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 .
The Amendments and Remarks filed 1/29/26 in response to the Office Action of 8/27/25 are acknowledged and have been entered.
Claims 1-7, 14, 15, 39, 42, 90, 95 and 102 are pending.
Claims 1, 4, 6, 7, 14, 15, 39, and 90 have been amended by Applicant.
Claims 14 and 90 remain withdrawn.
Claims 1-7, 15, 39, 42, 95, and 102 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Withdrawn
The rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
The rejections under 35 U.S.C. 103 are withdrawn.
Rejections Maintained
Double Patenting
Claims 1-7, 15, 39, 42, 95, and 102 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11312686 B2 in view of Sykes et al (US 2018/0263970 A1; 9/20/18) and Naik et al (Haematologica, 2019, 104: e102). The patent claims differ from the instant claims in that the patent claims are directed to DHODH inhibitors and the instant claims are directed to compositions comprising DHODH inhibitors and anti-CD38 therapeutic agents and methods of administering said compositions. However, it would have been obvious to generate and administer to human subjects with AML compositions comprising DHODH inhibitors of the patent claims and daratumumab of Sykes et al and Naik et al because Sykes et al teaches a method of treating a human subject with AML comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition/compound comprising a DHODH inhibitor ([0020]-[0028], in particular), Sykes et al teaches using the composition/compound in said method in combination with an anticancer agent such as the anti-CD38 humanized antibody daratumumab ([0175]-[0177], in particular), and Naik et al teaches daratumumab therapeutically reduces tumor burden in subjects with human AML cells (Figure 2, in particular). Further, the patent discloses the DHODH inhibitors are to be administered to subjects with AML (Abstract, in particular).
Request
In the Reply of 1/29/26, Applicant requests this rejection be held in abeyance. Applicant’s request has been considered, but has not been granted. The Office does not hold rejections in abeyance. The rejection is maintained.
Double Patenting
Claims 1-7, 15, 39, 42, 95, and 102 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11999697 B2 in view of Sykes et al (US 2018/0263970 A1; 9/20/18) and Naik et al (Haematologica, 2019, 104: e102). The patent claims differ from the instant claims in that the patent claims are directed to methods of administering DHODH inhibitors to subjects with a cancer such as AML and the instant claims are directed to compositions comprising DHODH inhibitors and anti-CD38 therapeutic agents and methods of administering said compositions to subjects with cancer such as AML. However, it would have been obvious to perform the patent method of treating mammalian subjects with cancer such as AML comprising administering compositions comprising DHODH inhibitors of the patent claims wherein the compositions further comprise daratumumab of Sykes et al and Naik et al because the patent method treats mammalian subjects with AML by administering DHODH inhibitors and Sykes et al teaches a method of treating a human subject with AML comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition/compound comprising a DHODH inhibitor ([0020]-[0028], in particular), Sykes et al teaches using the composition/compound in said method in combination with an anticancer agent such as the anti-CD38 humanized antibody daratumumab ([0175]-[0177], in particular), and Naik et al teaches daratumumab therapeutically reduces tumor burden in subjects with human AML cells (Figure 2, in particular).
Request
In the Reply of 1/29/26, Applicant requests this rejection be held in abeyance. Applicant’s request has been considered, but has not been granted. The Office does not hold rejections in abeyance. The rejection is maintained.
Double Patenting
Claims 1-7, 15, 39, 42, 95, and 102 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 18, 26-33, 35, 39-41, and 54 of copending Application No. 18/647273 in view of Sykes et al (US 2018/0263970 A1; 9/20/18) and Naik et al (Haematologica, 2019, 104: e102). The copending claims differ from the instant claims in that the copending claims are directed to compositions comprising DHODH inhibitors and methods of administering DHODH inhibitors to subjects with a cancer such as AML and the instant claims are directed to compositions comprising DHODH inhibitors and anti-CD38 therapeutic agents and methods of administering said compositions to subjects with cancer such as AML. However, it would have been obvious to perform the copending method of treating mammalian subjects with cancer such as AML comprising administering compositions comprising DHODH inhibitors of the copending claims wherein the compositions further comprise daratumumab of Sykes et al and Naik et al because the copending method treats mammalian subjects with a cancer such as AML by administering DHODH inhibitors and Sykes et al teaches a method of treating a human subject with AML comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition/compound comprising a DHODH inhibitor ([0020]-[0028], in particular), Sykes et al teaches using the composition/compound in said method in combination with an anticancer agent such as the anti-CD38 humanized antibody daratumumab ([0175]-[0177], in particular), and Naik et al teaches daratumumab therapeutically reduces tumor burden in subjects with human AML cells (Figure 2, in particular).
This is a provisional nonstatutory double patenting rejection.
Request
In the Reply of 1/29/26, Applicant requests this provisional rejection be held in abeyance. Applicant’s request has been considered, but has not been granted. The Office does not hold rejections, or provisional rejections, in abeyance. The provisional rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm 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, Samira Jean-Louis can be reached at (571)270-3503. 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.
/SEAN E AEDER/Primary Examiner, Art Unit 1642