DETAILED ACTION
Claims 1-2, 4-5, 7-8, 10-14, 16-17, 23-24, 26, 32, 34-36 are pending in the instant application.
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 claims priority to 371 of PCT/US2023/017648 filed 04/05/2023 which claims benefit of the U.S. Provisional Application Serial No. 63/362,502 filed 04/05/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Allowable subject matter
While a thorough search by the Examiner and a STIC search did not reveal prior art, independent claim 13 does not include all the limitations that render claim 1 allowable. Additionally, On July 2nd, the Examiner contacted the Attorney of Record Megan Hanley to discuss a potential Examiner’s Amendment to resolve the outstanding issue, i.e., canceling claim 13. However, the Applicant was unable to reach a decision.
Claims 1-2,4-5,7-8,10-12,14,16-17,23-24,26,32 and 34-36 are allowable.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (Bioconjugation and Fluorescence Labeling of Iron Oxide Nanoparticles Grafted with Bromomaleimide-Terminal Polymers, Biomacromolecules, 2018), Biopharma PEG (DSPE-PEG-Mal, PEG Lipids Supply, 2020), and Broadpharm (3,4-dibromo-mal-PEG8-acid, SDS dated 2018).
Qiao discloses iron oxide nanoparticles and their surface modification strategies. Qiao reports a surface modification and biofunctionalization strategy for iron oxide-based magnetic nanoparticles based on a bromomaleimide-terminated polymer with brushed PEG chains (Abstract).
Biopharma discloses commercially available DSPE-PEG-Maleimide (pg 1). DSPE-PEG-MAL is one of the most commonly used reactive phospholipids to conjugate antibodies, peptides or other ligands to the surface of liposome and other lipid PEG nanoparticles. Pegylated phospholipids have extended blood circulation time and higher stability for encapsulated drugs (pg 2). It is often used in targeted drug delivery with the lipid bilayer to improve drug solubility, the PEG to provide stealth property, extend circulation half-life and reduce non-specific protein binding or cell adhesion, and the reactive maleimide to bioconjugate targeting molecules including antibody, aptamer, protein, and peptide (pg 2).
Broadpharm discloses 3,4-dibromo-Mal-PEG8-acid. A functionalized PEG comprising a bromomaleimide has been commercially available since 2018.
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a PEG-lipid functionalized with bromomaleimide. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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