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, 2, 20, 42, 48, 53, 64, 68-69, 74-76, 90, 101, 107, 112, 123, 137, and 176 are pending.
Claims 20, 68-69, 74-76, 90, 101, 107, 112, 123, and 137 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US2020/032722, filed 5/13/2020; and further claims priority to provisional application number 62/855,910 and 62/847,810, filed 05/31/2019 and 05/14/2019, respectively.
Information Disclosure Statement
All references from IDS(s) received on 06/29/2022, 11/14/2022, 6/12/2023, 8/10/2023, 6/14/2024, 8/21/2024, and 3/18/2025 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 8/12/2025 have been fully considered and have been found not persuasive.
In a non-final dated 5/12/2025, Claims 1, 2, 31, 42, 48, 53, 64, and 176 were examined upon their merits.
In a non-final dated 5/12/2025, Claims 1, 2, 31, 42, 48, 53, 64, and 176 were rejected 35 U.S.C. 102. In response, the Applicant cancelled claim 31. The rejection for claim 31 is withdrawn and moot. The Applicant also amended claim 1 to include the CHK1 inhibitor is SRA737 and the subject is identified as having a cancer lacking a RAS mutation, and claim 42 to depend on claim 1.
In response to the first 102 rejection, based on the teachings of Threshold, the Applicant argues that amending claim 1 to specify the CHK1 inhibitor is SRA737 overcomes this anticipatory rejection. The Examiner finds this argument persuasive and the 102 rejection is withdrawn. However, a new 103 rejection is made necessitated by the amendments and can be found below.
In response to the second 102 rejection, based on the teachings of Hassig, the Applicant argues that amending claim 1 to specify the subject is identified as having a cancer lacking a RAS mutation overcomes this anticipatory rejection. The Examiner finds this argument persuasive and the 102 rejection is withdrawn. However, a new 103 rejection is made necessitated by the amendments and can be found below.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 42, 48, 53, 64, and 176 are rejected under 35 U.S.C. 103 as being unpatentable over Threshold Pharmaceuticals (US20150005263A1; cited in IDS filed 6/29/2022; “Threshold”) and further in view of Hassig, C. et al. (International Search Report and Written Opinion for International Application No. PCT/US2018/035566, referring to a priority date of 12/06/2018; support for analysis is found in WO2018222970A1; cited in IDS filed 6/12/2023; “Hassig”).
Threshold teaches a method of treating cancer with a therapeutically effective amount of a Chk1 inhibitor (Claim 1). Threshold teaches an example in “Both p53 Deficient Hela Cells and HT29 Cells” (Example 1), which are both wild-type RAS and therefore do not include a RAS mutation, as required by instant claim 1.
Threshold teaches the use of the Chk1 inhibitor in p53 deficient tumor cells (Claim 9), which would be considered a genetic abnormality in a DNA damage response repair gene, either as an alteration or underexpression, as required by instant claims 1 and 2.
Threshold also teaches the subject can be human (p.0049), as required by instant claim 176.
Threshold fails to teach the CHK1 inhibitor as SRA737, further administering with gemcitabine or an immune checkpoint inhibitor, or the dosing schedule, as required by instant claims 1, 2, 42, 48, 53, and 64.
Hassig teaches a method of treating a tumor in an individual having a cancer, the method comprising: administering a Chk1 inhibitor to the individual, wherein the tumor is identified as having genetic alterations (Claim 1). Hassig teaches the Chk1 inhibitor can be SRA737 (Claim 22), as required by instant claim 1.
Therefore, with respect to claim 1, it would be obvious to a person skilled in the art at the time to extract the method taught by Threshold and substitute the CHK1 inhibitor for another know CHK1 inhibitor, such as SRA737.
Hassig teaches the method to further comprise administering gemcitabine in combination with the Chk1 inhibitor (Claim 19), as required by instant claim 48.
Hassig teaches the dosing of the Chk1 inhibitor to be:
“Dosing schedules may include, but are not limited to, the following examples: daily dosing, 5 days of dosing followed by 2 days of non-dosing each week; 1 week of daily dosing followed by 1, 2, or 3 weeks of non-dosing; 2 or 3 weeks of daily dosing followed by 1, or 2 weeks of non-dosing; or twice daily dosing. In certain embodiments, SRA737 is administered at a dose of 1-300 mg/kg/day” (p.0042), as required by instant claim 42.
“Dosing schedules for either SRA 737 and/or gemcitabine may include, but are not limited to, the following examples: daily dosing, 5 days of dosing followed by 2 days of non-dosing each week; 1 week of daily dosing followed by 1, 2, or 3 weeks of non-dosing; 2 or 3 weeks of daily dosing followed by 1, or 2 weeks of non-dosing; or twice daily dosing. In certain embodiments, the methods comprise administration of SRA737 in combination with gemcitabine. In certain embodiments, SRA737 is administered at a dose of 1-300 mg/kg/day PO, for at least one day for at least one cycle, wherein the cycle is 1-35 days, and gemcitabine is administered at a dose of 1-200 mg/kg intravenously (IV) for at least one day for at least one cycle” (p.0043), as required by instant claim 53.
Hassig teaches where the method can further comprise administering an antibody or an antibody drug conjugate (Claim 17), as required by instant claim 64.
Finally, Hassig teaches where the subject is a human (p.0022), as required by instant claim 176.
Therefore, with respect to claims 42, 48, 53, 64, it would be obvious to a person skilled in the art at the time to extract the method of treating a non-RAS mutation based cancer with a CHK1 inhibitor, as taught by Threshold, and further administer gemcitabine or an immune checkpoint inhibitor, as well dosing it according to the methods of Hassig. A person skilled in the art would be motivated to do so because both Threshold and Hassig teach methods of treating mutation-based cancers with a CHK1 inhibitor.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the method taught by Threshold and substitute the CHK1 inhibitor for another know CHK1 inhibitor, such as SRA737, as taught by Hassig.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating a non-RAS mutation based cancer with a CHK1 inhibitor, as taught by Threshold, and further administer gemcitabine or an immune checkpoint inhibitor, as well dosing it according to the methods of Hassig. A person skilled in the art would be motivated to do so because both Threshold and Hassig teach methods of treating mutation-based cancers with a CHK1 inhibitor.
Therefore, claims 1, 2, 42, 48, 53, 64, and 176 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1, 2, 42, 48, 53, 64, and 176 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621