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 .
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.
Current Status of 18/259,112
This Office Action is in response to the amended claims of 06/03/2026.
Examiner have withdrawn double patenting rejection on record.
Claims 1 are currently amended; claims 2-9, 11, and 16-24 are previously presented; and claim 10 is original.
Claims 1-11 and 16-24 are examined in this office action.
This is 2nd non-final since new 112a and 112b rejections are made.
Priority
Effective filing date is 12/24/2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Response to Arguments
Examiner acknowledges the receipt of applicants claim amendment and remarks of 06/03/2026. Examiners have reviewed these remarks and amendments.
Regarding double patenting rejections, applicants have traversed the rejection
The Reference Application provides no reason or motivation to select these specific groups from the longer list of groups recited in claim 1 of the Reference Application. All of the working examples of the Reference Application are compounds wherein Rs is hydrogen. See Examples 1-64 of the Reference Application.
Examiner’s response,
Examiner agrees with applicant’s traversal. Since reference claims do not show any example of halogen substitution. There is no reason or motivations for halogen substitution on R1. Moreover, filing date for provisional reference application 19/253,018 is 07/11/2025, after the filing date of instant application,11/02/2023. Therefore, examiner have withdrawn the double patenting rejections.
Claim Rejections - 35 USC § 112 (new)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment does not reasonably provide enablement for prevention. The specification and/or prior art does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in making the determination as to whether one skilled in art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 19-23 are directed to limitations drawn to prevention of an ATR kinase mediated diseases.
State of the prior art:
ATR kinase mediated diseases are too numerous and the etiology of ATR kinase mediated disease remains largely unexplained.
Level of one of ordinary skill/ Level of predictability art
An ordinary person skilled in art is an artisan who is a medicinal chemist and/or physician that has experience treating cancer and have to navigate ways for preventing various disease associated with ATR kinase without knowing the etiology of each disease. There are no known methods of prevention as state above, therefore an artisan skilled in the art would not be able to determine the course of preventing such diseases.
A person skilled in art would not be able to envision preventing ATR kinase mediated diseases with the experiments disclosed in the specification (Wands factor (d)) because the specification does not provide guidance for preventing ATR kinase mediated diseases. (wand faction (e)). Moreover, preventions ATR kinase mediated diseases are unpredictable because no one method can prevent ATR kinase mediated diseases (wand factor (e)).
Amount of direction provided by the inventor:
Although the specification teaches methods of treating ATR kinase mediated diseases there is no working example that shows prevention of ATR kinase mediated diseases. Moreover, prevention of diseases/condition are unpredictable because no one method can prevent a disease/condition from occurring when the etiology and cause of the disease (e.g. lymphoma) remains largely unexplained.
It would require undue experimentation and be unduly burdensome to practice the claimed method of preventing ATR kinase mediated diseases because the etiology and cause of ATR kinase mediated diseases is unknown.
Therefore, method claims 19 are rejected for lacking scope of enablement for prevention of ATR kinase mediated diseases.
Claims 20-23 are also rejected for depending on rejected claim 19
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 1-11 and 16-24 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.
The term “prodrug” is not defined by claims 1-5, 7-10, and 17-19. The specification does not provide definition of the term “prodrug”. One of ordinary skill in the art could not reasonably determine the scope of the term “prodrug” (see Zawilska et.al. Pharmacological Reports, 2013, 65, Page 1-14). As drafted “prodrug” in claim 1-5, 7-10, and 17-19 renders the metes and bounds of claims 1-5, 7-10, and 17-19 indefinite.
Claims 6-7,11,16, 20-23 and 24 are also rejected for depending on rejected claims
Conclusion
No claims are allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
