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 .
The rejection under section 103 is maintained:
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.
Claims 20-22, 24-27, 30-34, 37, 39-42, 68-72 remain rejected under 35 U.S.C. 103 as being unpatentable over:
U.S. Publication No. 20160090603 based on an application by Carnes et al. (Carnes); or
Lipofectamine 2000 Reagent, 2013, downloaded 29 November 2024 from https://assets.thermofisher.com/TFS-Assets/LSG/manuals/Lipofectamine_2000_Reag_protocol.pdf (Lipofectamine); or
Zuris et al., Nat Biotechnol. 2014 Oct 30;33(1):73–80, newly cited (Zuris);
in view of:
Mahato, Advanced Drug Delivery Reviews 57 (2005) 699 – 712 (Mahato).
Paragraph 180 of Carnes teaches ribonucleoprotein complexes comprising ‘lipoplexes’, which are defined by Carnes as comprising cationic lipids and genetic material, CRISPR components and enhancer peptides.
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Carnes specifically contemplates lipid packages including nucleases:
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The lipid layer comprises cationic lipids are discussed, see paragraphs 0146+.
Carnes teaches eukaryotic host cells:
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Zuris teaches that common cationic lipid nucleic acid transfection reagents can mediate the potent delivery of Cas9:sgRNA nuclease complexes into cultured human cells in media containing 10% serum, see Abstract.
The primary references may not explicitly teach an enhancer element that comprises a polyamine moiety covalently attached to a nuclear localization signal sequence, wherein said polyamine moiety comprises a spermine moiety. However, it is for that proposition that the examiner joins the secondary references which teach eukaryotic transfection and nuclear localization with the recited enhancer elements:
Mahato demonstrates that Lipofectamine is cationic lipid available for gene therapy/editing (2,3-dioleyloxy-N-[2(sperminecarboxamido)ethyl]-N,N-dimethyl-1-propanammonium trifluoroacetate (DOSPA)), see page 700.
In this way, those of ordinary skill could have applied the recited enhancer elements in the manner required and in a predictable fashion for the purposes of obtaining the recited complexes. The primary references teach lipoplexes comprising protein and nucleic acids. The secondary references are added for the proposition that the recited enhancer element is applicable to these complexes. Specifically, Mahato teaches that the particular known technique of using the recited enhancer elements to facilitate transfection and nuclear localization of ribonucleoproteins was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to those methods that utilize transfection of ribonucleoproteins, such as the CRISPR reagents taught by the primary references, would have yielded predictable results. Accordingly, using the recited enhancer elements with the lipoplexes of the primary references to provide a nucleic acid-protein transfection agent would have been prima facie obvious.
Applicant argues that the references, specifically Carnes, does not teach or suggest an aqueous delivery platform.
However, Carnes specifically teaches aqueous delivery platforms:
“[0199] The present invention also includes a pharmaceutical composition including an effective amount of a delivery platform (e.g., any described herein). In some instances, the pharmaceutical composition includes a population of particles (e.g., any described herein) in an amount effective for modulating or modifying the plant or alga in combination with a pharmaceutically acceptable carrier, additive, or excipient. In other instances, the composition further includes a drug, an agrochemical, a nutrient, etc., which is not disposed as cargo within the particle.
[0200] The composition can be formulated in any useful manner with a plurality of delivery platforms (e.g., plurality or population of particles). Such formulations can be included with any useful medium, excipient (e.g., lactose, saccharide, carbohydrate, mannitol, leucine, PEG, trehalose, etc.), additive, propellant, solution (e.g., aqueous solution, such as a buffer). In one instance, the composition includes an aerosolized formulation, a liquid formulation, or a powdered formulation. The delivery platform can have any useful dimension (e.g., a mean particle size is of from about 2 to about 5 μm, or any described herein), colloidal stability, functionalization, surface charge, etc., for use in the formulation.
[0201] The present invention also relates to a composition including an effective amount of a plurality (e.g., a population) of particles (e.g., carriers and/or protocells) and an acceptable additive, excipient, preservative, or solution (e.g., an aqueous solution) [emphasis applied]”.)”
Therefore, Carnes teaches the required delivery platform, and the rejection is maintained.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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