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 .
Applicant’s election of Claims 1-2, 3 (sucrose solution), 9-11 and 14-22 in the reply filed on 07/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3 (Salt solution), 4-8 and 12-13 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 15-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Faltin et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan.
Regarding Claim 1, Faltin is directed to a method and a device for purifying biological molecules, more particularly nucleic acids or proteins, the method using at least one filter [0001].
Faltin discloses a method, the method comprising: providing a filter medium; passing a first fluid containing cells through the filter medium; passing a second fluid, and optionally a third and/or fourth fluid through the filter medium, wherein the second and/or third and/or fourth fluid disrupts at least one of the captured cells; and recovering an intracellular biological product in the first and/or second and/or third and/or fourth fluid (Abstract;, [ An apparatus for purifying biological molecules, especially nucleic acids or proteins, includes at least one filter and a circuit. A method of purifying biological molecules using the apparatus includes pumping at least some fluids into the circuit via the filter. Fluids with biological cells is pumped into the circuit via the filter, and cells retained on the filter are digested. Binding buffer is pumped into the circuit via the filter in order to bind the biological molecules to the filter. A washing buffer is pumped into the circuit via the filter in order to clean the biological molecules bound to the filter so that the biological molecules bound to the filter are enabled for further use]).
However, Faltin is silent to comprising a functionalized nonwoven; wherein at least some of the cells are captured by the functionalized nonwoven.
Berrigan is directed to a filter using the functionalized nonwoven substrate and a method of filtering a fluid. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples [0001].
Berrigan discloses wherein a filter medium comprising a functionalized nonwoven, wherein at least some of the cells are captured by the functionalized nonwoven (Abstract, [A functionalized nonwoven substrate and methods for preparing the same are described. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Faltin ‘s method, as taught by Berrigan, wherein a filter medium comprising a functionalized nonwoven, wherein at least some of the cells are captured by the functionalized nonwoven because the functionalized substrates are useful in selectively filtering and removing biological materials (See Berrigan, [0001]), yielding nothing more than predictable results.
Regarding claims 15-18 and 20-21, modified Faltin teaches all the limitations in claim 1 as set forth above.
Faltin discloses wherein at least some of the cells are captured electrostatically (Claim 16) ([0010], [In the first method step, there is an accumulation of the biological cells, the cells being retained on the filter according to the size-exclusion method and/or by electrostatic interactions when the sample liquid is pumped across the filter]).
Faltin also discloses the method of claim 1, wherein at least some of nucleic acids are captured (Claim 21) (Abstract, [An apparatus for purifying biological molecules, especially nucleic acids or proteins, includes at least one filter and a circuit]).
Faltin is silent to the method of claim 1, wherein the functionalized nonwoven is cationically charged (Claim 15), The method of claim 1, wherein at least some of the cells are captured by the functionalized nonwoven (Claim 16), the method of claim 1, wherein the functionalized nonwoven is grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer (Claim 17), the method of claim 17, wherein the monomer is MAPTA C (Methacrylamidopropyltrimethyl-ammonium chloride monomer (Claim 18), the method of any of claim 1, wherein intracellular biological product comprises AAV capsids, therapeutic/recombinant proteins, plasmids, DNA, RNA, viruses, virus like particles, exosomes, and mixtures thereof (Claim 20), the method of claim 1, wherein at least some of nucleic acids are captured by the functionalized nonwoven (Claim 21).
Berrigan discloses, wherein the functionalized nonwoven is cationically charged (Claim 15),
([0009], [the present disclosure provides an article comprising a nonwoven substrate and a copolymer grafted thereto comprising cationic nitrogen-containing ligand monomer unit]).
Berrigan discloses, wherein at least some of the cells are captured by the functionalized nonwoven (Claim 16), (Abstract, [A functionalized nonwoven substrate and methods for preparing the same are described. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples]).
Berrigan discloses wherein the functionalized nonwoven is grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer (Claim 17), ([0009], [comprising a nonwoven substrate and a copolymer grafted thereto comprising cationic nitrogen-containing ligand monomer unit, amide monomer units and "oxy" monomer units", as described more fully herein], [0021] , [a polymer grafted article comprising a nonwoven substrate, a grafted copolymer comprising interpolymerized monomer units of a) a cationic nitrogen-containing ligand monomer selected from quaternary ammonium monomers and guanidinyl monomers, including guanidine and biguanidine-containing monomers; b) an amide monomer, c) an "oxy monomer" comprising epoxy-functional and monoether-functional (meth)acrylates and (meth)acrylamides; and d) optionally a poly(alkylene oxide) monomer]),
Berrigan also discloses, wherein the monomer is MAPTA C Methacrylamidopropyltrimethyl-ammonium chloride monomer (Claim 18) ([0047], [Preferred quaternary salts of the aminoalkyl(meth)acryloyl monomers of Formula II include, but are not limited to, (meth)acrylamidoalkyltrimethylammonium salts (e.g., 3 methacrylamidopropyltrimethylammonium chloride)]).
Berrigan also discloses, wherein intracellular biological product comprises AAV capsids, therapeutic/recombinant proteins, plasmids, DNA, RNA, viruses, virus like particles, exosomes, and mixtures thereof (Claim 20) [[0010], [the article may be used as a filter element to purify or separate target materials, such as host cell proteins, DNA fragments, viruses, and cell debris, oligonucleotides or therapeutic proteins such as monoclonal antibodies (MAb), from a fluid mixture, such as those fluids produced by common cell product harvesting techniques]).
Berrigan also discloses the method of claim 1, wherein at least some of nucleic acids are captured by the functionalized nonwoven (Claim 21). (Abstract, [A functionalized nonwoven substrate and methods for preparing the same are described. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples]; [0002], [Detection, quantification, isolation and purification of target biomaterials, such as viruses and biomacromolecules (including constituents or products of living cells, for example, proteins, carbohydrates, lipids, and nucleic acids) have long been objectives of investigators]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Faltin ‘s method, as taught by Berrigan, wherein the functionalized nonwoven is cationically charged (Claim 15), wherein at least some of the cells are captured by the functionalized nonwoven (Claim 16), wherein the functionalized nonwoven is grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer (Claim 17), wherein the monomer is MAPTA C (Methacrylamidopropyltrimethyl-ammonium chloride monomer (Claim 18), wherein intracellular biological product comprises AAV capsids, therapeutic/recombinant proteins, plasmids, DNA, RNA, viruses, virus like particles, exosomes, and mixtures thereof (Claim 20), wherein at least some of nucleic acids are captured by the functionalized nonwoven (Claim 21), because the functionalized substrates are useful in selectively filtering and removing biological materials and removing biological materials, such as biocontaminates, from biological samples. (See Berrigan, [Abstract]), yielding nothing more than predictable results.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan, as applied to claim 1 above, and further in view of Dhamwichukor (US 20110045528 A1) herein known as Dhamwichukor.
Regarding claims 2-3, modified Faltin teaches all the limitations in claim 1 as set forth above.
However, modified Faltin is silent to the method of claim 1, wherein the second fluid has an osmotic potential less than the osmotic potential of the first fluid, and wherein the change in osmotic potential within the filter medium results in a disruption of at least one of the cells (Claim 2), The method of claim 2, wherein the second fluid is a sucrose solution (Claim 3).
Dhamwichukor is directed to disruption, extraction, and recovery of products from microbial organisms, and more particularly to novel apparatus and methods for osmotically treating microbial organisms (e.g., algae, bacteria, yeast, fungus, etc.) to facilitate subsequent disruption and/or extraction to enhance recovery of products (e.g., cellular and intracellular products. Particular preferred aspects relate to a surprisingly beneficial synergistic osmotic stress protocol comprising at least one hypotonic shock and at least two hypertonic shocks, wherein the last shock of the protocol is a hypertonic shock, wherein enhancing at least one of disruption and extraction of microbial cells is afforded [0002].
Dhamwichukor discloses wherein the second fluid has an osmotic potential less than the osmotic potential of the first fluid, and wherein the change in osmotic potential within the filter medium results in a disruption of at least one of the cells (Claim 2) (Abstract, [Provided are surprisingly beneficial osmotic stress shock methods for facilitating disruption and/or extraction of microorganisms, comprising a synergistic combination of at least one hypotonic shock and at least two hypertonic shocks, wherein the last shock is a hypertonic shock. Preferred aspects of the invention relate to facilitating disruption of a broad spectrum of microorganisms (e.g., algae, bacteria, yeast, fungus, etc.). In particular aspects the microbial cells are subjected to: a hypertonic/hypotonic/hypertonic tertiary shock; a hypotonic/hypertonic/hypertonic tertiary shock; or a hypotonic/hypertonic/hypotonic/hypertonic quaternary shock.])
Dhamwichukor also discloses wherein the second fluid is a sucrose solution (Claim 3). [0055], [Salt" or "Salt water", as used herein, refers to any salt or solution thereof that contains any type of salt, sugar, or solute molecule. For example, salt and salt water encompass any solute molecule or chemical that can alter the tonicity of a solution, including but not limited to NaCl, KCl, MgCl, NaSO.sub.4, KSO.sub.4, sugars (e.g., sucrose, glucose, glycerol, fructose and the like, carbonates, nitrates, etc.]; [0012] In particular embodiments of the methods, at least one hypotonic shock comprises a hypotonic shock equivalent to at least 5 g/L total dissolved salt/solids (TDS)]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Faltin ‘s method, as taught by Dhamwichukor, wherein the second fluid has an osmotic potential less than the osmotic potential of the first fluid, and wherein the change in osmotic potential within the filter medium results in a disruption of at least one of the cells (Claim 2), wherein the second fluid is a sucrose solution (Claim 3), in order to provide surprisingly beneficial osmotic stress shock methods for facilitating disruption and/or extraction of microorganisms (See Dhamwichukor, Abstract), yielding nothing more than predictable results.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan, as applied to the claim above, and further in view of Lebreton et al. (US-20150056196-A1) herein known as Lebreton.
Regarding claim 9, modified Faltin teaches all the limitations in claim 1 as set forth above.
However modified Faltin is silent to wherein a conductivity of the third fluid is different than that of the first fluid and different than that of the second fluid.
Lebreton is directed to protein purification. In particular, the invention relates to a method for purifying antibody from a composition comprising the antibody and at least one contaminant using cation exchange chromatography, wherein a high pH wash step is used to remove contaminants prior to eluting the desired antibody using an elution buffer with increased conductivity [0003].
Lebreton discloses wherein a conductivity of the third fluid is different than that of the first fluid and different than that of the second fluid. ([[0044], [Preferably, the conductivity of the first wash buffer herein is in the range from about 0.01 to about 5 mS/cm, preferably from about 0.1 to about 3 mS/cm, and most preferably from about 0.2 to about 2 mS/cm. Optionally, the first wash buffer is substantially free of a salt (such as NaCl) therein.]; Preferably, the conductivity of the second wash buffer herein is in the range from about 0.01 to about 5 mS/cm, preferably about 0.1 to about 3 mS/cm, and most preferably from about 0.5 to about 3.0 mS/cm.]; [0046] "Elution buffer" is used to elute the antibody of interest from the solid phase. Herein, the elution buffer has a substantially increased conductivity relative to that of the second wash buffer, such that the desired antibody product is eluted from the cation exchange material. Preferably, the conductivity of the elution buffer is substantially greater than that of the load and of each of the preceding buffers, namely of the equilibration buffer, first wash buffer, and second wash buffer. By "substantially greater" conductivity is meant, for example, that the buffer has a conductivity which is at least 2, 3, 4, 5 or 6 conductivity units (mS/cm) greater than that of the composition or buffer to which it is being compared.]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Faltin ‘s method, as taught by Lebreton, wherein a conductivity of the third fluid is different than that of the first fluid and different than that of the second fluid, in order to remove contaminants (See Lebreton, [0003] ), yielding nothing more than predictable results.
Regarding claim 11, modified Faltin teaches all the limitations in claims as set forth above.
Faltin discloses wherein the third fluid is water. ([0018], [an elution of the adsorbed target molecules from the filter can take place, it being possible to use water or an appropriate elution buffer for this purpose];, [0050], [Thereafter, the column is washed with wash buffer and the DNA eluted with 100 μl of water]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan, and further in view of Dhamwichukor (US 20110045528 A1) herein known as Dhamwichukor, as applied to claims above, and further in view of Nadarajah et al. (US 20140301977 A1) herein known as Nadarajah.
Regarding claim 10, modified Faltin teaches all the limitations in claims as set forth above.
However modified Faltin is silent to wherein a conductivity of the second fluid is greater than a conductivity of the first fluid.
Nadarajah is directed to methods for purifying a product from a composition comprising the product and at least one contaminant and formulations comprising the product purified by the methods [0002].
Nadarajah discloses to wherein a conductivity of the second fluid is greater than a conductivity of the first fluid ([0019], [In other embodiments, the elution buffer has conductivity greater than the conductivity of the loading buffer]; [0080], [In some embodiments, loading conditions, such as pH and conductivity, are determined where impurities strongly bind to the chromatography material]; [0089], [the product is eluted from the chromatography material at a pH and conductivity determined by high throughput screening wherein about all of the product elutes from the chromatography material and about all of the contaminants remain bound to the chromatography material]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Faltin ‘s method, as taught by Nadarajah, wherein a conductivity of the second fluid is greater than a conductivity of the first fluid, in order to the impurities strongly bind to the chromatography material (See Nadarajah, [0080]), yielding nothing more than predictable results.
Claim 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan, as applied to claim 1 above, and further in view of Weiss et al. (US 20100155323 A) herein known as Weiss.
Regarding claim 14 and 19, modified Faltin teaches all the limitations in claim 1 as set forth above.
However, modified Faltin is silent to the method of claim 1, wherein the functionalized nonwoven has a dynamic charge capacity (Claim 14), the method of claim 1, wherein the filter medium comprises multiple layers of functionalized nonwoven, each layer having a same or different calculated pore size and a same or different dynamic charge capacity (Claim 19).
Weiss is directed to functionalized nonwoven substrates, and methods for preparing the same. The present disclosure further relates to a filter using the functionalized nonwoven substrate and a method of filtering a fluid. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples [0002].
Weiss discloses, wherein the functionalized nonwoven has a dynamic charge capacity (Claim 14) ([0002], [The present disclosure relates to functionalized nonwoven substrates, and methods for preparing the same. The present disclosure further relates to a filter using the functionalized nonwoven substrate and a method of filtering a fluid. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples]; [0118], [As more and more material is progressively passed through the depth of the filter, the discontinuous gel collapses as negatively charged contaminates such as cell debris is captured and positively charged materials such as monoclonal antibodies are passed. This continues until the dynamic capacity of the filter element is reached]; [0122], [ Further, the microporous membranes may be polymer grafted to alter the surface characteristics thereof, such as hydrophilicity, hydrophobicity or charge binding capacity]).
Weiss also discloses wherein the filter medium comprises multiple layers of functionalized nonwoven, each layer having a same or different calculated pore size and a same or different dynamic charge capacity (Claim 19) ( [0097], [ When used in a filtration application, one or more layers of the functionalized substrate may be used, each of which layers may have the same, or different average fiber size, void volume, degree of polymer grafting, monomer composition of grafted polymer, porosity, tensile strength and surface area. In some embodiments, each subsequent layer may have a smaller effective pore size or smaller average fiber size so that finer contaminants may be filtered]); [0114], [In some embodiments the functionalized nonwoven substrate may be combined with conventional filter elements, such as microporous membranes. A filter comprising one or more layers of the instant functionalized nonwoven substrate can serve as a "prefilter" for removing contaminants and or protecting downstream processing, including additional downstream filters]; ([0122] The polymer grafted nonwoven substrate described herein may be combined with microporous membranes, including symmetric or asymmetric microporous membranes (having a gradient porosity), and single or multiple layers of such membranes. The microporous membranes may have symmetric pore size ranges of 0.01 to 150 .mu.m, preferably 0.1 to 100 .mu.m and thicknesses of 25 to 500 .mu.m. In another embodiment the grafted nonwoven substrate may be combined with asymmetric microporous membranes having gradient average pore sizes of 0.01 to 150 .mu.m. In other embodiments, multiple layers of microporous membranes may be used in combination, with each layer having successively finer porosity, such from 15 to 0.02 .mu.m, preferably 10 to 0.8 .mu.m and total thicknesses of 75 to 1200 .mu.m. Multiple layers of microporous membranes having both symmetric and gradient porosities may be used in combination. Further, the microporous membranes may be polymer grafted to alter the surface characteristics thereof, such as hydrophilicity, hydrophobicity or charge binding capacity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Faltin ‘s method, as taught by Lin, wherein the functionalized nonwoven has a dynamic charge capacity (Claim 14), wherein the filter medium comprises multiple layers of functionalized nonwoven, each layer having a same or different calculated pore size and a same or different dynamic charge capacity (Claim 19), Because one or more layers of the instant functionalized nonwoven substrate can serve as a "prefilter" for removing contaminants and or protecting downstream processing, including additional downstream filters (See Weiss,[0114]), yielding nothing more than predictable results.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over et al. (US 20170044483 A1) herein known as Faltin, in view of Berrigan et al. (US 20150099413 A1) herein known as Berrigan, as applied to claim 1 above, and further in view of Hobel et al. (US 20170044209 A1) herein known as Hobel.
Regarding claims 22, modified Faltin teaches all the limitations in claim 1 as set forth above.
Modified Faltin discloses the functionalized nonwoven (See Berrigan, Abstract, [A functionalized nonwoven substrate and methods for preparing the same are described. The functionalized substrates are useful in selectively filtering and removing biological materials, such as biocontaminates, from biological samples]).
However, modified Faltin is silent the method of claim 1, wherein the functionalized nonwoven reduces DNA concentrations in the first fluid below 10 ng/ml.
Hobel is directed to a method for obtaining a protein product from a fermentation broth wherein the fermentation broth has been subjected to a very effective process for removing host cell DNA [0001].
Hobel discloses, wherein the functionalized nonwoven reduces DNA concentrations in the first fluid below 10 ng/ml (Abstract, [A method for reducing the level of DNA in a fermentation broth is disclosed where the method includes a heating step where the broth is heated to a temperature of at least 70° C]; [0116], [Preferably the DNA level in the fermentation broth is reduced to a level below 1 μg/ml, preferably below 500 ng/ml, preferably below 200 ng/ml, preferably below 100 ng/ml, preferably below 50 ng/ml, preferably below 20 ng/ml, preferably below 10 ng/ml])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify modified Faltin ‘s method, as taught by Hobel, wherein the functionalized nonwoven reduces DNA concentrations in the first fluid below 10 ng/ml, in order to effectively remove host cell DNA (See Hobel, [0001]), yielding nothing more than predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOUD MOTAZ ABDEL LATIF whose telephone number is (571)272-6535. The examiner can normally be reached Monday-Friday 8:30-5pm.
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/MAHMOUD MOTAZ ABDEL LATIF/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
