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 1-8 are presently pending in this application.
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.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (U. S. Patent Publication No. 2021/0008537, which corresponds to WO 2021/007066, cited by Applicants).
Regarding claim 1, Lewis et al. teach a combination of a bodily fluid or dialysate solution and a titanium metallate ion exchanger selected from, inter alia, sitinakite topologies, wherein the titanium metallate ion exchanger has an empirical formula on an anhydrous basis of AmTiNbaSixOy, where A is an exchangeable cation selected from the group consisting of potassium ion, sodium ion, rubidium ion, cesium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof, m is the mole ratio of A to Ti and has a value from 0.10 to 3, a is the mole ratio of Nb to Ti and has a value from zero to 0.6, x is the mole ratio of Si to Ti and has a value from 0 to 3, and y has a value from 2.05 to 11. See paragraph [0012] of Lewis et al.
It is considered that because the formula of titanium metallate ion exchanger disclosed in Lewis et al. structurally reads upon that recited in Applicants’ claim 1, the limitation “titanium silicates and niobium-titanium silicates” is considered encompassed by this reference.
Further, it is noted that the values for A, Ti, m, a, x, and y disclosed in Lewis et al. encompass Applicants’ respectively claimed “A”, “m”, “a”, “1-a”, “x, and “y”.
Where claimed ranges “overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (CCPA 1976). See also MPEP 2144.05(I).
Regarding claim 2, Lewis et al. define bodily fluids as whole blood, blood plasma, other components of blood, and gastrointestinal fluids. See paragraph [0019] of Lewis et al.
Regarding claims 3-8, Lewis et al. teach an apparatus incorporating the aforementioned titanium metallate ion exchanger, wherein the titanium metallate ion exchanger may be supported or embedded in a porous biocompatible matrix. Lewis et al. further teach the feasibility in supporting the aforementioned titanium metallate ion exchanger in a porous network, wherein the porous network may consist of natural or synthetic polymers and biopolymers and mesoporous metal oxides and silicates. Natural polymers (biopolymers) that are suitable may comprise a cross-linked carbohydrate or protein, made of oligomeric and polymeric carbohydrates or proteins. The biopolymer is preferably a polysaccharide. Examples of polysaccharides include a-glucans having 1,3-, 1,4-, and/or 1,6-linkages. Exemplary biocompatible polymers include carbohydrates selected from glucose, fructose, sucrose, maltose, arabinose, mannose, galactose, lactose and oligomers and polymers of these. Exemplary proteins include albumin, ovalbumin, casein, myosin, actin, globulin, hemoglobin, myoglobin, gelatin and small peptides. See paragraphs [0013] and [0024] of Lewis et al.
Lewis et al. do not teach or suggest the limitations of Applicants’ claims 1 and 3 regarding (a) the titanium metallate ion exchanger being crystalline, (b) the titanium metallate ion exchanger exhibiting an x-ray diffraction pattern having at least one peak with a d-spacing between 7 Å and 8 Å with a relative intensity of 100%, and where said diffraction pattern has at least the peaks and d-spacings set forth in Table A when the material has the pharmacosiderite topology, (c) said diffraction pattern having at least the d-spacings set forth in Table B when the material has a sitinakite topology, or (d) diffraction pattern having at least one peak with a d-spacing between 7 Å and 8 Å with a relative intensity of 100% when the material is a pharmacosiderite-sitinakite intergrowth or a mixture of pharmacosiderite, sitinakite and pharmacosiderite-sitinakite intergrowth phases in any combination, as recited in Applicants’ claims 1 and 3.
It is noted that the peaks and d-spacings recited in Applicants’ Tables A and B in claims 1 and 3 are referred to in the alternative (“peaks and d-spacings set forth in Table A when the material has the pharmacosiderite topology:…or where said diffraction pattern has at least the d-spacings and intensities set for the in Table B when the material has the sitinakite topology…”), as is the limitation “or where said diffraction pattern having at least one peak with a d-spacing between 7 Å and 8 Å with a relative intensity of 100% when the material is a pharmacosiderite-sitinakite intergrowth or a mixture of pharmacosiderite, sitinakite and pharmacosiderite-sitinakite intergrowth phases in any combination.”
Therefore, because Lewis et al. teach the feasibility in the aforementioned metallate ion exchanger exhibiting a sitinakite topology (paragraph [0012] of Lewis et al.), and further teach that the titanium metallate ion exchanger has an empirical formula corresponding to that recited in Applicants’ claims 1 and 3, it would have been obvious to one of ordinary skill in the art before the effective filing date of Applicants’ invention to reasonably expect the metallate ion exchanger disclosed in Lewis et al. to exhibit an x-ray diffraction pattern having at least one peak with a d-spacing between 7 Å and 8 Å with a relative intensity of 100%, and having d-spacings and intensities comparable to that recited in Table B of Applicants’ claims 1 and 3, absent the showing of convincing evidence to the contrary.
It is well settled that when a claimed composition appears to be substantially the same as a composition disclosed in the prior art, the burden is properly upon the applicant to prove by way of tangible evidence that the prior art composition does not necessarily possess characteristics attributed to the CLAIMED composition. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Circ. 1990); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980); In re Swinehart, 439 F.2d 2109, 169 USPQ 226 (CCPA 1971). See also MPEP 2112.01(I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lewis et al. (U. S. Patent Publication No. 2021/0008266) corresponds to WO 2021/007062, cited by Applicants.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA L HAILEY whose telephone number is (571)272-1369. The examiner can normally be reached Monday-Friday, 7 a.m. to 3:30 p.m.
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/Patricia L. Hailey/Primary Examiner, Art Unit 1732 August 21, 2026
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