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 1-15 are pending in the instant application. Claims 1-12 and 15 are rejected. Claim 13 is objected. Claim 14 is allowed.
Information Disclosure Statement
The information disclosure statement filed on October 9, 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 1-12 and 15 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.
Regarding claims 1, 2 and 10, the phrases "especially a method of preparing greater than about 125g of the compound E9," “especially wherein the amino intermediate having formula II is compound 46” and “especially a method of preparing greater than about 2.5g of the amino intermediate 46,” respectively, render the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome, for example, by deleting the phrases mentioned above from the claims.
Regarding claim 15, the phrase “a bulk amount of a compound, wherein the compound is one and, in the respective amount” is confusing and renders the claim indefinite. The term “bulk amount” is not defined in the specification other than the listing of minimum amounts or ranges of amounts for each compound (e.g., see [47]).
This rejection can be overcome by amending the claim to read “A compound, wherein the compound is selected from (A) compound E9, wherein the compound is at least about 125g; (B) a carboxylic acid intermediate having the formula I, wherein the intermediate is at least about 125g; (C) an ester intermediate having the formula Ia, wherein the intermediate is at least about 125g; and (D) an amino intermediate 46, wherein the intermediate is at least about 2.5g” or something similar.
Claim Objections
Claim 13 is objected to because of the following informalities: a period is missing at the end of the claim. Appropriate correction is required.
Allowable Subject Matter
Claim 14 is allowed. No prior art was found.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622