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 .
DETAILED ACTION
Claims 1, 3-6, 8-10, 12, 13, 15, 51, 54-58, 61 and 68 are pending in the application. Claims 1, 3-6, 8-10, 12, 13, 15, 51, 58, 61 and 68 are rejected. Claims 54-57 are objected to.
Response to Amendment / Argument
Objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims or Applicant’s arguments. Therefore, arguments pertaining to these objections and rejections will not be addressed.
On page 66 of the response, Applicant traverses the objection to the specification referring to “enlarged chemical structures…”. The objection is maintained since the submitted copy is still replete with illegible structures. See, for example, the following structure on page 147:
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Enlarging the structure does not improve the resolution.
On page 67 of the response, Applicant addresses the rejection of claims 4-6 under 35 USC 112(b) based on amendment; however, the claims are still considered indefinite since not all variables are defined.
On page 68 of the response, Applicant traverses the prior art rejections over Cheng stating the prior art “compounds of Cheng require a positively charged nitrogen atom within the molecule – a quaternary amine group.” The instant claims recite that R1 can be optionally substituted alkyl (where the prior art compound contains the quaternary group). Since substitution is not limited in the instant claims, Applicant’s traversal is not found persuasive.
Specification
The disclosure is objected to because of the following informalities: The specification is replete with structures that are low resolution and/or contain atom labels that are illegible. See structures on pages 119-324.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 4-6 and 51 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 4 recites variable R10 and L2 that are not defined in the claim itself or anywhere in a parent claim. Dependent claims 5 and 6 are rejected as indefinite for the same reason since they do not provide the missing definition.
Claim 51 is rejected as indefinite since it depends from claim 2, which has been cancelled.
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)(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) 1, 3, 8, 9, 10, 12, 13, 15, 58 and 61 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by International Application Publication No. WO 2021/249896 A1 by Cheng et al., which claims priority to PCT/CN2020/095147, filed June 9th, 2020.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The prior art teaches the following compound on page 121 (support can be found on page 121 of the priority document):
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The compound is embraced by instant formula (I) where X is item (a), R1 is substituted C2 alkyl, R2 is hydrogen, one of R3 and R9 is hydrogen and the other is halogen (chloro), R4 and R8 are hydrogen, R5 is substituted C1 alkyl (-CF3) and R6 and R7 are hydrogen. These definitions are embraced by instant claims 1, 3, 8, 9, 10, 12, 13 and 15. Regarding instant claim 58, the prior art teaches step 7 on page 123 that corresponds to a reaction of step (i) where 2-chloro-4-[[3-[3-(trifluoromethyl)-1H-pyrazol-4-yl]imidazo[1,2-a]pyrazin-8-yl]amino]benzoic acid corresponds to formula (IXa) (support can be found on page 123 of the priority document). Regarding instant claim 61, the prior art teaches biological testing on page 272 as part of Table 2 that would have involved a mixture with water, which is a therapeutically inert carrier (support can be found on page 272 of the priority document).
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.
Claim 68 is/are rejected under 35 U.S.C. 103 as being obvious over International Application Publication No. WO 2021/249896 A1 by Cheng et al., which claims priority to PCT/CN2020/095147, filed June 9th, 2020.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compounds of the following general formula for use as in the treatment or prevention of bacterial infections (abstract, support can be found on pages 2-4 of the priority document):
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The prior art particularly teaches application in the treatment or prevention of infections with Acinetobacter baumannii on page 1, lines 3-6 (support can be found on page 1, lines 3-6 of the priority document).
As an example, the prior art teaches the following compound on page 121 (support can be found on page 121 of the priority document):
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The compound is embraced by instant formula (I) where X is item (a), R1 is substituted C2 alkyl, R2 is hydrogen, one of R3 and R9 is hydrogen and the other is halogen (chloro), R4 and R8 are hydrogen, R5 is substituted C1 alkyl (-CF3) and R6 and R7 are hydrogen.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach a specific embodiment where the compound above was administered to a mammal.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
At least in the interest of determining which disclosed example would provide optimum results in the utilities of the prior art, a person having ordinary skill in the art would have been motivated to test each disclosed example in the disclosed prior art utilities, which would have resulted in a method embraced by instant claim 68.
Allowable Subject Matter
Claims 54-57 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626