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 the Application
Claims 1, 7, 10, 13 and 16-17 are pending as of the response filed 04/30/2026. Claims 2-6, 8-9, 11-12 and 14-15 are cancelled. Applicant’s election of a species of the active component being administered, as disulfiram is maintained. Claims 1, 7, 10, 13 and 16-17 are examined herein.
Applicant’s arguments regarding the 35 U.S.C. 103 rejections of record over Marchand and Rahman have been fully considered and were found to be persuasive. Applicant’s discussion of additional references Na et al., Inoue et al., Jessel et al., and Barbut et al. with respect to the pain signaling neuropeptide, substance P levels in relation to neuropathic pain, have been carefully considered. Specifically, Applicant’s emphasize that the pain models of Marchand and Rahman are geared towards nociceptive pain and that a PHOSITA would not have a reasonable expectation of success in using disulfiram to treat neuropathic pain. In consideration of the fact that disulfiram is known in the art to cause peripheral neuropathy, Applicant’s arguments were found to be persuasive. The 35 U.S.C. 103 rejections of record over Marchand and Rahman are hereby withdrawn.
Applicant’s representative, Attorney Murphy, was contacted in an effort to move prosecution forward and place the application in condition for allowance. After a couple of rounds of discussion, it was decided that an Office action on the merits would be helpful to the Applicants (See attached interview summary).
In view of the pending claims, a rejection over the Wright reference is made. Since this constitutes a new ground of rejection, this Office action is non-final.
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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.
Regrading claim 7, the claim recites “administering to said subject a pharmaceutical composition consisting of one or more pharmaceutically acceptable additives and any of said (1) to (4)”. The use of the transitional phrase “consisting of” excludes any element, step, or ingredient not specified in the claim and therefore, introduces ambiguity regarding the scope of the claim with respect to the pharmaceutically acceptable additives. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 7 has been interpreted to read “administering to said subject a pharmaceutical composition[[ consisting of one or more pharmaceutically acceptable additives and]] of any of said (1) to (4)” (since a pharmaceutical composition will inherently include pharmaceutically acceptable additives),
OR alternatively “administering to said subject a pharmaceutical composition[[ consisting of]] comprising one or more pharmaceutically acceptable additives and any of said (1) to (4)”.
Claim Rejections - 35 USC § 102 – New
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 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.
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.
Claims 1, 7, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wright, IV (US 2017/0246194 A1, hereinafter Wright).
Regarding instant claims 1, 7, 13 and 16, Wright teaches a method for treating pain by administering an analgesic composition to a patient in need thereof, wherein the pain is chronic pain, such as neuropathic pain (Para. [0122]; Para. [0110]; Claim 63; Claim 29). Wright teaches embodiments wherein the analgesic composition comprises disulfiram (Para. [0011]) (i.e., a method for analgesia by administering a pharmaceutical composition that comprises disulfiram). Instant claim 1 recites the transitional phrase “comprises” that allows for the administration of addition elements not recited in the claim. Therefore, Wright anticipates the limitations of instant claims 1, 7, 13 and 16.
Allowable Subject Matter
Claims 10 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable (with respect to the elected species of disulfiram) if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 7, 13 and 16 are rejected.
Claims 10 and 17 are objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571) 272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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, Kortney L Klinkel can be reached on (571) 270-5239. 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.
/PADMAJA S RAO/Examiner, Art Unit 1627
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