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 Amendment
The amendments filed on 07/08/2025 has been entered. Claims 1, 5, 9, and 82 have been amended; claims 17-81 and 83-118 have been cancelled. Accordingly, claims 1-16, 82, and 119-121 are pending and under consideration.
Applicant’s amendments to the claims, drawing, and specification have overcome each and every objection previously set forth in the Non-final Office action mailed on 04/22/2025. Therefore, all claim objections and drawing objections are hereby withdrawn.
Response to Arguments
Applicant's arguments filed on 07/07/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks that describe the device of Folden and its use of a prime waste bag combined with primary reference Myrick on page 12-13 of Applicant’s remarks, Examiner respectfully disagrees. Folden is not relied upon for any teaching of a prime waste bag; rather, Folden is relied upon for the teaching of an operational method/technique controlled by the controller, such that one clamp is closed while another remains open during a bidirectional priming procedure. Myrick remains as the primary reference that discloses drawing blood into a blood circuit for an automated priming process. Furthermore, in response to applicant's argument that “Folden’s description of a priming process using saline and a prime waste bag does not describe or render obvious [the limitations of claim 1]” on page 12 of Applicant’s remarks, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). See rejection of claims below.
The amendments of claim 1 and claim 82 also necessitated a re-interpretation of the prior arts. See rejection of claims 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.
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 1-3, 6-8, 10, 82, 119, and 120-121 are rejected under 35 U.S.C. 103 as being unpatentable over Myrick et al. US 2010/0145248 A1 (previously cited, hereinafter Myrick) in view of Folden et al. US 2009/0076433 A1 (previously cited, hereinafter Folden).
Regarding claim 1, Myrick discloses a delivery system (Par. 20 – “a gas-enrichment system”) for delivering gas-enriched blood within a vasculature of a patient (Par. 20 – “the present invention provides a gas-enrichment system having an extracorporeal circuit for enriching a bodily fluid of a patient with a gas-enriched fluid”), the delivery system (Par. 20) configured for automated priming of a blood circuit of the delivery system (Par. 22 – “priming the extracorporeal circuit by effecting the bodily fluid to flow through the circuit... The step of priming the physiologic chamber and the gas-enrichment chamber is performed by the system automatically…”), the delivery system (Par. 20) comprising:
a blood circuit B (see annotated Fig. 1 below – blood circuit B, excluding physiologic fluid 3020), comprising:
a pump 2011 (Fig. 1 – fluid pump 2011) configured to circulate blood in the blood circuit B (see annotated Fig. 1 below, and Par. 64 – “a fluid pump assembly 2010 to operate as an automatic extracorporeal circuit that can adjust the r.p.m. (revolutions per minute) of the peristaltic pump to maintain the desired blood flow…”);
a mixing chamber 2106 (Fig. 14 – mixing chamber 2106; Examiner notes that the Par. 149 discusses that mixing chamber 2106 from Fig. 14 is a part of the cartridge device/gas-enrichment device 2100 of Fig. 1) configured to mix blood of the patient with a gas-enriched liquid to form a gas-enriched blood (Par. 149 – “This oxygen-rich saline is then introduced into the mixing chamber 2106 to be mixed with blood”);
a draw line 2020 (Fig. 1 – draw tube 2020) coupled to the mixing chamber 2106 (Fig. 14 – draw tube 2020 is connected to mixing chamber 2106) and configured to connect a catheter (Par. 184 – “The user may then connect the extracorporeal circuit by mounting the draw tube in position… and connected to the patient via a catheter”) to the mixing chamber 2106 (Fig. 1, Fig. 14, and Par. 181 – “…conducts bodily fluid from the patient through the draw line into the mixing chamber…”);
a return line 2030 (Fig. 1 – return tube 2030) coupled to the mixing chamber 2106 (Fig. 14 – return tube 2030 is connected to mixing chamber 2106) and configured to connect the catheter (Fig. 23 – infusion catheter, and Par. 148 – “…the return line 2030 is attached to the infusion catheter…”) to the mixing chamber 2106 (Fig. 1 and Fig. 14) and to interface with a second flow control mechanism 2070 (Fig. 1 – return clamp 2070); and
a controller 2080 (Fig. 1 – controller 2080) configured to control operation of the pump 2011 (Fig. 1 – controller 2080 has an arrowed line connecting to the blood pump assembly 2010 which comprises pump 2011, and Par. 115 – “the controller circuitry 2080 is a safety interlock logic block... The safety interlock 2090… stops the blood pump 2011”) and operation of the second flow control mechanisms 2070 (Fig. 1 – controller 2080 has an arrowed line connecting to the return clamp 2070, and Par. 115 – “ the controller circuitry 2080 is a safety interlock logic block… The safety interlock 2090 stops treatment by disabling powered (24V) electronics, which automatically closes the return safety clamp 2070…”) to perform priming of the blood circuit B (see annotated Fig. 1 below) while the catheter is connected to the blood circuit B (Par. 183-184 – “…priming of the extracorporeal circuit may be initiated. The user may then connect the extracorporeal circuit by mounting the draw tube in position through the pump head and connected to the patient via a catheter”), the controller 2080 (Fig. 1) configured for a direction of blood flow through the blood circuit B (see annotated Fig. 1 below – blood flows in a direction starting from the draw tube 2020 to the return tube 2030), the blood flow including drawing the blood through the return line 2030 (Fig. 1) during the priming (Fig. 1 – arrows shows flow direction flowing through the return tube 2030), and the controller 2080 (Fig. 1) configured for closure of the second flow control mechanisms 2070 to block blood flow in the return line 2030 and prevent room air and/or air bubbles from flowing to the catheter during priming (Fig. 1, and Par. 185 – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line while the return clamp 2070… are held closed. As the bodily fluid fills the chamber, hydrostatic pressure will build up in the pathway to verify that all components are properly connected with no leakage in the pathway… When a proper pressure is reached (approximately 5 psi), the vent value is opened to allow excess gas to escape”; in other words, with return clamp 2070 being closed during priming, no gas can flow into the return tube 2030 and reach the infusion catheter).
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Annotated Fig. 1 of Myrick
However, Myrick does not disclose a draw line configured to interface with a first flow control mechanism; a controller configured to control operation of the first control mechanism to perform bidirectional priming of the blood circuit, and the controller configured for alternating a direction of blood flow, the controller configured for alternating closure of the first and second flow control mechanism to alternatively block blood flow in the draw line and return line.
Folden, in the same field of endeavor of automatic prime of an extracorporeal blood circuit (Title), teaches draw line 280 (Fig. 5 – venous line 280) configured to interface with a first flow control mechanism 335 (Fig. 5 – clamp 335);
a controller 420 (Fig. 6 – controller 420) configured to control operation of the first control mechanism 335 (Fig. 6, and Par. 42 – “The controller 420 can also actuate the valves, or other occlusion devices, to cause the valves to seal off one or more tubes or lines”) to perform bidirectional priming of the blood circuit (Par. 10 – “The direction of flow of the priming fluid can be reversed in the circuit”, and Abstract describes priming of an “extracorporeal blood circuit”),
the controller 420 (Fig. 6) configured for alternating a direction of flow (Par. 41 – “…reversing the pump direction, the flow can be reversed in the circuit”, and Par. 42 – “The controller 420 is able to control the direction of the pump”), the controller configured for alternating closure of the first 335 and second flow control mechanism 330 (Fig. 5 – clamp 330, and Par. 42 – “The controller 420 can also actuate the valves, or other occlusion devices, to cause the valves to seal off one or more tubes or lines”; Fig. 5B shows closure of clamp 330, and Fig. 5C shows closure of clamp 335) to alternatively block flow in the draw line 280 and return line 210 (Fig. 5 – arterial line 210, and Par. 41 – “closing the clamp 330 on the arterial line 210 stops any fluid flow into or out of arterial line 210… closing only the clamp 335 on the venous line 280 and reversing the pump direction allows fluid to flow” ).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Myrick to further incorporate a first flow control mechanism in the draw line and incorporate the bidirectional priming performed by the controller as taught by Folden, such that the flow reversal allows for air to be removed from the circuit (Par. 6 of Folden). This bidirectional priming is done by the controller so that priming is done without the need for human manipulation (Par. 6 of Folden). Applying the known technique of bidirectional priming of Folden to the priming procedure of Myrick would yield a predictable result of removing air and gas out of the extracorporeal circuit. MPEP 2143.D.
Regarding claim 2, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising: closing the second flow control mechanism 2070 (Fig. 1 of Myrick) when causing the blood to flow in forward direction (Fig. 1 of Myrick – arrows show blood flow in one direction from draw tube 2020 to return clamp 2070, and Par. 185 of Myrick – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line while the return clamp 2070 and the vent valve 2107 of the mixing chamber are held closed”), the second flow control mechanism 2070 (Fig. 1 of Myrick) blocking blood flow in the return line 2030 (Fig. 1 of Myrick – since the return clamp 207 is placed upstream of the return tube 2030, closing the return clamp 2070 will prevent flow from entering said return tube 2030).
Regarding claim 3, Myrick in view of Folden discloses the invention of claim 2. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising: closing the first flow control mechanism 335 (Fig. 5C of Folden) and opening the second flow control mechanism 330 (Fig. 5C of Folden, and Par. 41 of Folden – “FIG. 5C, closing only the clamp 335 on the venous line 280…”) when causing the blood to flow in a reverse direction (Par. 41 of Folden – “FIG. 5C, closing only the clamp 335 on the venous line 280 and reversing the pump direction…”), the first flow control mechanism 335 (Fig. 5C of Folden) blocking blood flow in the draw line 280 (Fig. 5C of Folden – no flow towards the venous line 280, and Par. 40 of Folden – “engaging one of the clamps prevents fluid flow into or out of the respective line”).
Examiner notes that once the combination is made as discussed in claim 1, the first flow control mechanism 335 and the bidirectional/reversible priming of Folden will be incorporated into the system of Myrick. Thus, the limitation is met.
Regarding claim 6, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising:
determining that the draw line 2020 (Fig. 1 of Myrick) is primed (Par. 7 of Folden – “wherein flowing the fluid forces air out through the filter. The flowing is stopped after a quantity of fluid sufficient to fill the circuit completely has been released into the circuit and circulated and there is no longer air in the circuit”; Examiner notes that once the modification is made as discussed in claim 1, the bidirectional priming of Folden will be incorporated into the system of Myrick, including the step of determining the circuit/venous line is primed by the lack of air within the line, thus the limitation is met);
determining that the return line 2030 (Fig. 1 of Myrick) is primed (Par. 185-186 of Myrick – “At this point, the return clamp is released and the fluid is allowed to exit the return tube… the user verifies that no visible bubble is present in the exiting fluid”); and
in response to determining each of the draw line 2020 (Fig. 1 of Myrick) and the return line 2030 (Fig. 1 of Myrick) are primed (Par. 7 of Folden and Par. 185-186 of Myrick as cited above), causing circulation of blood through the catheter coupled to the draw line 2030 (Fig. 1 of Myrick; blood is already being drawn in via the draw line 2030 as discussed in Par. 184 of Myrick in claim 1 above) and the return line 2030 (Fig. 1 of Myrick, and Par. 186 of Myrick – “the user makes wet-to-wet connection between the return tube and the infusion catheter to complete the extracorporeal circuit”).
Regarding claim 7, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising:
receiving sensor data from a pressure sensor 2040 (Fig. 1 of Myrick – pressure sensor 2040; pressure sensor 2040 communicates with controller 2080 as depicted by arrowed line in Fig. 1 of Myrick), blood level sensor (Par. 185 of Myrick – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber…”); and
determining, based on the sensor data, that a priming process is successful or unsuccessful (Par. 185 of Myrick – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber until the fluid has reached a level appropriate for mixing action to commence”, and Par. 186 of Myrick – “After a small amount of bodily fluid has exited the return tube to establish a constant flow rate and pressure, the user verifies that no visible bubble is present in the exiting fluid”; in other words, the constant pressure indicates that air is no longer present, thus completing the priming process).
Regarding claim 8, Myrick in view of Folden discloses the invention of claim 7. Myrick in view of Folden further discloses wherein determining, based on the sensor data, that the priming process is successful or unsuccessful (Par. 186 of Myrick in claim 7 above) comprises:
comparing pressure data to a threshold (Par. 185 of Myrick – “When a proper pressure is reached (approximately 5 psi)…”); and
in response to determining that the pressure data satisfies the threshold, determining that the priming process is successful (Par. 185-186 of Myrick – “When a proper pressure is reached (approximately 5 psi), the vent value is opened to allow excess gas to escape… establish a constant flow rate and pressure, the user verifies that no visible bubble is present in the exiting fluid”).
Regarding claim 10, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising:
determining that a control is actuated (Par. 185 of Myrick – “the user may then begin priming the extracorporeal circuit by pressing the "priming switch"…”); and
in response to determining (Par. 185 of Myrick), causing the blood to flow in a first direction through the blood circuit B (see annotated Fig. 1 of Myrick above) through the mixing chamber 2106 (Fig. 14 of Myrick) to prime the return line 2030 (Fig. 1 of Myrick, and Par. 185 – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line”) and causing the blood to flow in a second, opposite direction (Fig. 5C of Folden, and Par. 41 of Folden – “closing only the clamp 335 on the venous line 280 and reversing the pump direction allows fluid to flow”) through the blood circuit to prime the draw line 280 (Fig. 5c of Folden).
Examiner notes that once the combination is made as discussed in claim 1, the bidirectional priming of Folden will be incorporated into the system of Myrick, including reversing the pump to move fluid in a backward direction. Thus, the limitation is met.
Regarding claim 82, Myrick discloses a method for priming of a blood circuit of a gas-enriched blood system (Par. 22 – “a method for priming an extracorporeal gas-enrichment system”), the method comprising:
performing, by a controller 2080 (Fig. 1 – controller 2080), a priming of the blood circuit B (see annotated Fig. 1 above) while a catheter is connected to the blood circuit B (Par. 183-184 – “…priming of the extracorporeal circuit may be initiated. The user may then connect the extracorporeal circuit by mounting the draw tube in position through the pump head and connected to the patient via a catheter”), the controller 2080 (Fig. 1) configured for a direction of blood flow through the blood circuit B (see annotated Fig. 1 below – blood flows in a direction starting from the draw tube 2020 to the return tube 2030)¸ the blood flow including drawing the blood through the return line 2030 (Fig. 1) during the priming (Fig. 1 – arrows shows flow direction flowing through the return tube 2030), and the controller 2080 (Fig. 1) configured for closure of second flow control mechanisms 2070 (Fig. 1 – return clamp 2070) to block blood flow in a return line 2030 (Fig. 1 – return tube 2030) and prevent room air and/or air bubbles from flowing to the catheter during priming (Fig. 1, and Par. 185 – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line while the return clamp 2070… are held closed. As the bodily fluid fills the chamber, hydrostatic pressure will build up in the pathway to verify that all components are properly connected with no leakage in the pathway… When a proper pressure is reached (approximately 5 psi), the vent value is opened to allow excess gas to escape”; in other words, with return clamp 2070 being closed during priming, no gas can flow into the return tube 2030 and reach the infusion catheter).
However, Myrick does not disclose a bidirectional priming of the blood circuit, the controller configured for alternating a direction of blood flow, and the controller configured for alternating closure of the first and second flow control mechanism to alternatively block blood flow in the draw line and return line.
Folden, in the same field of endeavor of automatic prime of an extracorporeal blood circuit (Title), teaches a bidirectional priming of the blood circuit (Par. 10 – “The direction of flow of the priming fluid can be reversed in the circuit”, and Abstract describes priming of an “extracorporeal blood circuit”), the controller 420 (Fig. 6 – controller 420) configured for alternating a direction of flow (Par. 41 – “…reversing the pump direction, the flow can be reversed in the circuit”, and Par. 42 – “The controller 420 is able to control the direction of the pump”), and the controller configured for alternating closure of the first 335 and second flow control mechanism 330 (Fig. 5 – clamp 330, and Par. 42 – “The controller 420 can also actuate the valves, or other occlusion devices, to cause the valves to seal off one or more tubes or lines”; Fig. 5B shows closure of clamp 330, and Fig. 5C shows closure of clamp 335) to alternatively block blood flow in the draw line 280 (Fig. 5 – venous line 280) and return line 210 (Fig. 5 – arterial line 210, and Par. 41 – “closing the clamp 330 on the arterial line 210 stops any fluid flow into or out of arterial line 210… closing only the clamp 335 on the venous line 280 and reversing the pump direction allows fluid to flow” ).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Myrick to further incorporate a first flow control mechanism in the draw line and incorporate the bidirectional priming performed by the controller as taught by Folden, such that the flow reversal allows for air to be removed from the circuit (Par. 6 of Folden). This bidirectional priming is done by the controller so that priming is done without the need for human manipulation (Par. 6 of Folden). Applying the known technique of bidirectional priming of Folden to the priming procedure of Myrick would yield a predictable result of removing air and gas out of the extracorporeal circuit. MPEP 2143.D.
Regarding claim 119, Myrick in view of Folden discloses the invention of claim 82. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising: closing the second flow control mechanism 2070 (Fig. 1 of Myrick) when causing the blood to flow in forward direction (Fig. 1 of Myrick – arrows show blood flow in one direction from draw tube 2020 to return clamp 2070, and Par. 185 of Myrick – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line while the return clamp 2070 and the vent valve 2107 of the mixing chamber are held closed”), the second flow control mechanism 2070 (Fig. 1 of Myrick) blocking blood flow in the return line 2030 (Fig. 1 of Myrick – since the return clamp 207 is placed upstream of the return tube 2030, closing the return clamp 2070 will prevent flow from entering said return tube 2030).
Regarding claim 120, Myrick in view of Folden discloses the invention of claim 119. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising: closing the first flow control mechanism 335 (Fig. 5C of Folden) and opening the second flow control mechanism 330 (Fig. 5C of Folden, and Par. 41 of Folden – “FIG. 5C, closing only the clamp 335 on the venous line 280…”) when causing the blood to flow in a reverse direction (Par. 41 of Folden – “FIG. 5C, closing only the clamp 335 on the venous line 280 and reversing the pump direction…”), the first flow control mechanism 335 (Fig. 5C of Folden) blocking blood flow in the draw line 280 (Fig. 5C of Folden – no flow towards the venous line 280, and Par. 40 of Folden – “engaging one of the clamps prevents fluid flow into or out of the respective line”).
Examiner notes that once the combination is made as discussed in claim 82, the first flow control mechanism 335 and the bidirectional/reversible priming of Folden will be incorporated into the method of Myrick. Thus, the limitation is met.
Regarding claim 121, Myrick in view of Folden discloses the invention of claim 82. Myrick in view of Folden further discloses wherein the controller is configured to perform operations comprising:
receiving sensor data from one or more of a pressure sensor 2040 (Fig. 1 of Myrick – pressure sensor 2040; pressure sensor 2040 communicates with controller 2080 as depicted by arrowed line in Fig. 1 of Myrick), blood level sensor (Par. 185 of Myrick – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber…”); and
determining, based on the sensor data, that a priming process is successful or unsuccessful (Par. 185 of Myrick – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber until the fluid has reached a level appropriate for mixing action to commence”, and Par. 186 of Myrick – “After a small amount of bodily fluid has exited the return tube to establish a constant flow rate and pressure, the user verifies that no visible bubble is present in the exiting fluid”; in other words, the constant pressure indicates that air is no longer present, thus completing the priming process).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden as applied to claim 1 above, and further in view of Noack US 2022/0105252 A1 (previously cited, hereinafter Noack).
Regarding claim 4, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising:
measuring, by a first pressure sensor 2040 (Fig. 1 of Myrick – pressure sensor 2040), a first pressure in the blood circuit B (see annotated Fig. 1 of Myrick above) between the pump 2011 (Fig. 1 of Myrick) and the second flow control mechanism 2070 (Fig. 1 of Myrick) in the blood circuit B (see annotated Fig. 1 of Myrick above, and Par. 72 – “The pressure in the return tube are monitored by the system via, for example, a pressure sensor 2040 coupled to the return line”) when the pump 2011 (Fig. 1 of Myrick) is causing the blood to flow in a first direction through the blood circuit B (see annotated Fig. 1 of Myrick above, and Par 185 of Myrick – “During the first stage of extracorporeal circuit priming, bodily fluid is drawn into the mixing chamber through the draw line... The pressure transducer monitors the change in pressure”);
comparing the first pressure to a threshold value (Par. 185 of Myrick – “When a proper pressure is reached (approximately 5 psi)…”; in other words, pressure in the return line has to be monitored continuously in order to determine that 5 psi is achieved).
However, Myrick in view of Folden does not currently disclose determining that the return line is primed when the first pressure exceeds the threshold value.
Noack, in the same field of endeavor of filling a blood treatment system (Abstract), teaches determining that the line is primed when the first pressure exceeds the threshold value (Par. 21 – “A delivery rate of the filling is preferably reduced as soon as the pressure in the first partial circuit… exceeds/exceed a first threshold value. The reduction of the filling can also comprise a complete stop of the filling”)..
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified controller of Myrick in view of Folden to further incorporate the concept of determining the line is primed based on a first pressure value exceeding a threshold value as taught by Noack, in order to reduce or stop the filling/priming (Par. 21 of Noack).
Regarding claim 5, Myrick in view of Folden in view of Noack discloses the invention of claim 4. However, the combination of Myrick, Folden, and Noack does not currently disclose wherein the controller is configured to perform operations comprising: measuring, by a second pressure sensor, a second pressure in the blood circuit between the pump and the first flow control mechanism in the blood circuit when the pump is causing the blood to flow in a second direction through the blood circuit; comparing the second pressure to a threshold value; and determining that the draw line is primed when the second pressure exceeds the threshold value.
Folden, in the same field of endeavor of automatic prime of an extracorporeal blood circuit (Title), teaches a second pressure 272 (Fig. 2 – pressure sensor 272) in the blood circuit 217 (Fig. 2 – region 217) between the pump 222 (Fig. 2 – reversible pump 222) and the first flow control mechanism 335 (Fig. 5 shows details of venous line 280 having the clamp 335; thus making the pressure sensor 272 positioned between the pump 222 and clamp 335) in the blood circuit 217 (Fig. 2) when the pump 222 (Fig. 2) is causing the fluid to flow in a second direction through the blood circuit (Fig. 5C shows a reversed flow direction starting from the arterial/reverse line 210).
Noack, in the same field of endeavor of filling a blood treatment system (Abstract), teaches comparing the pressure to a threshold value (Par. 21 – there is a first and second threshold value, thus indicating comparison); and determining that the line is primed when the pressure exceeds the threshold value (Par. 21 – “filling is preferably reduced as soon as the pressure in the first partial circuit and/or the transmembrane pressure exceeds/exceed a first threshold value. The reduction of the filling can also comprise a complete stop of the filling”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Myrick in view of Folden to further include a second pressure sensor between a pump a first flow control mechanism as taught by Folden, as one of ordinary skill in the art would have recognized that an additional pressure sensor can monitor the local pressure within the blood circuit. Furthermore, Myrick also discusses that “the location of the pressure sensor is not particularly limited so long as the pressure being measured correspond to the desired measurement location” in Par. 73, thus permitting the incorporation of a second pressure sensor of Folden into the Myrick’s system. Thus, the limitation “wherein the controller is configured to perform operations comprising: measuring, by a second pressure sensor, a second pressure in the blood circuit between a pump and a first flow control mechanism in the blood circuit when the pump is causing the blood to flow in a second direction through the blood circuit” is met.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified controller of Myrick in view of Folden to further incorporate the concept of determining the line is primed based on a pressure value exceeding a threshold value as taught by Noack, in order to reduce or stop the filling/priming (Par. 21 of Noack).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden as applied to claim 7 above, and further in view of Apel et al. US 2009/0230036 A1 (previously cited, hereinafter Apel).
Regarding claim 9, Myrick in view of Folden discloses the invention of claim 7. Myrick in view of Folden further discloses wherein determining, based on the sensor data, that the priming process is successful or unsuccessful (Par. 186 of Myrick in claim 7 above) comprises:
receiving, from a first blood level sensor in the mixing chamber 2106 (Fig. 14 of Myrick, and Par. 185 of Myrick – “The level sensor in the mixing chamber”), first blood level data indicating that the mixing chamber is full of blood (Par. 185 – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber until the fluid has reached a level appropriate for mixing action to commence”);
receiving, from a bubble trap 2060 (Fig. 1 – bubble detector 2060), second data (Fig. 1 of Myrick– the bubble detector 2060 communicates with the controller 2080 as depicted by the arrowed line in Fig. 1); and
in response to receiving the first blood level data, determining that the priming process is successful (Par. 185 of Myrick – “The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber until the fluid has reached a level appropriate for mixing action to commence. At this point, the return clamp is released and the fluid is allowed to exit the return tube. After a small amount of bodily fluid has exited the return tube… the user verifies that no visible bubble is present in the exiting fluid”).
However, Myrick in view of Folden does not explicitly disclose a second blood level sensor in a bubble trap, second blood level data indicating that the bubble trap is full of blood; and in response to receiving the second blood level data, determining that the priming process is successful.
Apel, in the same field of endeavor of filling of the blood side of a hemodialysis apparatus (Abstract), teaches a blood level sensor (Par. 22 – “detected by a filling level measurement in the chamber 44” and Claim 5 – “a level sensor coupled to the chamber”) in a bubble trap 44 (Fig. 2 – chamber 44, and Par. 2 – “It is already known to provide air separators formed as chambers”), second level data indicating that the bubble trap 44 (Fig. 2) is full of liquid (Claim 5 – “the complete escape of the air takes place by the detection of the filling level by means of a level sensor coupled to the chamber”);
and in response to receiving the second blood level data (Claim 4 – measurement of filling level), determining that the priming process is successful (Claim 5 – “the complete escape of the air takes place by the detection of the filling level by means of a level sensor coupled to the chamber”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Myrick in view of Folden to further incorporate a second blood level sensor as taught Apel, in order to inform of a complete escape of air/filling process when the filling level is met (Claim 5 of Apel).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden as applied to claim 1 above, and further in view of Volkar et al. US 2020/0038580 A1 (previously cited, hereinafter Volkar).
Regarding claim 11, Myrick in view of Folden discloses the invention of claim 1. However, Myrick in view of Folden does not disclose wherein the controller is configured to perform operations comprising: generating a data log comprising operational data that describes a bidirectional priming of the blood circuit.
Volkar, in the same field of endeavor of priming operation of patient lines (Title and Par. 8), teaches wherein the controller 900 (Fig. 6 – control device 900) is configured to perform operations comprising:
generating a data log comprising operational data that describes a priming of the circuit (Par. 103 – “the electronic control device 900 may be configured to continuously collect data and generate a log of all priming operations to track the replacement, or lack thereof, of the SUDS 190 with each priming operation”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Myrick in view of Folden to further generate a data log of priming operation as taught by Volkar, so that said data can be cross-reference with against a staff schedule to determine the work practices of individual users (Par. 103 of Volkar). The data log allows and enforces compliance with safe practices (Par. 103 of Volkar).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden in view of Volkar as applied to claim 11 above, and further in view of Zafiris US 2020/0316280 A1 (previously cited, hereinafter Zafiris).
Regarding claim 12, Myrick in view of Folden in view of Volkar discloses the invention of claim 11. The combination of Myrick, Folden, and Volkar further discloses wherein the controller 2080 (Fig. 1 of Myrick) is configured to perform operations comprising: detecting that the bidirectional priming (Par. 42 of Folden; Examiner notes that once the combination is made as discussed in claim 1, the reversible flow direction of Folden is incorporated within the device of Myrick) of the blood circuit is completed (Par. 185 of Myrick – “When a proper pressure is reached (approximately 5 psi), the vent value is opened to allow excess gas to escape. The level sensor in the mixing chamber continues to monitor the level of the bodily fluid in the chamber until the fluid has reached a level appropriate for mixing action to commence”; in other words, the controller 2080 control monitoring of the pressure sensor and level sensor to stay informed on the status of priming).
However, the combination does not disclose in response to detecting, sending the data log to a remote storage comprising cloud storage.
Zafiris, in the same field of endeavor of priming of a medical fluid delivery device (Abstract), teaches wherein the controller 120 (Fig. 1 – processor 120) is configured to perform operations comprising: in response to detecting (Par. 67 – “indication of priming”), sending the data log to a remote storage comprising cloud storage (Par. 67 – “the processor 120 to… transmit dialysis therapy status information to a remote or centralized server via a network (e.g., the Internet). In an embodiment, the processor 120 may create a data structure or log that includes an indication of priming…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the combination to further include sending a data log to a remote storage as taught by Zafiris, as one of ordinary skill in the art would have appreciated operational reports stored and saved so that clinicians can review when necessary.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden in view of Volkar as applied to claim 11 above, and further in view of Tiwari et al. US 2019/0287668 A1 (previously cited, hereinafter Tiwari).
Regarding claim 13, Myrick in view of Folden in view of Volkar discloses the invention of claim 11. The combination of Myrick, Folden, and Volkar does not disclose wherein the controller is configured to perform operations comprising: receiving a query for data describing operation of a pump, a pressure sensor, a temperature sensor, the first flow control mechanism on the draw line, or the second flow control mechanism on the return line; and in response to receiving the query, sending at least a portion of the data log to a remote device.
Tiwari, in the same field of endeavor of fluid delivery system (Par. 18), teaches wherein the controller 114 (Fig. 1A – connectivity agent 114) is configured to perform operations comprising: receiving a query for data (Fig. 1 and Par. 152 describes that connectivity agent 114 allows connection to the connectivity server 118; said server 118 is communicative to web portal 150 from which clinicians can select to view reports from machine 100; Par. 153 – “The connectivity agent 114 allows the renal therapy machine 100 to connect to connectivity server 118 and transfer data to and from the connectivity server 118”) describing operation of a pump (Par. 264 – “an example device prescription history report 2500 displayed on a clinician's display device 192. The device prescription history report allows the clinicians to view… maximum positive and negative pump pressures 2516 and 2518”), a pressure sensor (Par. 258 – “ reports that are presented to a clinician at web portal 150 displayed on a clinician's display device 192…an example patient treatment history report 1900 displayed on a clinician's display device 192 that allows the clinician to view the history of the treatment for a patient… including… the average systolic diastolic blood pressure before treatment 1910, the average systolic diastolic blood pressure after treatment 1912…”); and
in response to receiving the query sending at least a portion of the data log to a remote device 150 (Fig. 1 – web portal 150, and Par. 160 – “web portal 150 is a portal for clinicians and patients to access the website and system hub 120.. The system hub 120 scans through the renal therapy machine 100 log files to display the treatment data to a clinician through the web portal 150”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the combination to further allow receiving a query regarding operational data and send said data to a remote device as taught by Tiwari, in order to allow clinician’s access to the device and device treatment from anywhere they can access the internet (Par. 160 of Tiwari). This allows remote supervision over the delivery system to ensure proper settings of the device without in-person troubleshooting.
Regarding claim 14, Myrick in view of Folden in view of Volkar discloses the invention of claim 11. The combination of Myrick, Folden, and Volkar does not disclose wherein the controller is configured to perform operations comprising: determining that a value included in the data log is outside an expected range for that value; and generating data indicating that an error occurred during the bidirectional priming of the blood circuit.
Tiwari, in the same field of endeavor of fluid delivery system (Par. 18), teaches wherein the controller 112 (Fig. 1 – primary control processor ACPU 112) is configured to perform operations comprising:
determining that a value included in the data log is outside an expected range for that value (“ACPU 112… of renal therapy machine 100 walk the patient through the entire treatment process and instruct the patient... The instructions are according to a doctor's prescription and provide parameters by which machine 100 operates, such as the blood flowrate… Renal therapy machine 100 performs a treatment and records that the treatment has been performed according to the parameters”); and
generating data indicating that an error occurred during the treatment of the blood circuit (Par. 143 – “Errors, alerts, alarm conditions and whether or not treatment steps have been successfully performed are recorded”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the combination to have incorporate the operational concept of generation data of an error based on value outside the expected range in the data log as taught by Tiwari, in order to record said information into log files (Par. 143 of Tiwari) and allow service technician to investigate and retrieve said log files to determine the cause of the error (Par. 156 of Tiwari). Once the modification is made as discussed, said operational concept of Tiwari will be incorporated into the priming process of the combined device; thus, the data indicating an error will be with respect to the priming of the blood circuit. MPEP 2143.I.D. Thus, the limitation of “generating data indicating that an error occurred during the bidirectional priming of the blood circuit” is met.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden as applied to claim 1 above, and further in view of Myrick et al. US 2013/0294189 A1 (previously cited, hereinafter Myrick’).
Regarding claim 15, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the gas-enriched blood is formed by mixing the blood with oxygen-enriched liquid (Par. 20 of Myrick– “mixing the gas-enriched physiologic fluid with the bodily fluid of the patient”).
However, Myrick in view of Folden does not disclose oxygen-enrich liquid having a dissolved 02 concentration of 0.1 - 6 ml 02/ml liquid.
Myrick’, in the same field of endeavor of gas-enrichment of a flowing liquid (Title), teaches oxygen-enriched liquid having a dissolved 02 concentration of 0.5 and 3 ml 02/ml liquid (Par. 33 – “gas-enriched liquid is oxygen-supersaturated liquid that contains a dissolved oxygen concentration… between 0.5 and 3 ml O.sub.2/ml solvent”; Examiner notes that the working range of Myrick’s is fully within the claimed range of 0.1 – 6 ml 02/ml liquid, thus Myrick’ anticipates the claim limitation).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oxygen-enriched liquid of Myrick in view of Folden to have a dissolved 02 concentration of 0.5 and 3 ml 02/ml liquid as taught by Myrick’, in order to provide an oxygen therapy with higher oxygen concentration than conventional means (Par. 11 of Myrick’).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick in view of Folden as applied to claim 1 above, and further in view of Gipson US 2020/0188571 A1 (previously cited, hereinafter Gipson).
Regarding claim 16, Myrick in view of Folden discloses the invention of claim 1. Myrick in view of Folden further discloses wherein the gas-enriched blood is oxygen-enriched blood (Par. 71 of Myrick – “As the patient's blood mixes with the oxygen-supersaturated physiologic solution, oxygen-enriched blood is created”).
However, Myrick in view of Folden does not disclose having an elevated pO2 of 600-1500 mmHg.
Gipson, in the same field of endeavor of oxygenating a fluid (Par. 12), teaches oxygen-enriched blood having an elevated pO2 of 100-700 mmHg (Par. 51 – “forming a combined fluid; wherein the concentration of oxygen in the combined fluid is… preferably 100 to 700 mmHg”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oxygen-enrich blood of Myrick in view of Folden to have a partial pressure of dissolved oxygen of 100-700 mmHg as taught by Gipson, in order to oxygenate a fluid, such as blood (Par. 12 of Gipson) during heart operations (Par. 3 of Gipson).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the partial pressure level of the combination, from between 100 and 700 mmHg to 600 and 1500 mmHg, as Applicant appears to have placed no criticality on the claimed range (see Par. 141 of Applicant’s PG-PUB), and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Gipson would not operate differently with the claimed range because the claimed range overlaps the working range of Gipson.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ahmadi et al. US 2023/0355854 A1
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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