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 1-23 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1-17 and 23; directed to compound of formula (Ia)) and a species of present formula (Ia) with traverse in the reply filed April 27, 2026 is acknowledged.
Applicant traverse the restriction requirement on grounds Group I and II share a special technical feature, a compound of formula (Ia), and thus the Groups have unity of invention.
This is not found persuasive as the shared technical feature between the groups does not make a contribution over the prior art, as further indicated in the rejection under 35 U.S.C. 102 below.
The requirement is still deemed proper and is therefore made FINAL.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-2, 4-5, 7, 9-15, 17 and 23 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 3, 6, 8, 16, and 18-22 do not read on the presently searched and examined subject matter. Therefore, claims 3, 6, 8, 16, and 18-22 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
PNG
media_image1.png
117
628
media_image1.png
Greyscale
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 11/28/2023, 03/17/2026 and 04/06/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 4-5, 7, 9-15, 17 and 23 are 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 1 recites the limitation "R6" in the definition of formula (Ia) - see page 3, lines 3 and 12. There is insufficient antecedent basis for this limitation in the claim. There is no R6 present in the drawing of formula (Ia) which contains variables R1, R2, R3a, R3b, R3c, R4 and R5. Within the definitions for R1, R2, R3a, R3b, R3c, R4 and R5, R6 is not present.
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 1-2, 5, 7, 11, 14-15 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0127336 A1 (Li et al; Publication Date: 05/02/2019).
Li discloses small molecules that target Ras (e.g., K-Ras, H-Ras and/or N-Ras) and use of such compounds in the treatment of various diseases, such as cancer. See abstract and paras. 7-170.
PNG
media_image2.png
176
312
media_image2.png
Greyscale
Li discloses specific compound example Compound 133 on page 95 which corresponds to a compound of formula (Ia) wherein R1 and R5 join together to form a monocyclic 6-membered heterocycloalkyl group, R2 is C3 alkylene-R2c, R2c is NR12R13 – where R12 and R13 are C1 alkyl, , R3a is H, R3b is halo (fluoro), R3c is halo (chloro), R4 is naphthyl substituted with 1 R14 group, and R14 is OR12 – where R12 is H. See present claims 1-2, 5 and 11.
Compound 133 corresponds to a compound of present claim 7 where Z6 is O. Compound 133 also corresponds to a compound of claim 14 where x is 1. Compound 133 corresponds to a compound of claim 15 wherein R12a is H and x2 is 0.
Li discloses compounds described herein are formulated into pharmaceutical compositions. See para 758. Li discloses where pharmaceutical compositions are formulated in a conventional manner using one or more physiologically acceptable carriers comprising excipients and auxiliaries which facilitate processing of the active compounds into preparations which can be used pharmaceutically. See present claim 23.
Claims 1, 5, 7, 9-11, 13-15 and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/002102 A1 (Dai et al.; Priority to CN202110561238.1, Filed 5/22/2021).
Dai discloses compounds having a Formula (I)-(III), or a pharmaceutically acceptable salt thereof, as well as methods of preparing the compounds and methods of using the compounds, for example, in inhibiting KRAS G12D in a cancer cell, and/or in treating various cancer such as pancreatic cancer, colorectal cancer, lung cancer or endometrial cancer. See abstract and paras 5-13.
PNG
media_image3.png
142
169
media_image3.png
Greyscale
Dai discloses several specific compound examples in Table 1 which correspond to a compound of present formula (Ia), including Compound 1 and Compound 14. See pages 46-56. Compound 1 of Dai corresponds to a compound of formula (Ia) wherein R1 and R5 join together to form a monocyclic 6-membered heterocycloalkyl group, R2 is C1-alkylene-R2a, R2a is a 5-membered heterocycloalkyl group substituted with 1 R10, R3a is H, R3b is halo (fluoro), R3c is halo (chloro), R4 is naphthyl substituted with 1 R14 group, R10 is C1 alkyl, R14 is OR12, and R12 is H. See present claims 1 and 5.
Compound 1 corresponds to a compound of claim 7 where Z6 is NR9b and R9b is H. Compound 1 corresponds to a compound of claim 9 where R15 is H, R16 is C1 alkyl, and y is 0. Compound 1 corresponds to a compound of claim 14 where x is 1. Compound 1 corresponds to a compound of claim 15 wherein R12a is H and x2 is 0.
PNG
media_image4.png
148
160
media_image4.png
Greyscale
Compound 14 corresponds to a compound of formula (Ia) wherein R1 and R5 join together to form a monocyclic 6-membered heterocycloalkyl group, R2 is C1-alkylene-R2a, R2a is a 8-membered bicyclic heterocycloalkyl group, R3a is H, R3b is halo (fluoro), R3c is halo (chloro), R4 is phenyl substituted with 2 R14 – where R14 is halo (fluoro) as well as NR12R13, R12 and R13 are H. See present claims 1, 5, and 13.
Compound 14 corresponds to a compound of claim 7 where Z6 is NR9b and R9b is H. Compound 14 corresponds to a compound of claim 9 where R15 is H, R16 is C1 alkyl, and y is 0. Compound 14 corresponds to a compound of claim 10 where z is 0. Compound 14 corresponds to a compound of claim 14 where x is 1. Compound 14 corresponds to a compound of claim 15 wherein R12a is H and x2 is 0.
Dai discloses embodiments of the present disclosure are directed to a pharmaceutical composition comprising one or more of the compounds of the present disclosure, any of the compounds listed in Table A, or a pharmaceutically acceptable salt thereof, and optionally a pharmaceutically acceptable excipient. See pages 59-62 and para 101 in particular. See present claim 23.
Claims 1, 4, 9-12, 14-15 and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/247760 A1 (Tian et al.; Priority to CN202110561238.1 Filed 5/22/2021).
Tian discloses heterocyclic compounds or pharmaceutically acceptable salts thereof, which are useful in the treatment or prevention of cancers associated with H-ras, K-ras or N-ras inhibition. See abstract and pages 1-2.
Tian discloses specific compound example Compound 430 on page 148 which corresponds to a compound of formula (Ia) wherein R1 is a C1 alkylene-R1a, R1a is a C4 cycloalkyl ring substituted with 1 R9 group, R2 is C1-alkylene-R2a, R2a is a 8-membered bicyclic heterocycloalkyl group substituted with 1 R10, R3a is H, R3b is halo (fluoro), R3c is H, R4 is naphthyl substituted with 3 R14 groups - R14 is OR12, R12 is H, R14 is also halo (fluoro), R14 is also C2 alkynyl, R9 is NR12R13 – where R12 and R13 are C1 alkyl, R5 is H, and R10 is halo (fluoro). See present claims 1 and 4.
PNG
media_image5.png
207
266
media_image5.png
Greyscale
Compound 430 corresponds to a compound of claim 9 where R15 and R16 together form a 5-membered heterocycloalkyl ring and y is 1. Compound 430 corresponds to a compound of claim 10 where z is 1. Compound 430 corresponds to a compound of claim 14 where x is 3. Compound 430 corresponds to a compound of claim 15 wherein R12a is H and x2 is 2.
Tian discloses pharmaceutical compositions comprising compounds of the invention and a pharmaceutically acceptable carrier. See page 41 of Tian and see present claim 23.
Conclusion
Claims 3, 6, 8, 16, and 18-22 are withdrawn.
Claims 1-2, 4-5, 7, 9-15, 17 and 23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUINCY A. MCKOY/
Patent Examiner
Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights