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
Provisional application filed 07/02/2023 is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 19 and 20) in the reply filed on 08/25/2026 is acknowledged.
Claims 1-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2026.
Claims 19 and 20 are pending and under current examination.
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 19 is 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 claim 19, the ratio defining each amino acid relative to the other amino acids is indefinite because it is not described whether the amino acids that make up the ratio are in a percent by weight, moles, concentration, or volume.
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.
Claim(s) 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boo (KR 102543595 B1; see machine translation retrieved 09/30/2026), as evidenced by Bennett (WO 2013066966 A1).
Regarding claim 19, Boo teaches a cosmetic composition for promoting collagen production, comprising at least one amidated amino acid selected from the group consisting of glycinamide, glutaminamide, alaninamide, isoleucinamide, argininamide, threoninamide, or valinamide (i.e. derivatives of amino acids, see claim 8). The composition of Boo can be a topical formulation (para. [0101]), and can comprise suspending agents or thickeners (i.e. dermatologically acceptable carriers, para. [0107]). Boo describes that cells were treated with each amino acid at a concentration of 1 mM, and it was found that glycine, glutamine, and isoleucine were most effective in increasing collagen production (para. [0174]). Further, Boo teaches that a concentration of 1 mM of glycinamide (i.e. glycine derivative) promoted collagen production without affecting cell viability, but at 3-5 mM it reduced collagen production (para. [0180]). Boo discloses that glycinamide was able to increase collagen production starting at 0.25 mM, and demonstrated the greatest collagen production enhancement effect at 1-2 mM (para. [0180]). The cosmetic composition of Boo is used to improve skin wrinkles, improve skin moisturization, elasticity, and prevent skin aging (see claim 9).
One of ordinary skill in the art would be motivated to combine glycine, isoleucine, and glutamine, as Boo describes these amino acids most effectively increased production of collagen, at concentrations of 1-2 mM. Increasing production of collagen is known in the art to be effective in cosmetic compositions for anti-aging or anti-wrinkling. The concentration of amino acids recited in instant claim 19 overlaps with that of Boo, and as such is obvious. Further, the ratio of each amino acid to the other amino acids of instant claim 19 falls within the concentration range described in Boo, and is obvious. MPEP § 2144.05(I). A person of ordinary skill in the art would be motivated to optimize the cosmetic composition of Boo to comprise all three of glycine, glutamine, and isoleucine derivates at concentrations of 1 mM, as Boo teaches that these amino acids are most effective at this concentration to promote collagen production.
Boo teaches each component of the instant invention, and describes that the cosmetic composition is for improving skin wrinkles, improving skin elasticity, and preventing skin aging (see claim 9). However, Boo fails to teach that the composition targets skin regeneration and EGF expression specifically. Bennett also teaches a topical composition that is formulated to assist in the prevention or slowing of premature aging of skin, to reduce wrinkles, and maintain skin health (para. [0001]), and describes that the composition comprises alanine and glycine, teaching that the right mix of amino acids active act as a regenerative treatment for the skin (i.e. increasing skin regeneration, para. [0016]). Boo and Bennett are considered to be analogous to the claimed invention because they are in the same field of cosmetic compositions that are topical and used to reduce signs of aging, specifically in reducing appearance of wrinkles. As such, one of ordinary skill in the art would be motivated to optimize the composition of Boo and utilize it for the purpose of skin regeneration as Bennett teaches combinations of amino acids in anti-aging topical formulations can be used for this benefit. MPEP § 2143(I)(g).Additionally, it is noted that “[p]roducts of identical chemical compositions cannot have mutually exclusive properties.” In re Sprada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The cosmetic composition of Boo and instant invention have the same chemical composition, and as such their properties are inseparable. Since Boo describes the identical chemical structure of instant invention, the properties applicant discloses and/or claims are necessarily present. The properties that would be shared between instant invention and Boo include expression of EGF and improved skin regeneration of skin cells, as recited in instant claim 19.
Regarding claim 20, Boo teaches that the cosmetic composition is for improving skin wrinkles, improving skin elasticity, and preventing skin aging (see claim 9), and can further treat burns and wounds (see claim 4 and para. [0081]).
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.
Claim(s) 19 and 20 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 113-114 of U.S. Application 18/764,024 (hereafter App. ‘024).
Regarding claim 19, App. ‘024 claims a method for administering a topical formulation to the skin of a subject suffering from a skin condition (see claim 113). The topical formulation in the method of App. ‘024 comprises free amino acids or peptide combination of amino acids, and a therapeutically effective amount of a combination consisting of alanine, glutamine, glycine, and serine or salts thereof, wherein each free amino acid has a ratio to each of the other free amino acids of 1:100 or greater. Each of the amino acids of App. '024 is present at a concentration of 0.1-10 mM, and the therapeutically effective amount of the combination of components improves skin moisture when tested by a method detecting expression of epidermal growth factor (EGF), where the EGF marker gene expression is upregulated by 1.4-450 fold for formulation treated skin cells as compared to untreated skin cells. App. '024 describes that the composition used in the method of administration comprises a dermatologically acceptable vehicle and/or additive (i.e. carrier). App. '024 claims a method of administering a composition with all the same components of instant invention, and as such would have the same benefit of improving skin regeneration of skin cells in a subject, as recited in instant claim 1.
Regarding claim 20, App. '024 claims a method of administering a topical composition that improves a skin conditions such as atopic dermatitis, dermatitis, psoriasis, pruritus, eczema, a wound, or a burn (see claim 114).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of App. ‘024 are directed to the same combination of amino acids for treating a similar subject population.
The above rejections are nonprovisional nonstatutory double patenting rejections because the patentably indistinct claims of App. ‘024 have been patented.
Claim(s) 19 and 20 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claim 18 and 20 of U.S. copending Application 19/013,807 (hereafter App. ‘807).
Regarding claim 19, App. '807 claims a method of administering a topical formulation to the skin of a subject suffering from a skin condition, where the method improves the barrier integrity of skin cells (i.e. improving skin regeneration of skin cells, see claim 18). The topical formulation that is applied comprises free amino acids, a therapeutically effective amount of a combination of glutamine, glycine, alanine, and serine or salts thereof, wherein each free amino acid has a ratio to each of the other free amino acids of 1:100 or greater. App. '807 describes that the therapeutically effective amount of each component improves barrier integrity of the skin cells, and when detecting expression of an EGF skin barrier marker gene, the EGF skin marker gene is upregulated by a 1.5-40 average fold change of formulation treated as compared to untreated skin. Further, the composition administered in the method of App. ‘807 has amino acids present at a concentration between 0.1-10 mM, and comprises a dermatologically acceptable carrier.
Regarding claim 20, App. '807 claims a method of administering a topical formulation that improves at least one visual or tactile property, wherein the skin condition comprises a cosmetic skin condition, atopic dermatitis, dermatitis, psoriasis, pruritus, eczema, a wound, or a burn (see claim 20).
Claims 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 20 of copending Application 19/013,807. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of App. ‘807 are directed to the same combination of amino acids for treating a similar subject population.
The above rejections are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not yet in fact been patented.
Conclusion
Claim(s) 19 and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
