DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/22/2026 has been entered.
Claim Rejections - 35 USC § 112
.The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has amended the period for sustained release of low dose naltrexone for “about 28 to about 30 days”. Applicant states that “anyone of ordinary skill would understand the scope of this (time period) with reasonable certainty”. Understanding is not the problem. Support is cited from [0048] and [0071] initially. . First applicant is reminded that administration is different from sustained release. Applicant appears to equate administration with sustained release by citing paragraphs [0048] and [0071]. However , then adds [0159] – [0161] in which show support for “up to 28 days”, not “about 28 days to about 30 days”. The amended period of sustained release of “about 28 days to about 30 days’ is not supported by the original specification.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for 28 days, does not reasonably provide enablement for “about 28 days to about 30 days”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Applicant has amended the period for sustained release of low dose naltrexone for “about 28 to about 30 days”. Applicant states that “anyone of ordinary skill would understand the scope of this (time period) with reasonable certainty”. Understanding is not the problem. Scope of enablement is cited from [0048] and [0071] initially. . First applicant is reminded that administration is different from sustained release. Applicant appears to equate administration with sustained release by citing paragraphs [0048] and [0071]. However , then adds [0159] – [0161] in which show the scope of enablement for “up to 28 days”, not “about 28 days to about 30 days”. The amended period of sustained release of “about 28 days to about 30 days’ is not enabled for the scope of the invention.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartus et al (Vivitrex®).
The article by Bartus et al teaches the use of biodegradable microparticles for the treatment of alcohol and opiate dependency (see Abstract). Sustained release lasts for 28 days (Abstract). Administration is either subcutaneous or intramuscular (Page 1974, Drug Treatments and Experimental Design, second paragraph). While it is noted that applicant is claiming a “composition for treating an autoimmune disease”, a composition is a composition , no matter its intended use. Applicant may be claiming a heretofore unrecognized method of using the composition, but the instant claims are directed to a composition. While, Bartus et al does not set out a dosage of sustained release, those of ordinary skill would be able to select to maximize therapeutic results. The instant claims are obvious given the teachings of Bartus et al using a biodegradable naltrexone microparticle as taught by Bartus et al.
Conclusion
No claims are allowed. It is suggested that applicant refile the claims as a method of treating the two diseases which are enabled for treatment.
Plotnikoff et al is cited for its treatment of HIV and autoimmune diseases with an unencapsulated dose of 0.1mg to 10 mg of naltrexone.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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