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 .
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, but the previous prior art rejection reads upon the claimed invention with a modification using newly found secondary reference Pudil et al., (“Pudil 2”, US 2014/0158588).
On page 7-9 of the Remarks section as indicated by the page number at the bottom of each page, Applicant argues against the previous 103 prior art rejection of independent Claims 1 & 22. Applicant argues that the previous prior art references do not disclose the newly added limitations “wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate” in these claims. Applicant argues against previous secondary reference Babb et al., (“Babb”, US 4,326,955), disclosing this limitation because Babb combines sodium carbonate with HCl or acetic acid, not CO2, and that Babb uses multiple additions of sodium carbonate, whereas the present invention has a single injection of sodium carbonate and does not have concerns of calcium carbonate formation. Applicant also argues that the currently claimed invention uses some of the CO2 to react with sodium carbonate, and that Babb does not do so. In response, the Examiner finds that while Babb does not explicitly disclose these limitations, newly found secondary reference Pudil et al., (“Pudil 2”, US 2014/0158588), discloses these features instead. Furthermore, the Examiner notes that there is no explicit support for the added claim limitations to independent Claims 1 & 22. While paragraph [099] of the Specification states that each mole of sodium carbonate can turn one mole of CO2 into sodium bicarbonate, the Specification does not explicitly discuss that the dialysate downstream of the sorbent filter contains CO2 and that the sodium carbonate is chosen to explicitly react with CO2 in this dialysate to form bicarbonate. Paragraphs [061] and [062] do not demonstrate production of CO2 that is retained in the expelled dialysate, only that it may be degassed of CO2. For this reason, the Examiner has rejected these limitations under 112(a) as detailed in the 112(a) rejection section below.
Since Pudil 2 discloses this limitation instead, the remainder of Applicant’s remarks directed towards the other references are considered moot.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, 22 and its dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly added claim limitations to Claims 1 & 22 including “wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate” do not appear to have explicit support in the instant Specification because while paragraph [099] of the Specification states that each mole of sodium carbonate can turn one mole of CO2 into sodium bicarbonate, the Specification does not explicitly discuss that the dialysate downstream of the sorbent filter contains CO2 and that the sodium carbonate is chosen to explicitly react with CO2 in this dialysate to form bicarbonate. Paragraphs [061] and [062] do not demonstrate production of CO2 that is retained in the expelled dialysate, only that it may be degassed of CO2. As a result, it is not clear that the expelled filtered dialysate contains CO2 downstream and that sodium carbonate is specifically selected to react with the CO2 to form sodium bicarbonate. Thus, it is considered new matter.
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.
Claim(s) 1-3, 6, 7, 12, & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Pudil et al., (“Pudil 2”, US 2014/0158588).
Claims 1-3, 6, 7 are directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claims 1-3, 6, 7, & 21, Manda discloses in a first embodiment a system, (See paragraph [0009], [0147], [0169]), the system comprising: a sorbent filter configured to remove ammonia, (Sorbent Cartridge 104, See Figure 1, See paragraph [0141] & [0157]), said sorbent filter positioned in said dialysate flow path with said sorbent filter including an inlet to receive used dialysate and an outlet to expel filtered used dialysate, (Dialysate Regeneration Flow Path 101 with Sorbent Cartridge 104 to Ultrafilter 107, See Figure 1, See paragraph [0140], [0150]); a first reagent source containing a solution, (See paragraph [0146], Manda); a first pump connected to said first reagent source configured to directly inject the solution into the dialysate flow path, (Concentrate Pump 106, See Figure 1, See paragraph [0147], [0172]); a first mixer positioned in the dialysate flow path downstream of the first pump, the first mixer configured to mix the filtered used dialysate with the solution, (Junction point between Line of Concentrate Pump 106 and Flow Path 101 acts as mixer, See Figure 1, See paragraph [0147], [0172]); a conductivity sensor positioned in said dialysate flow path after said first mixer, said conductivity sensor configured to measure the level of dissolved solids in the filtered used dialysate after the first mixer, (Conductivity Sensor 116 or Refractive Index Sensor 117, See Figure 1, See paragraph [0149], [0157]); and a controller configured to adjust a flow rate of the direct introduction of the first reagent solution into the dialysate flow path by adjusting the first pump based at least on the level of dissolved solids in the filtered used dialysate, (See paragraph [0078] & [0155]).
Manda does not disclose that the system is a hemodialysis system, comprising a dialyzer, a blood flow path which transports blood through said dialyzer, said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line which connects to a patient's vein; a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate , and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate, wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate.
Soykan discloses a hemodialysis system, (See paragraphs [0018] and [0019], Soykan), comprising a dialyzer, (See paragraph [00247] & [00250], Soykan), a blood flow path which transports blood through said dialyzer, (See paragraph [0247]), said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line, (See paragraph [0249] & [0250]); a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, (See paragraph [00252]), said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate, (See paragraph [00252] & [00253]), and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate, (See paragraph [0299] & [0254]).
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 system of the first embodiment of Manda by incorporating a hemodialysis system, comprising a dialyzer, blood flow path which transports blood through said dialyzer, said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line; a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate as in Soykan because “there is a need for a modular system that can provide any one or combination of hemodialysis…and peritoneal dialysis”, (See paragraph [006], Soykan), thus it “can be used in a multimodal fashion”, (See paragraph [00246], Soykan), providing “for an easily portable dialysis system that can be transported to a clinical dialysis center,” (See paragraph [00246], Soykan), or “at home”, (See paragraph [0016], Soykan).
Modified Manda does not explicitly disclose connecting to a patient’s vein.
Giordano discloses connecting to a patient’s vein, (See paragraph [0009], [0018] & [0019], Giordano).
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 system of modified Manda by incorporating connecting to a patient’s vein because Soykan “provides an access to the blood of a patient for extracorporeal processing and return to the patient [which]…can be a fistula”, (See paragraph [00249], Soykan), in which Giordano provides a “venous blood line [that] may be a traditional flexible tube and needle for returning blood to a patient’s vein” in which “various constructions…may be employed to gain access to a patient’s blood…including an arteriovenous fistula”, (See paragraph [0019], Giordano), which “is the most commonly recognized access point”, (See paragraph [0009], Giordano).
Modified Manda does not explicitly disclose a control processor connected to said conductivity sensor to receive measurements from said conductivity sensor and said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump.
Rohde discloses a hemodialysis system, (See paragraph [0001], Rohde), with a control processor connected to said conductivity sensor, (See paragraph [0037], Rohde; A MEMS [micro-electromechanical systems] sensor includes a central unit that processes data which is a processor; See https://en.wikipedia.org/wiki/MEMS for evidence; further explanation in Conclusion section), to receive measurements from said conductivity sensor, (See paragraph [0037], Rohde), said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump, (See paragraph [0058], Rohde).
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 system of modified Manda by incorporating a control processor connected to said conductivity sensor to receive measurements from said conductivity sensor and said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump as in Rohde so that the conductivity sensor “may be used to monitor and control the process, as well as the final product”, (See paragraph [0060], Rohde), “thus keeping precisely proportioned flows”, (See paragraph [0058], Rohde).
Modified Manda does not disclose the first reagent source containing a solution consisting essentially of sodium carbonate where the solution consisting essentially of sodium carbonate is injected into the dialysate flow path and to mix with the solution consisting essentially of sodium carbonate.
Babb discloses a system with the first reagent source containing a solution consisting essentially of sodium carbonate, (Line 14 contains aqueous sodium carbonate that is further supplied to Reservoir 17 which receives dialysate components from Line 24, See Figure 1, See column 2, lines 65-68, column 3, lines 1-5, lines 13-20, lines 33-45), where the solution consisting essentially of sodium carbonate is injected into the dialysate flow path and to mix with the solution consisting essentially of sodium carbonate, (Line 14 contains aqueous sodium carbonate that is further supplied to Reservoir 17 which receives dialysate components from Line 24, See Figure 1, See column 2, lines 65-68, column 3, lines 1-5, lines 13-20, lines 33-45; The Examiner takes the position that a solution of additional aqueous sodium carbonate is directly injected via line 14/16 into a position of the dialysate flow path (which contains the dialysate components in liquid form), in which the solution is directly injected/mixed into the dialysate fluid).
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 system of modified Manda by incorporating the first reagent source containing a solution consisting essentially of sodium carbonate where the solution consisting essentially of sodium carbonate is injected into the dialysate flow path and to mix with the solution consisting essentially of sodium carbonate as in Babb because “sodium bicarbonate solutions are more difficult to use because sodium bicarbonate solutions are not bacteriostatic and thus may present sterility problems”, (See column 1, lines 52-55, Babb), so it uses sodium carbonate, (See column 1, lines 1-5, lines 23-25, Babb). By doing so, “prolonged existence of sodium bicarbonate in the dialysate liquid prior to use is avoided”, (See column 2, lines 15-19, Babb).
Modified Manda does not disclose wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate.
Pudil discloses wherein the expelled filtered used dialysate comprises CO2, (See paragraph [0282], [0283], Pudil), and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate, (See paragraph [0305], Pudil).
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 system of modified Manda by incorporating wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate as in Pudil in order to “achieve the desired bicarbonate concentration”, (See paragraph [0292], Pudil), “in order to achieve a specific therapeutic goal related to a patient’s acid-base balance”, (See paragraph [0283], Pudil).
Additional Disclosures Included:
Claim 2: The system of claim 1, wherein the conductivity sensor comprises a sodium level sensor configured to measure the level of sodium in the dialysate, (See paragraph [0073], [0157], & [0161], Manda).
Claim 3: The system of claim 2, wherein the control processor is further configured adjust a flow rate of the first solution consisting essentially of sodium carbonate by adjusting the first pump based at least on the level of sodium in the dialysate, (See paragraph [0154], Table 3, Manda; and see Babb).
Claim 21: The system of claim 1, wherein the controller is further configured to receive the feedback signal and increase an injection rate of the solution consisting essentially of sodium carbonate if the conductivity value is less than a predetermined optimum conductivity value, and wherein the controller is further configured to decrease the injection rate of the solution consisting essentially of sodium carbonate if the conductivity value is higher than the predetermined optimum conductivity value, (See paragraph [0058], Rohde; and see Babb).
Claims 6, 7 & 12 are directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claims 6, 7 & 12, modified Manda discloses the system of claim 1, but does not explicitly disclose in the specified combination further comprising: a second reagent source containing a second reagent solution comprising a solution of a plurality of mineral compounds; and a second pump configured to inject the second reagent solution into the dialysate flow path of the sorbent filter, wherein the second pump is located upstream of the first pump.
Embodiment 2 of Manda discloses further comprising: a second reagent source containing a second reagent solution comprising a solution of a plurality of mineral compounds, (Concentrate Sources 402-406, Figure 4, See paragraph [0169], Manda); and a second pump configured to inject the second reagent solution into the dialysate flow path of the sorbent filter, wherein the second pump is located upstream of the first pump, (Concentrate Pumps 407-411, Figure 4, See paragraph [0169], Manda).
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 system of modified Manda by incorporating further comprising: a second reagent source containing a second reagent solution comprising a solution of a plurality of mineral compounds; and a second pump configured to inject the second reagent solution into the dialysate flow path of the sorbent filter, wherein the second pump is located upstream of the first pump as in Embodiment 2 of Manda because “one of skill in the art will understand other ions can be used in formulation of peritoneal dialysate, and each can be contained in a separate ion concentrate source or combined into one or more combined ion concentrate sources” such that “the amount of each of the concentrates moved into the peritoneal dialysate generation flow path….can be controlled to result in a peritoneal dialysate having a prescribed solute concentration, as determined by a doctor or health care provider”, (See paragraph [0169], Manda), such that “greater individualization and therapy customization can be achieved for each patient”, (See paragraph [0175], Manda).
Additional Disclosures Included:
Claim 7: The system of claim 6, further comprising a second mixer disposed upstream of the first mixer, wherein the second mixer is configured to mix the dialysate with the second reagent solution before first reagent is injected into the dialysate flow path by the first pump, (Junction points between Lines of Concentrate Sources 402-406 and Peritoneal Dialysate Generation Flow Path 401, Figure 4, See paragraph [0169], Manda).
Claim 12: The system of claim 6, wherein the control processor is further configured to adjust a flow rate of the second reagent solution by adjusting the second pump based at least on the level of sodium in the filtered used dialysate, (See Table 3, paragraph [0154], [0169], Manda).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Pudil et al., (“Pudil”, US 2015/0367055).
Claim 5 is directed to a system, an apparatus type invention group.
Regarding Claim 5, modified Manda discloses the system of claim 1, but does not explicitly disclose wherein the sodium carbonate solution has a concentration of approximately 1.5 M.
Pudil discloses wherein the sodium carbonate solution has a concentration of approximately 1.5 M, (See paragraph [0019], Pudil; Pudil discloses a range in which it makes obvious to select the claimed value).
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 system of modified Manda by incorporating wherein the sodium carbonate solution has a concentration of approximately 1.5 M as in Pudil in order to provide “a solutions through the zirconium phosphate [in the sorbent cartridge] where the solution(s) contain appropriate solutes”, (See paragraph [0001], Pudil), for “sorbent recharging”, (See Abstract, Pudil), in which Manda also has a sorbent cartridge for recharging with zirconium phosphate, (See paragraphs [0141] & [0142], Manda), at a certain level to achieve this result effectively.
Claims 8-10 is rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Callan et al., (“Callan”, US 2004/0060865).
Claims 8-10 are directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claims 8-10, modified Manda discloses the system of claim 6, wherein the second reagent solution comprises a solution of calcium chloride (CaCl2), magnesium chloride (MgCl2), and potassium acetate (KAc), (See paragraph [0169], [0141], Manda).
Modified Manda does not explicitly disclose potassium acetate.
Callan discloses calcium chloride, magnesium chloride and potassium acetate, (See paragraph [0027], [0038] & [0052]).
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 system of modified Manda by incorporating potassium acetate as in Callan because the presence of a buffering anion “in the dialysate precursor composition” mitigates “problems associated with fluctuations in the pH of the dialysate during a dialysis treatment”, (See paragraph [0026], Callan), and to select concentration values which are result-effective variables where “where the combined composition meets or exceeds the [Association for the Advancement of Medical Instrumentation] AAMI-quality standard set for dialysate”, (See paragraph [0059], Callan), that results in “improved dialysate formulations that increase the efficiency of the hemodialysis treatment”, (See paragraph [0013], Callan).
Additional Disclosures Included:
Claim 9: The system of claim 8, further comprising wherein the CaCl2 in the second reagent solution has a concentration between 25 and 40 millimolar (mM), (See paragraphs [0008], [0009], [0016], [0027], [0059]; Callan anticipates the claimed range at 40 mEq/L which is equivalent to 40 mM), wherein the MgCl2 in the second reagent solution has a concentration between 12.5 and 20 mM, (See paragraphs [0008], [0009], [0052], [0057]; Callan anticipates the claimed range at 20 mEq/L which is equivalent to 40 mM), and wherein the KAc in the second reagent solution has a concentration between 75 and 120 mM, (See paragraph [0038], [0052], [0053]; Callan discloses an overlapping range from 0.01 to 150 mEq/L equivalent to 0.01 to 150 mM in which the value may be selected because it is result-effective variable according to the motivation set forth above).
Claim 10: The system of claim 8, wherein the CaCl2 in the second reagent solution has a concentration of 32.04 mM, (See paragraphs [0008], [0009], [0016], [0027], [0059]; Callan overlaps with the claimed value at 32.04 mEq/L which is equivalent to 32.04 mM in which the value may be selected because it is result-effective variable according to the motivation set forth above), wherein the MgCl2 in the second reagent solution has a concentration of 16.02 mM, (See paragraphs [0008], [0009], [0052], [0057]; Callan overlaps with the claimed value at 16.02 mEq/L which is equivalent to 16.02 mM in which the value may be selected because it is result-effective variable according to the motivation set forth above), and wherein the KAc in the second reagent solution has a concentration of 96.12 mM, (Callan overlaps with the claimed value at 96.12 mEq/L which is equivalent to 96.12 mM in which the value may be selected because it is result-effective variable according to the motivation set forth above).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Fitzgerald et al., (“Fitzgerald”, US 2017/0319770).
Claim 11 is directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claim 11, modified Manda discloses the system of claim 6, but does not disclose wherein the first reagent source is between 1 and 3 liters, and the second reagent source is between 0.5 and 1.0 liters.
Fitzgerald discloses wherein the first reagent source is between 1 and 3 liters and the second reagent source is between 0.5 and 1.0 liters, (See paragraphs [0216]-[0219], Fitzgerald; Fitzgerald discloses a volume of 0.5 to 4 liters for at least two sources, overlapping over the entire claimed range).
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 system of modified Manda by incorporating wherein the first reagent source is between 1 and 3 liters and the second reagent source is between 0.5 and 1.0 liters as in Fitzgerald because “shipping and storage of the sheer volume of fluids required is space consuming” so “an improved peritoneal dialysis system is needed”, (See paragraphs [0021] & [0022], Fitzgerald). Thus, the volume of the reagent source is selected as a result effective variable such that the containers “may be used for several PD fluid preparation cycles”, (See paragraph [0216] or [0217], Fitzgerald), while “the fluid circuit…may be reused for multiple treatments”, (See paragraphs [0235], Fitzgerald), reducing “significantly both the amount of dialysis solution stored and handled by PD patients and the amount of waste produced”, (See paragraph [0025], Fitzgerald), and “different content for the concentrates may be adopted depending on the needs of patient P and his/her specific circumstances”, (See paragraph [0219], Fitzgerald)
Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Pudil et al., (“Pudil”, US 2014/0190886).
Claims 14 & 15 are directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claims 14 & 15, modified Manda discloses the system of claim 13, but does not disclose wherein the conductivity sensor is pre-calibrated such that a certain conductivity value is expected given an optimum level of sodium in the filtered used dialysate.
Pudil discloses a system wherein the conductivity sensor is pre-calibrated such that a certain conductivity value is expected given an optimum level of sodium in the filtered used dialysate, (See paragraph [0410] or [0446], Pudil).
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 system of modified Manda by incorporating wherein the conductivity sensor is pre-calibrated such that a certain conductivity value is expected given an optimum level of sodium in the filtered used dialysate as in Pudil so that “calibration, temperature, electronic drift and other errors between separate conductivity meters can be reduced or eliminated” and “allows for the performance or efficiency of various system components to be evaluated as well as the determination of the amount of urease in the dialysate”, (See paragraph [0410], Pudil).
Additional Disclosures Included:
Claim 15: The system of claim 14, wherein the optimum level of sodium concentration is between 130 and 145 mM, (See paragraph [0209], Pudil).
Regarding Claims 16-20, modified Manda discloses the system of claim 6, wherein the conductivity sensor comprises a sensor body, (See paragraphs [0182], [0170], Manda).
Modified Manda does not disclose that the conductivity sensor also comprises an electrode.
Pudil discloses that the conductivity sensor also comprises an electrode, (See paragraph [0182], [0511], [0512], Pudil).
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 system of modified Manda by incorporating that the conductivity sensor also comprises an electrode as in Pudil in order to utilize an electrode as part of the conductivity sensor that can “determine a patient’s pre-dialysis blood sodium concentration” because “in some cases it is beneficial to the patient if their blood sodium concentration before and after a dialysis session remains the same which can result in less fluid gain between dialysis sessions”, (See paragraph [0511], Pudil).
Additional Disclosures Included:
Claim 17: The system of claim 16, wherein the electrode is coupled to the control system, (See paragraph [0169], Manda), wherein the control system is coupled to the first pump and the second pump, (See paragraphs [0169], [0171]-[0172], Manda), and wherein the control system is configured to control the amount of the solution consisting essentially of sodium carbonate and second reagent solution into the dialysate flow path, (See paragraphs [0169]-[0170], Manda; and see Babb).
Claim 18: The system of claim 16, wherein the control system wherein the processor is configured to determine the conductivity value of the filtered used dialysate, (See paragraph [0169], [0182], Manda), based on readings from the electrode, (See paragraphs [0511] & [0512], Pudil), and wherein the determined conductivity value is configured to control the amount of the solution consisting essentially of sodium carbonate and second reagent solution into the dialysate flow path so as to establish a feedback control loop between the first pump, the second pump, and the conductivity sensor, (See paragraph [0169]-[0172] & [0180], Manda; and see Babb).
Claim 19: The system of claim 16, wherein the electrode comprises a two, three, or four pole electrode, (Rod Electrodes 603B/605B, See paragraphs [0218], [0519], Pudil), configured to measure a conductivity value of the dialysate, (See paragraphs [0423], [0512], [0519], Pudil).
Claim 20: The system of claim 16, wherein the electrode is disposed into a slot of the sensor body, (See paragraphs [0182], [0195], Manda; and See paragraphs [0218], [0227], [0512], Pudil), and wherein the slot is sealed using adhesive and is configured to secure the electrode housed within the sensor body, (See paragraphs [0182], [0195], Manda ; See paragraph [0512] & [0513], Pudil).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manda et al., (“Manda”, US 2017/0281847), in view of Soykan et al., (“Soykan”, WO 2012/148781), in further view of Giordano et al., (“Giordano”, US 2016/0074568), in further view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Babb et al., (“Babb”, US 4,326,955), in further view of Pudil et al., (“Pudil”, US 2014/0190886), in further view of Pudil et al., (“Pudil 2”, US 2014/0158588).
Claim 22 is directed to a hemodialysis system, an apparatus or device type invention group.
Regarding Claim 22, Manda discloses in a first embodiment a system, (See paragraph [0009], [0147], [0169]), the system comprising: a sorbent filter configured to remove ammonia, (Sorbent Cartridge 104, See Figure 1, See paragraph [0141] & [0157]), said sorbent filter positioned in said dialysate flow path with said sorbent filter including an inlet to receive used dialysate and an outlet to expel filtered used dialysate, (Dialysate Regeneration Flow Path 101 with Sorbent Cartridge 104 to Ultrafilter 107, See Figure 1, See paragraph [0140], [0150]); a first reagent source containing a solution, (See paragraph [0146], Manda); a first pump connected to said first reagent source configured to directly inject the solution into the dialysate flow path, (Concentrate Pump 106, See Figure 1, See paragraph [0147], [0172]); a first mixer positioned in the dialysate flow path downstream of the first pump, the first mixer configured to mix the filtered used dialysate with the solution, (Junction point between Line of Concentrate Pump 106 and Flow Path 101 acts as mixer, See Figure 1, See paragraph [0147], [0172]); a conductivity sensor positioned in said dialysate flow path after said first mixer, said conductivity sensor configured to measure the level of dissolved solids in the filtered used dialysate after the first mixer, (Conductivity Sensor 116 or Refractive Index Sensor 117, See Figure 1, See paragraph [0149], [0157]); and a controller configured to adjust a flow rate of the direct introduction of the first reagent solution into the dialysate flow path by adjusting the first pump based at least on the level of dissolved solids in the filtered used dialysate, (See paragraph [0078] & [0155]).
Manda does not disclose that the system is a hemodialysis system, comprising a dialyzer, a blood flow path which transports blood through said dialyzer, said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line which connects to a patient's vein; a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate , and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate, wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate.
Soykan discloses a hemodialysis system, (See paragraphs [0018] and [0019], Soykan), comprising a dialyzer, (See paragraph [00247] & [00250], Soykan), a blood flow path which transports blood through said dialyzer, (See paragraph [0247]), said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line, (See paragraph [0249] & [0250]); a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, (See paragraph [00252]), said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate, (See paragraph [00252] & [00253]), and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate, (See paragraph [0299] & [0254]).
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 system of the first embodiment of Manda by incorporating a hemodialysis system, comprising a dialyzer, blood flow path which transports blood through said dialyzer, said blood flow path includes an arterial blood line which connects to a patient's artery and a venous blood line; a dialysate flow path, isolated from the blood flow path, which transports dialysate through said dialyzer, said dialysate flow path including a dialysate flow path inlet which receives fresh dialysate and a dialysate flow path outlet which expels used dialysate and wherein the sorbent filter is further configured to remove toxins which have permeated from blood plasma through the dialyzer and into the dialysate as in Soykan because “there is a need for a modular system that can provide any one or combination of hemodialysis…and peritoneal dialysis”, (See paragraph [006], Soykan), thus it “can be used in a multimodal fashion”, (See paragraph [00246], Soykan), providing “for an easily portable dialysis system that can be transported to a clinical dialysis center,” (See paragraph [00246], Soykan), or “at home”, (See paragraph [0016], Soykan).
Modified Manda does not explicitly disclose connecting to a patient’s vein.
Giordano discloses connecting to a patient’s vein, (See paragraph [0009], [0018] & [0019], Giordano).
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 system of modified Manda by incorporating connecting to a patient’s vein because Soykan “provides an access to the blood of a patient for extracorporeal processing and return to the patient [which]…can be a fistula”, (See paragraph [00249], Soykan), in which Giordano provides a “venous blood line [that] may be a traditional flexible tube and needle for returning blood to a patient’s vein” in which “various constructions…may be employed to gain access to a patient’s blood…including an arteriovenous fistula”, (See paragraph [0019], Giordano), which “is the most commonly recognized access point”, (See paragraph [0009], Giordano).
Modified Manda does not explicitly disclose a control processor connected to said conductivity sensor to receive measurements from said conductivity sensor and said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump.
Rohde discloses a hemodialysis system, (See paragraph [0001], Rohde), with a control processor connected to said conductivity sensor, (See paragraph [0037], Rohde; A MEMS [micro-electromechanical systems] sensor includes a central unit that processes data which is a processor; See https://en.wikipedia.org/wiki/MEMS for evidence; further explanation in Conclusion section), to receive measurements from said conductivity sensor, (See paragraph [0037], Rohde), said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump, (See paragraph [0058], Rohde).
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 system of modified Manda by incorporating a control processor connected to said conductivity sensor to receive measurements from said conductivity sensor and said control processor also connected to said first pump to control the speed of said first pump and automatically adjust the pump as in Rohde so that the conductivity sensor “may be used to monitor and control the process, as well as the final product”, (See paragraph [0060], Rohde), “thus keeping precisely proportioned flows”, (See paragraph [0058], Rohde).
Modified Manda does not disclose the first reagent source containing a solution of sodium carbonate where the solution of sodium carbonate is injected into the dialysate flow path and to mix with the solution of sodium carbonate.
Babb discloses a system with the first reagent source containing a solution of sodium carbonate, (Line 14 contains aqueous sodium carbonate that is further supplied to Reservoir 17 which receives dialysate components from Line 24, See Figure 1, See column 2, lines 65-68, column 3, lines 1-5, lines 13-20, lines 33-45), where the solution of sodium carbonate is injected into the dialysate flow path and to mix with the solution of sodium carbonate, (Line 14 contains aqueous sodium carbonate that is further supplied to Reservoir 17 which receives dialysate components from Line 24, See Figure 1, See column 2, lines 65-68, column 3, lines 1-5, lines 13-20, lines 33-45; The Examiner takes the position that a solution of additional aqueous sodium carbonate is directly injected via line 14/16 into a position of the dialysate flow path (which contains the dialysate components in liquid form), in which the solution is directly injected/mixed into the dialysate fluid).
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 system of modified Manda by incorporating the first reagent source containing a solution of sodium carbonate where the solution of sodium carbonate is injected into the dialysate flow path and to mix with the solution of sodium carbonate as in Babb because “sodium bicarbonate solutions are more difficult to use because sodium bicarbonate solutions are not bacteriostatic and thus may present sterility problems”, (See column 1, lines 52-55, Babb), so it uses sodium carbonate, (See column 1, lines 1-5, lines 23-25, Babb). By doing so, “prolonged existence of sodium bicarbonate in the dialysate liquid prior to use is avoided”, (See column 2, lines 15-19, Babb).
Modified Manda does not explicitly disclose wherein the sodium carbonate solution has a concentration of 1.5 M.
Pudil discloses wherein the sodium carbonate solution has a concentration of 1.5 M, (See paragraph [0019], Pudil; Pudil discloses a range in which it makes obvious to select the claimed value).
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 system of modified Manda by incorporating wherein the sodium carbonate solution has a concentration of 1.5 M as in Pudil in order to provide “a solutions through the zirconium phosphate [in the sorbent cartridge] where the solution(s) contain appropriate solutes”, (See paragraph [0001], Pudil), for “sorbent recharging”, (See Abstract, Pudil), in which Manda also has a sorbent cartridge for recharging with zirconium phosphate, (See paragraphs [0141] & [0142], Manda), at a certain level to achieve this result effectively.
Modified Manda does not disclose wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate.
Pudil discloses wherein the expelled filtered used dialysate comprises CO2, (See paragraph [0282], [0283], Pudil), and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate, (See paragraph [0305], Pudil).
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 system of modified Manda by incorporating wherein the expelled filtered used dialysate comprises CO2 and wherein the sodium carbonate reacts with the CO2 to form sodium bicarbonate as in Pudil in order to “achieve the desired bicarbonate concentration”, (See paragraph [0292], Pudil), “in order to achieve a specific therapeutic goal related to a patient’s acid-base balance”, (See paragraph [0283], Pudil).
Conclusion
PNG
media_image1.png
380
979
media_image1.png
Greyscale
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached on 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M PEO/Primary Examiner, Art Unit 1779
Prosecution Insights