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 .
Claims 1-16 are pending in the instant application. Claims 1-8, 12 and 16 are rejected. Claims 9-11 and 13-15 are allowed.
Information Disclosure Statement
The information disclosure statement filed on June 30, 2025 has been considered and a signed copy of form 1449 is enclosed herewith.
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 1-8, 12 and 16 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.
With regards to claims 1-8 and 16, the claims are drawn to a “pharmaceutical combination” of 5-amino-2,3-dihyro-1,4-phthalazinedione or one of its pharmaceutically acceptable salts, hydrates or solvates and a 6’-methoxycinchonan-9-ol or a pharmaceutically acceptable salt thereof and the phrase “pharmaceutical combination” renders the claims indefinite. Since the phrase is not defined in the specification, it is unclear what can and cannot be included in the combination (i.e., it is unclear whether a carrier or pharmaceutically acceptable expedient is included in the combination or if the two compounds are present in a package for delivery). Appropriate correction is required.
Claim 12 recites the limitation "wherein said substance, composition or combination" and claim 9, from which the claim depends, does not disclose a substance or the word “combination”. Therefore, there is insufficient antecedent basis for this limitation in the claim. This rejection can be overcome by amending the phrase to read “wherein said composition”.
Allowable Subject Matter
Claims 9-11 and 13-15 are allowed. No prior art was found.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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