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 .
Claim Status
Claims 1-15 were originally presented on 08/11/2023. The preliminary amendments to the claims also filed 08/11/2023 have been received and entered. No claims were cancelled or newly added.
Claims 1-15 are pending.
Priority
This application is the U.S. national phase of International Application No. PCT/EP2022/053021 filed February 8, 2022 which designated the U.S. and claims priority to EP 21157280.5 filed February 16, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 08/11/2023 has been received and entered into the present application. As reflected by the attached, completed copy of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
Claim Objections
Claims 1 and 14-15 are objected to because of the following informalities:
In lines 1-2, the word “of” should be inserted between “compound” and “formula (I), i.e., “…at least one compound of formula (I)…”
In line 6, the word “if” appears to be a typo and should read “of”, i.e., “…or a residue of formula (III)…”
The claims contain two periods – one after “at least one compound formula (I) or (II)” in lines 1-2 and one at the end of the claims. The period following “at least one compound formula (I) or (II)” should be a colon.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Here, independent claim 1 is a “use” claim, i.e., it claims “[c]osmetic use” of a topical composition comprising at least one compound of formula (I) or (II) “for preventing and/or treating skin ageing”. The claims therefore do not purport to claim a process, machine, manufacture, or composition of matter. See MPEP 2173.05(q).
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 the applicant regards as his invention.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-11 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.
Independent claim 1 is a “use” claim, i.e., it claims “[c]osmetic use” of a topical composition comprising at least one compound of formula (I) or (II) “for preventing and/or treating skin ageing”. The claims are indefinite under 35 U.S.C. 112(b) because they merely recite a [cosmetic] use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP 2173.05(q).
Dependent claims 2-11 are included in this rejection because they too fail to recite any active, positive steps delimiting how the use of claim 1 is actually practiced.
Claims 2-4, 6, 8-10, and 12-13 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.
The rejected claims recite the claim terms “preferably”, “most preferably”, and/or “in particular”. These phrases are construed similarly to “such as” and render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In this case, it is not clear whether the “preferably”, “most preferably”, and/or “in particular” embodiments are claim limitations, i.e., whether the claims are intended to be limited to only the “preferably”, “most preferably”, and/or “in particular” embodiments. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102/103
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 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.
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(s) 1-6, 8, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over FR2973234A1 (Published 10/05/2012) (Citations below refer to the attached Machine Translation to English of FR2973234A1).
FR ‘234 teaches the use of an arginase inhibitor compound for braking the fall of keratin fibres and in particular the hair, the eyebrows and/or the eyelashes (p.1, 1st paragraph of English Translation; Claim 1). Regarding claims 1-6 and 11-13, the arginase inhibitor is alpha aminoisobutyric acid, N-G-hydroxy-L-arginine, 1-ethyl-3-(3-dimethylaminopropyl-L-arginine, 1-ethyl-3-(3-dimethylaminopropyl)-carbodiimide, octopine, N-tosyl-L-arginine, N-p-tosyl-L-arginine methyl ester (p.4, 1st full paragraph of English Translation; Claim 5)1. The arginase inhibitor is present in a composition suitable for topical application to the scalp and the skin, containing a physiologically acceptable medium, in particular a cosmetic or dermatological composition (p.5, 3rd full paragraph of English Translation; Claim 8). Regarding claim 8, the arginase inhibitor is present in the composition in a content of between 0.01 and 30% by weight relative to the total weight of said composition, more preferentially at a concentration of 1 to 12% (p.5, 2nd full paragraph of English Translation; Claim 14). Regarding claim 14, a composition suitable for topical administration can in particular be in the form of an emulsion (p.5, 6th full paragraph of English Translation).
The claims are anticipated by FR ‘234 in so far as the reference teaches the cosmetic use of topical compositions comprising, inter alia, a compound of formula II, i.e., N-tosyl-L-arginine or N-p-tosyl-L-arginine methyl ester. As required by claims 12 and 13, the compositions are topically applied to the skin, i.e., the scalp. For example, FR ‘234 teaches in Claim 9 a process for the cosmetic treatment of human keratin fibres chosen from the hair, the eyebrows and/or the eyelashes, to brake the fall of said fibres, characterized in that it consists in applying to the scalp and/or directly to said keratin fibres, a cosmetic composition comprising, in a physiologically acceptable medium, at least one arginase inhibitor, in leaving it in contact with the scalp and/or said keratin fibres and optionally in rinsing the scalp and/or said fibres.
Alternatively, it would have been obvious to a person of ordinary skill in the art to topically apply a cosmetic composition comprising N-tosyl-L-arginine or N-p-tosyl-L-arginine methyl ester to the scalp of a subject as expressly suggested and motivated by the teachings of FR ‘234. In this regard, FR ‘234 teaches that N-tosyl-L-arginine and N-p-tosyl-L-arginine methyl ester are arginase inhibitors useful in the cosmetic compositions and methods taught therein, which comprise topically applying a cosmetic composition comprising an arginase inhibitor to the scalp of a subject. In view of the teachings of the FR ‘234, a person of ordinary skill in the art would have a reasonable expectation of success that topically applying a cosmetic composition comprising an arginase inhibitor, e.g., N-tosyl-L-arginine or N-p-tosyl-L-arginine methyl ester, to the scalp of a subject would provide a therapeutic benefit to a subject.
Conclusion
Claims 1-14 are rejected.
Claims 1 and 14-15 are objected to.
No claims are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
Tel. No.: (571) 272-9038
1 N-tosyl-L-arginine is a compound of the claimed Formula (II) wherein R1 is “aryl”; R2 is OH; R4 is H; and R5 is H. N-p-tosyl-L-arginine methyl ester is a compound of the claimed Formula (II) wherein R1 is “aryl”; R2 is a C1-C6alkoxy group (C1 alkoxy); R4 is H; and R5 is H.