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 Claims
Claims 1-2, 7-10, 13-15, 19-21, 28-31, 34, 37, 40, 42-46, 49-54, 57-60, 68, 71-76 and 79 are pending. Claims 30-31, 34, 37, 40, 42-46, 49-54, 57-60, 68, 71-76 and 79 are withdrawn. Claims 1-2, 7-10, 13-15, 19-21, and 28-29 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 2/16/2024 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 7-10, 13-15, 19-21, and 28-29) in the reply filed on 5/26/2026 is acknowledged.
Claims 30-31, 34, 37, 40, 42-46, 49-54, 57-60, 68, 71-76 and 79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 15 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.
Claim 15 contains the trademark/trade name “VIVITROL”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe long-acting naltrexone and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1, 2, 7, 13, 14, 15, 19, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Daoust et al. (US6512009), as evidenced by Qatari et al. (Alcohol Clinical & Experimental Research, 2006, Abstract).
Daoust et al. is drawn to a “combination for the treatment of alcohol and drug dependence containing an opioid antagonist and a NMDA receptor complex modulator” (see title). Regarding instant claims 1, 2, 13-15, 19, 20, 21, Daoust et al. teach the following in claim 1:
“A pharmaceutical composition for the treatment of alcohol and drug dependence comprising a therapeutically effective amount of a combination of:
an opioid antagonist which is either naloxone or naltrexone; and
a NMDA [N-methyl-D-aspartate] receptor complex modulator which is acamprosate.”
Additionally, Daoust et al. discloses the following Example 3 (capsule with extended release) in column 4:
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. Specifically, regarding the limitations of instant claims 1 and 2 regarding: “occupies at least 10% [higher percentages in instant claim 2] of the subject’s u-opioid receptors in vivo as measured by positron emission tomography with a [11C]-carfentanil ligand”, the prior art amount of naltrexone (u-opioid receptor modulator) in Example 3 shown supra overlap with amounts of the instant specification:
“In some embodiments, the u-opioid receptor modulator is administered in an amount of about 1 mg to about 90 mg” (see instant specification para. [0023]).
Therefore, the prior art would inherently have the effect of “occupies at least 10% [higher percentages in instant claim 2] of the subject’s u-opioid receptors in vivo as measured by positron emission tomography with a [11C]-carfentanil ligand” with the same amount of a u-opioid receptor modulator, such as naltrexone.
Regarding instant claim 7, Qatari teaches acamprosate as a partial NMDA agonist (see abstract, lines 11-12).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8-10 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daoust et al. (US6512009), in view of Jones et al. (Frontiers in Psychiatry, 2018, 9(277), 1-10), and further in view of Walpole et al. (BMC Public Health, 2012, 12:439, 1-6).
**The 102 rejection supra of claims 1, 2, 7, 13, 14, 15, 19, 20, and 21 over Daoust et al. (US6512009), as evidenced by Qatari et al. (Alcohol Clinical & Experimental Research, 2006, Abstract), is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Daoust fails to highlight ketamine as an NMDA receptor modulator used in combination with a u-opioid receptor modulator.
Jones discloses a review wherein ketamine was found useful in the treatment of alcohol and opioid use disorders (see abstract- results and conclusion). Within the review, Jones teaches the following:
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Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not disclose ketamine together in a pharmaceutical composition comprising a u-opioid receptor modulator, particularly naltrexone.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 8, 9 and 28, it would have been obvious to a PHOSITA to explore the substitution of ketamine for Daoust’s acamprosate in a pharmaceutical composition with a u-opioid receptor modulator. Both ketamine and acamprosate were known NMDA receptor modulators useful in the treatment of substance use disorders. While the emphasis of Daoust is not on ketamine treatment, Daoust does teach ketamine’s ability to produce a voltage-dependent open channel block within the NMDA receptor (see column 1, lines 52-67). A skilled artisan would have been motivated to substitute acamprosate for ketamine with a reasonable expectation of success in arriving at an effective pharmaceutical composition capable of treating a disease or diseases.
Regarding instant claims 10 and 29, Walpole teaches that the average body mass globally is 62 kg ( see p. 3, right column, second para.). From Jones’s review above, 0.5 mg/kg/h ketamine (NMDA receptor modulator) is equivalent to 31 mg per hour, which is embraced by the ranges of the instant claims. “In the case where the claimed ranges ’overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). It would have been obvious to a PHOSITA to arrive at the claimed ranges with a reasonable expectation of success at arriving at an effective pharmaceutical composition capable of treating a disease or diseases.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
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