DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/5/2025 has been entered.
Claim Status
Claims 1-2, 10-11, 58-59, 69, 95, and 121-130 remain pending in the present application. Claims 1, 58, 95, and 130 are currently amended. Claims 3-9, 12-57, 60-68, 70-94, and 96-120 are previously canceled.
Withdrawn Objections/Rejection
Applicant’s amendments have been acknowledged, and overcome each and every objection previously set forth in the final office action mailed 8/7/2025. All previous objections have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 10-11, 58-59, 69, 95, and 121-130 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 58, and 95 have been amended to recite control of “at least one of a flow rate of the gas-enriched blood or an oxygen concentration of the gas-enriched liquid”.
However, Applicant’s specification appears to only recite control of the flow of oxygen enriched saline and/or the concentration of O2 in saline. Thus, the controller controlling flow rate of the gas-enriched blood does not appear supported.
The remaining claims are rejected via their respective dependencies on the independent claims. Appropriate correction is required, i.e., to amend to the claims to recite limitations that are supported by Applicant’s application as filed, or to point out where the limitations are supported by the Application as filed.
Response to Arguments
Applicant’s amendments with respect to claims 1, 58, and 95, particularly in specifying controlling of flow rate of gas-enriched blood or oxygen concentration of gas-enriched liquid, necessitated a new grounds of rejection. Thus, Applicant’s arguments with respect to claims 1, 58, and 95have 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.
Spears was previously presented but is now introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1, 58, and 95.
Lee and Baker remains in the present rejection for disclosing and/or rendering obvious the remaining limitations of the claims.
Additionally, although not relied upon for this particular matter, Conway appears to also teach adjusting the concentration of oxygen in a gas-enriched liquid.
Applicant’s arguments that it would not have been obvious to have modified the device of Myrick to comprise oxygen sensors and the alarm of Lee has been considered, but is not found persuasive.
Applicant also argues that Lee is directed to detecting abnormal conditions, while Myrick uses a highly oxygen-enriched saline solution. Thus, applying Lee’s detection and control circuits to Myrick would result in Lee’s system detecting abnormal conditions.
However, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. See MPEP 2141.03 (I), which relates to the Level of Ordinary Skill in the Art.
In the instant case, one of ordinary skill in the art would understand how to adapt the programming of Lee to the expected conditions of Myrick, particularly as the general concept of monitoring and maintaining desired therapeutic conditions is widespread throughout the medical arts and in the concepts of general automation. In fact, Lee explicitly states signal ranges and thresholds are set by an operator (Col. 6, lines 18-22).
Further, Lee describes concerns with acid-base disorders. There is no indication or evidence of record that the therapy of Myrick would cause such conditions.
Applicant’s arguments regarding the dependent claims are moot as claims 1, 58, and 95 remain rejected as set forth 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.
Claims 1-2, 10-11, 58-59, 121-123, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Myrick et al. (US 2013/0269416 A1), in view of Lee (US 4,717,548 A), Baker Jr. et al. (US 2010/0292548 A1), and Spears et al. (US 2001/0001111 A1).
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 (¶ 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);
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 (¶ 123 describes how the processor can monitor for occlusion events; ¶s 125-133 also describe bubble detection and signal processing), 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, 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, and generating an alert based on the one or more blood oxygen signals, the processor compares a measured oxygen value 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, 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 that 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 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 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 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 (¶ 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);
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 (¶ 123 describes how the processor can monitor for occlusion events; ¶s 125-133 also describe bubble detection and signal processing), 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 be 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 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 modified the controller of Myrick and Lee 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 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 and Baker 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 and Baker 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).
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Myrick, in view of Baker, and Spears.
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 (¶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);
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
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 processor compares a measured oxygen value 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 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 and Baker still does 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).
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781