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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/031,219
This Office Action is in response to the amended claims of 12/11/2025.
Claims 2-3, 18, 20,25 and 27 are original; claims 6, 8, 10 13, 15, 17, 19, 24 and 26-30; and claims 1 and 23 are currently amended.
Claims 1-3, 6, 8, 10,13,15,17-20 and 23-30 are examined in this office action.
Examiner have withdrawn 112(b) indefinite rejection on file.
Priority
The effective filing date is 10/12/2020 because claims find support in the provisional application no. 63/090,336.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 12/11/2025. Examiner have reviewed these remarks and amendments.
Regarding 112 rejections, applicant amended claim 1 to more specifically indicate that step (iii) applies only when R is a nitrogen-protecting group. A skilled artisan would understand from the plain language of the claim that the method requires step (i), either step (ii)(a) or (ii)(b), and then step (iii) if R is a nitrogen-protecting group, and that there is nothing in the claim indicating that the method can be practiced without either step (ii)(a) or (ii)(b), thus rendering moot 112(b) indefinite rejection. 112(b) rejection is withdrawn.
Response to Amendments
Claim Rejections - 35 USC § 112 (new rejection)
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 28 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 28 recites the limitation of claim 1 “wherein R is a nitrogen-protecting group and the process further comprises removing the nitrogen-protecting group from Compound IIA and methylating the resulting deprotected amine to form Compound IIA wherein R is methyl”. Applicant amended claim 1 where in claims 28 has insufficient antecedent basis for formula I in claim 1. Claim 1 does not contain the limitation “wherein R is a nitrogen-protecting group and the process further comprises removing the nitrogen-protecting group from Compound IIA and methylating the resulting deprotected amine to form Compound IIA wherein R is methyl”. Rather, claim 1 is drawn to: “if R is a nitrogen-protecting group, removing the nitrogen-protecting group from Compound IV and methylating the resulting deprotected amine to form Compound A". As drafted the lack of antecedent basis, above, renders the metes and bounds of claim 28 undefined. Hence renders claim 28 indefinite under 35 USC 112(b).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 28 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 28, refers to “wherein R is a nitrogen-protecting group and the process further comprises removing the nitrogen-protecting group from Compound IIA and methylating the resulting deprotected amine to form Compound IIA wherein R is methyl” and fails to properly further limit base claim 1, since claim 1 has no limitations drawn to “wherein R is a nitrogen-protecting group and the process further comprises removing the nitrogen-protecting group from Compound IIA and methylating the resulting deprotected amine to form Compound IIA wherein R is methyl”. Thus claim 28 is rejected under 35 U.S.C. 112(d).
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).
Conclusion
Claim 28 is rejected
Claims 1-3, 6, 8, 10,13,15,17-20 23-27 and 29-30 are allowable as written.
Prior art of Mukesh et.al (11,999,731 B2) describe the following synthesis of derivative of compound A
PNG
media_image1.png
526
292
media_image1.png
Greyscale
PNG
media_image2.png
554
383
media_image2.png
Greyscale
(column 40 and 41) which does not describe the synthesis of compound IIA from compound II of independent claim 1. Moreover, compound II of claim 1 is not present in the synthesis and R of compound A is isopropyl. Furthermore, publication date of Mukesh et.al is (10/27/2022) is after the priority date of the instant claims, thus Mukesh is a close art but not a prior art for claim 1.
Claims in US patent No. 11,358,965 B2(publication date Dec. 3, 2020) recites compounds of compound A but not the process of making compound of compound A, therefore US ‘965 B2 is not a double patenting art.
Claims in US patent No. 11,999,731 B2 (publication date October 27 2022) recites compounds of formula but not the process of making compound of compound A, therefore US ‘731 B2 is not a double patenting art.
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 Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625