Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s arguments, filed 7/3/2025, 10/7/2025 and 1/22/2026, have been fully considered but they are not deemed to be (fully) persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects 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 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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4, 11-19, 21, 23-24 are rejected under pre-AIA 35 U.S.C. 102(a) and (b) as being anticipated by WO2005074887 A2 to Uhrich. Uhrich discloses a nanoparticle (abstract) comprising a polymer containing a polyol (page 7, third full paragraph) comprising sucrose (a saccharide made up of two fructose units linked together, which reads on the present polymer comprising two or more of the structural unit –[A]- where “A” is fructose and the structural unit comprises two units of fructose) (pages 7-8, bridging paragraph to page 8, first full paragraph; pages 10-11, bridging paragraph and further comprising a polyglycol linkage, -(CH2-CH2-O)n, where n is 1-10 or 2-20 (page 8, second full paragraph). The nanoparticles further comprise a targeting ligand (page 4, second full paragraph through page 5, second full paragraph; page 7, first paragraph). The targeting ligand may be bound to the nanoparticle via carboxylate ester (page 7, first and second paragraph). The targeting agent comprises a ligand for targeting cells (a cellular receptor) (page 4, second full paragraph through page 5, second full paragraph; page 7, first paragraph). The targeting ligand may comprise antibodies and antibody fragments (page 7, first paragraph). The targeting ligand may comprise folic acid (page 7, first paragraph). The nanoparticle comprises at least one therapeutic agent incorporated therein or coupled thereto (page 4, second and third full paragraphs; page 7, second paragraph). The therapeutic agent may be an agent for treating cancer, including paclitaxel (a taxane; a taxol; a chemotherapeutic agent; as it is an anticancer drug, it is deemed to read on a camptothecin-based drug) (abstract; claim 234). Uhrich teaches an aqueous solution comprising a plurality of its nanoparticles (pages 13-14, bridging paragraph).
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s arugment that Ulrich does not provide evidence that the disclosed amphiphilic macromolecules are capable of encapsulating nucleic acid therapeutics or delving them across cell membranes, the examiner’s response is that the present claims are not directed to a method of encapsulating nucleic acid therapeutics and delivering them across cell membranes. Ulrich’s disclosure provides sufficient guidance to the artisan that the therapeutic may be paclitaxel and the artisan, in reading this disclosure would find it obvious to use paclitaxel in the invention (abstract; claim 234). Ulrich is a saccharide made up of two fructose units linked together, which reads on the present polymer wherein the polymer comprises two or more of the structural unit –[A]- where “A” is fructose and the structural unit comprises two units of fructose (pages 7-8, bridging paragraph to page 8, first full paragraph; pages 10-11, bridging paragraph).
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4, 11-21, 23-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO2005074887 A2 to Uhrich in view of Devi (Cancer Gene Therapy, 2006). The relevant portions of Uhrich are given above.
Uhrich fails to teach “wherein at least one therapeutic agent comprises a plasmid, a genomic DNA, siRNA, shRNA, miRNA, antisense oligonucleotide, a chimeric nucleotide, an aptamer, or a combination thereof” as required by claim 20.
Devi teaches that siRNA may be used to treat cancer (abstract; Concluding remarks).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate an siRNA as the therapeutic agent of Uhrich. The motivation for this is that Uhrich teaches therapeutic agents useful in treating cancer, and by incorporating siRNA as the therapeutic agent of Uhrich, cancer may be treated.
Applicant reiterates their arguments regarding Uhrich above. The examiner has addressed applicant’s arguments regarding Uhrich above.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the polyols of Uhrich do not satisfy applicant’s “[A],” the examiner’s response is that sucrose taught by Ulrich is a saccharide made up of two fructose units linked together, which reads on the present polymer wherein the polymer comprises two or more of the structural unit –[A]- where “A” is fructose and the structural unit comprises two units of fructose (pages 7-8, bridging paragraph to page 8, first full paragraph; pages 10-11, bridging paragraph).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
January 24, 2026