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
This application is a CON of PCT/US2022/074713 (08/09/2022)
PCT/US2022/074713 has PRO 63/231,095 (08/09/2021).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tabuteau (WO2020146412, published 2020-07-16, cited by Applicant).
Tabuteau teaches administration of a combination of dextromethorphan and bupropion to human subjects twice a day in amounts of 45 and 105, respectively (Example 3, [461]; claims 1, 8, 9, 11). Tabuteau teaches the patient receiving the combination was suffering from MDD and is in remission ([461]-[494]). Tabuteau teaches “treating” includes prevention of depression ([271]). Tabuteau teaches patients responding early and receiving continued treatment (Figs. 13-17). Thus, claim 1 is anticipated.
Regarding claim 2 specifying treatment-resistant depression, Tabuteau teaches the resistant depression is treated (claim 12).
Regarding claim 3, Tabuteau teaches the patient had failed treatment with at least two antidepressants ([139]).
Regarding claim 4, Tabuteau teaches the patient has a MADRS score of 12 or less over at least 4 weeks ([461]-[494], Figs. 13-14).
Regarding claim 5, Tabuteau teaches administration twice daily for about 1 year ([225]).
Regarding claims 6-7, Tabuteau teaches the compounds are formulated for immediate release and sustained release ([339]).
Regarding claim 8, Tabuteau teaches oral administration ([438]).
Regarding claim 9, Tabuteau teaches administration as solid dosage form ([225]).
Regarding claim 10, as with claim 1, Tabuteau teaches administration of the same compounds in the same amounts in a manner that would prevent relapse in the same patient. Regarding claims 11-18, as with claims 2-9, Tabuteau teaches the same limitations.
Regarding claim 19, as with claims 1 and 10, Tabuteau teaches administration of the same compounds in the same amounts in a manner that would delay relapse in the same patient.
Thus, the claims are anticipated.
Response to Remarks - 35 USC § 102
Applicant argues that the cited art teaches “treating active depression, not to maintaining remission in patients who have already achieved stable remission” as per the amended claims.
Giving the claims their broadest reasonable interpretation in view of the claim amendment includes a patient who is in remission and receives a further treatment/dose. Such a patient would include one on a treatment regimen such as in Tabuteau’s Figs. 13-17 that went was in remission but continued receiving the treatment. Thus, the argument is not persuasive. In addition, the argument is not persuasive because Tabuteau teaches “treating” includes prevention of depression ([271]) would is equivalent to maintaining remission in a patient previously treated. Furthermore, one skilled in the art would at once envisage administering the combination to a patient in remission to prevent future occurrence of depression. MPEP 2131.02 (III).
Double Patenting
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims in the corresponding of U.S. Patent Nos. listed below. Although the claims at issue are not identical, they are not patentably distinct from each other because they are each to a method or dosage form for treating depression which either alone anticipates or in view of Tabuteau (WO2020146412, published 2020-07-16) is rendered obvious to one of ordinary skill in the art as they treat the same disease with the same composition.
US 10105327 – claims 1-28
US 10548857 – claims 1-15
US 10772850 – claims 1-28
US 10780064 – claims 1-18
US 10786469 – claims 1-24
US 10799497 – claims 1-4
US 10864209 – claims 1-12
US 10874664 – claims 1-10
US 10874663 – claims 1-14
US 10874665 – claims 1-15
US 10881657 – claims 1-8
US 10894046 – claims 1-27
US 10925842 - claims 1-20
US 10933034 – claims 1-12
US 10940124 – claims 1-20
US 10945973 – claims 1-29
US 10966942 – claims 1-20
US 10966974 – claims 1-12
US 11020389 – claims 1-18
US 11123343 – claims 1-23
As well as the claims of: US 11382874, US 11364233, US 11357744, US 11344544, US 11311534, US 11298352, US 11298351, US 11291638, US 11291665, US 11285146, US 11285118, US 11273134, US 11253492, US 11234946, US 11229640, US 11207281, US 11147808, US 11141416, US 11129826, US 12390428, US 12357697, US 12042473, US 11896563, US 11779579, US 11617747, US 11590124, US 11576909, US 11571417, US 11541021, US 11426370, US 11419867.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the corresponding copending Application Nos. listed below (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because they are each to a method or dosage form for treating depression which either alone anticipates or in view of Tabuteau (WO2020146412, published 2020-07-16) is rendered obvious to one of ordinary skill in the art as they treat the same disease with the same composition.
17/541461
17/498507
17/571110
18/967488
18/418010
18/174278
18/435115
18/601603
18/318210
18/923576
19/238194
19/258712
19/278685
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks – Double Patenting
Applicant argues that the instant claims are distinguished by “maintaining remission in patients who have already achieved stable remission” as per the amended claims. Applicant also argues that each of the cited patents and applications are directed to treating active depression, not maintaining remission in patients who have already achieved stable remission.
This argument is not persuasive as detailed in the response in the 35 USC rejection.
Conclusion
No claims allowed.
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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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