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 .
Response to Amendments
The amendments made to the claims 06/23/2026 have been entered.
Restriction/Species Election
Claim 1 has been found allowable in view of the arguments presented in the remarks submitted 06/23/2026.
Claims 15, 19, and 23 have been rejoined.
Withdrawn Objections
In view of the amendments made to the claims, the objections made in the prior office action have been withdrawn.
In view of the amendments made to the claims, the 112(b) rejections have been withdrawn.
In view of the arguments made in the remarks submitted 06/23/2026, the 103 rejection made in the prior office action has been withdrawn. Applicant has shown the instant process has the advantage of “allowing the intermediates and the final product to be isolated by crystallization or precipitation in high purity” and “higher chiral purity” over the process taught in Wang.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo (WO2014173289, of the record).
Guo on p. 142 discloses the following compound 177.
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The compound embraces a compound of Formula II in claim 23.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (WO2018033853, of the record).
Wang on p. 9 teaches a synthetic scheme that includes compound BG-9, shown below.
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Wang in the same scheme teaches a method of reducing a -CN group to an amide group.
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Note that the critical difference between the reactant in the reduction step and the instant compound is the lack of a protecting group. However, this protecting group is present in the BG-9 compound above. One of ordinary skill in the art would find it obvious to apply the reduction step shown above to compound BG-9 to arrive at the protected compound of instant claim 23.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to apply the reduction step to compound BG-9 to arrive at compound of formula VII, as in claim 23. One of ordinary skill in the art would be motivated to make the modification to the BG-9 in efforts to optimize a synthetic scheme. See KSR B.
These new rejections have been necessitated as applicant overcame the prior 103 rejections.
Allowable Subject Matter
Claims 1-22 and 24-25 are considered allowable over the prior art.
The instant claims are drawn to a process that has the advantage of producing a product “in high purity” and “higher chiral purity” over the process taught in Wang.
Conclusion
Claim 23 is rejected.
Allowable subject matter indicated.
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 LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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