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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 January 2026 has been entered.
Response to Amendment
This Office Action is responsive to the RCE filed 20 January 2026. As per the RCE: no claims have been amended, cancelled, or added. Thus, claims 1-23 are presently pending and under examination.
Response to Arguments
Response to Arguments Regarding 35 USC § 112
Applicant’s arguments, see pg. 5-6 of Remarks, filed 20 January 2026, with respect to 112(a) and 112(b) rejections of claims 1-21 have been fully considered and are persuasive. Thus, the 112(a) and 112(b) rejection of claims 1-21 have been withdrawn.
Response to Arguments Regarding 35 USC § 102/103
Applicant’s arguments with respect to claim(s) 1-9, 11-20 and 22-23, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Primarily, Applicant argues the combination of Fritz and Sherman to teach the limitation of an “unbound nitrite”, thus, Examiner has removed Fritz as a primary reference and has established Sherman (previously cited) as the primary reference that teaches the extracorporeal circuit and the infusion of unbound nitrite. Additionally, Examiner would like to thank Applicant for clarifying in the remarks that “unbound nitrites refers to nitrites not bound in an eluting matrix but in solution”, which is clearly taught by Sherman.
Thus, claims 1-3, 9, 11-20, and 22-23 are rejected under 35 USC 103, as shown in detail below.
No additional specific arguments were presented with previous 35 U.S.C 103 rejections of dependent claims 4-8, 10, and 21, nor specifically with respect to the previously cited Wang, Sullenger, or Bowley references.
Therefore, claims 4-8, 10, and 21 remain rejected under 35 USC 103, as described in detail below.
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.
Claim(s) 1-3, 9, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (US 2018/0256637 A1, previously cited), hereinafter Sherman further in view of Wajih, Nadeem, et al. "Erythrocytic bioactivation of nitrite and its potentiation by far-red light." Redox biology 20 (2019): 442-450., hereinafter Wajih (previously cited).
Regarding claim 1, Sherman discloses a method for inhibiting device thrombosis for a patient ([0012] “The present disclosure provides methods for maintaining physiological levels of nitrite in a subject undergoing hemodialysis. The present disclosure also provides methods for preventing myocardial infarction, sudden cardiac death, stroke, cardiovascular disease, high blood pressure, pulmonary hypertension, and/or renal hypertension in a subject undergoing hemodialysis.”), the method comprising:
circulating blood through an extracorporeal circuit coupled to the patient (Figure 1: view the blood flow from the dialysis patient through the extracorporeal circuit);
infusing unbound nitrite into the blood ([0163] “An aqueous solution of sodium nitrite was prepared by dissolving 3 mg of sodium nitrite in 1 liter of purified water. This sodium nitrite solution complied with the AAMI quality specification for nitrate (and nitrite) since the resulting sodium nitrite solution had a nitrite anion concentration of approximately 2 mg/L. The sodium nitrite solution was infused directly into dialysate tubing between the hemodialysis machine and the dialyzer”, Table 4, [0167] “nitrite can either pass along or pass through a dialyzer if the nitrite is added to the unspiked dialysate from the hemodialysis machine at a location between the hemodialysis machine and the dialyzer membrane.”) such that nitrite is bioactivated by red blood cells to form nitric oxide ([0008] “nitrite is reduced to nitric oxide. Since nitric oxide is a vasodilator, the reduction of nitrite to nitric oxide protects cardiac function by increasing blood flow to ischemic tissues”)
Although, Sherman does not explicitly state unbound nitrite, Sherman does teach a sodium nitrite solution wherein the solution contains a nitrite anion concentration which would be obvious to one skilled in the art that the nitrite anion is the unbound nitrite.
Sherman fails to disclose illuminating the blood with far-red light to increase bioactivation of the nitrite by the red blood cells.
However, Wajih teaches a method to explore whether nitrite and far red light treatment might have other potential benefits related to treating thrombosis (pg. 447, 5.Discussion) wherein blood was collected by venipuncture and nitrite was added to the plasma mixture (3.5. Turbidity assay of fibrinogen polymerization) such that the unbound nitrite is bioactivated by red blood cells to form nitric oxide (pg. 445, 4.4 Far red light and nitrite prolongs lag time of clotting in presence of RBCs: “nitrite is bioactivated by RBCs and this action is potentiated by far red light.”) and further illuminating the blood with far-red light to increase bioactivation of the unbound nitrite by the red blood cells (pg. 443, 3.1 Far red light treatment: “A “deep red” LED source (M660L4, Thorlabs, NJ) at a center wavelength of 660 nm was used to illuminate the samples”, pg. 445, 4.4 Far red light and nitrite prolongs lag time of clotting in presence of RBCs: “nitrite is bioactivated by RBCs and this action is potentiated by far red light.”, pg. 443, 3.2 Photoacoustic imaging: “Male Sprague Dawley rats were either give nitrite containing water (100 mg/L) or control water”) .
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman to incorporate the teachings of Wajih to illuminate the blood with far-red light to increase bioactivation of the nitrite by the red blood cells, as these prior art references are directed to providing blood with nitrite for treating cardiovascular disease that can occur during hemodialysis. One would be motivated to do this as Wajih shows that far red light potentiates the effects of nitrite in a RBC-dependent manner in vitro and in vivo (pg. 445, 5. Discussion) and illumination with far red light combined with nitrite treatment further increased the lag time compared to nitrite treatment alone which support the notion that far red light enhances nitrite bioactivation by RBCs, producing NO activity that may be useful in treating thrombosis (pg. 448, 5. Discussion), as recognized by Wajih.
Regarding claim 2, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman further discloses wherein infusing the unbound nitrite into the blood comprises infusing the unbound nitrite in line with the extracorporeal circuit ([0163] “The sodium nitrite solution was infused directly into dialysate tubing between the hemodialysis machine and the dialyzer”, [0167] ““nitrite can either pass along or pass through a dialyzer if the nitrite is added to the unspiked dialysate from the hemodialysis machine at a location between the hemodialysis machine and the dialyzer membrane”, view Figure 1: the nitrite spiked dialysis is in contact with the blood of the extracorporeal circuit at the dialyzer membrane 90 which is in line with the extracorporeal circuit).
Although, Sherman does not explicitly state unbound nitrite, Sherman does teach a sodium nitrite solution wherein the solution contains a nitrite anion concentration which would be obvious to one skilled in the art that the nitrite anion is the unbound nitrite.
Regarding claim 3, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman further discloses wherein infusing the unbound nitrite into the blood comprises continuously infusing the unbound nitrite for a period of time while the blood circulates through the extracorporeal circuit ([0164] “the infusion pump infused the sodium nitrite solution into the tubing through the valve at a rate of 250 mL/hour”, [0102]-[0103])
Regarding claim 9, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman fails to disclose wherein illuminating the blood with the far-red light comprises illuminating the blood with the far-red light emitted at a wavelength of 660 nm.
However, Wajih teaches wherein illuminating the blood with the far-red light comprises illuminating the blood with the far-red light emitted at a wavelength of 660 nm (pg. 443, 3.1 Far red light treatment: “A “deep red” LED source (M660L4, Thorlabs, NJ) at a center wavelength of 660 nm was used to illuminate the samples”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman to incorporate the teachings of Wajih to illuminate the blood with far-red light emitted at a wavelength of 660 nm, as these prior art references are directed to providing blood with nitrite and combined far-red light treatment. One would be motivated to do this as evidence suggests far-red (600 – 700 nm) light has positive effects including vasodilation, increased blood flow, reduction of inflammation, and releasing NO from NO containing species, as recognized by Wajih (pg. 443, 1. Introduction).
Regarding claim 22, Sherman in view of Wajih teaches the method of claim 1 (as shown above).
Sherman further discloses wherein infusing unbound nitrite into the blood comprises infusing a nitrite solution into the blood ([0096] “ intradialytically contacting said subject's blood with a nitrite-spiked dialysate, wherein an aqueous solution comprising sodium nitrite is added to an unspiked dialysate as the unspiked dialysate flows from a dialysis machine to a dialyzer membrane”).
Claim(s) 4-8, 11-20, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Wajih as applied to claim 1 above, and further in view of Wang (GB 2438375 A, previously cited), hereinafter Wang.
Regarding claim 4, Sherman in view of Wajih teach the method of claim 1 (as shown above). Wajih further teaches where “one can imagine devices where far red light is applied internally through implantable devices (e.g. stents, IVC filters) so that one achieves local reduction in thrombosis” (pg. 448, 5. Discussion). However, Sherman, and Wajih, alone or in combination fail to teach wherein illuminating the blood with the far-red light comprises illuminating the blood with the far-red light in line with the extracorporeal circuit.
However, Wang teaches a hemodialysis apparatus comprising a blood irradiation means 6 (Abstract) wherein illuminating the blood with the far-red light comprises illuminating the blood with the far-red light in line with the extracorporeal circuit ([0016] “one or more of the electromagnetic sources emit radiation at one or more wavelengths between about 500 nm and about 850nm”, view Figure 1: blood irradiation means 6 in line with the extracorporeal circuit).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to illuminate the blood with the far-red light comprises illuminating the blood with the far-red light in line with the extracorporeal circuit, as these prior art references are directed to treating blood. One would be motivated to do this so that the treatment with red light done together with the circuit has better efficiency than when done independently of the circuit, as recognized by Wang ([0060]).
Regarding claim 5, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein illuminating the blood with the far-red light comprises continuously illuminating the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit.
However, Wang teaches wherein illuminating the blood with the far-red light comprises continuously illuminating the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit ([0058] “Blood irradiation means 6 comprises a plurality of electromagnetic radiation sources 7, which illuminate blood in the artery-blood circuit 4 and/or vein-blood circuit 5. The electromagnetic sources 7 of the blood irradiation means 6 provide electromagnetic radiation in a continuous rage of wavelengths between 500 nm -850 nm (integrated tungsten/halogen light source). The electromagnetic sources 7 are attached to two cylindrically shaped support frames each of which has an inner passage way. The passage way of one of the support frames encloses the artery-blood circuit; the passage way of the other support frame encloses the vein-blood circuit.”, [0059] “Light-illumination therapy may be performed at any stage of blood circulation, including sections of blood circulation both in vivo and in vitro.”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman in view of Wajih to incorporate the teachings of Wang where illuminating the blood with the far-red light comprises continuously illuminating the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit, as these prior art references are directed to treating blood. One would be motivated to do this so that the treatment with red light done together with the circuit has better efficiency than when done independently of the circuit, as recognized by Wang ([0060]).
Regarding claim 6, Sherman in view of Wajih teach the method of claim 1 (as shown above). Sherman and Wajih, alone or in combination, fail to teach wherein illuminating the blood with the far-red light comprises passing the blood through a section of tubing disposed between a pair of light sources.
However, Wang teaches wherein illuminating the blood with the far-red light comprises passing the blood through a section of tubing disposed between a pair of light sources ([0053] “In certain embodiments of the present invention, electromagnetic sources are distributed spatially around the portion of a blood circuit which is subjected to electromagnetic radiation. For example, if the irradiated portion of a blood circuit is a cylindrical tubing, then the light sources are disposed on a cylindrical surface having a diameter larger than the diameter of the tubing; alternatively, the light sources are disposed directly within the cylindrical tubing and may or may not come into contact with blood directly.”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to illuminate the blood with the far-red light comprises passing the blood through a section of tubing disposed between a pair of light sources, as these prior art references are directed to treating blood. One would be motivated to do this to distribute the radiation evenly within the circuit to be irradiated and to provide the appropriate amount of radiation , as recognized by Wang ([0054]).
Regarding claim 7, Sherman in view of Wajih further in view of Wang teaches the method of claim 6 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the section of tubing is arranged in a coil.
However, Wang further teaches wherein the section of tubing is arranged in a coil ([0053] “In certain embodiments, the irradiated portion of a blood circuit which is a cylindrical tubing is arranged into a helical coil, having a hollow inner passage way that extends the entire way of the coil.”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the section of tubing arranged in a coil, as these prior art references are directed to treating blood. One would be motivated to do this distribute the radiation evenly within the circuit to be irradiated and to provide the appropriate amount of radiation , as recognized by Wang ([0054]).
Regarding claim 8, Sherman in view of Wajih further in view of Wang teaches the method of claim 6 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the pair of light sources comprise a pair of light-emitting diodes.
However, Wang further teaches wherein the pair of light sources comprise a pair of light-emitting diodes ([0023] “one or more of the irradiation source are selected from the group consisting of: one or more light emitting diodes”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the pair of light sources comprise a pair of light-emitting diode, as these prior art references are directed to treating blood. One would be motivated to do this to deliver the specific wavelength of light as needed.
Regarding claim 11, , Sherman discloses a system for inhibiting device thrombosis for a patient, ([0012] “The present disclosure provides methods for maintaining physiological levels of nitrite in a subject undergoing hemodialysis. The present disclosure also provides methods for preventing myocardial infarction, sudden cardiac death, stroke, cardiovascular disease, high blood pressure, pulmonary hypertension, and/or renal hypertension in a subject undergoing hemodialysis.”), the system comprising:
an extracorporeal circuit configured to circulate blood of the patient (Figure 1: view the blood flow from the dialysis patient through the extracorporeal circuit, [0031]);
a nitrite infusion device coupled to the extracorporeal circuit (Figure 1: view the dialyzer membrane 90 that takes the aqueous solution comprising sodium nitrite 40 in contact with the blood in the extracorporeal circuit) configured to infuse unbound nitrite into the blood ([0163] “An aqueous solution of sodium nitrite was prepared by dissolving 3 mg of sodium nitrite in 1 liter of purified water. This sodium nitrite solution complied with the AAMI quality specification for nitrate (and nitrite) since the resulting sodium nitrite solution had a nitrite anion concentration of approximately 2 mg/L. The sodium nitrite solution was infused directly into dialysate tubing between the hemodialysis machine and the dialyzer”, Table 4, [0167] “nitrite can either pass along or pass through a dialyzer if the nitrite is added to the unspiked dialysate from the hemodialysis machine at a location between the hemodialysis machine and the dialyzer membrane.”) such that nitrite is bioactivated by red blood cells to form nitric oxide ([0008] “nitrite is reduced to nitric oxide. Since nitric oxide is a vasodilator, the reduction of nitrite to nitric oxide protects cardiac function by increasing blood flow to ischemic tissues”)
Although, Sherman does not explicitly state unbound nitrite, Sherman does teach a sodium nitrite solution wherein the solution contains a nitrite anion concentration which would be obvious to one skilled in the art that the nitrite anion is the unbound nitrite.
Sherman fails to disclose one or more light sources disposed along the extracorporeal circuit and configured to illuminate the blood with far-red light to increase bioactivation of the unbound nitrite by the red blood cells.
However, Wang teaches a hemodialysis apparatus comprising a blood irradiation means 6 (Abstract) with one or more light sources disposed along the extracorporeal circuit and configured to illuminate the blood with the far-red light ([0016] “one or more of the electromagnetic sources emit radiation at one or more wavelengths between about 500 nm and about 850nm”, [0053] “In certain embodiments of the present invention, electromagnetic sources are distributed spatially around the portion of a blood circuit which is subjected to electromagnetic radiation. For example, if the irradiated portion of a blood circuit is a cylindrical tubing, then the light sources are disposed on a cylindrical surface having a diameter larger than the diameter of the tubing; alternatively, the light sources are disposed directly within the cylindrical tubing and may or may not come into contact with blood directly.”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman to incorporate the teachings of Wang to have the one or more light sources disposed along the extracorporeal circuit and configured to illuminate the blood with the far-red light, as these prior art references are directed to treating blood. One would be motivated to do this so that the treatment with red light done together with the circuit has better efficiency than when done independently of the circuit, as recognized by Wang ([0060]).
Sherman and Wang, alone or in combination fail to teach illuminat[ing] the blood with far-red light to increase bioactivation of the unbound nitrite by the red blood cells.
However, Wajih teaches a method to explore whether nitrite and far red light treatment might have other potential benefits related to treating thrombosis (pg. 447, 5.Discussion) wherein blood was collected by venipuncture and nitrite was added to the plasma mixture (3.5. Turbidity assay of fibrinogen polymerization) and further illuminating the blood with far-red light to increase bioactivation of the unbound nitrite by the red blood cells (pg. 443, 3.1 Far red light treatment: “A “deep red” LED source (M660L4, Thorlabs, NJ) at a center wavelength of 660 nm was used to illuminate the samples”, pg. 445, 4.4 Far red light and nitrite prolongs lag time of clotting in presence of RBCs: “nitrite is bioactivated by RBCs and this action is potentiated by far red light.”, pg. 443, 3.2 Photoacoustic imaging: “Male Sprague Dawley rats were either give nitrite containing water (100 mg/L) or control water) .
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wang to incorporate the teachings of Wajih to illuminate the blood with far-red light to increase bioactivation of the nitrite by the red blood cells, as these prior art references are directed to providing blood with nitrite and combined far-red light treatment. One would be motivated to do this as Wajih shows that far red light potentiates the effects of nitrite in a RBC-dependent manner in vitro and in vivo (pg. 445, 5. Discussion) and illumination with far red light combined with nitrite treatment further increased the lag time compared to nitrite treatment alone which support the notion that far red light enhances nitrite bioactivation by RBCs, producing NO activity that may be useful in treating thrombosis (pg. 448, 5. Discussion), as recognized by Wajih.
Regarding claim 12, Sherman, Wang, and Wajih teach the method of claim 11 (as shown above). Sherman further discloses wherein the nitrite infusion device is configured to infuse the unbound nitrite in line with the extracorporeal circuit ([0163] “The sodium nitrite solution was infused directly into dialysate tubing between the hemodialysis machine and the dialyzer”, [0167] ““nitrite can either pass along or pass through a dialyzer if the nitrite is added to the unspiked dialysate from the hemodialysis machine at a location between the hemodialysis machine and the dialyzer membrane”, view Figure 1: the nitrite spiked dialysis is in contact with the blood of the extracorporeal circuit at the dialyzer membrane 90 which is in line with the extracorporeal circuit).
Although, Sherman does not explicitly state unbound nitrite, Sherman does teach a sodium nitrite solution wherein the solution contains a nitrite anion concentration which would be obvious to one skilled in the art that the nitrite anion is the unbound nitrite.
Regarding claim 13, Sherman in view of Wang further in view of Wajih teaches the method of claim 11 (as shown above). Sherman further discloses wherein the nitrite infusion device is configured to infuse the unbound nitrite for a period of time while the blood circulated through the extracorporeal circuit ([0164] “the infusion pump infused the sodium nitrite solution into the tubing through the valve at a rate of 250 mL/hour”, [0102]-[0103]).
Regarding claim 14, Sherman, Wang, and Wajih teaches the system of claim 11 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the one or more light sources are configured to illuminate the blood with the far-red light in line with the extracorporeal circuit.
However, Wang teaches a hemodialysis apparatus comprising a blood irradiation means 6 (Abstract) wherein the one or more light sources are configured to illuminate the blood with the far-red light in line with the extracorporeal circuit ([0016] “one or more of the electromagnetic sources emit radiation at one or more wavelengths between about 500 nm and about 850nm”, view Figure 1: blood irradiation means 6 in line with the extracorporeal circuit).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the one or more light sources are configured to illuminate the blood with the far-red light in line with the extracorporeal circuit, as these prior art references are directed to treating blood. One would be motivated to do this so that the treatment with red light done together with the circuit has better efficiency than when done independently of the circuit, as recognized by Wang ([0060]).
Regarding claim 15, Sherman, Wang, and Wajih teaches the system of claim 11 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the one or more light sources are configured to illuminate the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit.
However, Wang teaches wherein the one or more light sources are configured to illuminate the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit ([0058] “Blood irradiation means 6 comprises a plurality of electromagnetic radiation sources 7, which illuminate blood in the artery-blood circuit 4 and/or vein-blood circuit 5. The electromagnetic sources 7 of the blood irradiation means 6 provide electromagnetic radiation in a continuous rage of wavelengths between 500 nm -850 nm (integrated tungsten/halogen light source). The electromagnetic sources 7 are attached to two cylindrically shaped support frames each of which has an inner passage way. The passage way of one of the support frames encloses the artery-blood circuit; the passage way of the other support frame encloses the vein-blood circuit.”, [0059] “Light-illumination therapy may be performed at any stage of blood circulation, including sections of blood circulation both in vivo and in vitro.”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang wherein the one or more light sources are configured to illuminate the blood with the far-red light for a period of time while the blood circulates through the extracorporeal circuit, as these prior art references are directed to treating blood. One would be motivated to do this so that the treatment with red light done together with the circuit has better efficiency than when done independently of the circuit, as recognized by Wang ([0060]).
Regarding claim 16, Sherman, Wang, and Wajih teach the system of claim 11 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the extracorporeal circuit comprises a section of tubing adjacent to the one or more light sources.
However, Wang teaches wherein the extracorporeal circuit comprises a section of tubing adjacent to the one or more light sources ([0053] “In certain embodiments of the present invention, electromagnetic sources are distributed spatially around the portion of a blood circuit which is subjected to electromagnetic radiation. For example, if the irradiated portion of a blood circuit is a cylindrical tubing, then the light sources are disposed on a cylindrical surface having a diameter larger than the diameter of the tubing; alternatively, the light sources are disposed directly within the cylindrical tubing and may or may not come into contact with blood directly.”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman, and Wajih to incorporate the teachings of Wang to have the extracorporeal circuit comprise a section of tubing adjacent to the one or more light sources, as these prior art references are directed to treating blood. One would be motivated to do this to distribute the radiation evenly within the circuit to be irradiated and to provide the appropriate amount of radiation , as recognized by Wang ([0054]).
Regarding claim 17, Sherman, Wang, and Wajih further in view of Wang teaches the system of claim 16 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the section of tubing is arranged in a coil.
However, Wang further teaches wherein the section of tubing is arranged in a coil ([0053] “In certain embodiments, the irradiated portion of a blood circuit which is a cylindrical tubing is arranged into a helical coil, having a hollow inner passage way that extends the entire way of the coil.”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the section of tubing arranged in a coil, as these prior art references are directed to treating blood. One would be motivated to do this distribute the radiation evenly within the circuit to be irradiated and to provide the appropriate amount of radiation , as recognized by Wang ([0054]).
Regarding claim 18, Sherman, Wang, and Wajih teach the system of claim 16 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein illuminating the blood with the far-red light comprises passing the blood through a section of tubing disposed between a pair of light sources.
However, Wang teaches wherein the one or more light sources comprise a pair of light sources, and wherein the section of tubing is disposed between a pair of light sources ([0053] “In certain embodiments of the present invention, electromagnetic sources are distributed spatially around the portion of a blood circuit which is subjected to electromagnetic radiation. For example, if the irradiated portion of a blood circuit is a cylindrical tubing, then the light sources are disposed on a cylindrical surface having a diameter larger than the diameter of the tubing; alternatively, the light sources are disposed directly within the cylindrical tubing and may or may not come into contact with blood directly.”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the one or more light sources comprise a pair of light sources, and wherein the section of tubing is disposed between a pair of light sources, as these prior art references are directed to treating blood. One would be motivated to do this to distribute the radiation evenly within the circuit to be irradiated and to provide the appropriate amount of radiation , as recognized by Wang ([0054]).
Regarding claim 19, Sherman, Wang, and Wajih teach the method of claim 18 (as shown above). Sherman and Wajih, alone or in combination fail to teach wherein the pair of light sources comprise a pair of light-emitting diodes.
However, Wang further teaches wherein the pair of light sources comprise a pair of light-emitting diodes ([0023] “one or more of the irradiation source are selected from the group consisting of: one or more light emitting diodes”, view Figure 1: blood irradiation means 6).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Wang to have the pair of light sources comprise a pair of light-emitting diode, as these prior art references are directed to treating blood. One would be motivated to do this to deliver the specific wavelength of light as needed.
Regarding claim 20, Sherman, Wang, and Wajih teach the system of claim 11 (as shown above). Wang teaches wherein “the electromagnetic sources emit radiation at one or more wavelengths between 500 nm and about 850 nm”. Sherman, and Wang, alone or in combination fail to teach wherein the one or more light sources are configured to emit the far-red light at a wavelength of 660 nm.
However, Wajih teaches wherein the one or more light sources are configure to emit the far-red light emitted at a wavelength of 660 nm (pg. 443, 3.1 Far red light treatment: “A “deep red” LED source (M660L4, Thorlabs, NJ) at a center wavelength of 660 nm was used to illuminate the samples”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wang to incorporate the teachings of Wajih to illuminate the blood with far-red light emitted at a wavelength of 660 nm, as these prior art references are directed to providing blood with nitrite and combined far-red light treatment. One would be motivated to do this as evidence suggests far-red (600 – 700 nm) light has positive effects including vasodilation, increased blood flow, reduction of inflammation, and releasing NO from NO containing species, as recognized by Wajih (pg. 443, 1. Introduction).
Regarding claim 23, Sherman in view of Wang and further in view of Wajih teaches the system of claim 11 (as shown above). Sherman further discloses wherein the nitrite infusion device coupled to the extracorporeal circuit is configured to infuse a nitrite solution into the blood ([0096] “ intradialytically contacting said subject's blood with a nitrite-spiked dialysate, wherein an aqueous solution comprising sodium nitrite is added to an unspiked dialysate as the unspiked dialysate flows from a dialysis machine to a dialyzer membrane”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Wajih as applied to claim 1 above, and further in view of Bowley (US Patent 4,111,659 A, previously cited), hereinafter Bowley.
Regarding claim 10, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman and Wajih, alone or in combination, fail to teach the method further comprising maintain the blood circulating through the extracorporeal circuit at a predetermined temperature using a circulating water bath.
However, Bowley teaches a heat and mass transfer device usable for cooling and oxygenating blood wherein “various devices have been introduced for the purpose of maintaining the temperature of the perfused organism within the normal physiological range. Water baths, warm air, infrared radiant energy and heating wires have been used with varying degrees of success.” (Column 4, lines 42-48).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Bowley to have the method further comprising maintain the blood circulating through the extracorporeal circuit at a predetermined temperature using a circulating water bath, as these prior art references are directed to extracorporeal circuits. One would be motivated to do this to prevent thermo injury or any damage to the red blood cells, as recognized by Bowley (Column 4, lines 48-49).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Wang in view Wajih as applied to claim 11 above, and further in view of Bowley (US Patent 4,111,659 A, previously cited), hereinafter Bowley.
Regarding claim 21, Sherman in view of Wang and further in view of Wajih teaches the system of claim 11 (as shown above). Sherman, Wang, and Wajih, alone or in combination fail to teach the system further comprising a circulating water bath configured to maintain the blood circulating through the extracorporeal circuit at a predetermined temperature.
However, Bowley teaches a heat and mass transfer device usable for cooling and oxygenating blood wherein “various devices have been introduced for the purpose of maintaining the temperature of the perfused organism within the normal physiological range. Water baths, warm air, infrared radiant energy and heating wires have been used with varying degrees of success.” (Column 4, lines 42-48).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman, Wang, and Wajih to incorporate the teachings of Bowley to have a circulating water bath configured to maintain the blood circulating through the extracorporeal circuit at a predetermined temperature, as these prior art references are directed to extracorporeal circuits. One would be motivated to do this to prevent thermo injury or any damage to the red blood cells, as recognized by Bowley (Column 4, lines 48-49).
Alternatively, Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Wajih as applied to claim 1 above, and further in view of Sullenger et al. (US 2014/0275226 A1, previously cited), hereinafter Sullenger.
Regarding claim 10, Sherman in view of Wajih teaches the method of claim 1 (as shown above). Sherman and Wajih, alone or in combination fail to teach the method further comprising maintain the blood circulating through the extracorporeal circuit at a predetermined temperature using a circulating water bath.
However, Sullenger teaches a method for controlling coagulation wherein the “extracorporeal minicircuit consisted of…a circulating water bath system” ([0143]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman and Wajih to incorporate the teachings of Sullenger to have the method further comprising maintain the blood circulating through the extracorporeal circuit at a predetermined temperature using a circulating water bath, as these prior art references are directed to extracorporeal circuits. One would be motivated to do this to prevent heat loss and to maintain the temperature at a predetermined temperature, as recognized by Sullenger ([0143]).
Alternatively, Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman in view of Wang further in view Wajih as applied to claim 11 above, and further in view of Sullenger et al. (US 2014/0275226 A1, previously cited), hereinafter Sullenger.
Regarding claim 21, Sherman in view of Wang and further in view of Wajih teaches the system of claim 11 (as shown above). Sherman, Wang, and Wajih, alone or in combination fail to teach the system further comprising a circulating water bath configured to maintain the blood circulating through the extracorporeal circuit at a predetermined temperature.
However, Sullenger teaches a method for controlling coagulation wherein the “extracorporeal minicircuit consisted of…a circulating water bath system” ([0143]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sherman, Wang, and Wajih to incorporate the teachings of Sullenger to have a circulating water bath configured to maintain the blood circulating through the extracorporeal circuit at a predetermined temperature, as these prior art references are directed to extracorporeal circuits. One would be motivated to do this to prevent heat loss and to maintain the temperature at a predetermined temperature, as recognized by Sullenger ([0143]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gladwin, Mark T., et al. "Nitrite as a vascular endocrine nitric oxide reservoir that contributes to hypoxic signaling, cytoprotection, and vasodilation." American Journal of Physiology-Heart and Circulatory Physiology 291.5 (2006): H2026-H2035. teaches the infusion of nitrite into the blood and its beneficial impacts.
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/William J Levicky/ Primary Examiner, Art Unit 3796
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