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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Current Status of 17/904,144
This Office Action is responsive to the amended claims of 31 August 2025.
Claims 12-20 have been examined on the merits. Claims 12-15 and 17-20 are currently amended. Claim 16 is original.
Priority
The effective filing date is 16 March 2021.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 31 August 2025.
Applicants revised the claims thereby rendering moot the claim objection (made within paragraph 7 of the previous Office Action).
Applicants struck “substantially” throughout the claims thereby rendering moot the indefiniteness rejection (made within paragraphs 8-10 of the previous Office Action).
Applicants did not fix the antecedent basis issue with “salt” therefore Examiner is maintaining the indefiniteness rejection (made within paragraph 11 of the previous Office Action) of claim 18.
The indefiniteness rejection of claim 20 (made within paragraph 12 of the previous Office Action) is maintained. While Applicants’ revisions to claim 20 help, these revisions are not complete and hence the underlying rationale for the indefiniteness rejection remains. Examiner has revised this rejection to account for revisions Applicants have yet to (and still must) make to render moot this rejection.
The anticipatory 35 USC 102 prior art rejection is withdrawn, as Applicants canceled the previously rejected claims 1-10.
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.
Claims 18 and 20 are 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 18 recites the limitation "the salt" (Applicants’ amendments). There is insufficient antecedent basis for the “salt” limitation in the claim.
As drafted, “the salt” amendment renders the metes and bounds of claim 18 undefined (hence rendering claim 18 indefinite) since there is no antecedent basis to “salt” in claims 16 or 18. This rejection can be remedied by adding an alternative “salt” limitation to the polymorph of claim 16—if the amendment does not introduce new matter.
This rejection is properly made FINAL since rejection is maintained: Applicants have not resolved the issue(s) underlying the rationale for this rejection.
The limitations within parentheticals: “(including but not limited to … ”) within claim 20 render the metes and bounds of claim 20 undefined (hence rendering claim 20 indefinite) since: 1) limitations are not permitted to be surrounded by parentheticals [only abbreviations can be surrounded by parentheticals] and 2) the artisan does not know if the limitations within parentheticals are merely exemplary or are required limitations. This same rationale applies to “e.g.” and “e.g.” within parentheticals.
Similarly, the artisan does not know if the limitations following “including but not limited to” are merely exemplary or are required limitations. Similarly, the artisan does not know if the limitations following “e.g.” are merely exemplary or are required limitations.
Similarly, limitations within parentheticals (see, above) are not permitted—as in (but not exhaustive list): “(senile dementia)” atop page 5 of 7. Please remove all limitations within parentheticals in the claim.
To assist Applicants, the Examiner has included a copy of his pen mark-ups signifying all areas of claim 20 that introduce indefiniteness, per the rationale, above:
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536
1410
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732
1388
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Please resolve the above to expedite allowance.
This rejection is properly made FINAL as it is being maintained since Applicants’ claim 20 revisions have not yet remedied the indefiniteness rejection.
Response to Amendment
Claim Objections
Claims 12, 14, and 16 are similarly objected to as these claims contain highly pixelated images of illustrations of compounds of formula I. The high level of pixelation dulls the resolution of the compound and makes it difficult to confidently discern the identity of heteroatoms and substituents of the compounds. Claims 13, 15, and 17-20 are similarly objected to as these claims refer back to claims 12, 14, and/or 16 but do not remedy the basis underlying the rationale for this objection.
Please revise by enlarging the illustrations and darkening all bonds and heteroatoms.
Claim 19 is objected to as there is a typographical oversight within line 2: “effective amount of the or a polymorph”. Please revise, but keep in mind any remedies followed for overcoming the claim 18 indefiniteness rejection (below). Perhaps revise to: -- effective amount of the [[or a]] polymorph -- ? Any revision should not introduce a new 35 USC 112 issue.
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 20 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 20 contains the limitation: “alcohol, benzodiazepines, barbiturates, opioids, or cocaine” (see middle of page 5 of 7). However, these limitations render the metes and bounds of claim 20 undefined (hence rendering claim 20 indefinite) since the artisan does not understand how these substances are considered “diseases” covered by the preamble and scope of claim 20. Perhaps Applicants’ revisions missed, but intended to disclose the following disease: an addiction to these substances? Revision to: -- chemical dependencies and addictions to alcohol, benzodiazepines, barbiturates, opioids, or cocaine -- should remedy the rejection.
This rejection is properly made FINAL due to Applicants’ claim amendments.
**Any amendments must have support in the original disclosure.**
Conclusion
Claims 12-17 and 19 are objected to for poor resolution and other issues (see “Claim Objections”, above).
Claims 18 and 20 are not presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound and salt according to instant claims 12 and 14 and a polymorph of claim 16.
A search for the naphthoate salt of the compound of claim 12 and a search for the L-pyroglutamate salt of claim 14 only retrieves the instant application and no prior art reference. The MANNING reference (WO 2009/155054 A2, previously provided to Applicants) does not teach (and one could not immediately envisage) the L-pyroglutamate salt of claim 14.
A search for a polymorph of the instant claim 16 compound only retrieved the instant application and pre-grant publication.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625