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 .
Status of Claims
This office action is in reply to Applicant’s Arguments/Remarks filed on 07/09/2026. This application 19/464,471 was filed on 1/29/2026, is a continuation of U.S. Pat. App. No. 19/182,010, filed April 17, 2025; which is a continuation of U.S. Pat. App. No. 18/952,791, filed November 19, 2024, now abandoned; which is a continuation of U.S. Pat. App. No. 18/056,804, filed November 18, 2022, now abandoned; which is a continuation of U.S. Pat. App. No. 17/707,221, filed March 29, 2022, now U.S. Pat. No. 11,517,544; which is a continuation of U.S. Pat. App. No. 17/482,241, filed September 22, 2021, now U.S. Pat. No. 11,285,118; which is a continuation-in-part of 17/103,819, filed November 24, 2020, now U.S. Pat. No. 11,141,388; which is a continuation-in-part of 16/894,713, filed June 5, 2020, now U.S. Pat. No. 10,898,453.
Claims 1-18 are pending. Applicant amended claims 1, 12, 13, and 18.
Claims 1-18 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 103
The examiner withdraws the rejections to claims 1-18 based on the based on the remarks and amendments to the claims made by Applicant.
MAINTAINED AND/OR MODIFIED REJECTIONS
Response to Arguments
The Remarks of July 9, 2026 have been fully considered but are not fully persuasive for the reasons below.
Applicant’s Argument:
Applicant argues in substance that “the instant claims contain limitations beyond just administering to a human being for the treatment of agitation associated with Alzheimer's disease a composition comprising dextromethorphan and bupropion.” (see remarks on pages 5-6).
Additionally, applicant argues that “the instant claims recite administering a first dosage form containing one dose of dextromethorphan once a day and then twice a day, and then administering a second dosage from containing a different dose of dextromethorphan twice a day. Such a dosing regimen is not recited in the claims of, for example, U.S. Patent No. 11,007,189 or 12,239,642.”
Furthermore, applicant asserts; “the instant claims recite that the human patient does not have anorexia nervosa or bulimia”, and that the “administration to such a patient population is not recited in the claims of, for example, U.S. Patent No. 11,007,189 or 12,239,642.”
Finally, “claims 1 and 18 have been amended to recite that the human patient has an MMSE score of 10 to 24 at the time of first administration of the first dosage form”.
Examiner’s Response:
The examiner appreciates applicant’s arguments; however, respectively disagrees. At the onset, the proper scope of the claim should be realized. The instant claims 1-18 are obvious variants/modifications of the claims of the cited reference patents/applications, for example: US 12,576,078 (claims 1-18) and US 12,433,884 (claims 1-17 and 21) recite claims that are significantly identical for both the dosing regimens of the exact same pharmaceutical compositions as well as the scope of the instant claims, including the instant dependent claims and their respective limitations.
Additionally, with regards to the limitation restricting patient population that does not have anorexia nervosa or bulimia, and the administration to such a population, the examiner did not find any significant support or evidence within the specification that would make this a unique group of individuals and render the instant claims novel, solely based off of exclusion of this particular demographic. Moreover, the conflicting claims of USPN’s 12,576,078 (claims 1-18) and US 12,433,884 (claims 1-17 and 21) do not recite that the patient population has anorexia nervosa, bulimia, or any eating disorder. Consequently, it would still be an obvious modification of the cited claims of these two US patents to practice the claimed invention in patients that do not have anorexia nervosa or bulimia.
Furthermore, with regards to the amendment of claims 1 and 18 that recite the human patient has an MMSE score of 10 to 24 at the time of first administration of the first dosage form, the examiner has determined that this amendment is also found within the patented applications mentioned above. The claim recites a range of score that is exactly the same range claimed within the patented applications as well.
Thus, the examiner respectfully maintains double patenting and provisional double patenting rejections outlined in the instant claims due to the scope of the limitations as currently patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 recites wherein the human patient has a Mini-Mental State Examination score between 10 and 24 without further limiting independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over the allowed claims of the following U.S. Patents:
11,007,189 (claims 1-16)
11,273,134 (claims 1-20, particularly 9, 13, and 17)
11,207,281 (claims 1-22, particularly 5 and 16)
11,419,867 (1-20, particularly 9, 13, and 17)
11,382,874 (claims 1-20, particularly 9, 13, and 17)
11,253,492 (claims 1-28, particularly claims 6, 13, 20, and 27)
11,426,370 (claims 1-17, particularly claims 8, 11, and 14)
11,285,118 (claims 1-17, particularly claims 9, 13, and 17)
11,285,146 (claims 1-20, particularly claims 9, 13, and 17)
11,291,665 (claims 1-20, particularly claims 9, 13, and 17)
11,291,638 (claims 1-20, particularly claims 9,13 and 17)
11,298,352 (claims 1-20, particularly claims 9,13 and 17)
11,344,544 (claims 1-20, particularly claims 9,13 and 17)
11,364,233 (claims 1-20, particularly claims 8, 17 and 26)
11,382,874 (claims 1-20, particularly claims 9,13 and 17)
11,147,808 (claims 1-29, particularly claims 6, 12, 17, 23)
12,194,005 (claims 1-19)
12,263,161 (claims 1-22, particularly claims 1, 6, and 11)
12,194,036 (claims 1-18, particularly claim 1)
12,239,642 (claims 1-22, particularly claim 1)
18/669,417 (claims 1-24)
18/541,574 (claims 1 and 3-26; renumbered 1-25)
19/182,010 (claims 1 and 3-19; renumbered 1-18)
12,433,884 (claims 1-17 and 21)
12,576,078 (claims 1-18)
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the patented claims are drawn to a method of co-administering to the human being for the treatment of agitation associated with Alzheimer’s disease administering a composition comprising dextromethorphan and bupropion. Accordingly, the instant claims would have been obvious over the claims of the patents cited above.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following pending claims of copending applications:
Application No. 17/541,461 (claims 1-22, particularly claims 5 and 16)
Application No. 17/930,829 (claims 21-45)
Application No. 18/061,091 (claims 1-20)
Application No. 18/777,011 (claims 21-38, particularly claim 21)
Application No. 18/778,708 (claims 16-37)
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and the claims of the copending applications cited above are drawn to a method, they are not patentably distinct from each other because the claims of the copending applications are drawn to a method of co-administering to the human being for the treatment of agitation associated with Alzheimer’s disease administering a composition comprising dextromethorphan and bupropion. Accordingly, the instant claims would have been obvious over the claims of the copending applications cited above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Therefore, instant claims 1-18 are an obvious variation of claims that are presented in US Patented and copending applications.
Conclusion
Claims 1-18 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR INAM whose telephone number is (571)272-0821. The examiner can normally be reached 7:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHAR INAM/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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