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 .
Priority
The instant application is a national stage entry of PCT/CN2021/111278, filed August 6, 2021, which claims priority to PCT/CN2020/107884, filed August 7, 2020, PCT/CN2020/110005, filed August 19, 2020, PCT/CN2021/085190, filed April 2, 2021, and PCT/CN2021/105708, filed July 12, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 7, 2023 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(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 18, 38, 48, 65, and 66 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 2 teaches that Z3 of the compounds of Formula (I) can be CH, N, or S. Claim 18 (2) discloses that Z3 includes C(CH3) and (3) teaches that Z3 includes O, S(O), and S(O)2. Claim 65 discloses compounds (VIII), (IX), (X), (XI), and (XII) that do not have the allowed substitutions of Z3 from claim 2. Claim 2 teaches that R1 is hydrogen, halogen, alkyl, -S(O)2(Rb), or -S(O)(NH)(Rb). Claim 38 teaches that R1 can be cyano, hydroxyl, C1-3 haloalkyl, C1-3 hydroxyalkyl, -C(O)N(Ra)2, -C(O)ORa, or -P(O)(Rb)2. Claim 48 teaches that R1 includes cyano. Claim 2 teaches that V is a direct bond or -N(Ra)-, and does not disclose Rd. Claim 66 discloses that V can be C1-3 alkyl, R1 can be hydroxyl, cyano, or -P(O)(Rb)2, and Rd. Based on the permitted substitutions for the compound of formula (I) in claim 2, the dependent claims identified above recite alternative substituents that are not among those permitted in claim 2. Accordingly, these claims do not further limit the compound of formula (I) of claim 2 and are improper under 35 U.S.C. §112(d). Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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, 7, 18, 36, 38, 46, 62, 65, 69-71, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cai (WO 2020/259601 A1, found in IDS filed 02/07/2023).
Cai discloses compounds of Formula (I)
PNG
media_image1.png
157
172
media_image1.png
Greyscale
that may be used to treat ATR-mediated disorders including cancer (Abstract).
PNG
media_image2.png
227
609
media_image2.png
Greyscale
Example 13 is a disclosed species of the claimed compound (pg. 48). Example 13 is a compound of Formula (I’) and (I) of instant claims 1 and 2 where Z1 is N, Z2 is C, Z3 is CH, Z4 is N, V is a direct bond, Ring A is a 5-membered heteroaryl, R1 is a C1 alkyl, n is 1, m is 0, Ring B is a 5-membered heteroaryl, and R3 is
PNG
media_image3.png
77
66
media_image3.png
Greyscale
. The substitutions of Z1, Z2, and Z3 read on (2) of claim 7 and (2) of claim 18. Ring A is a pyrazole ring with a C1 alkyl substitution, anticipating the limitations of claims 36, 38, and 46. Ring B is a pyrazole ring anticipating the first depicted structure of claim 62. The structure of Example 13 anticipates general structure (V) of instant claim 65. Example 13 clearly anticipates claim 69 as the compound is claimed as the first entry found on pg. 14 of the claims. Claim 15 of Cai teaches pharmaceutical compositions comprising the claimed compounds and a pharmaceutically effective carrier, anticipating instant claim 70. Paragraphs [0094-0097] disclose methods of treatment for ATR-mediated diseases including cancer. The methods comprise administering the compounds or a composition comprising the compounds for the treatment of cancer and discloses that the compounds are ATR inhibitors. Administration of an ATR kinase inhibitor to a subject will inherently result in the inhibition of ATR kinase in that subject. Accordingly, the reference anticipates the instant method claims of 71 and 74.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 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.
Claims 1, 2, 48, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Cia in view of Burgdorf (WO 2020/049017 A1, found in IDS filed 02/07/2023).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 nonobviousness.
The above discussion is incorporated by reference into this rejection. Cia teaches the compounds of claims 1 and 2. Cia teaches that the heterocyclic group at R1 can be optionally substituted, but does not clearly indicate the allowed substitutions. The reference similarly teaches that R2 can be an optionally substituted C3-6 cycloalkyl, but does not indicate the allowed substitutions [0012].
Burgdorf teaches compounds of Formula Ia and Ib
PNG
media_image4.png
198
353
media_image4.png
Greyscale
that are ATR kinase inhibitors that can be used in the treatment of cancer (Abstract). The reference teaches that R1 can be 1-methylsulfonyl-cycloprop-1-yl (pg. 4, line 20), and that R3 is H or A where A is unbranched C1-6 alkyl where 1-7 hydrogen atoms may be replaced with OH, F, Cl, and/or Br and one or two non-adjacent CH2 groups can be replaced by O or NH (pg. 5, lines 11-14).
The artisan would have a background in organic chemistry and medicinal chemistry and would be familiar with developing small molecule kinase inhibitors. The artisan would have experience in the design, synthesis, and optimization of small molecule kinase inhibitors. The artisan would be familiar with the structure, function, and inhibitions mechanisms of kinases known in the art. The artisan would be capable of applying common medicinal chemistry principles to modify lead compounds to improve pharmacokinetic and pharmacodynamic properties.
The artisan would have been motivated by the teachings of Cia to modify the heterocyclic group at R1 to include an optional substitution. The artisan would have similarly been motivated to modify R2 based on the teachings of Cia to include an optionally substituted C3 cycloalkyl group. The lack of disclosure of acceptable optional substitutions of R1 and R2 in Cia would lead the artisan to other known ATR inhibitors with disclosed substitutions, such as Burgdorf. The artisan would have been motivated to use a methylsulfonyl group (-S(O)2(Me)) on the cycloalkyl moiety of R2 and an alkyl group with optional substitution at R1 based on the disclose of Burgdorf. The artisan would expect that these substitutions would result in a small molecule ATR inhibitor that would be effective at treating ATR mediated cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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, Andrew Kosar can be reached at (571)272-0913. 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.
/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625