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 .
Election/Restrictions
Claim 1 is allowable. The restriction requirement of Groups I-III, as set forth in the Office action mailed on 06/11/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Claims 7-8 and 13-14, directed to methods of using and methods of preparing the claimed compounds are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of the Claims
Claims 1 and 6-14 are pending in this application. Claims 2-5 and 15-20 have been cancelled by applicant.
Examiner Notes
Claims 1, 6, and 9-13 are allowed. Claims 7-8 and 14 are free of the prior art, but stand rejected over formal matters.
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 7-8 and 14 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 7 is indefinite because it pertains to a ‘method of use’ but fails to recite an active step. Examiner suggests amending the claim as follows: “A method of treatment and/or prophylaxis of diseases, the method comprising administration of the compound of Formula (I) to a subject in need thereof; wherein the diseases comprise bacterial infections, and wherein the bacterial infections comprise a Gram-negative bacterial infection, wherein the compound of formula (I) has the following structure: (…)” – or something to that effect.
Claim 8 is indefinite because it is unclear whether the claimed ‘method of use’ is meant to be directed towards ‘use’ for manufacture of a medicament or ‘use’ for a treatment and/ or prophylaxis of diseases. Examiner suggests amending the claim language to clarify what kind of method Applicant seeks to claim. For instance:
For a method of manufacture, Examiner suggests: “A method for manufacturing a medicament for use in a treatment and/or prophylaxis of diseases, wherein the diseases comprise bacterial infections, and wherein the bacterial infections comprise a Gram-negative bacterial infection; wherein the medicament comprises a compound of formula (I) (…)” – or something to that effect.
Claim 14 states: “…P1 and P2 represent independently the protecting group under acidic conditions.” This limitation is unclear. Does applicant intend for P1 and P2 to be a protective group which may be removed under acidic conditions? Or does applicant intend to say P1 and P2 are protecting groups which are stable under acidic conditions? The metes and bounds of the claim are unclear, since it is not clear what class of protecting group applicant is referring to.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 103
In view of claim amendments and the Oath filed 12/04/2025, the 35 USC § 103 rejections of record have been withdrawn.
Double Patenting
In view of claim amendments and the Oath filed 12/04/2025, the Double Patenting rejections of record have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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