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 .
Election/Restriction
Applicant’s election without traverse of compound 3 in the reply filed on 2026 January 20 is acknowledged. Due to the election, a search of claims 1, 6, 8, 10, 17, 18, 21-23, 28, 29, 36, 37, 46, 47, 49, 51. and 54-56, in which E is NR6 and one of variables X, Y, Z and W is N and the remainder are CR4 has been executed.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2023 June 29 and 2024 August 28 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 51 is objected to because of the following informalities: compounds 28 and 211 appear to be the same. If they are same, only of them needs to be recited within the claims. If there are any other pairs of duplicate compounds recited in the claims, they should be removed within the claim Appropriate correction is required.
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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, 21-23, 28, 29, 36, 37, 46, 49, and 55 are rejected under 35 U.S.C. 101 because formula (I) encompasses a natural product. ITOH (Medicinal Chemistry Research, 2018, 27, 412-419) describe ellipticine and olivacine (page 412, column 2, paragraph 1; page 413, figure 1). These compounds are present of the leaves of Ochrosia elliptica Labill. In these compounds, the following examined definitions apply: V and RD are each H; E is NH; R2 is H or Me or H; R3 is Me; X is CH or CMe; Y is N; and Z and W are CH. Compositions are described (page 414, column 2, paragraph 2).
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Claim Rejections - 35 USC § 112
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.
Claim 56 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating a subject suffering from a condition or disease characterized by G4C2 expansion repeats with a compound of formula (I). Thus, the claims taken together with the specification imply a compound of formula (I) can treat a disease or condition characterized by G4C2 expansion repeats.
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The state of the prior art and (4) the predictability or unpredictability of the art:
GOODMAN (Trends in Genetics, 2020, 36(2), 81-92) describes that more research is required to understand what disorders are related to G4C2 expansion repeats (page 87, paragraph 5 to page 89, paragraph 3).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in treating a subject suffering from a disease or condition characterized by G4C2 expansion repeats, their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how what disease or condition is characterized by G4C2 expansion repeats.
The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification does not provide guidance for treating a subject suffering from a disease or condition characterized by G4C2 expansion repeats.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to what disease or condition is characterized by G4C2 expansion repeats and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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, 21-23, 28, 29, 36, 37, 46, 49, and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ITOH (Medicinal Chemistry Research, 2018, 27, 412-419) describe the following compounds: ellipticine and olivacine (page 412, column 2, paragraph 1; page 413, figure 1) and S-16020 (page 413, figure 2). Ellipticine and olivacine are present of the leaves of Ochrosia elliptica Labill. In these compounds, the following examined definitions apply: (V, RD) are (H, H) or (OH, H); E is NH or NMe; R2 is H or Me or H; R3 is Me; X is CH or CMe; Y is N; and Z and W are CH. Compositions are described (page 414, column 2, paragraph 2).
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Claim(s) 1, 6, 8, 21, 23, 28, 29, 36, 47, 49, and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DUCROCQ (Journal of Medicinal Chemistry, 1980, 23, 1212-1216) describe compounds 4, 8, 10-14, 16, 19, 28, and 29 of table 1 (page 1214-1215). In these compounds, the following examined definitions apply: V is OH or OMe; RD is H; E is NH; R2 is H; R3 is Me; X is C[NH-[propylene-NEt2], [propylene-NH2], [ethylene-NMe2]], NH-phenyl, or NMe2; Y is N; and Z and W are CH. Compositions are described (page 1216, column 2, paragraph 3).
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Claim(s) 1, 6, 21-23, 28, 29, 36, 47, 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SRIVENUGOPAL (US 20160346231, published 2016 December 1). Srivenugopal describes a compound and composition comprising the same (page 2; paragraph [0009]; page 1, paragraph [0006]). In this compound, the following examined definitions apply: V is OH; RD is H; E is N-Me; R2 is H; R3 is Me; X is C-C(O)-NH-ethylene-NMe2; Y is N; and Z and W are CH.
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Claims 1, 17, 21-23, 28, 29, 36, 37, 46, 49, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SAINSBURY (The Chemistry of Antitumor Agents, 1990, chapter 18, pages 410-435) describe ellipticine and compounds (17), (49) (50), (page 410, scheme 18.1; page 412, scheme 18.2; page 419, scheme 18.10; and pages 423-424). Ellipticine is present of the leaves of Ochrosia elliptica Labill. In these compounds, the following examined definitions apply: (V, RD) is selected from (H, H), (OH, H), (NH2, H), (F, H), (Cl, H), or (Br, H); E is NH or NMe; R2 is H or Me or H; R3 is Me; and variables (X, Y, Z, and W) is (CH, CH, N, CH), (CH, N, CH, CH), or (CMe, N, CH, CH). Compositions are described (pages 431-432, section 18.5).
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R = H
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Conclusion
Claims 1, 6, 8, 17, 21-23, 28, 29, 36, 37, 46, 47, 49, 51, and 54-56 are not allowed. Claim 51 is free of the prior art of record and objected to for the reasons stated above
Claims 10 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: SRIVENUGOPAL (US 20160346231, published 2016 December 1). Srivenugopal describes a compound and composition comprising the same (page 2; paragraph [0009]; page 1, paragraph [0006]). In this compound, the following examined definitions apply: V is OH; RD is H; E is N-Me; R2 is H; R3 is Me; X is C-C(O)-NH-ethylene-NMe2; Y is N; and Z and W are CH. This compound does not anticipate or render obvious a compound of claim 51 because there is no teaching that a hydroxyl group is an alternative embodiment to an OMe for variable V (see compound 28 or 211 of the examined claim 51).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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