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
The instant application is a national stage entry of PCT/EP2022/052853, filed February 7, 2022, which claims priority to European Patent Application No. 21156802.7, filed February 12, 2021.
Current Status of 18/546,003
This Office Action is responsive to the claims of 08/10/2023. Claims 1-5 have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/10/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The scheme depicting the synthesis of the compounds of Formula (I) found on page 5 of the specification
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lacks proper labeling and fails to depict structures corresponding to the claimed compounds. Critical heteroatoms and carbon atoms required by the claimed structures are missing from the illustrated intermediates. Accordingly, the figure does not describe a synthesis of the claimed compounds and cannot be relied upon as enabling disclosure.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 merely adds the intended use of treatment of Alzheimer’s disease to the compound of Formula (I), which does not impose a structural or functional limitation on the compound of claim 1. Claim 3 similarly does not impose any structural or functional limitations and only adds non-limiting intended use language. The intended use language of these claims does not carry patentable weight and therefore does not further limit the compound of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 3 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.
Claim 3 recites “use of a compound of Formula (I) according to claim 1 in the manufacture of for the treatment of Alzheimer’s disease,” but as written it is unclear what statutory category of invention is being claimed. It is ambiguous whether the claim is intended to recite a process of making a medicament, a pharmaceutical composition comprising the compound, a method of treating the disease, or some other form of use. Because the claim fails to distinctly point out and adequately define the subject matter regarded as the invention, the scope of the claim is indefinite.
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.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is framed as a “use,” which is not itself a statutory class of invention under 35 U.S.C. §101. The language does not recite the steps of a process of making a medicament, nor does it define a composition, manufacture, or method of treatment. Instead, the claim merely expresses an intended use of the compound of claim 1 without actually claiming a statutory category of invention. Accordingly, claim 3 is non-statutory.
Allowable Subject Matter
Claims 1 and 4-5 are indicated as allowable because they contain subject matter that appears to be novel and nonobvious over the prior art of record. However, the application is not in condition for allowance due to the rejections of claims 2 and 3 and the objection to the specification.
The following is the examiner’s state reasons for allowance of the indicated claims. The closest prior art is Semenov (Semenov, Vyacheslav E., et al. "6‐Methyluracil Derivatives as Bifunctional Acetylcholinesterase Inhibitors for the Treatment of Alzheimer's Disease." ChemMedChem 10.11 (2015): 1863-1874, found in IDS filed 08/10/2023). The reference discloses 6-methyluracil derivatives that are acetylcholinesterase inhibitors useful in the treatment of Alzheimer’s disease. The reference discloses compound 3d
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(Table 1, pg. 1865), a free base form of the claimed compounds of formula (I) which are acetylcholinesterase inhibitors useful for the treatment of Alzheimer’s disease. Table 1 of the specification of the instant application directly compares compound 3d and shows that the claimed salts have greater AChE inhibiting activity and are less toxic compared to compound 3d. These properties are unexpected results that would not have been obvious to arrive at based on the teachings of Semenov. Semenov discloses quaternary nitrogen containing compounds
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but expressly teaches away from their use because the compounds cannot cross the blood brain barrier (Figure 1, pg. 1864). Therefore, the currently claimed compounds and methods using these compounds novel and non-obvious in view of the prior art at the time of filing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625