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 .
Claims 1-9 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/7/24 and 3/3/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 102a1 as being anticipated by O’Riordan et al. (US PGPub 2005/0244942).
The claimed invention is drawn to a method for purifying a virus, comprising a step of ultrafiltering an aqueous dispersion comprising a virus, a surfactant, and an inorganic salt.
The method further comprises a step of extracting a virus from a cell containing the virus and obtaining the aqueous dispersion, which step is performed before the ultrafiltration step.
The method further comprising a step of purifying by column chromatography after ultrafiltration.
The inorganic salt is selected from a chloride ion, sulfide ion, phosphate ion or a carbonate ion, and a more specific salt is selected from a sodium chloride, magnesium chloride and a magnesium sulfate. The inorganic salt is 80 to 800mM with respect to the total amount of the aqueous dispersion.
The surfactant is selected from a non-ionic, anionic, cationic and zwitterionic surfactant.
The surfactant is 0.01 to 2.0 mass % with respect to the total amount of the aqueous dispersion.
O’Riordan et al. teach propagation of adenovirus in HEK 293 cells, infected cells were harvested, centrifuged into a pellet and frozen. The frozen pellet was resuspended in PBS that contains 0.1% Tween-80 (a non-ionic surfactant), 10% glycerol, 2mM of MgCl2 and 50uM of ZnCl2. In addition, the PBS already contained 1.5 mM KH.sub.2P0.sub.4, 150 mM NaCl, 5 mM Na.sub.2HP0.sub.4 pH 7.5. The resuspended cells were lysed, treated with benzonase to remove containing DNA and filtered using ultrafiltration. [see paragraph 94] O’Riordan et al. also teach that the lysate can be directly chromatographed or subjected to chromatography after ultrafiltration. [see paragraph 94] The amount of NaCl2 (150mM) and 0.1% of Tween-80, meet the claim limitations of an inorganic salt is 80 to 800mM with respect to the total amount of the aqueous dispersion, and the surfactant is 0.01 to 2.0 mass % with respect to the total amount of the aqueous dispersion, respectively.
Therefore, O’Riordan et al. anticipate the instant invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for purifying Adeno Associated Virus present in an aqueous dispersion with a surfactant and an in organic salt by using ultrafiltration, does not reasonably provide enablement for purifying viruses, such as enveloped viruses present in an aqueous dispersion with a surfactant and an in organic salt by using ultrafiltration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims. The claimed invention is drawn to a method for purifying a virus, comprising a step of ultrafiltering an aqueous dispersion comprising a virus, a surfactant, and an inorganic salt.
The method further comprises a step of extracting a virus from a cell containing the virus and obtaining the aqueous dispersion, which step is performed before the ultrafiltration step.
The method further comprising a step of purifying by column chromatography after ultrafiltration.
The inorganic salt is selected from a chloride ion, sulfide ion, phosphate ion or a carbonate ion, and a more specific salt is selected from a sodium chloride, magnesium chloride and a magnesium sulfate. The inorganic salt is 80 to 800mM with respect to the total amount of the aqueous dispersion.
The surfactant is selected from a non-ionic, anionic, cationic and zwitterionic surfactant.
The surfactant is 0.01 to 2.0 mass % with respect to the total amount of the aqueous dispersion.
*The claimed surfactants function as detergents.
State of the prior art/Predictability of the art. The state of the prior art raises concerns for enveloped viruses and the damage that surfactants can cause. For example, Roberts (Biotechnol. Prog., 2014, Vol. 30, No. 6, pages 1341-1347) state that triton X-100 can be used to inactivate enveloped viruses [see right column of page 1341 and “Solvent/detergent” section and Table 3]. Examples of the viruses tested by Roberts are HSV-1, Sindbis, SFV and MuLV. Triton X-100 is a surfactant and therefore raises concerns of using surfactants in an aqueous dispersion as claimed to attempt to purify enveloped viruses, which are included in the breadth of the claimed method.
Working examples. The working examples in the specification focus on purifying AAV utilizing the active steps of the claimed method.
Amount of experimentation necessary. Additional research is required in order to determine how effective exposing an enveloped virus in an aqueous dispersion to a surfactant and then subsequently purifying it since surfactants can damage/inactivate enveloped viruses. .
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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