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 .
DETAILED ACTION
Claims 1-7, 9-13 and 16-23 are currently pending in the instant application. Claims 1, 2 and 4 are rejected, claims 3, 5 and 6 are objected and claims 7, 9-13 and 16-23 are withdrawn from consideration in this Office Action.
I. Priority
The instant application is a CON of PCT/US2021/019490, filed on February 24, 2021 which claims benefit of US Provisional Application 62/981,516, filed on February 25, 2020.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 2, 2023, February 9, 2023 and March 11, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Restriction/Election
A. Election: Applicant's Response
Applicants' election without traverse of Group I in the reply filed on August 19, 2025 is acknowledged.
Subject matter not encompassed by elected Group I are withdrawn from further consideration pursuant to 37 CFR 1.142 (b), as being drawn to nonelected inventions.
B. Status of the Claims
i. Scope of the Search and Examination of Elected Subject Matter
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(6)
The above structure is the provisional elected species.
ii. Extended Prior Art Search M.P.E.P. §803.02
Following election, the Markush-type claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. If the Markush-type claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush-type claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. On the other hand, should the examiner determine that the elected species is allowable, the examination of the Markush-type claims will be extended. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the non-elected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species.
As indicated above, Examiner searched the compound based on the elected species, above, in response to the requirement to restrict the products of Formula (I), wherein: there was no prior art of record that anticipated or rendered obvious the elected species and therefore the scope of the subject matter was extended or broadened in pursuant to M.P.E.P. § 803.02.
The prior art search was extended to include the products of formula (I)
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wherein:
X is CH or N;
Y is CF3;
Z is CN;
Ra is as defined in claim 1;
W1 is ORd;
Rd is as defined in claim 1;
W2 is as defined in claim 1;
W3 and W4 as defined in claim 1;
A is a pyrazole substituted by CN.
.
iii. Non-elected Subject Matter Withdrawn 37 C.F.R. §1.142(b)
The non-elected subject matter withdrawn are the compounds of formula (I), claims 1-7 (in-part) wherein:
All variables are as defined in claim 1 excluding compounds wherein
Y is CF3;
Z is CN;
W1 is ORd; and
A is an optionally substituted pyrazole as defined in claim 1.
Claim 7 will be withdrawn from consideration at this point because it is drawn to a compound that does not fall within the elected scope that has been search and examined based on Applicants species election.
IV. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 2 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. Specifically, claim 2 contains the definition for variable A being defined as NRbRc or a 5 to 10 aryl or heteroaryl group but the claim is drawn to the structure
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which does not have a variable A present. In the above structure, variable A can only be NRbRc. It is unclear what Applicants are attempting to claim with the variable A definition being present but not present in the structural formula II. Therefore, the claim is considered indefinite. Applicants are suggested to amend claim 2 by deleting the definition for variable A to overcome the rejection.
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.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being
anticipated by Narayanan, et al. (WO 2017/214634 A1). The instant invention claims
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wherein:
X is CH or N;
Y is CF3;
Z is CN;
Ra is as defined in claim 1;
W1 is ORd;
Rd is as defined in claim 1;
W2 is as defined in claim 1;
W3 and W4 as defined in claim 1;
A is a pyrazole substituted by CN.
The Narayanan, et al. teaches selective androgen receptor degrader (SARD) ligands such as
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(See page 22) wherein X is CH; Y is CF3; Z is CN; Ra is H; W2 is Me; W1 is OH; W3 and W4 are H; A is a pyrazole substituted by CN. These compounds are useful for treating diseases or conditions such as prostate cancer, triple negative breast cancer, alopecia, etc. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2 and 4 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 21 and 22 of U.S. Patent No. 12,202,815. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim a compound of the formula I claims
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wherein:
X is CH or N;
Y is CF3;
Z is CN;
Ra is as defined in claim 1;
W1 is ORd;
Rd is as defined in claim 1;
W2 is as defined in claim 1;
W3 and W4 as defined in claim 1;
A is a pyrazole substituted by CN.
Determining the Scope and Content of the Issued Patent
Claim 1 of the issued patent claims
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Ascertaining the Differences Between the Instant Application and the Issued Patent
The instant application is drawn to a broader scope that encompasses the species of the issued patent’s claimed invention.
Finding Prima Facie Obviousness
The genus compound of the instant application encompasses the species compound of the patented claims 1-4, 21 and 22. The scope of the compounds in the patented claims 1-4, 21 and 22 and the scope of the claims 1, 2 and 4 of the instant application overlap and include patented subject matter in the instant claims. Therefore, one of ordinary skill in the art would be motivated to prepare and claim the scope of the compounds in the issued patent again in the instant application since the scope already patented falls within the full scope of the instant claims 1, 2 and 4. As a result, the claims are rejected under obviousness-type double patenting.
V. Objections
Dependent Claim Objections
Dependent Claims 3, 5 and 6 are objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
VI. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 6:30 AM-3:00PM.
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.
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).
/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626