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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 September 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a national stage entry of PCT/CA2023/050366 filed 21 March 2023. Claims 1-2, 4-6, 10-12, 16, 18-20, 31, 34, 39, 43, 48, 50, and 54-55 are currently pending. Claims 3, 7-9, 13-15, 17, 21-30, 32-33, 35-38, 40-47, 49, 51-53, and 56-57 are cancelled. Claims 1-2, 4-6, 10-12, 16, 18-20, 31, 34, 39, 43, 48, 50, and 54-55 are examined on the merits within.
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1-2, 4-6, 10-11, 39, 43, 48, 50, and 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira et al. (Int. J. Nanomedicine, 2016).
Regarding instant claims 1-2, 39, 43, 50, Vieira et al. teach liposome based strategies for effective drug delivery across the blood brain barrier. See abstract. Cationic lipids can be incorporated into the bilayer, facilitating their association with nucleic acids for gene therapy. See Figure 4. Table 5 shows various liposomes for drug delivery, including delivery of siRNA using a liposome comprising DODAP, DSPC, C16 Cer-PEG2000 and cholesterol with a particle size of 178 nm. Other particles include sizes of 60-90 nm. The liposomes can additionally comprise antibody ligands. See Table 5.
Regarding instant claims 3-6, liposomes comprise DSG-PEG2000. See Table 5.
Regarding instant claim 11, the liposome comprises DSPC or DOPC. See Table 5.
Regarding instant claims 54-55, Table 5 sites various instances of the use of liposomes in gene therapy.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the amount of cationic lipid, helper phospholipid, cholesterol, and pegylated lipid to achieve the desired therapeutic effects. In addition, it would have been obvious to substitute one cationic lipid for another to yield predictable results.
5. Claim(s) 12, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira et al. (Int. J. Nanomedicine, 2016) as applied to claims 1-2, 4-6, 10-11, 39, 43, 48, 50, and 54-55 above and further in view of Qasba et al. (WO2008/143944).
Vieira et al. do not teach glycosylation.
Qasba et al. teach a method for engineering a nanoparticle comprising: attaching to the C terminal or N-terminal end of a biological substrate a nanoparticle; and using the biological substrate with the nanoparticle as an acceptor substrate for a pp-GalNAc-T; and transferring one or more GaINAc residue or GaINAc analogue sugars to the acceptor substrate; thereby engineering a nanoparticle. See claim 13. The acceptor polypeptide is selected from SEQ ID NO: 3 (GAGGPIMAAATPAPAAK). See claim 23. This corresponds to a sequence comprising SEQ ID 12.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use GalNAc to modify the liposome because Qasba et al. galactose-beta (l,4)-N-acetylglucosamine linkages are important for many recognition events that control how cells interact with each other in the body, and how cells interact with pathogens. See page 2.
6. Claim(s) 31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira et al. (Int. J. Nanomedicine, 2016) as applied to claims 1-2, 4-6, 10-11, 39, 43, 48, 50, and 54-55 above and further in view of Yi et al. (Biomaterials Research, 2018).
Vieira et al. do not teach cyclooctene.
Yi et al. teach scFV was attached to dibenzocyclooctene-modified hybrid multifunctional nanoparticles by click chemistry. The size slightly increased and the nanoparticles showed enhanced binding to HER2-positive MCF7 cells, showing the binding of the antibody did not change after modification by click chemistry. See Application in Nanoparticle Modification.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to link cyclooctyne to the antibody to modify biological ligands without changing the function.
Conclusion
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
