DETAILED ACTION
Claims 1-9 are currently pending in the instant application. Claims 1, 7 and 8 are rejected, claim 2 is objected and claims 3-6 and 9 are considered allowable in this Office 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 .
I. Priority
The instant application claims benefit of US Provisional Application 63/406,861, filed on September 15, 2022.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 13, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 1 is drawn to a process for preparation of a compound of formula (V)
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wherein the process proceeds via cyclopentanone. The process does not provide any steps showing how cyclopentanone is used to prepare the compound of formula (V) or does not provide any steps that show the final product of formula (V) is obtained. For example, an omitted step is
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. This step is essential to show how the cyclopentanone is being used to prepare the compound of formula (V) and therefore, should be present in the claim.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 8 is drawn to a process for preparation of ipconazole wherein the process proceeds via an intermediate of formula (VI) prepared according to claim 2. The process does not provide any steps showing how the intermediate of formula (VI) is used to prepare ipconazole or does not provide any steps that show the final product is obtained. For example, an omitted step is
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. This step is essential to show how the compound
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formula (VI) is being used to prepare ipconazole and therefore, should be present in the claim.
Claim 7 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. Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicants are suggested to amend claim 7 to delete the phrase “preferably methanol” to overcome the rejection.
Claim 8 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 8 is drawn to “A process for preparation of ipconazole, wherein the process proceeds via an intermediate of formula (VI) prepared according to claim 2”. However, in claim 2 formula (VI) is referred to as “a compound of formula (VI)” not an “intermediate” of formula (VI) as seen in claim 8. The limitation “an intermediate of formula (VI)” lacks antecedent basis because it is unclear if the intermediate of formula (VI) is a different compound than the “compound of formula (VI)” and therefore, it does not clearly refer back to the same limitation in claim 2. Applicants are suggested, for example, to amend claim 8 so that the term “intermediate” is now “compound” so that the claim language is consistent with claim 2.
IV. Objections
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 is drawn to a process for preparation of a compound of formula (VI) and is followed by the structure
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which is labeled with Formula (IV) not Formula (VI). Applicants are suggested to amend claim 2 so that the above structure is labeled Formula (VI). Appropriate correction is required.
***The closest prior art is EP0267778 which teaches a process for preparing ipconazole by using an alkyl ester of 2-oxocylopentanecarboxylic acid to prepare the final product but does not teach a process which uses cyclopentanone
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as a starting material as seen in the instant claimed process. The process step of reacting cyclopentanone with acetone to obtain the compound
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is not taught in the prior art.
V. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626