under-eye concealers (paragraph 0165). Van Dan Nest teaches [that] the cosmetic or pharmaceutical composition can further comprise a firming and/or redensifying and/or restructuring agent selected, for example Syn®-Coll [INCI: Palmitoyl Tripeptide-5] (paragraph 0181). Van Dan Nest teaches [that] the terms “treatment” and “care” are accompanied by the qualifications “cosmetic” and/or “non-therapeutic”, it means that the treatment or care is such and, for example, has the aim of improving or maintaining the aesthetic appearance of the skin, hair, nails and/or mucous membranes. In particular, the treatment can have the aim of improving cosmetic properties of the skin, hair, nails and/or mucous membranes such as, for example and not restricted to, the level of hydration, elasticity, firmness, shine, tone or texture, which properties affect the aesthetic appearance of the skin, hair, nails and/or mucous membranes (paragraph 0036). Van Dan Nest teaches [that] the cosmetic or pharmaceutical composition can further comprise an agent that stimulates the synthesis of dermal or epidermal macromolecules selected, for example and not restricted to, from the group consisting of fibronectin synthesis-stimulating agent [such as Palmitoyl Tripeptide-5] (paragraph 0182). Van Dan Nest teaches [that] the administration can be topical or, for example, transdermal. In this aspect of the invention, the compound of the invention may be present in a cosmetic composition, for example a cosmetic composition as described herein. In one embodiment, the method involves administering the cosmetically effective amount of the compound or administering the composition at night, i.e., during the period from sunset to sunrise (paragraph 0142). Van Dan Nest teaches [that] the compound of the invention is useful in the cosmetic, non-therapeutic treatment and/or care of the skin, including: the treatment of skin wrinkles (paragraph 0127). Van Dan Nest teaches [that] in the context of this invention, the term “aging” refers to the changes experienced by the skin with age (chronoaging) or through exposure to the sun (photoaging) or to environmental agents such as tobacco smoke, extreme climatic conditions of cold or wind, chemical contaminants or pollutants, and includes all the external visible and/or perceptible changes through touch, such as and not restricted to, the development of discontinuities on the skin such as wrinkles, fine lines (paragraph 0038). Van Dan Nest teaches [that] the compounds of the invention are used in the cosmetic or pharmaceutical compositions of this invention at cosmetically or pharmaceutically effective concentrations to achieve the desired effect; for example in amounts with respect to the total weight of the composition of: from 0.00000001% (in weight) to 20% (in weight); from 0.000001% (in weight) to 15% (in weight), from 0.00001% (in weight) to 10% (in weight); or from 0.0001% (in weight) to 5% (in weight) (paragraph 0154). Van Dan Nest teaches [that] the frequency of application or administration can vary greatly, depending on the needs of each subject, with a recommendation of an application from once a month to ten times a day, preferably from once a week to four times a day, more preferably from three times a week to twice a day, even more preferably once a day (paragraph 0148).
Van Dan Nest does not explicitly teach topically applying thereto a composition comprising an effective amount of creatine, palmitoylTripeptide-5 and bifida ferment lysate so as to increase fibronectin synthesis and thereby providing an anti-aging treatment and/or improved wound healing as compared to an untreated control so as to yield an improved aesthetic appearance of the human skin (as stated within claim 1 of the present invention). Van Dan Nest does not teach that wound healing is improved (as stated within claim 3 of the present invention). Van Dan Nest does not explicitly teach topically applying to the skin of the human at least once daily for a period of at least four weeks a composition comprising an effective amount of creatine, palmitoylTripeptide-5 and bifida ferment lysate in a cosmetically acceptable vehicle to improve the aesthetic appearance of said human’s skin, wherein said skin is in need of increased fibronectin production (as stated within claim 4 of the present invention). Van Dan Nest does not teach the concentrations of creatine in the amount of 0.0001% to 10% (w/w) and the bifida ferment lysate in an amount of 0.0001% to 10% (w/w) (as stated within claim 8 of the present invention).
Marchant teaches [that the] hydrogel composition provides useful materials for personal care, health care, medical and pharmaceutical applications, among others (abstract). Marchant teaches [that the composition can include] bifida ferment lysate [and] creatine (paragraphs 0134 and 0136). Marchant teaches [that] the term "personal care products" as used herein includes, without limitation, cosmetics, toiletries, cosmeceuticals, beauty aids, personal hygiene and cleansing products that are applied to the skin, hair, scalp, and nails of humans and animals (paragraph 0225). Marchant teaches [that] the hydrogels can be employed as emulsifiers, spreading aids and carriers for enhancing the efficacy, deposition and delivery of chemically and physiologically active ingredients and cosmetic materials, and as a vehicle for improving the psychosensory and aesthetic properties of a formulation in which they are included (paragraph 0225). Marchant teaches [that the composition] may include one or more active ingredients with one or more of the following advantages: sustained delivery, consistency in dosage, enhanced delivery, dosage control, efficiency, and bioavailability for: wound healing, burn healing, scar reducing (paragraph 0223). Marchant teaches that exemplary anti-wrinkle agents and/or anti-aging agents [to be added to the composition] include Syn®-Coll [INCI: palmitoyl tripeptide-5] (paragraph 0132).
Regarding claim(s) 1-5, 9 and 13, the composition as taught by Van Dan Nest can be modified to further include bifida ferment lysate and creatine as taught by Marchant in which, one of ordinary skill within the field of cosmetics and molecular biology would reasonably expect that the combined aforementioned references effectively teach that all of the ingredients combined within the form of a cosmetic such as a cream (e.g. lotions are considered a cosmetically acceptable vehicle) or a foundation would have the ability to assist in wound healing as well as treat skin that has fine lines (it is known in the art that fine lines normally lead to wrinkles) and wrinkles thus leading to an improved aesthetic appearance. In addition, one skilled in cosmetics and molecular biology would know that the lysate of bifida tends to contain a number of proteins and compounds which supports Van Dan Nest reference when the reference states that the compounds can be incorporated into a cosmetic composition. Moreover, one of ordinary skill within molecular biology would reasonably expect that the application of the cosmetic composition to a subject in need would intrinsically increase or assist in fibronectin production.
Regarding claim 8, the combined aforementioned references does not explicitly teach the all of the ingredients within the composition together in the amounts listed by the applicant in the claim of the present invention, however, as discussed in MPEP section 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).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. Therefore, one skilled in cosmetics and molecular biology would have been motivated to optimize the concentrations of all of the ingredients in order to create a succinct composition to be used on the skin of a subject in need for improving aesthetic appearance in which the composition focuses on aspects of wound healing as well as reducing or treating fine lines and wrinkles.
In addition, these references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients within a cosmetic composition to assist with the aesthetic appearance of skin. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from them having been used individually in the prior art. Based on the disclosure by these references that these substances are used in compositions, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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