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 .
Response to Amendment
Applicant’s arguments filed 12/16/2025 have been entered. Claims 1-7,9-10 and 12-13 are pending in the application, claims 12, 13 are withdrawn, the 112(b) rejections previously set forth are withdrawn in view of the arguments and amendment.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
In responses to applicant’s argument that Yeh does not teach the recited membrane urea binding capacity and citing Yeh paragraph 0046, Yeh paragraph 0046 discusses the binding capacity of the sorbent particles, not that of a membrane with the particles embedded, with respect to the argument that the embedding of the sorbent in the membrane provides unexpected synergistic results, as Yeh teaches the particles embedded in a membrane, the results would be inherent absent clarification of structural differences.
Additionally, see MPEP 716.02 for details regarding allegations of unexpected results. The burden of establishing results are unexpected and significant falls on applicant. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims, and must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.”
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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, 3-5, 7, 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Yeh (US PG Pub 2010/0004588).
With respect to claim 1, Yeh teaches sorbents for use in dialysis (abstract), sorbents including ion exchange resins which may be kept in separate beds or layers or may be intermixed (0032-0034), preparation of ion exchange resins using nanoclays sorbents such as clays or standard polystyrene beads or styrene ion exchange resins treated with compounds including glyoxols, including phenylglyoxal have excellent urea uptake (0046, wherein the particulate material comprises a urea sorbent that binds urea), the sorbent particles incorporated into filters into devices including filters, and embodiments with hollow fibers prepared with particles embedded (0051-0065) a membrane comprising embedded particulate material, permeable polymeric membranes (0050-0053, 0060-0065, the membrane is a porous polymeric membrane), the polystyrene/styrene a macromolecular composition comprising a polymeric backbone grafted with moieties that can covalently capture urea).
Yeh teaches the nanoclay or ion exchange resin have a small particle size, and nanoclay particle sorbents with particle sizes of about 1 to about 1000 nm (0047-0049, wherein the particle size of the particulate material is at most 250 μm along the largest diameter) while Yeh’s examples are directed to nanoclay sorbent as Yeh teaches commercial ion exchange resins can be used (0033), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to Yeh’s incorporate the treated glyoxal polystyrene sorbent (macromolecular sorbent) with into the membrane as Yeh teaches commercial ion exchange resins can be used and that standard polystyrene beads or styrene ion exchange resins treated with compounds including glyoxols, including phenylglyoxal have excellent urea uptake (0046).
While Yeh does not explicitly teach the at least 10% binding is covalent capture of urea, or the membrane has a urea binding capacity of at least 1.8mmol/g. Yeh teaches polystyrene beads or styrene ion exchange resins treated with compounds including glyoxols, including phenylglyoxal have excellent urea uptake as noted above (0046), examiner notes the instant specification discloses examples of urea sorbents that covalently capture urea are ninhydrin-type sorbents; phenylglyoxaldehyde (PGA)-type sorbents; triformylmethyl (TFM)-type sorbents, as the sorbent appears to be the same or similar to that of the prior art, embedded in membranes as discussed above; absent clarification of structural differences, the claimed at least 10% of urea binding is covalent capture of urea and the membrane has a urea binding capacity of at least 1.8mmol/g is considered inherent.
With respect to claim 3, the membrane according to claim 1, is taught above. As discussed above, Yeh teaches the nanoclay or ion exchange resin with small particle size and sorbents with particle sizes of about 1 to about 1000 nm (0047-0049, wherein the particle size of the particulate material is at most 150 μm along the largest diameter).
With respect to claim 4, the membrane according to claim 1, is taught above. Yeh teaches filters including flat filters and hollow fibers (0050-0065), the membrane is in the form of a hollow fibre, a full fibre, or a flat sheet).
With respect to claim 5, the membrane according to claim 1, is taught above. Yeh teaches polyetersufone, polysufone (0050-0065, polyurethane, cellulose acetate, polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), thermoplastic elastomers, ethylene vinyl alcohol copolymer, polyurethanes, (C6/L35-58, wherein the membrane comprises at least one polymer selected from polysulfone, polyethersulfone, polyphenylenesulfone, polyarylethersulfone, polyamide, polyetherimide, polyimide, polyethylene-co-vinyl alcohol, polyethylene-co-vinyl acetate, cellulose acetate, cellulose triacetate, polyvinylidene fluoride, polyvinylchloride, polyacrylonitrile, polyurethane, polyether ether ketone, and/or polyacrylic acid).
With respect to claim 7, the membrane according to claim 1, is taught above. Yeh teaches particulate materials including polystyrene with glyoxal groups enhance their ability to absorb urea (0046), as noted above with respect to claim 1, while Yeh does not explicitly provide at least 50% of urea binding is covalent capture of urea; examiner notes the instant specification discloses examples of urea sorbents that covalently capture urea are ninhydrin-type sorbents; phenylglyoxaldehyde (PGA)-type sorbents; triformylmethyl (TFM)-type sorbents, as the sorbent appears to be the same or similar to that of the prior art, absent clarification of structural differences, the claimed at least 50% of urea binding is covalent capture of urea is considered inherent.
With respect to claim 9, the membrane according to claim 1, is taught above. Yeh teaches particles with glyoxal groups enhance ability to absorb urea, including phenylglyoxal (0046), the urea sorbent is selected from a ninhydrin-type sorbent, a phenylglyoxaldehyde-type sorbent, and/or a triformylmethyl-type sorbent. See 112(b) rejection above. Examiner notes the instant specification provides that these types of sorbents are known in the art (Example 1.1, 1.2).
With respect to claim 10, the membrane according to claim 1, is taught above. see 112(b) rejection above, Yeh teaches in addition to sorbents, ion exchange styrene resins, and it is possible to use ion exchange resins (0046, 0032-0034, 0049), the particulate material further comprises activated carbon particles, ion exchange particles. Yeh teaches a hydrophilic resin such as PVP (0059-0062), the membrane further comprises an additive such as a hydrophilic additive.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yeh (US PG Pub 2010/0004588), in view of Boggs (US 6,099,734).
With respect to claim 2, the membrane according to claim 1, is taught above. Yeh teaches sorbent particles in the spinning solution at about 0.1% to about 3%, or 0.1-5% (0059-0065), but is does not explicitly teach the particulate material is present in the membrane in a range of from 5 wt% to 80 wt%, based on the total dry weight of the membrane and the particulate material).
Boggs teaches polymeric matrix membranes with particulate sorbent material immobilized within the matrix (abstract, C3, a porous polymeric membrane comprising embedded particulate material), useful for removing compounds from biological fluids (C1/L1-15), sorbent in the form of powder, beads, or other particles (C6/L58-67), particles with diameters of less than about 20 um, less than about 10 um (C7/L3-26, the particle size of the particulate material is at most 250 µm along the largest diameter), particulate materials can include activated charcoal and polystyrene beads (C7/L1-26), and particulate by weights should be greater than about 50% (C7 /L26-44) and blends of particulate material where for example 10 grams of particulate is added to a polymer solution with 10 grams of polymer and 90 grams of solvent to provide a membrane with 50% particulates (C10/L15-45), Yeh teaches in one embodiment polymer in 1.0-1.7 % of spinning solution and 0.1-5% particles (0062-0063), providing evidence that Yeh’s solutions would provide similar ratios or particulate material is present in the membrane in a range of from 5 wt% to 80 wt%, based on the total dry weight of the membrane and the particulate material, alternatively it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide particulate material is present in the membrane in a range of from 5 wt% to 80 wt%, based on the total dry weight of the membrane and the particulate material, as Boggs teaches particulate by weights should be greater than about 50% (C7 /L26-44) and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yeh (US PG Pub 2010/0004588), in view of Natan US PG Pub 2018/0021499).
With respect to claim 6, the membrane according to claim 1, is taught above. Yeh teaches permeable membranes and filters and use in dialysis (0052, abstract), but does not explicitly teach the membrane has a water permeability of at least 1 L/(m2h-Bar). Examiner notes instant specification p. 6 L27-40 discloses ultrafiltration membranes typically have a water permeability of about 50-800 L/(m2 h bar), and that use of ultrafiltration membranes are known for use in dialysis and would be an obvious engineering choice, as illustrated by Natan. Natan teaches particles for sequestering/sorbing urea from dialysate (abstract, 0004), a composition comprising a sorbent associated with or forming a membrane and incorporation of particles into ultrafiltration membranes (0005, 0052, 0060, 0074). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as ultrafiltration membranes are in the art for use dialysis, as Yeh and Natan each teach membranes comprising particles for filtering biological fluids in dialysis, and Natan specifically teaches particles embedded membranes for use as ultrafiltration and dialysis membranes, and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yeh (US PG Pub 2010/0004588), in view of Poss (US PG Pub 2005/0131141).
With respect to claim 9, the membrane according to claim 1, is taught above. Yeh teaches particles with glyoxal groups enhance ability to absorb urea, including phenylglyoxal (0046), the urea sorbent is selected from a ninhydrin-type sorbent, a phenylglyoxaldehyde-type sorbent, and/or a triformylmethyl-type sorbent. See 112(b) rejection above. Examiner notes the instant specification provides that these types of sorbents are known in the art (Example 1.1, 1.2). Yeh does not teach aldehyde.
Poss teaches resin materials capable of removing constituents from physiological solutions, such as urea (abstract), acetylated macromolecular polystyrene beads that result in higher concentrations of active chemical binding sites and enhancing the chemical reactivity of the compositions with respect to removing constituents, such as urea, from a fluid (0009-0010, 0022-0028), ninhydrin and phenyglyoxal polymetric materials are known in the art (0004-0005) and the macromolecular composition comprises ketoaldehyes, preferably, the ketoaldehyde is a phenylglyoxal (0012), the composition enhances uptake of and facilitates binding capabilities with urea (0010, 0024, 0067), and chemical binding of urea (0018), glyoxalation and processing of polymerized polystyrene (0028-0035, phenylglyoxaldehyde-type sorbent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Poss’ taught acetylated macromolecular polystyrene beads, comprising aldehydes, which chemically bind to urea, as Yeh’s taught sorbent, as according to Poss the beads result in higher concentrations of active chemical binding sites and enhance the chemical reactivity of the compositions with respect to removing constituents, and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANNIE MCDERMOTT whose telephone number is (571)272-4479. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1777
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1777