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 amendment filed 6/8/2026 has been entered:
Claims 1-2, 10-11, 58-59, 69, 95, and 121-130 remain pending in the present application. Claims 1, 58, and 95 are currently amended. Claims 3-9, 12-57, 60-68, 70-94, and 96-120 are previously canceled.
Applicant’s arguments have been acknowledged, and overcome each and every 112(a) previously set forth in the non-final office action mailed 1/9/2026. All previous 112(a) rejections have been withdrawn.
Response to Arguments
Applicant’s amendments with respect to claims 1 and 95, particularly in specifying a blood pressure parameter necessitated a new grounds of rejection. Thus, Applicant’s arguments with respect to claims 1 and 95 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.
Myrick remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
A new grounds of rejection is made in view of previously uncited portions of Spears, which is relied upon as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1, and 95.
Lee and Baker remain in the present rejection for disclosing and/or rendering obvious the remaining limitations of the claims.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “Error! Reference source not found.” Instead of referring to a preceding claim. In an effort to promote compact prosecution, claim 10 is interpreted as depending on claim 1.
Appropriate correction is required.
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 95 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick et al. (US 2013/0269416 A1), in view of Baker Jr. et al. (US 2010/0292548 A1), and Spears et al. (US 2001/0001111 A1).
Regarding claim 95, Myrick discloses a method for controlling gas enrichment therapy in a patient (device made of modules 1000, 2000, and 3000 in Fig. 2; Abstract; (¶s 63, 118, and 123-133 describe how therapy is controlled) comprising:
measuring, via one or more sensors, one or more physiological parameters of blood of the patient where gas-enriched blood is delivered to the patient (¶s 62-64, 125, and 139-141 describe further sensors, the sensors measuring parameters of blood in the blood circuit, such as bubbles within the blood, which would be where gas-enriched blood is delivered to the patient);
transmitting one or more signals to a processor (¶ 123 describes how the processor can monitor for occlusion events; ¶s 125-133 also describe bubble detection and signal processing), the one or more signals corresponding to a measured value of the one or more physiological parameters from the at least one sensor (properties of the blood being interpreted as physiological parameters) and measured where the gas-enriched blood is delivered (being within the blood circuit is interpreted as being where gas-enriched blood is delivered to the patient); and
generating, by the processor and based on the measured value, an alert through a user interface indicating a measured value of the physiological parameter indicative of an effectiveness of the gas enrichment therapy (¶s 63, 65, 118, and 123; proper fluid levels, bubbles, or occlusions would be indicative of the effectiveness of therapy; ¶ 86 indicates further alerts).
Myrick does not explicitly teach the physiological parameters being an oxygen parameter and a blood pressure parameter of blood of the patient, the processor compares a measured oxygen parameter and blood pressure parameter to one or more preprogrammed target ranges, and controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the oxygen parameter and the blood pressure parameter within the preprogrammed therapeutic target ranges.
However, Baker teaches a blood oxygen monitoring system (system 10 in Fig. 1), thus being in the same field of endeavor, comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition), and using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Myrick to compare the measured value to a preprogrammed target range, as taught by Baker. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination of Myrick, and Baker still does not explicitly teach the physiological parameters being a blood pressure parameter of blood of the patient, the processor compares a measured blood pressure parameter to one or more preprogrammed target ranges, and controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the oxygen parameter and the blood pressure parameter within the preprogrammed therapeutic target ranges.
However, Spears teaches an extracorporeal blood oxygenation apparatus (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient (monitoring devices 22 and 23 described in ¶ 47) where the controller receives one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered (¶ 47 describes how the a system shut-down can be activated) and comparing the measured value of blood pressure of the patient to one or more preprogrammed therapeutic target ranges (¶ 47) and controlling a flow rate of blood based on the measured value of the blood pressure of the patient being within the one or more therapeutic ranges (¶ 47), and which uses an aqueous oxygen carrier (¶ 32), wherein a processor controls the flow rate of blood to maintain physiological parameters (¶s 50-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and device of Myrick, Lee, and Baker to comprise the blood pressure sensors and the processor controls the flow rate of gas-enriched blood, as taught by Spears. Doing so would thus comprise measuring a blood pressure parameter of the blood of the patient where gas-enriched blood is delivered to the patient, transmitting a measured value of the blood pressure parameter from the one or more sensors and measured where the gas-enriched blood is delivered, comparing, by the processor, the measured value of the blood pressure parameter to one or more preprogrammed therapeutic range, and controlling, by the processor, at least a flow rate of gas-enriched blood based on the comparison to maintain the measured value of the blood pressure parameter within the one or more preprogrammed therapeutic target ranges.
Doing so would be advantageous in providing control to reach optimal or target values of blood oxygenation (¶s 50-51 of Spears).
Claims 1-2, 10-11, 58-59, 121-123, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Myrick, in view of Lee (US 4,717,548 A), Baker, and Spears.
Regarding claim 1, Myrick teaches a system for controlling gas enrichment therapy in a patient (device made of modules 1000, 2000, and 3000 in Fig. 2; Abstract); the system comprising:
a gas-enrichment system configured to enrich a liquid with gas to form a gas enriched liquid and to mix the gas enriched liquid with blood to form gas enriched blood (¶ 43 describes oxygen-enriched saline; also ¶ 55);
a plurality of fluid conduits fluidly coupled to the gas enrichment system (at least draw tube 2020 and return tube 2030; ¶s 69 and 123), at least one conduit of the plurality of fluid conduits configured for flow of blood from the patient to the gas enrichment system (draw tube 2020; ¶ 54), and at least one conduit of the plurality of conduits configured for flow of the gas-enriched blood from the gas enrichment system to the patient (return tube 2030; ¶s 54-56);
a blood pump coupled to at least one conduit of the plurality of fluid conduits (fluid pump 2011) for pumping blood to and from the gas enrichment system and the patient (¶s 54-56);
at least one sensor configured to measure one or more blood oxygen parameters where the gas enriched-blood is delivered to the patient (¶ 46 indicates various sensors, such as pressure sensor 2040; ¶s 62-64, 125, and 139-141 describe further sensors, the sensors measuring parameters of blood in the blood circuit which is delivered to the patient);
a user interface configured to receive user input (display module 3000) configured to receive user input and emit at least one of a visual alert and an audible alert (¶s 44, 87-89 and 123; the visual alert being provided as communications through LCD 3011); and a controller (system controller 2080) comprising:
a processor (¶ 73 indicates a microprocessor), a memory (¶s 73 and 112 indicate memory), and associated circuitry communicate coupled to the at least one sensor and the user interface (Figs. 1 and 8 best show how the sensors, user interface, and processor are connected; ¶ 73 indicates circuitry), wherein the processor is configured to:
receive one or more signals corresponding to a measured value of the one or more blood oxygen parameters from the at least one sensor at where the gas-enriched blood is delivered (¶ 123 describes how the processor can monitor for occlusion events; ¶s 125-133 also describe bubble detection and signal processing, both of which are in the blood circuit which delivers gas-enriched blood), and
generate, based on the measured value, an alert through the user interface indicative of the measured value of the blood oxygen parameter, which is indicative of an effectiveness of the gas enrichment therapy (¶s 63, 118, and 123; proper fluid levels or occlusions would be indicative of the effectiveness of therapy; ¶ 86 indicates further alerts).
Myrick does not explicitly teach the sensor being an oxygen sensor configured to measure blood oxygen in the blood of the patient; at least one blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient, and
the processor being coupled to said oxygen sensor, configured to receive one or more blood oxygen signals corresponding to a measured value of blood oxygen in the blood of the patient from the at least one oxygen sensor, receive one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered, and generating an alert based on the one or more blood oxygen signals, the processor compares a measured oxygen value and the measured value of the blood pressure of the patient to one or more preprogrammed target ranges, and controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the blood oxygen in the blood of the patient and the measured value of the blood pressure of the patient, and generating, based on the one or more blood oxygen signals and value of blood pressure, an alert through the user interface indicative of the measured value of the blood oxygen and the measured value of the blood pressure.
However, Lee teaches a blood perfusion monitoring system (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a blood oxygenation circuit with an oxygen sensor in the form of a pO2 sensor (pO2 sensing electrode described in Col. 4, lines 46-58), a processor coupled to said oxygen sensor and receives one or more blood oxygen signals corresponding to a measured value of blood oxygen in the blood of the patient from the at least one oxygen sensor (described in Col. 4, line 59 – Col. 5, line 12), and generating an alert based on the one or more blood oxygen signals (Col. 3, lines 41-54 and Col. 5, lines 49-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick to comprise the oxygen sensor and alarm of Lee. Doing so with thus comprise the device having at least one oxygen sensor configured to measure and oxygen in the blood of a patient, the processor being coupled to the oxygen sensor and configured to receive one or more blood oxygen signals, and generate, based on one or more blood oxygen signals, and alert through the user interface indicative of the measured value of the blood oxygen, which would also be indicative of an effectiveness of gas enrichment therapy. Doing so would be advantageous to allow for appropriate corrections for abnormal treatment conditions (Col. 1, lines 17-54 of Lee).
However, the combination of Myrick and Lee does not explicitly teach at least one blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient, the controller is configured to receive one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered, that the controller compares a measured value of the blood oxygen in the blood of the patient to a preprogrammed target range, and controlling, by the controller, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the blood oxygen in the blood of the patient and the measured value of the blood pressure of the patient within the preprogrammed therapeutic target range, and generating, based on the one or more blood oxygen signals and value of blood pressure, an alert through the user interface indicative of the measured value of the blood oxygen and the measured value of the blood pressure.
However, Baker teaches a blood oxygen monitoring system (system 10 in Fig. 1),thus being in the same field of endeavor, comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition), and using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Myrick and Lee to compare the measured value to a preprogrammed target range. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination of Myrick, Lee, and Baker still does not explicitly teach at least one blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient, the controller is configured to receive one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered, controlling, by the controller, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the blood oxygen in the blood of the patient and the measured value of the blood pressure of the patient within the preprogrammed therapeutic target range, and generating, based on the value of blood pressure, an alert through the user interface indicative of the measured value of the blood oxygen and the measured value of the blood pressure.
However, Spears teaches an extracorporeal blood oxygenation apparatus (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient (monitoring devices 22 and 23 described in ¶ 47) where the controller receives one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered (¶ 47 describes how the a system shut-down can be activated) and comparing the measured value of blood pressure of the patient to one or more preprogrammed therapeutic target ranges (¶ 47) and controlling a flow rate of blood based on the measured value of the blood pressure of the patient being within the one or more therapeutic ranges (¶ 47), and generating an alert indicative of the measured value of blood pressure (the system shut-down is interpreted as providing an alert), and which uses an aqueous oxygen carrier (¶ 32), wherein a processor controls the flow rate of blood to maintain physiological parameters (¶s 50-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and device of Myrick, Lee, and Baker to comprise the blood pressure sensors and the processor controls the flow rate of gas-enriched blood, as taught by Spears. Doing so would thus comprise at least one blood pressure sensor configured to measure blood pressure of the patient where the gas-enriched blood is delivered to the patient, the controller is configured to receive one or more blood pressure signals corresponding to a measured value of the blood pressure of the patient measured at where the gas-enriched blood is delivered, controlling, by the controller, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the blood oxygen in the blood of the patient and the measured value of the blood pressure of the patient within the preprogrammed therapeutic target range, and generating, based on the value of blood pressure, an alert through the user interface indicative of the measured value of the measured value of the blood pressure (particularly as Lee teaches providing an alert based on physiological parameters).
Doing so would be advantageous in providing control to reach optimal or target values of blood oxygenation (¶s 50-51 of Spears).
Regarding claim 2, Myrick further teaches the gas enrichment system configured to enrich a liquid with oxygen to form an oxygen-enriched liquid to be mixed with blood (¶ 43 indicates enriched saline).
Regarding claim 10, Myrick further teaches the gas-enrichment system comprises a cartridge (cartridge 2100; ¶s 44-46).
Regarding claim 11, Myrick further teaches the cartridge system has three chambers (Fig. 4 shows three chambers ; ¶s 55 and 61-63).
Regarding claim 58, Myrick discloses a system for controlling gas enrichment therapy in a patient (device made of modules 1000, 2000, and 3000 in Fig. 2; Abstract); the system comprising:
a gas enrichment system configured to enrich a liquid with gas to form a gas enriched liquid and to mix the gas enriched liquid with blood to form gas enriched blood (¶ 43 describes oxygen-enriched saline; also ¶ 55);
a plurality of fluid conduits fluidly coupled to the gas enrichment system (at least draw tube 2020 and return tube 2030; ¶s 69 and 123), at least one conduit of the plurality of fluid conduits configured for flow of blood from the patient to the gas enrichment system (draw tube 2020; ¶ 54), and at least one conduit of the plurality of conduits configured for flow of the gas-enriched blood from the gas enrichment system to the patient (return tube 2030; ¶s 54-56);
a blood pump coupled to at least one conduit of the plurality of fluid conduits (fluid pump 2011) for pumping blood to and from the gas enrichment system and the patient (¶s 54-56);
at least one sensor configured to measure one or more physiological parameters at where gas-enriched blood is delivered to the patient (¶ 46 indicates various sensors, such as pressure sensor 2040; ¶s 62-64, 125, and 139-141 describe further sensors, the sensors measuring parameters of blood in the blood circuit, the blood circuit being where gas-enriched blood is delivered to the patient);
a user interface configured to receive user input (display module 3000) configured to receive user input and emit at least one of a visual alert and an audible alert (¶s 44, 87-89 and 123; the visual alert being provided as communications through LCD 3011); and a controller (system controller 2080) comprising:
a processor (¶ 73 indicates a microprocessor), a memory (¶s 73 and 112 indicate memory), and associated circuitry communicate coupled to the at least one sensor and the user interface (Figs. 1 and 8 best show how the sensors, user interface, and processor are connected; ¶ 73 indicates circuitry), wherein the processor is configured to:
receive one or more signals corresponding to a measured value of the one or more physiological parameters from the at least one sensor at where gas-enriched blood is delivered to the patient (¶ 123 describes how the processor can monitor for occlusion events; ¶s 125-133 also describe bubble detection and signal processing; both of which are in the blood circuit which delivers gas-enriched blood), and
generate, based on the measured value, an alert through the user interface indicative of the measured value of the physiological parameter, which is indicative of an effectiveness of the gas enrichment therapy (¶s 63, 118, and 123; proper fluid levels or occlusions would receive indicative of the effectiveness of therapy; ¶ 86 indicates further alerts).
Myrick does not explicitly teach the sense parameters being physiological parameters in the blood of the patient, wherein the processor receives one or more signals corresponding to a measured value of said physiological parameter in the blood of the patient, and generates, based on the one or more signals and alert or the processor compares a measured value of the blood oxygen in the blood of the patient to a preprogrammed target range, and controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the one or more physiological parameters in the blood within the preprogrammed therapeutic target range.
However, Lee teaches a blood perfusion monitoring system (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a blood oxygenation circuit with sensor measuring physiological parameters in the blood of the patient (pO2 sensing electrode described in Col. 4, lines 46-58), a processor coupled to said oxygen sensor and receives one or more blood oxygen signals corresponding to a measured value of blood oxygen in the blood of the patient from the at least one oxygen sensor (described in Col. 4, line 59 – Col. 5, line 12), and generating an alert based on the one or more blood oxygen signals (Col. 3, lines 41-54 and Col. 5, lines 49-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick to comprise the oxygen sensor and alarm of Lee. Doing so with thus comprise the device having at least one sensor configured to measure one or more physiological parameters in the blood of the patient, the processor being configured to receive one or more signals corresponding to the measured physiological parameter in the blood of the patient, and generate, based on the one or more signals, and alert through the user interface. Doing so would be advantageous to allow for appropriate corrections for abnormal treatment conditions (Col. 1, lines 17-54 of Lee).
However, the combination of Myrick and Lee does not explicitly teach the processor compares a measured value of the blood oxygen in the blood of the patient to a preprogrammed target range, and controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the one or more physiological parameters within the preprogrammed therapeutic target range.
However, Baker teaches a blood oxygen monitoring system (system 10 in Fig. 1),thus being in the same field of endeavor, comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition), and using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Myrick and Lee to compare the measured value to a preprogrammed target range. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination of Myrick, Lee, and Baker still do not explicitly teach controlling, by the processor, at least one of a flow rate of gas-enriched blood or an oxygen concentration of gas enriched liquid based on the comparison to maintain the measured value of the one or more physiological parameters within the preprogrammed therapeutic target range.
However, Spears teaches an extracorporeal blood oxygenation apparatus (Fig. 1; Abstract), thus being in the same field of endeavor, which uses an aqueous oxygen carrier (¶ 32), wherein a processor controls the flow rate of blood (¶s 50-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and device of Myrick and Baker such that the processor controls the flow rate of gas-enriched blood, as taught by Spears. Doing so would thus comprise controlling the flow rate of gas-enriched blood to maintain the measured value of the physiological parameters to be within the preprogrammed therapeutic range. Doing so would be advantageous in providing control to reach optimal or target values of blood oxygenation (¶s 50-51 of Spears).
Regarding claim 59, Myrick further teaches the gas enrichment system configured to enrich a liquid with oxygen to form an oxygen enriched liquid to be mixed with blood (¶ 43 indicates enriched saline).
Regarding claim 121, Lee teaches having preprogrammed thresholds for other physiological parameters (Col. 6, lines 15-26).
The combination of Myrick and Lee do not explicitly teach the threshold being for comparing a measured value of the blood oxygen to a target value of the blood oxygen or range of target values of the blood oxygen.
However, Baker teaches a blood oxygen monitoring system (system 10 in Fig. 1),thus being in the same field of endeavor, comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition), and using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the controller of Myrick, Lee, Baker, and Spears to compare the measured value for blood oxygen to a target value or range for blood oxygen. Doing so would thus comprise the alert being generated based on comparing a measured value of the blood oxygen to a target value of the blood oxygen. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
Regarding claim 122, the combination of Myrick, Lee, Baker, and Spears substantially disclose the invention of claim 121. Myrick further teaches providing hyperbaric blood with a pO2 of greater than 760 mmHg (¶s 8, 10, and 21).
Baker also teaches the target value being blood pO2 (¶s 22 and 33).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have further modified the controller of Myrick, Lee, Baker, and Spears to specifically measure and compare pO2, as taught by Baker. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination does not explicitly teach the target value of blood pO2 being within a range of 760-1200 mmHg.
However, it would have been obvious to one having ordinary skill in the art before the
effective filing date of the claimed invention to modify pressure range of Myrick, Lee, Baker, and Spears from greater than 760mmHg to between 760 and 1200 mmHg as applicant appears to have placed no criticality on the claimed range (¶ 9 indicates this range only being “in certain implementations”; ¶s 120-123 disclose a large variety of different ranges) 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).
Regarding claim 123, the combination of Myrick, Lee, Baker, and Spears substantially disclose the invention of claim 121. Myrick further teaches providing hyperbaric blood with a pO2 of greater than 760 mmHg (¶s 8, 10, and 21).
Baker also teaches the target value being blood pO2 (¶s 22 and 33).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the controller of Myrick, Lee, Baker, and Spears to specifically measure and compare pO2, as taught by Baker. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination does not explicitly teach the target value of blood pO2 being within a range of 760-1500 mmHg.
However, it would have been obvious to one having ordinary skill in the art before the
effective filing date of the claimed invention to modify pressure range of Myrick, Lee, Baker, and Spears from greater than 760mmHg to between 760 and 1500 mmHg as applicant appears to have placed no criticality on the claimed range (¶ 9 indicates this range only being “in certain implementations”; ¶s 120-123 disclose a large variety of different ranges) 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).
Regarding claim 129, the combination of Myrick, Lee, Baker, and Spears substantially disclose the invention of claim 58.
Baker further teaches a blood oxygen monitoring system (system 10 in Fig. 1),thus being in the same field of endeavor, comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition), and using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Myrick, Lee, Baker, and Spears to compare measured value for blood oxygen to a target value or range for blood oxygen. Doing so with thus comprise the alert being generated based on comparing a measured value of the blood oxygen to a target value of the blood oxygen. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
Myrick further teaches providing hyperbaric blood with a pO2 of greater than 760 mmHg (¶s 8, 10, and 21). However, the combination does not explicitly teach a range of 760-1500 mmHg.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify pressure range of Myrick, Lee, Baker, and Spears from greater than 760mmHg to between 760 and 1200 mmHg as applicant appears to have placed no criticality on the claimed range (¶ 9 indicates this range only being “in certain implementations”; ¶s 120-123 disclose a large variety of different ranges) 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.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick, Lee, Baker, and Spears, as applied to claim 58 above, and further in view of Hansson et al. (US 2016/0270733 A1).
Regarding claim 69, Myrick does not explicitly teach the one or more physiological parameter comprises arterial blood pressure.
However, Hansson teaches a blood circuit with physiological monitoring (entirety of Fig. 1; Abstract; ¶ 2 specifies extracorporeal blood oxygenation), thus being in the same field of endeavor, which measures arterial pressure (¶s 66, 83-85, 105, and 149; Figs. 3A-C) and triggers an alarm (Abstract and ¶s 17 and 23 indicate an alarm if cardiac arrest is detected). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick, Lee, Baker, and Spears wherein one of the physiological parameters comprises arterial blood pressure. Doing so would be advantageous in minimizing the risks for extracorporeal blood circuits, particularly for cardiac arrest (¶s 4-6 of Hansson).
Claims 124-128 are rejected under 35 U.S.C. 103 as being unpatentable Myrick, Lee, Baker, and Spears, as applied to claim 121 above, and further in view of Conway et al. (US 2021/0260266 A1)
Regarding claim 124, the combination of Myrick, Lee, Baker, and Spears does not explicitly teach the target value being calculated based on a flow rate of the gas-enriched blood and an oxygen concentration of the gas-enriched liquid.
However, Conway teaches a blood gas exchanged with flow control (Figs. 1-4; Abstract), thus being in the same field of endeavor, in which blood gas targets are determined based on blood flow rate (end of ¶ 24 describes how gas partial pressures are typically maintained with gas flow rate; ¶s 26-29, and 37-41 also describe a blood flow target and a gas flow target).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick, Lee, Baker, and Spears to have the target value calculated based on a flow rate of the gas-enriched blood and an oxygen concentration of the gas-enriched blood. Doing so would be advantageous in meeting the patient’s metabolic requirements (¶s 10-11 of Conway).
Regarding claim 125, Myrick further teaches the system being designed for operate at 100 ml/min (¶ 64), which lies within the claimed range of 50-150 ml/min.
Regarding claim 126, Myrick further teaches using an oxygen-supersaturated physiological fluid (¶ 61).
Spears also teaches using an aqueous oxygen carrier having an oxygen concentration between 0.5-3 ml of O2 per milliliter of liquid carrier (¶ 32).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-enriched liquid of Myrick, Lee, Baker, and Spears, to have the oxygen concentration be between 0.5-3 ml of O2 per milliliter of liquid, as taught by Spears. Doing so would be advantageous in minimizing the amount of aqueous carrier needed to be added to the blood (¶ 12 of Spears).
The combination does not explicitly teach exactly 0.4-1.5 milliliters of oxygen per milliliter of liquid.
However, it would have been obvious to one having ordinary skill in the art before the
effective filing date of the claimed invention to modify the concentration from 0.5-3 ml of O2 0.4-1.5 ml as claimed, as applicant appears to have placed no criticality on the claimed range (¶s 120-123 provide a series of “examples” over a variety of ranges) 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).
Regarding claim 127, Myrick further teaches using an oxygen-supersaturated physiological fluid (¶ 61). However, the combination of Myrick, Lee, Baker, and Spears does not explicitly teach the oxygen concentration of the gas-enriched liquid is between a 0.4-1.5 milliliters of oxygen per milliliter of liquid (STP).
Spears also teaches having an oxygen concentration between 0.5-3 ml of O2 per milliliter of liquid carrier (¶ 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-enriched liquid of Myrick, Lee, and Baker, to have the oxygen concentration be between 0.5-3 ml of O2 per milliliter of liquid, as taught by Spears. Doing so would be advantageous in minimizing the amount of aqueous carrier needed to be added to the blood (¶ 12 of Spears).
The combination does not explicitly teach exactly 2-3 milliliters of oxygen per milliliter of liquid.
However, it would have been obvious to one having ordinary skill in the art before the
effective filing date of the claimed invention to modify the concentration from 0.5-3 ml of O2 2-3 ml as claimed, as applicant appears to have placed no criticality on the claimed range (¶s 120-123 provide a series of “examples” over a variety of ranges) 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).
Regarding claim 128, Spears further teaches the processor is configured to adjust the oxygen concentration of the gas-enriched blood based on the value of measured blood oxygen (¶s 50-51 describe how the ratio of oxygenated liquid to blood can be adjusted to control the level of blood oxygenation, and can also control blood flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick, Lee, Baker, Spears, and Conway to adjust the concentration of the gas-enriched blood based on the value of measured blood oxygen, as taught by Spears. Doing so would be advantageous in adjusting to optimal or target levels of blood oxygenation (¶ 50 of Spears)
Claim 130 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick and Lee as applied to claim 58 above, and further in view of Conway.
Regarding claim 130, Lee teaches having preprogrammed thresholds for other physiological parameters (Col. 6, lines 15-26).
As previously stated, Baker teaches comprising a sensor for pO2 (¶ 22 describes sensor 14 measuring partial pressure of arterial blood; ¶ 33 describes giving alerts in response to changes in condition). Baker also teaches using blood oxygen parameters to make adjustments to physiological parameters, specifically using a controller to maintain a narrow range of pO2 (i.e. comparing measured values to a target range and making adjustment to maintain said range; ¶ 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Myrick, Lee, Baker, and Spears to compare the measured value to a preprogrammed target range. Doing so would be advantageous in preventing medical issues associated with inappropriate oxygen levels (¶ 37 of Baker).
The combination still does not explicitly teach the target value being calculated based on a flow rate of the gas-enriched blood in an oxygen concentration of the gas-enriched liquid.
However, Conway teaches a blood gas exchanged with flow control (Figs. 1-4; Abstract), thus being in the same field of endeavor, in which blood gas targets are determined based on blood flow rate (end of ¶ 24 describes how gas partial pressures are typically maintained with gas flow rate; ¶s 26-29, and 37-41 also describe a blood flow target and a gas flow target).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Myrick and Le Myrick, Lee, Baker, and Spears e to have the target value calculated based on a flow rate of the gas-enriched blood and an oxygen concentration of the gas-enriched blood. Doing so would be advantageous in meeting the patient’s metabolic requirements (¶s 10-11 of Conway).
Conclusion
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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