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 .
Status of the Claims
Claims 1-25 and 27 are pending. Claims 2-16, 19, 22-24 and 27 are withdrawn. Claims 1, 17-18 and 20-21 are rejected. Claim 25 is objected to.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-25, drawn to a compound of Formula (I), classified in C07D 403/12.
II. Claim 27, a method of treating a patient suffering from a neurological condition by administering a compound of Formula (I), classified in A61P 25/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed could be used in a materially different process. For example, Nagarathnam et al. in WO 03/030909 A1 teach Example 243, Nagarathnam et al. teach the compound 243,
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, in Table 4 on page 73. Compound 243 is embraced by instant Formula (I),
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, wherein:
G1 is CF3;
G2 is H; and
A and B together are
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.
Nagarathnam et al. describe the compound as “useful in the treatment of cancer and viral infections”. See abstract.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions require a different filed of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Election of Species
This application contains claims directed to the following patentably distinct species:
- a compound of Formula (I) as recited in claim 1, examples of which are in claim 25.
The species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, all claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the species or groupings of patentably distinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
During a telephone conversation with Attorney Amit Singhai on 11/03/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-25 and of the elected species Example 1,
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. Affirmation of this election must be made by applicant in replying to this Office action. Claims 2-16, 19, 22-24 and 27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 17-18, 20-21 and 25 read on Applicant’s species election of Example 1. Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to the scope of claim 25 and the scope of Formula (IV) of claim 17 wherein X6 is NH; X7 is CH; R1 is CF3; R2 is aryl-substituted or unsubstituted alkyl wherein the aryl may be further substituted with one or more halogens; and R15 and R16 are each hydrogen.
Since art was found on a nonelected species, subject matter not embraced by the above-identified non-elected species is therefore withdrawn from further consideration. Claims 2-16, 19, 22-24 and 27 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.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application claims benefit to PRO 63/411,846 filed 09/30/2022.
Information Disclosure Statement
The information disclosure statement (IDS) dated 01/14/2025 has been considered.
Claim Objections
Claims 1, 17, 21 and 25 are objected to because of the following informalities:
Claim 1 is objected to for the following:
In the line beginning “G1 is” on page 2, “or” should be moved after “ethyl” for proper grammatical format;
In the paragraph beginning “wherein the one or more substituents…” on page 2, line 4, “-CF2-cycloalky” should be changed to “-CF2-cycloalkyl” for proper spelling; and
In the paragraph beginning with “wherein the one or more substitutions…” on page 2, line 7, the claim recites a limitation wherein A and B may be substituted with “-COOH (and ester thereof)”. The Examiner recommends either deleting the parenthetical phrase “(and ester thereof)”, or replacing it with language consistent with the definition of ester provided in the specification, for instance on page 62, lines 5-8.
Claim 17 is objected to for the following:
In the paragraph beginning with “R12, R13, and R14…” on page 6, lines 2 and 3, “C1-C6-alkenyl” and “C1-C6-alkynyl” should be amended to state “C2-C6-alkenyl” and “C2-C6-alkynyl” since alkenyl and alkynyl groups must have at least two carbons present. See also the definition of alkenyl on page 26, lines 10-12 of the specification.
In the paragraph beginning with “R12, R13, and R14…” on page 6, line 4, “-CF2-cycloalky” should be changed to “-CF2-cycloalkyl” for proper spelling.
Claims 21 are 25 are objected for being written in improper Markush format. See MPEP 2173.05(h).
Claim 21, line 3 should be amended as follows: “ethyl, vinyl, and -CH2-CN.”
Claim 25 should be amended to include the word “and” between the last two items of the table on page 22.
Appropriate correction is required.
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.
Claims 17-18 and 20-21 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 17, R1 and R2 in Formula (IV)
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are not defined. As such, the metes and bounds of the claim are indefinite. Applicant may overcome the rejection by, for example, amending the claim so that R1 and R2 are defined within claim 17.
Dependent claims 18 and 20-21 are rejected as indefinite for the same reason since they do not correct the indefiniteness issue of their parent claim.
Claim Rejections - 35 USC § 112(d)
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.
Claim 17-18 and 21 are rejected under 35 U.S.C. 112(d) 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 17 recites limitations of R12, R13, and R14 that are outside the scope of possible substitutions for the A and B rings of claim 1 from which claim 17 depends. Specifically, claim 17 states that R12, R13, and R14 may be a C3-C6-cycloalkyl, C3-C6-halocycloalkyl, and nitro, which are not supported by claim 1. Likewise, claim 17 recites that R15 and R16 may be a nitro group, which is not supported by claim 1 as a substituent on the A and/or B rings.
Dependent claims 18 and 21 are rejected for the same reason as they do not correct the dependency issue of their parent claim.
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 1, 17-18 and 20-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nagarathnam et al. in WO 03/030909 A1.
Nagarathnam et al. teach the compound 243,
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, in Table 4 on page 73. Compound 243 is embraced by instant Formula (I),
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, wherein:
G1 is CF3;
G2 is H; and
A and B together are
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.
Compound 243 is also embraced by instant Formula (IV) of claim 17,
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, wherein:
R1 is CF3;
R2 is H;
X6 is N and X7 is C (see also instant claim 18);
R12 and R14 are each hydrogen (see also instant claim 20); and
R15 and R16 are each hydrogen (see also instant claim 21).
Allowable Subject Matter
Claim 25 is free of the prior art.
The closest prior art is from Nagarathnam et al. in WO 03/030909 A1. Nagarathnam et al. teach compounds of Formula (I),
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, as kinase inhibitors. The compounds of claim 25 are also kinase inhibitors with the same pyrimidine ring core as the prior art, either as the monocyclic pyrimidine, or fused with another aryl or heteroaryl. However, the compounds disclosed by Nagarathnam et al. do not anticipate the present compounds of claim 25, nor do they render the instant claims obvious as positional isomers, homologs, or other close structural relationships. The subject matter of claim 25 is thus novel and nonobvious.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached on (571) 272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626