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, 4, 5, 7, 12, 17, 20-21, 24-25, 32-34, 37-39, 41 and 45-46 are pending. Claims 1, 2, 5, 7, 24, 25, 32, 37, 38, 39, 45, and 46 are allowable. Claims 4, 20, 33-34, and 41 are objected to. Claims 12, 17, and 21 are rejected.
Election/Restrictions
Claim 1 is allowable. Claims 2, 4, 12, 17, 20, 21, 33, 34, 38, 39, and 41, previously withdrawn from consideration as a result of a restriction requirement, include all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions, as set forth in the Office action mailed on 6/27/2025, is hereby withdrawn and claims 2, 4, 12, 17, 20, 21, 33, 34, 38, 39, and 41 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendments/Arguments
Applicant’s 1/6/2026 amendments have overcome all claim objections from the 10/6/2025 Office Action. Applicant’s 1/6/2026 remarks have overcome objections to specification from 10/6/2025 Office Action. Therefore, applicant remarks from 1/6/2026 will not be further addressed.
Because of the rejoinder described supra, novel objections and rejections are presented below.
Claim Objections
Claim 4 is objected to because of the following informalities:
Line 4, “hydrochloric salt Form” should read “hydrochloric salt form”;
Line 5, “Phosphate salt Form” should read “phosphate salt form”.
Claim 12 is objected to because of the following informalities:
Line 15, “Hydrochloric” should read “hydrochloric”.
Claim 17 is objected to because of the following informalities:
Line 1, “Hydrochloric” should read “hydrochloric”.
Claim 20 is objected to because of the following informalities:
Line 1, “Phosphate” should read “phosphate”.
Claim 21 is objected to because of the following informalities:
Line 1, “Phosphate” should read “phosphate”.
Claim 33 is objected to because of the following informalities:
Line 3, “Hydrochloric” should read “hydrochloric”;
Line 5, “Phosphate” should read “phosphate”.
Claim 34 is objected to for depending from claim 33 and not remedying the deficiencies.
Claim 41 is objected to because of the following informalities:
Line 4, “Phosphate” should read “phosphate”;
Line 5, “Tartrate” should read “tartrate”.
Appropriate correction is required.
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 12, 17, and 21 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 12 recites the limitation "the compound" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends removing this limitation.
Claim 12 recites the limitation "hydrochloric acid" in line 15. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends changing the language to “hydrochloric salt” to be consistent with claim 4.
Claim 17 recites the limitation "the compound" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends removing this limitation.
Claim 17 recites the limitation "hydrochloric acid" in multiple locations. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends changing the language to “hydrochloric salt” to be consistent with claim 4.
Claim 21 recites the limitation "the compound" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends removing this limitation.
Allowable Subject Matter
Claims 1, 2, 5, 7, 24, 25, 32, 37, 38, 39, 45, and 46 are allowable.
Conclusion
Applicant’s amendments and a rejoinder necessitated the new ground(s) of rejection presented in this Office Action. Accordingly, THIS ACTION IS MADE FINAL. 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 extension fee 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 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 on 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
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626