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 .
Priority
The instant application was filed 02 April 2024 and claims priority to provisional application 63/456,654 filed 03 April 2023. The effective filing date of the instant application is 03 April 2023.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16) in the reply filed on 18 August 2026 is acknowledged.
Claims 17-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 August 2026.
Claim Rejections - 35 USC § 103
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.
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(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (WO 2020077170 A1) in view of Wan (Overcoming pancreatic cancer immune resistance by codelivery of CCR2 antagonist using a STING-activating gemcitabine-based nanocarrier, Materials Today, 2023), as evidenced by medchemexpress.com.
Regarding claim 1, Sun teaches (entire teaching) nanoparticles formulated from polymers (para. 69) and may comprise gemcitabine (para. 9), which is interpreted as an agent to activate a STING pathway through the instant claims.
Regarding claim 2, nanoparticles or micelles (para. 11) may have a diameter size of 10-20 nm (para. 69).
Regarding claim 3, in some embodiments, the amphiphilic (para. 68) polymers are described as self-assembled (para. 96).
Regarding claims 5 and 6, Sun teaches the conjugation of nucleoside analogues to the amphiphilic polymers (para. 68).
Regarding claims 7, 8, 14, and 15, the composition may comprise gemcitabine (para. 9).
Regarding claim 9, Sun describes therapeutic agents (gemcitabine) or pendant groups attached to the polymer backbone through a linking moiety that is labile in vivo (paras. 7-10).
Regarding claim 16, the amphiphilic polymers (para. 68) has a hydrophobic polymer backbone with pendant groups with a plurality of hydroxyl groups (nucleoside analogues, para. 9) conjugated to it (para. 68) and further includes a second plurality of pendant groups attached to the hydrophobic backbone and comprising at least one hydrophilic polymer (abs).
Sun does not teach a CCR2 antagonist, such as PF-04136309 in claims 1, 4, 10-13.
Regarding claims 1, 10, 12, 13, Wan teaches the codelivery of STING-activating gemcitabine with CCR2 antagonist in the form of a nanocarrier (title, abs). Wan teaches that PF-04136309 loaded into the gemcitabine-polymer structure led to improved tumor immune microenvironment (pg. 46).
Regarding claim 4, Sun describes loading second compounds into the micelles (para. 23), where it is interpreted that loading is done physically, as opposed to chemical or covalent bonding (instant specification, para. 107).
Regarding claim 11, PF-04136309 has a weight of 0.56859 kDa (evidenced by medchemexpress.com, pg. 1).
Since Sun does not teach a CCR2 antagonist, such as PF-04136309 in claims 1, 4, 10-13, one of ordinary skill in the art would have been motivated to use Wan’s teaching of PF-04136309 with gemcitabine in a nanocarrier system with a reasonable expectation of success. Sun teaches anticancer treatment (para. 71) through the combination of different chemotherapeutic or therapeutic drugs (para. 56) and Wan teaches gemcitabine with PF-04136309 in a nanocarrier system. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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