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
Priority and Status of the Claims
1. This application claims benefit of the provisional application:63/640,100 04/29/2024; 63/562,155 03/06/2024; and 63/581,551 09/08/2023
2. Claims 1-2, 6-13, 76 and 79 are pending in the application.
3. 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 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.
Claim Rejections - 35 USC § 102
4. 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)(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.
Claim 1 is rejected under 35 U.S.C. 102 (a) (2) as being anticipated by Landry et al. US 2024/0025919 A1.
Applicants claim a compound of formula (I), i.e.,
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374
544
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, wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is absent or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionallu substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Landry et al. ‘919 discloses three compounds, i.e., compound No. 257, 258 and 259, see columns 422-426. They clearly anticipate the instant compounds of formula (I), wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is absent or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionallu substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 6-13, 76 and 79 are rejected under 35 U.S.C. 103(a) as being obvious over Landry et al. US 2024/0025919 A1. It is noted that Landry et al. ‘919 is 102(a)(2) reference.
Applicants claim a compound/composition of formula (I), i.e.,
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374
544
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, wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is absent or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1. Dependent claims 2, 6-13, 76 and 79 further limit the scope of compounds, i.e., specific variables X, L1, R1a and R1b, and methods of use for treating cancer.
Determination of the scope and content of the prior art (MPEP §2141.01)
Landry et al. ‘919 discloses a compound/composition of the formula (1), i.e.,
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184
234
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, wherein X is NR6 and R6 is hydrogen or alkyl, R3 is halogen or hydrogen, R1 is phenyl or pyridinyl, L1 is alkylene, and R2 is heterocycle,
see columns 448 and 441-447. A number of compounds have been exemplified in
columns 422-426. Landry et al. ‘919 compound/composition is used for treating cancer, see columns 448.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Landry et al. ‘919 is that the instant claims are embraced within the scope of Landry et al. ‘919.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-2, 6-13, 76 and 79 prima facie obvious because one would be motivated to employ compounds/ compositions of Landry et al. ‘919 to obtain instant invention.
The motivation to make the claimed compounds/composition derived from the known compounds/compositions of Landry et al. ‘919 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
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).
6.1 Claim 1 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Dai et al. US 12,448,400. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a compound of formula (I), i.e.,
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374
544
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, wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is absent or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Dai et al. ‘400 claims a compound of formula (Ib-1), i.e.,
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312
374
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, wherein X is N, RA is
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266
396
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or
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214
252
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, RD is F, RB is
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178
238
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, and -O-Lc-Rc is
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168
258
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, see claim 1 in columns 369-371.
The difference between instant claims and Dai et al. ‘400 is that the instant claims are embraced within the scope of Dai et al. ‘400.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ compounds of Dai et al. ‘400 to obtain instant invention.
The motivation to make the claimed compounds derived from the known compounds of Dai et al. ‘400 would possess similar activity to that which is claimed in the reference.
6.2 Claim 1 is provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Dai et al. co-pending application No. 18/825,960, over claim 1 of Dai et al. co-pending application No. 18/756,455, over claim 1 of Dai et al. co-pending application No. 18/303,813 and over claim 62 of Dai et al. co-pending application No. 18/334,924 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a compound/composition of formula (I), i.e.,
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374
544
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, wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is absent or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Dai et al. ‘960 claims a compound of formula (I), i.e.,
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284
362
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, wherein where in X is N, CH or CRx, L1 is O, S, or CR1aR1b,
L2 is CR2aR2b, L3 is a bond or CR3aR3b; Lc is a bond; RA is heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Dai et al. ‘455 claims a compound of formula (J), i.e.,
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386
516
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, wherein X is N, CH or CRx, L1 is O, S, or CR1aR1b, L2 is O, S, or CR2aR2b, L3 is absent or CR3aR3b, and L4 is a bond or CR4aR4b; Lc is a bond; RA is phenyl or naphthyl, heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Dai et al. ‘813 claims a compound of formula (I), i.e.,
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284
362
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, wherein where in X is N, CH or CRx, L1 is O, S, or CR1aR1b,
L2 is CR2aR2b, L3 is a bond or CR3aR3b; Lc is a bond; RA is heteroaryl, RB is H, RC is H, alkyl, cycloalkyl optionally substituted with Rc3 and Rc3 is heterocycle, R1-R4 are H or alkyl, and RD is halo, see claim 1.
Dai et al. ‘924 claims a compound of formula (Ib-5) or (Ib-6), i.e.,
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334
558
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or
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328
546
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, wherein
R1b is H or methyl, Rc3 -CH2Orc3a1 or F, see claim 62.
The difference between instant claims and Rai et al. ‘960, ‘455, ‘813 and ‘924 is that the instant claims are embraced within the scope of Rai et al. ‘960, ‘455, ‘813 and ‘924.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ compounds of Rai et al. ‘960, ‘455, ‘813 and ‘924 to obtain instant invention.
The motivation to make the claimed compounds derived from the known compounds of Rai et al. ‘960, ‘455, ‘813 and ‘924 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
September 8, 2026
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