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 Objections
Claims 11, 12 and 35 are objected to because of the following informalities:
(i) Claims 11 and 12 recite the phrase “the polymer comprises silicone dioxide”. The term “silicone” has a typographical error. The phrase should be corrected to “the polymer comprises silicon dioxide”.
(ii) Claim 35 recites the phrase “to filter the blood and produced an amount of filtered blood. The phrase should be corrected to “to filter the blood and produce an amount of filtered blood.
Appropriate correction is required.
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 1-4, 6-7, 14, 17, 29, and 32-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kharat et al., (IN 2020,2102,9811 A, hereinafter as “Kharat”).
Regarding claim 1, Kharat teaches a medical device for hemodialysis comprising an outer case made of acrylonitrile butadiene styrene and a polylactic acid nanofiber membrane made by electrospinning (Abstract). Kharat discloses a nanofiber composition comprising a polymer and nanoparticles comprising nickel, cobalt and tetraphenylborate (Abstract; Fig. 8, p. 3, lines 19-20).
In regard to claim 2, Kharat discloses that the polymer comprises polylactic acid (PLA) (p. 2, lines 11-12), which is one of the of the expressly recited polymers.
In regard to claim 3, Kharat discloses that the nanoparticles comprise nickel (Fig.1, p. 3, line 12-13).
In regard to claim 4, Kharat discloses that the nanoparticles comprise cobalt (Fig.1, p. 3, line 14-15).
In regard to claim 6, Kharat discloses that the nanoparticles comprise tetraphenylborate (Fig. 8, lines 10-12).
In regard to claim 7, Kharat discloses that the nanoparticles comprise nickel nanoparticles and cobalt nanoparticles (Fig.1, p. 3, line 12-13; Fig.1, p. 3, line 14-15; Fig. 4, lines 15-16).
In regard to claim 14, Kharat discloses that nanofiber composition comprising tetraphenylborate nanoparticles (p. 6, lines 38-39).
Regarding claim 17, Kharat discloses a cartridge comprising one or more membranes, wherein each membrane comprises a nanofiber composition (p. 2, lines 10-11), wherein the nanofiber composition comprises a polymer and one or more nanoparticles comprising nickel, cobalt, and tetraphenylborate (Fig. 8, p. 8, lines 11-12; Fig. 9 and Fig. 12, lines 12-15).
Regarding claim 29, Kharat discloses a device (Fig. 13-14, p. 3, lines 34-40) comprising:
a filtration chamber 207 configured to receive blood 102 comprising urea (Figs, 13-15; p. 3 lines 34-40); and
one or more membranes disposed within said filtration chamber, wherein each membrane comprises nanofibers (Figs, 13-14; p. 3 lines 34-40) comprising a polymer and nanoparticles comprising one or more of nickel, cobalt, and tetraphenylborate (Figs. 1-5, lines 12-20; Fig. 8, p. 8, lines 11-12; p. 2, lines 11-13; Fig. 9, lines 32-34), and wherein the nanofibers are capable of binding urea, converting urea to ammonia, and subsequently binding ammonia (Fig. 9, p. 13, lines 14-16; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6).
Regarding claim 32, Kharat discloses a method of reducing the concentration of urea from blood (Abstract; p. 2, lines 14-15), comprising:
providing blood comprising urea to a device comprising a cartridge 101 (i.e., outer case), wherein the cartridge comprises one or more membranes (Fi.g.12, lines 29-32), wherein each membrane comprises a nanofiber composition, comprising a polymer and one or more of nickel, cobalt, and tetraphenylborate nanoparticles (Fig. 12, p. 2, lines 29-35; Fig. 9, p. 13 lines, 14-16; Fig. 8, p. 8, lines 11-12);
contacting the blood with the membrane for a sufficient amount of time to allow binding of urea and conversion of urea to ammonia (p. 2, lines 20-23; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6); and
pumping the blood through the cartridge 101 at a sufficient pressure to allow binding of ammonia to the membrane, thereby reducing the concentration of urea in the blood (Figs. 14-15, p. 9, line 10 thru p. 10, line 17; Figs. 9 and 12, p. 13, lines 9-16; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6).
Regarding claim 33, Kharat discloses a method of treating a subject with a disease condition characterized by elevated blood urea concentration (p. 1, lines 9-18; p. 11, lines 7-8), the method comprising:
obtaining a sample of the subject's blood (201, Fig. 15, p. 9, lines 32-36);
pumping the sample 204 through a nanofiber composition 207, comprising a polymer and nanoparticles comprising one or more of nickel, cobalt, and tetraphenylborate, for a time period sufficient to allow the nanofiber composition to bind urea, convert urea to ammonia, and subsequently bind ammonia, thereby creating a filtered blood sample 211 (i.e., clean blood, Fig. 15, p. 9, line 40; p. 13, lines 13-16; Fig. 8, p. 8, lines 11-12); and
returning the filtered blood sample 211 to the subject 201, thereby treating the subject 201 (Fig. 15, p. 9, line 40 thru p. 10, line 2).
In regard to claim 34, Kharat discloses a method of treating a mammal (i.e., animal model) for elevated blood urea concentration (p. 9, lines 12-16; p. 11, lines 7-8) comprising:
providing blood 102 comprising urea to a device comprising one or more membranes, wherein each membrane comprises a nanofiber composition, nanofibers comprising a polymer and nanoparticles, wherein the nanoparticles comprise one or more of nickel, cobalt, and tetraphenylborate, and wherein the nanofibers are capable of binding urea, converting urea to ammonia, and subsequently binding ammonia (Fig. 8, p. 8, lines 11-12; Fig. 12, p. 9, lines 11-28; p. 13, lines 13-16; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6);
contacting the blood with the membrane for a sufficient amount of time to allow binding of urea and conversion to ammonia (Fig. 12-15, p. 9, lines 11-40; p. 13, lines 13-16; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6); and
pumping the blood through the cartridge at a sufficient pressure and flow rate to allow binding of ammonia to the nanofibers, thereby reducing the concentration of urea in the blood (Fig. 12-15, p. 9, lines 11-40; p. 13, lines 13-16; Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution, p. 6, lines 5-6).
In regard to claim 35, Kharat discloses a method of treating a subject with a disease condition characterized by elevated urea concentration in blood (p. 1, lines 9-18; p. 11, lines 7-8), the method comprising:
administering ex vivo hemofiltration to said subject wherein blood is removed from the subject 201 and filtered through a device comprising a filtration chamber 207 (Figs,15; p. 3 lines 34-40) (1) configured to receive blood 102 comprising elevated urea concentration (Fig. 13-14; p. 11, lines 7-8; p. 11, lines 7-8), and (2) composed of one or more membranes, wherein each membrane comprises a nanofiber composition comprising a polymer and nanoparticles comprising nickel, cobalt and tetraphenylborate (Fig. 12, p. 2, lines 29-35; Fig. 9, p. 13 lines, 14-16; Fig. 8, p. 8, lines 11-12);
the subject and filtered through a device comprising a filtration chamber (1) configured to receive blood comprising elevated urea concentration (p. 11, lines 7-8; p. 11, lines 7-8), and (2) composed of one or more membranes, wherein each membrane comprises a nanofiber composition comprising a polymer and nanoparticles comprising nickel, cobalt and tetraphenylborate (Fig. 12, p. 2, lines 29-35; Fig. 9, p. 13 lines, 14-16; Fig. 8, p. 8, lines 11-12);
incubating the blood or plasma with the one or more membranes for a sufficient time to allow binding of urea to the nanofiber (2 min incubation, p. 5, line 29-35), conversion of urea to ammonia, and subsequent binding of ammonia to the nanofibers (Na-Tetraphenylborate resins, wherein the Nickel-Cobalt nanoconjugates are constructed on Na-Tetraphenylborate resins and Na- Tetraphenylborate resins are used for the ammonia reduction, where tetraphenylborate resins bind ammonium ions via ion exchange, with the BPh4- anion selectively capturing NH4+ from solution p. 6, lines 5-6);
pumping the blood 204 through the device 207 at a pressure and flow rate sufficient to filter the blood and produced an amount of filtered blood 211 (Fig. 15, p. 9, line 40; p. 13, lines 13-16; Fig. 8, p. 8, lines 11-12); and
returning filtered blood 211 to said subject 201, wherein the filtered blood 211 is reduced in urea concentration by at least about 73% (urea reduction from 64 mg/dl to 17 mg/dl within 60 min, equivalent to about 73% reduction, p. 11, lines 36-37) which anticipates the reduced urea concentration claim range of at least 50%.
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 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 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.
Claims 5, 8, 9, and 10 are rejected under 35 USC 103 as being unpatented over Kharat, as applied to claim 1 above, and further in view of Wang et al., (Journal of Materials Research, 2019, hereinafter as “Wang”).
Regarding claim 5, Kharat discloses the electrospun polylactic acid (PLA) nanofiber membrane comprising nickel and cobalt nanoparticles for blood urea reduction, but does not explicitly disclose the nanoparticles comprises silver nanoparticles (Abstract; p. 2, lines 11-13; Fig. 9; lines 32-34).
Wang teaches durable electrospun PAN/Ag nanoparticle nanofiber membranes prepared by electrospinning, with silver nanoparticles incorporated into a polymer nanofiber membrane (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-8).
Kharat and Wang are analogous because both references are directed to electrospun polymer nanofiber membranes employed in filtration and biomedical applications.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the nanofiber composition by Kharat to include silver nanoparticle taught by Wang because silver nanoparticles are known functional additives in such membranes that improves antibacterial activity of nanofibers (Wang: p. 1672, right column, lines 27-29).
In regard to claim 8, Kharat discloses nickel nanoparticles in the nanofiber composition (Figs. 1-5, lines 12-20; p. 2, lines 11-13; Fig. 9, lines 32-34), and Wang discloses silver nanoparticles in electrospun polymer fiber nanofiber membranes (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-8). It would have been obvious to one of ordinary skill in the art to modify the nanofiber composition containing nickel by Kharat to include silver nanoparticle taught by Wang because silver nanoparticles are known functional additives in such membranes that improves antibacterial activity of nanofibers (Wang: p. 1672, right column, lines 27-29).
In regard to claim 9, Kharat discloses cobalt nanoparticles in the nanofiber composition (Figs. 1-5, lines 12-20; p. 2, lines 11-13; Fig. 9, lines 32-34), and Wang discloses silver nanoparticles in electrospun polymer fiber nanofiber membranes (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-5). It would have been obvious to one of ordinary skill in the art to modify the nanofiber composition containing cobalt by Kharat to include silver nanoparticle taught by Wang because silver nanoparticles are known functional additives in such membranes that improves antibacterial activity of nanofibers (Wang: p. 1672, right column, lines 27-29).
In regard to claim 10, Kharat discloses nickel nanoparticles, cobalt nanoparticles and tetraphenylborate electrospun in the nanofiber membrane (Figs. 1-5, p. 3, lines 12-20), and Wang discloses silver nanoparticles in electrospun polymer fiber nanofiber membrane (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-5). It would have been obvious to one of ordinary skill in the art to modify the nanofiber composition by Kharat to include silver nanoparticle taught by Wang because silver nanoparticles are known functional additives in such membranes that improves antibacterial activity of nanofibers (Wang: p. 1672, right column, lines 27-29).
Claim 11 is rejected under 35 USC 103 as being unpatented over Kharat, as applied to claim 1 above, and further in view of Newsome et al., (Journal of Applied Polymer Science, 2014, hereinafter as “Newsome”).
Regarding claim 11, Kharat discloses a nanofiber composition comprising a polymer and nickel/cobalt nanoparticles (Abstract; Figs. 1-5, p. 3, lines 12-20).
But Kharat does not disclose the polymer comprises silicon dioxide.
However, Newsome teaches electrospinning silica or silicon dioxide/ polyvinyl pyrrolidone (PVP) composition composite nanofibers, and discloses silicon dioxide nanoparticles dispersed in PVP solution to create silicon dioxide/polymer composite nanofibers (Abstract; Fig.1, SEM images of electrospun SiO2/PVP nanofibers using polymer solutions with different PVP concentrations, p. 3, left column, Optimization of Electrospinning Composite SiO2/PVP Nanofibers, lines 1-22).
Kharat and Newsome are analogous because these references are directed to electrospun polymer nanofiber membranes employed in filtration and biomedical applications.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the nanofiber composition containing nickel and cobalt nanoparticles by Kharat to include silicone dioxide taught by Newsome because silicon dioxide is a known functional additive in such membranes that improves adsorption efficiency of nanofibers (Newsome: p. 40966, left column, first paragraph, lines 8-11).
Claims 12, and 13 are rejected under 35 USC 103 as being unpatented over Kharat, as applied to claim 1 above, and further in view of Wang, and Newsome.
In regard to claim 12, Kharat discloses cobalt nanoparticles in the nanofiber composition (Abstract; Figs. 1-5, p. 3, lines 12-20) but does not disclose the polymer comprises silicon dioxide.
Wang teaches durable electrospun PAN/Ag nanoparticle nanofiber membranes prepared by electrospinning and discloses silver nanoparticles incorporated into a polymer nanofiber membrane (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-8) but also does not disclose the polymer comprises silicon dioxide.
However, Newsome teaches electrospinning silicon dioxide/ polyvinyl pyrrolidone (PVP) composition composite nanofibers, and discloses silicon dioxide nanoparticles dispersed in PVP solution to create silicon dioxide/polymer composite nanofibers (Abstract; Fig.1, SEM images of electrospun SiO2/PVP nanofibers using polymer solutions with different PVP concentrations, p. 3, left column, Optimization of Electrospinning Composite SiO2/PVP Nanofibers, lines 1-22).
Kharat, Wang and Newsome are analogous because these references are directed to electrospun polymer nanofiber membranes employed in filtration and biomedical applications.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to add in the modified nanofiber composition containing cobalt and silver nanoparticles by Kharat/Wang as applied to claim 9 to include silicon dioxide taught by Newsome because silicon dioxide is a known functional additive in such membranes that improves adsorption efficiency of nanofibers (Newsome: p. 40966, left column, first paragraph, lines 8-11).
In regard to claim 13, Kharat discloses the nickel/cobalt nanofiber membrane, and cobalt nanoparticles in the nanofiber composition (Abstract; Figs. 1-5, p. 3, lines 12-20), Wang discloses silver nanoparticles incorporated into a polymer nanofiber membrane (Abstract; Figs. 2a-2c; p. 1671, Results and Discussions section, left column, first paragraph, lines 1-8), and Newsome discloses PVP in silica/PVP composite nanofibers (Fig.1, SEM images of electrospun SiO2/PVP nanofibers using polymer solutions with different PVP concentrations, p. 3, left column, Optimazation of Electrospinning Composite SiO2/PVP Nanofibers, lines 1-22). It would have been obvious to one of ordinary skill in the art to add in the modified nanofiber composition containing cobalt nanoparticles, silver nanoparticles, silicon dioxide by Kharat/Wang/Newsome as applied to claim 11 to include PVP taught further by Newsome because PVP is a known functional additive in such membranes that improves adsorption efficiency of nanofibers when combined with silicon dioxide (Newsome: p. 40966, left column, first paragraph, lines 8-11).
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached on 571-272-5954. The fax phone number for the organization where this application or processing is assigned is 571-273-8300.
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/WILSON GALLARDO MENDOZA/Examiner, Art Unit 1772
/YOUNGSUL JEONG/Primary Examiner, Art Unit 1772
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