DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: please also insert the publication numbers of each application number listed.
Appropriate correction is required.
The abstract of the disclosure is objected to because the first sentence lacks appropriate subject-verb grammatical structure. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 2, 4-12 & 14-21, are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Koops, (US 2006/0099414), in view of Buck et al., (“Buck”, US 2010/0294714).
Regarding Claims 2 & 4-11, a first embodiment (Embodiment 1) of Koops discloses a method of removing toxins from a liquid, (See paragraphs [0030]-[0032], [0070]; “In a preferred embodiment of invention however, the porous fibres are applied to isolate desired molecules. In particular such an application concerns the isolation of macromolecules such as peptides, proteins, nucleic acid or other organic compounds. As disclosed, fibres may be either hollow or solid”), the method comprising the step of contacting the liquid comprising the toxins to a membrane, (See paragraphs [0030]-[0032], [0070]), comprising i) at least one hydrophobic polymer selected from the group consisting of polysulfones, polyethersulfones, polyarylethersulfones, polyamides and polyacrylonitriles, (See paragraph [0039]; “The polymeric material may be a polymer including elastomers, a copolymer, mixture of polymers, mixture of copolymers or a mixture of polymers and copolymers. Examples of polymeric materials suitable for use in the preparation of porous fibres according to the method of the invention include polysulphone (PSF), polyethersulphone (PES), polyamide (PA), polyetherimide (PEI), polyimide (PI), polyethylene-co-vinylalcohol (EVAL), polyethylene-vinylacetate (EVAC), cellulose acetate (CA), cellulose triacetate (CTA), polyvinylidenefluoride (PVDF), polyvinylchloride (PVC) polyacrylonitrile (PAN), polyurethane (PUR) polyether ether ketone (PEEK) polyacrylicacid (PAA)”) and at least one hydrophilic polymer (See paragraph [0044]; “Also for various reasons additives may be applied such as for instance to influence viscosity of the polymer solution, as pore and/or to introduce hydrophilicity. Possible additives include, but are not limited to polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethyleneoxide (PEO), dextran, glycerol, diethylene glycol, (higher) alcohols such as octanol, carboxylic acids or organic acids, such as oxalic acid, maleic acid, tartaric acid, fumaric acid, salts, such as LiCl and CaCl2”),
wherein the membrane comprises particles, wherein the particles comprise a) hydrophilic particles, b) hydrophobic particles, or c) a combination of both, (See paragraphs [0035] and paragraph [0037]; “Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, union exchange resins, silica type particles, for instance unmodified or derivatised with C2, C4, C6, C8 or C18 or ion exchange functionalities, zeolites, ceramic particles, such as TiO2, Al2O3, and the like, magnetic colloidal particles, porous or non-porous polymeric particles, such as porous polystyrene or styrene-divinylbenzene type particles either unmodified or derivatised with for instance sulphonic acids, quaternary amines and the like, molecular imprinted particles and homogeneous catalyst particles”; and See paragraph [0037]; “The term particulate material as used herein is intended to encompass particles having regular, in particular spherical or irregular shapes, as well as shards, fibres and powders, including metal powders, plastic powders for instance powdered polystyrene, normal phase silica, fumed silica and activated carbon”), and
wherein the particles have an average diameter of between 0.1 μm and 15 μm, (See paragraph [0038]; “Particles with an average particle (diameter) up to 100 μm may be used. It is preferred the average particle size is less than 50 μm and is preferably in the range of 0.1 to 30 μm, preferably smaller than 20 μm, anticipating the claimed range from 0.1 to 15 μm”), wherein the endogenous toxins are removed via adsorption or isolation from the liquid to the membrane, (See paragraphs [0031] & [0032]).
Embodiment 1 of Koops does not disclose in this particular embodiment wherein the membrane comprises 20-40 wt.-% of the particles, or the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone.
Another (second) embodiment (Embodiment 2) of Koops discloses:
the membrane comprises 20-40 wt.-% of particles, (See paragraph [0052]; In an embodiment the fibre that is prepared according to the method of the invention comprises 20-70% by weight of polymeric material and 30-80% by weight of particulate material, preferably 60-70% by weight of particulate material, anticipating the claimed range from 20 to 40% or 30 to 40%).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the hollow fiber or flat sheet membrane of Embodiment 1 of Koops by incorporating the membrane comprising 20-40 wt.-% of particles as in Embodiment 2 of Koops since “suitable adsorptive particles will be apparent to those skilled in the art”, (See paragraph [0035], Koops), and the proportion used has “a distinct influence on the ultimate pore structure of the matrix”, (See paragraph [0049], Koops), which may be selected for via "a balance between particle load and accessibility, depending on a particular application of the polymeric matrix," (See paragraph [0050], Koops), resulting in macrovoids, “which may be beneficial in view of convective transport and diffusional resistance in the polymeric matrix,” (See paragraph [0050], Koops).
Modified Koops does not explicitly disclose that the toxins are endogenous, the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone. In separate examples, Koops suggests values of at least one hydrophobic polymer and at least one hydrophilic polymer that overlap with the claimed range, (See paragraph [0069] & [0071]; 7 wt% octanol and 13.8 wt % PES).
Buck discloses a membrane, (See paragraph [0001] & [0003], Buck) for removing toxins where the toxins are endogenous, (See paragraph [0004] & [0085], Buck), and with the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone, (See paragraph [0020], Buck). Additional features of this disclosure are included as part of the overall combination, and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the membrane of modified Koops by incorporating with the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone as in Buck in order to provide “exceptional selectivity and permeability of a membrane of the present invention, which is a function of the membrane…composition”, (See paragraph [0002], Buck), “to select between molecules of medium size and larger proteins which are preferably retained”, (See paragraph [0036], Buck), as also desired in Koops, (See paragraph [0032], Koops), in which such “membranes…present special advantages when they are used in connection with different kinds of medical treatments”, (See paragraph [0001], Koops).
Additional disclosures included:
Claim 4: The membrane according to claim 2, wherein the hydrophobic particles are chosen from the group consisting of activated carbon, carbon nanotubes, hydrophobic silica, styrenic polymers, polydivinylbenzene polymers and styrene-divinylbenzene copolymers (See paragraph [0037], Koops; The term particulate material as used herein is intended to encompass particles having regular, in particular spherical or irregular shapes, as well as shards, fibres and powders, including metal powders, plastic powders for instance powdered polystyrene, normal phase silica, fumed silica and activated carbon).
Claim 5: The membrane according to claim 2, wherein the hydrophilic particles are anion exchange particles (See paragraph [0035], Koops; Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, anion exchange resins).
Claim 6: The membrane according to claim 2, wherein the hydrophilic particles are cation exchange particles (See paragraph [0035], Koops; Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, anion exchange resins).
Claim 7: The method of claim 2, wherein the liquid is a solution based on water, (See paragraph [0001], [0030], Buck).
Claim 8: The method of claim 2, wherein the liquid is an aqueous solution, (See paragraph [0001], [0030], Buck).
Claim 9: The method of claim 8, wherein the aqueous solution is dialysate, (See paragraph [0083], Buck).
Claim 10: The method of claim 8, wherein the aqueous solution is water, (See paragraph [0001], [0030], Buck).
Claim 11: The method of claim 2, wherein the method is performed in an extracorporeal system, (See paragraph [0003], [0001], [0011], Buck).
Regarding Claims 12 & 14-21, a first embodiment (Embodiment 1) of Koops discloses a method of removing toxins from a liquid, (See paragraphs [0030]-[0032], [0070]; “In a preferred embodiment of invention however, the porous fibres are applied to isolate desired molecules. In particular such an application concerns the isolation of macromolecules such as peptides, proteins, nucleic acid or other organic compounds. As disclosed, fibres may be either hollow or solid”), the method comprising the step of contacting the liquid comprising the toxins to a membrane, (See paragraphs [0030]-[0032], [0070]), comprising i) at least one hydrophobic polymer selected from the group consisting of polysulfones, polyethersulfones, polyarylethersulfones, polyamides and polyacrylonitriles, (See paragraph [0039]; “The polymeric material may be a polymer including elastomers, a copolymer, mixture of polymers, mixture of copolymers or a mixture of polymers and copolymers. Examples of polymeric materials suitable for use in the preparation of porous fibres according to the method of the invention include polysulphone (PSF), polyethersulphone (PES), polyamide (PA), polyetherimide (PEI), polyimide (PI), polyethylene-co-vinylalcohol (EVAL), polyethylene-vinylacetate (EVAC), cellulose acetate (CA), cellulose triacetate (CTA), polyvinylidenefluoride (PVDF), polyvinylchloride (PVC) polyacrylonitrile (PAN), polyurethane (PUR) polyether ether ketone (PEEK) polyacrylicacid (PAA)”) and at least one hydrophilic polymer (See paragraph [0044]; “Also for various reasons additives may be applied such as for instance to influence viscosity of the polymer solution, as pore and/or to introduce hydrophilicity. Possible additives include, but are not limited to polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethyleneoxide (PEO), dextran, glycerol, diethylene glycol, (higher) alcohols such as octanol, carboxylic acids or organic acids, such as oxalic acid, maleic acid, tartaric acid, fumaric acid, salts, such as LiCl and CaCl2”),
wherein the membrane comprises particles, wherein the particles comprise a) hydrophilic particles, b) hydrophobic particles, or c) a combination of both, (See paragraphs [0035] and paragraph [0037]; “Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, union exchange resins, silica type particles, for instance unmodified or derivatised with C2, C4, C6, C8 or C18 or ion exchange functionalities, zeolites, ceramic particles, such as TiO2, Al2O3, and the like, magnetic colloidal particles, porous or non-porous polymeric particles, such as porous polystyrene or styrene-divinylbenzene type particles either unmodified or derivatised with for instance sulphonic acids, quaternary amines and the like, molecular imprinted particles and homogeneous catalyst particles”; and See paragraph [0037]; “The term particulate material as used herein is intended to encompass particles having regular, in particular spherical or irregular shapes, as well as shards, fibres and powders, including metal powders, plastic powders for instance powdered polystyrene, normal phase silica, fumed silica and activated carbon”), and
wherein the particles have an average diameter of between 0.1 μm and 15 μm, (See paragraph [0038]; “Particles with an average particle (diameter) up to 100 μm may be used. It is preferred the average particle size is less than 50 μm and is preferably in the range of 0.1 to 30 μm, preferably smaller than 20 μm, anticipating the claimed range from 0.1 to 15 μm”), wherein the endogenous toxins are removed via adsorption or isolation from the liquid to the membrane, (See paragraphs [0031] & [0032]).
Embodiment 1 of Koops does not disclose in this particular embodiment wherein the membrane comprises 20-40 wt.-% of the particles, or the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone.
Another (second) embodiment (Embodiment 2) of Koops discloses:
the membrane comprises 20-40 wt.-% of particles, (See paragraph [0052]; In an embodiment the fibre that is prepared according to the method of the invention comprises 20-70% by weight of polymeric material and 30-80% by weight of particulate material, preferably 60-70% by weight of particulate material, anticipating the claimed range from 20 to 40% or 30 to 40%).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the hollow fiber or flat sheet membrane of Embodiment 1 of Koops by incorporating the membrane comprising 20-40 wt.-% of particles as in Embodiment 2 of Koops since “suitable adsorptive particles will be apparent to those skilled in the art”, (See paragraph [0035], Koops), and the proportion used has “a distinct influence on the ultimate pore structure of the matrix”, (See paragraph [0049], Koops), which may be selected for via "a balance between particle load and accessibility, depending on a particular application of the polymeric matrix," (See paragraph [0050], Koops), resulting in macrovoids, “which may be beneficial in view of convective transport and diffusional resistance in the polymeric matrix,” (See paragraph [0050], Koops).
Modified Koops does not explicitly disclose that the toxins are endogenous, the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone. In separate examples, Koops suggests values of at least one hydrophobic polymer and at least one hydrophilic polymer that overlap with the claimed range, (See paragraph [0069] & [0071]; 7 wt% octanol and 13.8 wt % PES).
Buck discloses a membrane, (See paragraph [0001] & [0003], Buck) for removing toxins where the toxins are endogenous, (See paragraph [0004] & [0085], Buck), and with the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone, (See paragraph [0020], Buck). Additional features of this disclosure are included as part of the overall combination, and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the membrane of modified Koops by incorporating with the at least one hydrophobic polymer comprising 80 to 99% by weight of total polymer and of polyvinylpyrrolidone comprising 1-20% by weight of the total polymer, and wherein about 10-45% of the of the polyvinylpyrrolidone comprises a high molecular component polyvinylpyrrolidone and about 55-90% of the polyvinylpyrrolidone comprises a low molecular component polyvinylpyrrolidone as in Buck in order to provide “exceptional selectivity and permeability of a membrane of the present invention, which is a function of the membrane…composition”, (See paragraph [0002], Buck), “to select between molecules of medium size and larger proteins which are preferably retained”, (See paragraph [0036], Buck), as also desired in Koops, (See paragraph [0032], Koops), in which such “membranes…present special advantages when they are used in connection with different kinds of medical treatments”, (See paragraph [0001], Koops).
Additional disclosures included:
Claim 14: The membrane according to claim 12, wherein the hydrophobic particles are chosen from the group consisting of activated carbon, carbon nanotubes, hydrophobic silica, styrenic polymers, polydivinylbenzene polymers and styrene-divinylbenzene copolymers (See paragraph [0037], Koops; The term particulate material as used herein is intended to encompass particles having regular, in particular spherical or irregular shapes, as well as shards, fibres and powders, including metal powders, plastic powders for instance powdered polystyrene, normal phase silica, fumed silica and activated carbon).
Claim 15: The membrane according to claim 12, wherein the hydrophilic particles are anion exchange particles (See paragraph [0035], Koops; Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, anion exchange resins).
Claim 16: The membrane according to claim 12, wherein the hydrophilic particles are cation exchange particles (See paragraph [0035], Koops; Suitable adsorptive particles will be apparent to those skilled in the art and include cation exchange resins, anion exchange resins).
Claim 17: The method of claim 12, wherein the liquid is a solution based on water, (See paragraph [0001], [0030], Buck).
Claim 18: The method of claim 12, wherein the liquid is an aqueous solution, (See paragraph [0001], [0030], Buck).
Claim 19: The method of claim 18, wherein the aqueous solution is dialysate, (See paragraph [0083], Buck).
Claim 20: The method of claim 18, wherein the aqueous solution is water, (See paragraph [0001], [0030], Buck).
Claim 21: The method of claim 12, wherein the method is performed in an extracorporeal system, (See paragraph [0003], [0001], [0011], Buck).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: after conducting thorough searching and consideration of the prior art in the relevant fields of endeavor, the Examiner has determined that dependent Claims 3 & 13 contain subject matter that would be allowable over the closest prior art references, Koops et al., ("Koops", US 2006/0099414), and, Buck et al., ("Buck", US 2010/0294714). Specifically, Koops and Buck do not disclose and/or make obvious the claim limitation of "the membrane is prepared from a polymer solution comprising 1-10 wt. % of the particles, 10-26 wt.% of the hydrophobic polymer, and 8-15 wt.% polyvinylpyrrolidone".
Claims 3 & 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
