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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-21, Species 1A, and Species 2A in the reply filed on 12/1/2025 is acknowledged.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 11 and 20 are objected to because of the following informalities:
Claim 11 recites “higher the dialysis”, which should read “higher than the dialysis.”
Claim 20 recites “module ,” (with a space between the word and the comma).
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, 2, 5, 7, 8, 10, 12, 15-18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer (US 2018/0353668).
With respect to claim 1, Meyer teaches a portable hemodialysis system (Fig. 1, portable system; paragraphs [0307] and [0343]), comprising: a housing (Fig. 5F, base module 803 defines and is enclosed by a housing) at least partially storing a dialysis fluid regeneration module (Fig. 2, Fig. 5E, sorbent cartridge 703 is mounted on base module 803; para. [0368]) configured to remove urea from a dialysis fluid (removal of waste species including urea; paragraphs [0178], [0272], and [0319]), and a dialysis fluid management module (Fig. 5F, base module 803) comprising a control circuit (Fig. 2, controller 802; para. [0091]) operably connected to a first pump (Fig. 1, dialysate pump 305) fluidically connected with the dialysis fluid regeneration module (Fig. 2, sorbent cartridge 703; para. [0348]), and
a blood handling module (Fig. 2, Fig. 5G, therapy cassette 820) fluidically connectable to the dialysis fluid regeneration module (Figs. 1-2, therapy cassette 820 is fluidically connectable to sorbent cartridge 703; para. [0368]) at a blood handling module docking interface (Figs. 5C-5D, connection ports 506S, 507S, 508S, 509S, 510S, 515S, 516S, 517S, 519S, 522S, 523S, 524S, 530S, 531S and locking mechanism define a docking interface; para. [0384]-[0385]) formed in the housing (Figs. 5D and 5F, the housing defined by base module 803), wherein the blood handling module (Fig. 2, therapy cassette 820) comprises a blood conduit (Fig. 1, blood side; para. [0307]) and a dialysis fluid conduit (Fig. 1, dialysate side; para. [0316]) extending along a dialyzer membrane (Fig. 1, membrane 702),
wherein the dialysis fluid management module (Fig. 5F, base module 803; paras. [0336], [0368], and [0407]) is configured to actuate the first pump (Fig. 1, pump 305) to pump the dialysis fluid (Fig. 1, dialysate pump 305 provides the pumping action to cause the dialysate to flow through the flow path 110; para. [0318]) through the dialysis fluid regeneration module (Fig. 1, sorbent cartridge 703) and through the dialysis fluid conduit (Fig. 1, dialysate side; para. [0316]) of the blood handling module (Fig. 2, therapy cassette 820) when the blood handling module (Fig. 2, therapy cassette 820) is docked at the blood handling module docking interface (Fig. 5D, locking mechanism is actuated to lock the cassette 820 in place at the defined docking interface; para. [0385]).
With respect to Claim 2, Meyer teaches that the dialysis fluid regeneration module (Fig. 2, Fig. 5E, sorbent cartridge 703) comprises at least one of a photo-oxidation module, an electro-oxidation module, or a sorbent module (Figs. 2 and 5E, sorbent cartridge 703).
With respect to Claim 5, Meyer teaches that the control circuit (Fig. 2, controller 802; paras. [0091], [0368], and [0407]) is configured to pump the dialysis fluid through the dialysis fluid regeneration module (Fig. 1, sorbent cartridge 703) at a flow rate less than about 200mL/min (Fig. 1, dialysate pump 305 is operates at a rate from about 50 to about 800 mL/min, which includes at least part of the claimed range with sufficient specificity; para. [0348]).
With respect to Claim 7, Meyer teaches that the dialysis fluid regeneration module (Fig. 1, sorbent cartridge 703) is fluidically connected to a gas removal module (Fig. 1, degassing module 705) configured to remove a gas from the dialysis fluid (Fig. 1, degassing module 705 removes gases introduced into the dialysate; para. [0321]) through at least one of a valve (Fig. 16, valve 410) or a gas-permeable membrane (Fig. 16, membrane 710; para. [0321]).
With respect to Claim 8, Meyer teaches that the gas removal module (Fig. 1, degassing module 705) comprises a vacuum configured to draw gas from the dialysis fluid (a vacuum is applied to the gas side of the module to draw dissolved gas from solution; para. [0327]).
With respect to Claim 10, Meyer teaches that the dialysis fluid conduit (Fig. 1, dialysate side; para. [0316]) of the blood handling module (Fig. 2, therapy cassette 820) receives the dialysis fluid from a dialysis fluid outlet coupling (Fig. 1, Fig. 5E, outlet port 514; para. [0404]) and provides the dialysis fluid to a dialysis fluid inlet coupling (Figs. 1 and Fig. 5E, inlet port 513; para. [0404]) formed in the blood handling module docking interface (Figs. 5C-5D, the defined docking interface), the dialysis fluid outlet coupling (Fig. 5E, outlet port 514) and the dialysis fluid inlet coupling (Fig. 5E, inlet port 513) being in fluidic connection with the dialysis fluid regeneration module (Fig. 5C, sorbent cartridge 703; para. [0404]).
With respect to Claim 12, Meyer teaches that the blood handling module docking interface (Figs. 5C-5D, the defined docking interface) comprises a sensor array (Fig. 1B; bubble detector 601, pressure sensor 602, bubble detector 603, and pressure sensor 604 define a sensor array) configured to interface with a bloodstream (Fig. 1, extracorporeal flow path 100) in the blood conduit (Fig. 1, blood side; para. [0307]) when the blood handling module (Fig. 2, Fig. 5G, therapy cassette 820) is docked with the blood handling module docking interface (Fig. 5D, locking mechanism is actuated to lock the cassette 820 in place at the defined docking interface; para. [0385]).
With respect to Claim 15, Meyer teaches that the system further comprises a fluid reservoir (Fig. 1, solution reservoir 201; alternatively, Fig. 5G, concentrate reservoir 205) reversibly coupled with a reservoir docking interface (Fig. 5F, base module 803 defines a reservoir docking interface; para. [0387]; Fig. 5G, therapy cassette 820 comprises concentrate reservoir 205, para. [0388]) of the housing (Fig. 5F, the housing defined by base module 803; Fig. 5G, cassette 820), wherein the fluid reservoir (Fig. 1, solution reservoir 201; Fig. 5G, concentrate reservoir 205) is in fluidic connection with the dialysis fluid regeneration module (Fig. 1 depicts flow from reservoir 201 to sorbent cartridge 703 via valves 404 and 405; Fig. 1 also depicts outlet of cartridge 703 in fluid communication with outlet of reservoir 205 at outlet of pump 306; para. [0336]).
With respect to Claim 16, Meyer teaches that the control circuit (Fig. 2, controller 802; para. [0091]) is operatively connected (Figs. 1-2, the actions of the base module are controlled by controller 802; para. [0368]) to an electrolyte management module (Fig. 1, pump 306; para. [0375]) configured to regulate an electrolyte level in the dialysis fluid by providing electrolytes from the fluid reservoir (Fig. 1, pump 306 is operated to infuse electrolytes from cation concentrate reservoir 205 to the priming solution; para. [0361]-[0362] and [0414]-[0417]).
With respect to Claim 17, Meyer teaches that the fluid reservoir (Fig. 1, solution reservoir 201) comprises at least one of an electrolyte solution container, a saline reservoir, a waste fluid reservoir, or an excess dialysate fluid reservoir (Fig. 1, solution reservoir 201 contains a dialysate; para. [0443]).
With respect to Claim 18, Meyer teaches a second pump (Fig. 1, balance control pump 303) fluidically connected to the fluid reservoir (Fig. 1, reservoir 201) and the dialysis fluid regeneration module (Fig. 1, sorbent cartridge 703).
With respect to Claim 21, Meyer teaches a portable hemodialysis system (Fig. 1, portable system; para. [0307] and [0343]), comprising: a housing (Fig. 5F, base module 803 defines and is enclosed by a housing) at least partially storing a dialysis fluid regeneration module (Figs. 2 and Fig. 5E, sorbent cartridge 703 is mounted on base module 803; para. [0368]) configured to remove urea from a dialysis fluid (removal of waste species including urea; para. [0178], [0272], and [0319]), and a dialysis fluid management module (Fig. 5F, base module 803) comprising a control circuit (Fig. 2, controller 802; para. [0091]) operably connected to a first pump (Fig. 1, dialysate pump 305) fluidically coupled to pump the dialysis fluid (Fig. 1, dialysate pump 305 provides the pumping action to cause the dialysate to flow through the flow path 110; para. [0318]) through the dialysis fluid regeneration module (Figs. 2 and 5E, sorbent cartridge 703),
wherein a blood handling module docking interface (Figs. 5C-5D, connection ports 506S, 507S, 5088S, 509S, 510S, 515S, 516S, 517S, 519S, 522S, 523S, 524S, 530S, 531S and locking mechanism define a docking interface; para. [0384]-[0385]) is formed in the housing (Fig. 5F, the housing defined by base module 803), comprising a dialysis fluid inlet coupling (Fig. 5E, inlet port 513) and a dialysis fluid outlet coupling (Fig. 5E, outlet port 514) in fluidic connection with the dialysis fluid regeneration module (Fig. 5E, sorbent cartridge 703; para. [0318]-[0319]), and at least a portion of a second pump (Fig. 1, Fig. 5C, blood pump 302) configured to pump blood through a blood conduit (Fig. 1, blood pump 302 conveys blood through the dialyzer 701; para. [0307]) of a blood handling module (Figs. 2 and Fig. 5G, therapy cassette 820) docked with the blood handling module docking interface (Fig. 5D, locking mechanism is actuated to lock the cassette 820 in place at the defined docking interface; para. [0385]), wherein the blood handling module (Fig. 2, therapy cassette 820) comprises the blood conduit (Fig. 1, blood side; para. [0307]) and a dialysis fluid conduit (Fig. 1, dialysate side; para. [0316]) extending along a dialyzer membrane (Fig. 1, membrane 702), the dialysis fluid conduit (Fig. 1, dialysate side; para. [0316]) extending from the dialysis fluid inlet coupling (Fig. 5E, inlet port 513) to the dialysis fluid outlet coupling (Fig. 5E, outlet port 514) when the blood handling module (Fig. 2, therapy cassette 820) is docked with the blood handling module docking interface (Fig. 5D, locking mechanism is actuated to lock the cassette 820 in place at the defined docking interface; para. [0385]).
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.
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer.
With respect to Claim 6, Meyer teaches that the control circuit (Fig. 2, controller 802) is operably connected to a second pump (Figs 1 and 5C, blood pump 302) disposed in the housing (Fig. 5F, the housing defined by base module 803) and configured to pump blood through the blood circuit (Fig. 1, blood pump 302 conveys blood through the dialyzer 701; para [0307]
of the blood handling module (Figs. 2 and 5G, therapy cassette 820) docked with the blood handling module docking interface (Fig. 5D, locking mechanism is actuated to lock the cassette 820 in place: para. [0385]), wherein the control circuit (Fig. 2, controller 802) is configured to control the first pump (Fig. 1, dialyzer pump 305) and the second pump (Figs. 1 and 5C, blood pump 302) to maintain a pressure gradient across the dialyzer membrane (Fig. 1. a pressure gradient is maintained across the membrane 702; para. [0196]).
Meyer does not explicitly teach that the pressure gradient is maintained between about 10-300 mmHg. However, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05. II. A.). In this case, Meyer teaches that a transmembrane pressure gradient must be maintained in order to drive water and solutes across the membrane to the filtrate compartment (para. [0196]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Meyer’s system to maintain the pressure gradient across the dialyzer between 10-300 mmHg, or in any other pressure range that was determined to be optimal for a given application, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
With respect to Claim 11, Meyer does not explicitly teach that the hemodialysis system has an operating orientation wherein the dialysis fluid inlet coupling is disposed gravitationally higher than the dialysis fluid outlet coupling. However, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a nonobvious change in functionality (MPEP 2144.04 VI. C.). In this case, a skilled artisan would have recognized that placing the fluid inlets higher than the fluid outlets would enhance movement of fluid through the system due to the force of gravity. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Meyer’s hemodialysis system to have the dialysis fluid inlet coupling is disposed gravitationally higher than the dialysis fluid outlet coupling, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Hinds et al. (US 2020/0054810).
With respect to Claims 3 and 4, Meyer does not explicitly teach that the dialysis fluid regeneration module comprises a photo-oxidation module, wherein the photo-oxidation module comprises an anode/cathode array formed as a panel comprising a plurality of dialysate fluid channels disposed adjacent to a light source.
Hinds is in the field of urea removal from a dialysate and teaches a system (Fig. 2, dialysis system; para. [0054]) wherein the dialysis fluid regeneration module (Fig. 2, urea oxidation unit 700) comprises a photo-oxidation module (Fig. 2, photo-chemical oxidation unit 720), and wherein the photo-oxidation module (Fig. 2, photo-chemical oxidation unit 720) comprises an anode/cathode array (Fig. 5A, Fig. 5B, anode 722, cathode 742, and spacer 732 define an anode/cathode array) disposed adjacent to a light source (Fig. 5B, light array 752). Specifically, the anode/cathode array (Fig. 5A, Fig. 5B, the anode/cathode array defined by the anode 722, cathode 742, and spacer 732) is formed as a panel (Fig. 5A-5B, the defined anode/cathode array is a panel) comprising a plurality of dialysate fluid channels formed therein (Fig. 5A, spacer 732 defines a plurality of dialysate fluid channels).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application Meyer’s hemodialysis system to use a photo-chemical oxidation unit having an anode/cathode array formed as a panel with a plurality of dialysate fluid channels formed therein as the dialysis fluid regeneration module, taught by Hinds, in order to provide a well-known, alternate means for regenerating dialysis fluid, and to maximize exposure of the dialysate within the array, thereby maximizing urea removal while minimizing system size (para.[0068]).
Claims 13, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Fulkerson (US 2009/0120864).
With respect to Claim 13, Meyer does not specifically teach that the sensor array comprises a temperature sensor and a second sensor respectively configured to measure a temperature and a second parameter of the bloodstream, wherein the temperature sensor is configured to sense the temperature of the bloodstream at a first location in the bloodstream upstream of a second location in the bloodstream where the second sensor senses the second parameter of the bloodstream.
Fulkerson teaches a portable dialysis system (100; Figs. 1-3; para. [0002]) comprising a blood temperature sensor (311, Fig. 3; para. [0045]) and an air-in-line sensor (316, Fig. 3; para. [0045]) disposed downstream of the temperature sensor (Fig. 3), wherein the temperature sensor senses the temperature of blood at a first location that is upstream of the air-in-line sensor. This configuration ensures that blood being returned to the patient is of the correct temperature and free of entrained air bubbles (para. [0045]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Meyer’s hemodialysis system to have Fulkerson’s temperature sensor and air-in line sensor arrangement in order to provide a well-known means for ensuring that blood being returned to the patient is of the correct temperature and free of entrained air bubbles (para. [0045]).
With respect to Claim 19, Meyer does not explicitly teach a power supply operably connected to the control circuit.
Fulkerson teaches a portable dialysis system (100; Fig. 1; para. [0002]) comprising a power supply (Fig. 1, batteries; para. [0029]) operably connected to the control circuit (Fig. 1; control unit 120; para. [0029]), thereby making the system portable [0029]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Meyer’s hemodialysis system to have a power source such as batteries operably connected to the control circuit, as suggested by Fulkerson, in order to provide portable electrical power to the system.
With respect to Claim 20, Meyer does not specifically teach a wearable article containing the dialysis fluid regeneration module and the blood handling module, the article being selected from the group consisting of a backpack, a vest, a briefcase, a purse, and a jacket.
Fulkerson further teaches that the portable dialysis system comprises a wearable article (Fig. 6A, Fig. 6B, easy-to-carry bag; para. [0017] and [0029]) containing the dialysis fluid regeneration module (Fig. 1, regenerations system 115) and the blood handling module (Fig. 1, belt unit 105; para. [0029]), the wearable article (Fig. 6A, Fig. 6B, easy-to-carry bag; para. [0029]) being selected from the group consisting of: a backpack, a vest, a bag (Fig. 6A, Fig. 6B, easy-to-carry bag; para. [0029] and [0063]), a briefcase, a purse, and a jacket. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Meyer’s dialysis system to include a bag, as taught by Fulkerson, in order toto provide an easy-to-carry system, thereby facilitating patient mobility during treatment.
Allowable Subject Matter
Claims 9 and 14 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.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to Claim 9, the prior art does not teach or suggest that the control circuit regulates evaporation of the dialysis fluid by modulating a urea removal rate in the dialysis fluid regeneration module, based upon at least one of a temperature of the dialysis fluid or a volume of the dialysis fluid, in combination with the other limitations of claims 1 and 9.
With respect to Claim 14, the prior art does not teach or suggest that the control circuit is configured to cause the sensor array to move between an undocked position and a docked position, in combination with the other limitations of claims 1 and 14.
It is unclear why one of ordinary skill in the art would have been motivated to modify Meyer’s hemodialysis system to arrive at the inventions of claims 9 or 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kamen (US 2014/0102958) teaches a modular hemodialysis system.
Doyle (US 2020/0000995) teaches a portable hemodialysis system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781