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 .
Claim Status
Claims 1-11 are pending and are examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/7/24 and 8/19/25 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.
Claims 1, 2, 3, 4, 5, 6, 7, 9, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dietz (WO 2018/042060).
Regarding Claim 1, Dietz teaches a method of transferring at least one protein of interest in a plurality of proteins to the protein capture membrane ([0001] Open-pore membrane with internal space-spanning polymer structure network for electrophoretically selective separation),
the method comprising: electrophoretically transferring the plurality of proteins to a porous substrate ([0001] Open-pore membrane with internal space-spanning polymer structure network for electrophoretically selective separation),
the porous substrate comprising: a first side and a second side, and a plurality of interstices extending contiguously from the first side to the second side ([0016] an open-cell membrane for the electrophoretic separation),
wherein the interstices are coated with a protein-reactive coating, thereby covalently binding at least a portion of the plurality of proteins to the protein-reactive coating ([0053] The space-filling or space-spanning open-pore polymer structures according to the invention are preferably achieved by "self-assembly" of mono- / oligomers into polymeric textures and are preferably covalently and / or electrostatically bonded to the surfaces of the open-pore carrier membrane in the pores of the porous support membrane).
Regarding Claim 2, Dietz teaches the protein capture membrane according to the method of claim 1, wherein the interstices have a diameter of about 500 nm or less than about 500 nm ([0017] an open-porous carrier membrane having pores with a minimum diameter of 50 nm to 500 μm).
Regarding Claim 3, Dietz teaches the protein capture membrane according to the method of claim 1, wherein the porous substrate has a thickness from the first side to the second side of about 50-100 µm ([0309] The thickness of the carrier material, resp. the open-pore carrier membrane is preferably between 5µm and 10mm, more preferably between 50μm and 3mm).
Regarding Claim 4, Dietz teaches the protein capture membrane according to the method of claim 1, wherein the porous substrate has a thickness from the first side to the second side of about 100 µm ([0309] The thickness of the carrier material, resp. the open-pore carrier membrane is preferably between 5µm and 10mm, more preferably between 50μm and 3mm).
Regarding Claim 5, Dietz teaches the protein capture membrane according to the method of claim 1, wherein the protein-reactive coating comprises a silane derivative ([0317] For coating, the surfaces of the open-pore carrier membrane are to be prepared with suitable measures from the prior art. The binding can be chemosorptive or physiosorptive. Preferred compounds with which a full-surface covering of the surfaces of the open-pore carrier membrane can be effected by means of a covalent bond are, for example, aminosilanes, such as (3-aminopropyl) triethoxysilane (APTS) or and (3-trimethoxysilylpropyl) diethylenetriamine (TAPTES)).
Regarding Claim 6, Dietz teaches the protein capture membrane according to the method of claim 5, wherein the silane derivative is covalently bound to the porous substrate ([0317] For coating, the surfaces of the open-pore carrier membrane are to be prepared with suitable measures from the prior art. The binding can be chemosorptive or physiosorptive. Preferred compounds with which a full-surface covering of the surfaces of the open-pore carrier membrane can be effected by means of a covalent bond are, for example, aminosilanes, such as (3-aminopropyl) triethoxysilane (APTS) or and (3-trimethoxysilylpropyl) diethylenetriamine (TAPTES)).
Regarding Claim 9, Dietz teaches the protein capture membrane according to the method of claim 1, wherein the protein-reactive coating is selected from the group consisting of 3-thiocyanatopropyltriethoxysilane, triethoxysilylundecanal, trimethoxy[2-(7-oxabicyclo[4.1.0]hept-3-yl)ethyl]silane, (3-glycidyloxypropyl)triethoxysilane, 3-isocyanatopropyltriethoxysilane, N-[5-(trimethoxysilyl)-2-aza-1-oxopentyl]caprolactam, 11-(succinimidyloxy)undecyldimethylethoxysilane, 2-(4-chlorosulfonylphenyl)ethyltrimethoxysilane and triethoxysilylbutyraldehyde ([0317] For coating, the surfaces of the open-pore carrier membrane are to be prepared with suitable measures from the prior art. The binding can be chemosorptive or physiosorptive. Preferred compounds with which a full-surface covering of the surfaces of the open-pore carrier membrane can be effected by means of a covalent bond are, for example, aminosilanes, such as (3-aminopropyl) triethoxysilane (APTS) or and (3-trimethoxysilylpropyl) diethylenetriamine (TAPTES).).
Regarding Claim 10, Dietz teaches the method according to claim 1, wherein the porous substrate comprises nanoporous alumina or porous glass ([0307] Suitable inorganic materials preferably include ceramic or metallic materials such as, for example, alumina, or glass. On the other hand, fiber textures can also be produced from inorganic materials. These can be put together to fabric associations, z. B. as a glass fiber fabric.).
Regarding Claim 11, Dietz teaches the method according to claim 1, wherein the method comprises: separating the plurality of proteins using electrophoresis prior to transferring to the porous substrate ([0345] With the membranes of the invention also a selectivity to other organic compounds having negative charge groups is found. Proteins usually have one under physiological conditions negative surface charge and can be transported electrophoretically. With uncoated porous membranes, the achievable transport amount of carboxylic acids and proteins through the membrane is proportional to each other. In diffusion and electrodialysis, which were carried out with the membranes of the invention, there was virtually no transport of proteins through the membrane, whereas compared to uncoated membranes, the transport rate for carboxylic acids was increased (Example 3). But also small anionic compounds were retained, such as chloride and sulfate ions. Thus, the membranes according to the invention ensure a high selectivity for the separation of carboxylic acids from aqueous media or aqueous mixtures of substances.).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dietz (WO 2018/042060), in view of Rasmussen (US Pub 2011/0217752).
Regarding Claim 7, Dietz teaches the protein capture membrane according to the method of claim 1.
Dietz is silent to the protein-reactive coating is selected from the group consisting of:
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Rasmussen teaches in the related art of making functionalized substrates. See Abstract. [0058] In other embodiments, the ligand functional (co)polymer itself is coated on the base substrate. Useful crosslinkers in these instances include amine reactive compounds such as bis- and polyaldehydes such as glutaraldehyde, bis- and polyepoxides such as butanedioldiglycidylether and ethyleneglycoldiglycidylether, polycarboxylic acids and their derivatives (e.g., acid chlorides), polyisocyanates, formaldehyde-based crosslinkers such as hydroxymethyl and alkoxymethyl functional crosslinkers, such as those derived from urea or melamine, and amine-reactive silanes, such as 3-glycidoxypropyltrimethoxysilane, 3-glycidoxypropyltriethoxysilane, 5,6-epoxyhexyltriethoxysilane, (p-chloromethyl)phenyltrimethoxysilane, chloromethyltriethoxysilane, 3-isocyanatopropyltriethoxysilane, and 3-thiocyanatopropyltriethoxysilane.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected thiocyanatopropyltriethoxysilane, as taught by Rasmussen, for the protein-reactive coating in the protein capture membrane, as taught by Dietz, to allow for selectively binding and removing biological materials, such as viruses, from biological samples, in [0002].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dietz (WO 2018/042060), in view of Braeken (US Pub 2011/0003322).
Regarding Claim 8, Dietz teaches the protein capture membrane according to the method of claim 7.
Dietz is silent to the protein-reactive coating is triethoxysilylundecanal
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Braeken teaches in the related art of sensing layer. A silane triethoxysilylundecanal (TESU) self-assembled monolayer is deposited on the oxide surface. The functional group of this silane layer for immobilising the enzymes is an aldehyde, which can directly couple to the amino groups of the enzymes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted triethoxysilylundecanal, as taught by Braeken, for the protein-reactive coating in the method of Dietz, to immobilize enzymes, as taught by Braeken.
Conclusion
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798