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 .
It appears a restriction/Election was improperly submitted in this application that was intended for a different application. Examiner will work on removing the action from the file folder. In the meantime, the Requirement for Restriction/Election mailed 1/14/2026 is hereby withdrawn and vacated. The following action replaces the Requirement for Restriction/Election and should have been the subsequent Office Action.
Applicants' arguments, filed 12/11/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burks et al (Cholecystokinin Receptor-Targeted Polyplex Nanoparticle Inhibits Growth and Metastasis of Pancreatic Cancer, March 7, 2018).
Burks et al. discloses in Figure 1C, the structure of a species of claim 12. Further, Figure 4C, discloses using the construct of Figure 1c for in vivo detection of pancreatic intraepithelial neoplasia lesions in a subject (rats are subjects according to the instant specification definition at pg 5) with fluorescently labeled Cy3 gastrin siRNA (see Figure 1E).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Burks et al (Cholecystokinin Receptor-Targeted Polyplex Nanoparticle Inhibits Growth and Metastasis of Pancreatic Cancer, March 7, 2018) in view of Ruoslahti et al (WO2011127405).
Burks et al is discussed above for teaching in vivo detection of pancreatic intraepithelial neoplasia lesions in a subject using the construct of instant claim 12 and fluorescently labeled Cy3 gastrin siRNA, but does not teach the additional detectable moieties of component c in instant claims 3-11. Burks et al further teaches the use of the theronostic NPs as labeled to localize small tumors for diagnostic purposes (pg 30, left column, last ¶ spanning to right column).
Ruoslahti et al teaches known detectable agents include fluoropores, Ga-67, and sulfoates (pg 20 lines 7-16 and pgs 53-57).
It would have been obvious to one of ordinary skill in the art to substituted known detectable agents disclosed in by Ruoslahti et al into the composition of Burks et al, given the common purpose of providing in vivo detection. See MPEP 2144.06.
It would then have been obvious to use the constructs for the disclosed purposes of Burks.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612