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 .
Priority
No priority data has been filed in this application. Accordingly, the effective filing date of this application is the actual filing date of April 10, 2023.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-4) drawn to a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of arginine; proline; glycine; aloe vera gel; and a penetration enhancer; and hyaluronic acid as a species of a penetration enhancer; in the reply filed on February 4, 2026 is acknowledged. The traversal is on the ground(s) that the use of the product as a hair care product as an example does not establish a materially different process of use as required under the product/process-of-use standard since applying an aqueous gel to a human's skin from a dispenser is not materially different in kind. Applicant argues that a difference in intended use or therapeutic purpose, without a materially different process, does not establish distinctness under MPEP §806.05(h).
These arguments are found not persuasive since invention I is drawn to an aqueous gel composition comprising arginine; proline; glycine; aloe vera gel; and a hyaluronic acid. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus the intended use of claim 1 is not afforded patentable weight. Thus the composition of group I can be used in a materially different process for using the product such as application to the hair as a hair treatment which is a distinct process from Invention II which requires application to the human skin for transdermal administration for the treatment of some disorder. Thus, as detailed in the restriction requirement, a search burden exists since the prior art applicable for the composition is not necessarily applicable to the claimed method of Invention II since a prior art for the composition would not necessarily disclose transdermal application for the treatment of a condition.
Applicant’s arguments with respect to the election of a species of a treatment condition are moot since, Applicant did not elect invention II and thus no election of a treatment condition is required.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-4 are currently presented for examination.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu CN-104666179 A (see Machine English translation provided) as evidenced by Parsons et al. (1982, Poultry Science 61:939-946).
Claims 1 and 2 of the instant application claim a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of arginine; proline; glycine; aloe vera gel; and a penetration enhancer which is a form of hyaluronic acid.
Zhu teaches aqueous gel compositions comprising water 85-92%; propylene glycol 1-3%; glycerin 0.5 to 1.6%; trehalose 0.3 to 0.8%; corn gluten amino acids 0.2 to 0.7%; hydroxyethyl cellulose 0.2 to 0.8%; allantoin 0.1 to 0.6%; ubiquinol 0.3 to 0.8%; aloe vera gel 0.4 to 0.9%; elastin 0.2 to 0.8%; 3-o-ethyl ascorbic acid 0.2 to 0.8%; sodium hyaluronate 1 to 1.8%; elongation sea algae extract 0.6 to 1.3%; phenoxyethanol 0.2 to 0.5%, cordate extract 0.1 to 0.5% yeast b-glucan 0.2 to 0.8% white birch bark extract 0.2 to 0.7%; essence 0.1 to 0.3%. (abstract, pages 3-9 and Examples 1-9 on pages 9-17).
Claims 1-8 of Zhu claim an aqueous gel composition comprising: Water 85~92%; Propylene glycol 1~1.3%; Glycerin 0.5~1.6%; Corn gluten amino acids 0.2~0.7%; Hydroxyethyl cellulose 0.2~0.8%; Aloe vera gel 0.4~0.9%; and Sodium hyaluronate 1~1.8%.
Thus the cited claims of the instant application are anticipated since Zhu teaches and claims an aqueous composition comprising water; aloe vera gel; sodium hyaluronate which is a form of hyaluronic acid; and gelling/thickening agents including propylene glycol, glycerin, and Hydroxyethyl cellulose to form a gel. The composition of Zhu also specifically contains Corn gluten amino acids, which as evidenced by Parsons et al. comprise the amino acids arginine, proline and glycine (see Table 1 page 940).
Accordingly, Zhu et al. inherently teaches an aqueous gel composition comprising arginine; proline; glycine; aloe vera gel; and a penetration enhancer which is a form of hyaluronic acid.
With respect to the claimed intended use of “for transdermal supplementation” It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus since Zhu discloses a composition comprising the same components as claimed, the composition of Zhu is inherently capable for transdermal supplementation.
Thus claims 1 and 2 are rejected in view of the cited prior art teachings.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu CN-104666179 A (see Machine English translation provided) as evidenced by Parsons et al. (1982, Poultry Science 61:939-946) as applied to claims 1 and 2 above and further in view of Paillot et al. (Journal of Bioactive and Compatible Polymers 2021, Vol. 36(4) 334–347).
Claim 3 of the instant application claims the composition further contains copper (II) acetate.
Zhu is as set forth above.
Zhu does not teach including copper (II) acetate.
However, Zhu teaches that the formulation is a face mask for soothing and repairing fragile skin to enhance muscle energy (pages 2-3). Zhu teaches the formulation includes ingredients for the following purposes: to soothe, repair and care for fragile skin, enhance skin vitality and solve sensitive, dry, dark yellow, sagging and other skin problems, immunopotentiating activity, stimulates cell activity and enhances skin's vitality, effectively repairs skin and reduces skin wrinkles, anti-inflammatory, antibacterial and promoting skin cell repair (page 9).
Paillot teaches there is an increasing interest in the development of new antimicrobial materials for their use in a myriad of applications such as cosmetics (page 335). Paillot teaches that copper (II) acetate is reported to have a remarkable antimicrobial activity which can be used as an antimicrobial agent against common cosmetic proliferating pathogens (page 335). Paillot demonstrates that copper (II) acetate may serve as an antimicrobial agent in cosmetics (pages 343-345).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Zhu which teaches a formulation as a face mask for soothing and repairing fragile skin to enhance muscle energy wherein the formulation includes ingredients for the following purposes: to soothe, repair and care for fragile skin, enhance skin vitality and solve sensitive, dry, dark yellow, sagging and other skin problems, immunopotentiating activity, stimulates cell activity and enhances skin's vitality, effectively repairs skin and reduces skin wrinkles, anti-inflammatory, antibacterial and promoting skin cell repair; with the teachings of Paillot et al. which demonstrates that copper (II) acetate may serve as an antimicrobial agent in cosmetics. Thus an ordinary skilled artisan would have been motivated to add copper (II) acetate to the formulation of Zhu to further improve the properties of the composition by adding antimicrobial properties to the formulation and thus preventing contamination and preserving the composition and improving storage. Thus claim 3 of the instant application is rendered obvious in view of the cited prior art teachings.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu CN-104666179 A (see Machine English translation provided) as evidenced by Parsons et al. (1982, Poultry Science 61:939-946) as applied to claims 1 and 2 above and further in view of Ehrman et al. U.S. Publication No. 2014/0336275 A1.
Claim 4 of the instant application claims the composition further contains undeclenoyl phenylalanine.
Zhu is as set forth above.
Zhu does not teach including undeclenoyl phenylalanine.
However, Zhu teaches that the formulation is a face mask for soothing and repairing fragile skin to enhance muscle energy (pages 2-3). Zhu teaches the formulation includes ingredients for the following purposes: to soothe, repair and care for fragile skin, enhance skin vitality and solve sensitive, dry, dark yellow, sagging and other skin problems, immunopotentiating activity, stimulates cell activity and enhances skin's vitality, effectively repairs skin and reduces skin wrinkles, anti-inflammatory, antibacterial and promoting skin cell repair (page 9).
Ehrman et al. examples of skin care actives include N-undecylenoyl-L-phenylalanine (i.e. undeclenoyl phenylalanine), wherein N-undecylenoyl-L-phenylalanine is a material that belongs to a broad class of N-acyl phenylalanine derivatives and is known as a topical skin tone evening agent [0097].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Zhu which teaches a formulation as a face mask for soothing and repairing fragile skin to enhance muscle energy wherein the formulation includes ingredients for the following purposes: to soothe, repair and care for fragile skin, enhance skin vitality and solve sensitive, dry, dark yellow, sagging and other skin problems, immunopotentiating activity, stimulates cell activity and enhances skin's vitality, effectively repairs skin and reduces skin wrinkles, anti-inflammatory, antibacterial and promoting skin cell repair; with the teachings of Ehrman et al. which teaches examples of skin care actives including N-undecylenoyl-L-phenylalanine (i.e. undeclenoyl phenylalanine), wherein N-undecylenoyl-L-phenylalanine is a material that belongs to a broad class of N-acyl phenylalanine derivatives and is known as a topical skin tone evening agent [0097]. Thus an ordinary skilled artisan would have been motivated to add undeclenoyl phenylalanine to the formulation of Zhu to further improve the properties of the composition by increasing the composition’s ability to even skin tone and thus further enhance skin vitality. Thus claim 4 of the instant application is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-4 are rejected. Claims 5-8 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM