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 .
Current Status of 18/559,859
This Office Action is responsive to the amended claims and Applicant remarks of 07/16/2026. Claims 1, 4, and 6-11 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/IB2022/054321, filed 05/10/2022, which claims the benefit of priority to U.S. Provisional Patent Application No. 63/187,023, filed 05/11/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/09/2023 and 07/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 07/16/2026 is acknowledged.
Drawings
The drawings are objected to because the boxed portions in the upper right hand corners of Figures 3 and 4 are grainy and difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
Claims 1, 4, 6, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cortes (https://library.ehaweb.org/eha/2019/24th/267466/jorge.cortes.combination.therapy.using.asciminib.plus.imatinib.28ima29.in.html?f=) in view of GLEEVEC (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021588s053lbl.pdf).
Cortes teaches a method of treating chronic myeloid leukemia (CML) comprising administering asciminib in combination with imatinib (Methods). Patients were administered asciminib at dosages of 40, 60, and 80 mg once daily or 40 mg twice daily, in combination with imatinib administered at a dosage of 400 mg once daily (Methods). The reference teaches that the combination therapy demonstrated promising preliminary efficacy in the treatment of CML (Conclusion). The reference does not expressly teach the administration of the pharmaceutical combination with food.
GLEEVEC teaches that Gleevec (imatinib) should be taken with a meal and a large glass of water (pg. 1, left column, Dosage and Administration).
The artisan would have experience in organic chemistry, medicinal chemistry, pharmaceutical sciences, or a related field. The artisan would have experience in the development of therapeutic methods for treating diseases, including leukemia, and would be familiar with available leukemia treatments, dosing regimens, and methods of administration. The artisan would have been familiar with pharmacokinetic considerations relevant to drug administration, including dosing conditions and potential effects of food on drug exposure.
The artisan would have been motivated to administer the imatinib combination of Cortes together with food in accordance with the established dosing instructions for imatinib and would reasonably expect successful treatment of CML.
Claims 1, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cortes and GLEEVEC in view of FDA (https://www.govinfo.gov/content/pkg/FR-2019-02-26/pdf/2019-03247.pdf).
The teaching of Cortes and GLEEVEC are discussed above and are incorporated by reference into this rejection. The references teach claim 1, but are silent on a low fat meal being administered with the pharmaceutical combination.
FDA teaches that food can significantly affect the pharmacokinetics of orally administered drugs and that the effect may vary depending on the macronutrient content of the meal (Background). The reference further teaches that low-fat meals are a recognized meal condition for evaluating food effects (Background).
The artisan would have experience in organic chemistry, medicinal chemistry, pharmaceutical sciences, or a related field. The artisan would have experience in the development of therapeutic methods for treating diseases, including leukemia, and would be familiar with available leukemia treatments, dosing regimens, and methods of administration. The artisan would have been familiar with pharmacokinetic considerations relevant to drug administration, including dosing conditions and potential effects of food on drug exposure.
The artisan would have been motivated to investigate the effect of meal conditions on the pharmaceutical combination of Cortes because food was recognized in the art as affecting the absorption and pharmacokinetic properties of orally administered drugs. The art further recognized low-fat meals as a conventional meal condition for assessing food effects. In view of these teachings, the artisan would have been motivated to evaluate administration of the pharmaceutical combination of Cortes with a low-fat meal to determine the effect of such meal conditions on drug exposure and administration as part of routine evaluation of the treatment regimen.
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
Prosecution Insights