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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites: “having structural formula” which should recite the article “a” or “the” preceding the term “structural”;
“1C-6C alkyl” which should recite “C1-C6 alkyl”;
“tert-butyloxycarboryl” which should recite “tert-butyloxycarbonyl”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claims 12 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for compounds of formula I/II and methods of preparing and uses thereof, does not reasonably provide enablement for:
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(claim 15) . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The criteria for enablement set out in In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the claims—The instant claims cover
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(claim 12) and
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(claim 15) .
Level of skill in this art—The level of skill in the art is high.
State of the prior art—Various NAMPT agonists, methods of preparation thereof, methods or drugs for anti-aging or treatment of neurodegenerative diseases are known.
Working examples—The disclosure shows examples of 66 drugs of formula I/II and biological tests thereof.
Direction and Guidance—The amount of guidance presented in the specification is insufficient to enable exceedingly broad scope of the instant claims. The claims encompass any NAMPT agonists, methods of preparation thereof, methods or drugs for anti-aging or treatment of neurodegenerative diseases whereas the disclosure is only drawn to those related to compounds of formula I/II. A PHOSITA would not be enabled to make and use for example a yet undiscovered NAMPT agonist. The methods of treatment/drugs of treatment do not even require an NAMPT agonist, and the method of treatment does not even require a drug. Accordingly, the entire scope of said limitations cannot be considered enabled.
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.
Claims 11-17 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 11 recites “(such as trifluoromethyl)” in multiple instances; the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 recites “the benzene ring in formula I or formula II can also be substituted by other aromatic rings.” First, there is a lack of antecedent basis as each formula has two benzene rings and it is unclear whether one or both is referenced by this statement. This is further complicated by the fact that the variables R1-R10 can be phenyl (a benzene ring). Second, the claim further recites “The other aromatic rings are …” The substituents of each ring are already defined by Formula I/II via the definitions of R1-R10. In order for either benzene ring to be substituted by other aromatic rings such as those listed, one of R1-R10 would have to be substituted. The definitions of R1-10 do not encompass all of the “other aromatic rings” recited, such as naphthalene. Accordingly, it is unclear whether the claim is limited by the definitions of R1-R10; whether R1-R10 can be the “other aromatic rings” rather than groups falling under the definitions of R1-R10; and whether a particular or any benzene ring on a compound of Formula I/II can be substituted by other aromatic rings.
Claims 13-14 and 16-17 refer to “the aromatic compound represented by formula I or formula II”. The claim limitations are not dependent from any claim which refers to said compound and therefore lack antecedent basis. Claims 13 and 14 refer to (E) and (F) of claim 12, respectively, which lack antecedent basis for a compound of formula I/II. Claims 16 and 17 depend from claim 15 which does not recite a compound of Formula I/II. Even if construed to refer to the specification, the claim is indefinite because while the specification defines aromatic compounds represented by formula I/II, the definitions of variables within the specification are non-limiting. Furthermore, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO2018132372A1.
The compound ethyl 4-(3-benzylureido)benzoate and its synthesis are taught on p. 106 (Example 34, Para. [00268]. The compound is an NAMPT agonist (Table B-3, Para. [01277]). The compounds of the disclosure are useful for treating neurological diseases including Alzheimer’s disease (Para. [0037]). The compound anticipates a compound of Formula II of claim 11 wherein X is NH; Y is O; n is 0; R10 is ester, and R1-R9 are each H; (G) and (H) of claim 15; and claims 16-17 are also anticipated by the compound. The synthetic method anticipates (E) of claim 12; claim 13 is also anticipated. The compounds are useful for treatment of Alzheimer’s disease which anticipates (F) of claim 12; claim 14 is also anticipated. Note intended use is not given patentable weight, but the intended uses of treating neurodegenerative diseases or anti-aging are nevertheless taught by the prior art. Accordingly, claims 11-17 are anticipated.
Note that the claims have only been rejected to the extent necessary to determine patentability. Additional references which may anticipate or render the claims obvious have not been applied herein. In view of the breadth of the claims, myriad species in the prior art appear to anticipate the claims on file. See ISR/Written Opinion for example. Applicant is advised to consider such art of record in order to promote compact prosecution.
Conclusion
Claims 11-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623