DETAILED ACTION
Primary Examiner acknowledges Claims 1-15 are pending in this application as originally filed on April 18, 2024.
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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the abstract, filed on April 18, 2024, includes legal phraseology by the use of the word “means”. Appropriate clarification and correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 1, Lines 9, 12, 14, and 16; Claim 2, Line 2; and Claim 4, Line 3 recite “the main solenoid valve”; however, this limitation lacks antecedent basis in the claims. It appears this limitation should recite “the at least one main solenoid valve” to refer back to the introduction of this term in Claim 1, Line 3. Dependent claims, Claims 3 and 5-15, incorporate the indefinite subject matter from which they depend. Appropriate clarification and correction is required.
Specifically, Claim 1, Line 3 recites the term “flow rate control means”; however the breadth and scope of this limitation is unclear. Primary Examiner presumes by the use of the word “means” without the “means plus function” limitation, Applicant IS NOT attempting to invoke 112(6/f). Dependent claims, Claims 2-15, incorporate the indefinite subject matter from which they depend. Explicitly, Claim 11 positively recites the terms “flow rate control means” and “secondary flow rate control means”. Appropriate clarification and correction is required.
Specifically, Claim 1, Lines 5 and 16 recite the term “operating means”; however the breadth and scope of this limitation is unclear. Primary Examiner presumes by the use of the word “means” without the “means plus function” limitation, Applicant IS NOT attempting to invoke 112(6/f). Dependent claims, Claims 2-15, incorporate the indefinite subject matter from which they depend. Explicitly, Claims 2, 4-6, 8, 12, and 15 positively recite the term “operating means”. Appropriate clarification and correction is required.
Specifically, Claim 15, Line 6 recites the limitation “typically” which appears to be indefinite as it is unclear whether the limitations following the phrase are a part of the claimed invention. Appropriate clarification and correction is required.
Specifically, Claim 15, Line 6 recites the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate clarification and correction is required.
Specifically, Claim 15, Line 12 recites the term “NO delivery device”; however, this recitation appears to lack antecedent basis in the claims. In Claim 15, Line 3, there is the recitation of “an apparatus for supplying NO”. The terms “apparatus” and “device” are distinct. Appropriate clarification and correction is required.
Claim Rejections - 35 USC § 103
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 1-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bathe et al. (5,558,083) in view of Taube (2021/0128032).
As to Claims 1 and 2, Bathe discloses an apparatus (Figure 1) for supplying NO (“Nitric Oxide Delivery System” Title), comprising: a main gas circuit (defined by the flow of gas from 10 to 42, wherein 10 – “In the FIG. 1, a supply of nitric oxide is provided in the form of a cylinder 10 of gas.” Column 3, Lines 40-60, “Suffice at this point is to state that the proportional control valve 18 provides a predetermined flow of nitrogen through a suitable conduit into the conduit to be mixed with the NO/nitrogen gas from cylinder 10 and which then enters the shutoff valve 14.” Column 4, Lines 1-15, “For example, the cylinder 10 may be supplying a concentration of nitric oxide that is too high for the particular flows in the system and therefore the concentration may be reduced to a more desirable level. If, of course, the supply of nitric oxide from cylinder 10 is suitable for the particular application, the addition of supplemental nitrogen is unnecessary.” Column 4, Lines 10-25; and wherein 42 – “The patient limb 40, obviously, leads to the patient indicated by the block 42.” Column 5, Lines 1-15) for conveying an NO/N2 gaseous mixture (10, “Suffice at this point is to state that the proportional control valve 18 provides a predetermined flow of nitrogen through a suitable conduit into the conduit to be mixed with the NO/nitrogen gas from cylinder 10 and which then enters the shutoff valve 14.” Column 4, Lines 1-15), flow rate control means (via operation of 24, “A further proportional control valve 24 is positioned with suitable conduit to receive the NO/nitrogen gas from the purge valve 20. Typical of such proportional control valves for both the proportional control valve 18 in the nitrogen supply system and the proportional control valve 24 in the NO/nitrogen stream may be obtained commercially from various companies, including MKS Instruments, Inc. of Andover, Mass. and which provide electronic control of gases.” Column 4, Line 35-50; “A flow sensor 26 is located in the downstream conduit from proportional control valve 24 and senses the flow from such valve.” Column 4, Lines 50-60; “A further inlet 44 is formed in the delivery adaptor 28 and which receives the NO/nitrogen gas from the proportional control valve 24 through flow sensor 26.” Column 5, Lines 10-25) comprising at least one main solenoid valve (24, “A flow sensor 26 is located in the downstream conduit from proportional control valve 24 and senses the flow from such valve.” Column 4, Lines 50-60) arranged on the main gas circuit (defined by the flow of gas from 10 to 42), and operating means (56, “ A signal processing means, such as a CPU 56 is provided to solve certain equations and algorithms to operate the nitric oxide delivery system. CPU 56 receives a signal from an input device 58 indicative of the concentration the user desires to be administered to the patient. CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64. Another input to CPU 56 is provided by the NO sensor 65 through signal line 67. The NO sensor 65 senses the concentration of NO in the supply cylinder 10 so that the user can verify that the proper supply is being utilized or, alternatively, the CPU 56 may use that input to adjust the system to adapt for any concentrations of NO in the supply within certain limits. … Control signals are transmitted from CPU 56 to proportional control valve 18, shutoff valve 14, purge valve 20, and proportional valve 24 via signal lines 66, 68, 70, and 72 respectively.” Column 5, Line 55 thru Column 6, Line 20) configured to control the at least one main solenoid (24) in order to control the flow rate (“CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64.” Column 5, Line 60 thru Column 6, Line 5; “As the gas is delivered from the gas delivery system, its flow is sensed by the flow transducer 46 in delivery adapter 28 and a signal is transmitted indicative of that flow to the CPU 56.” Column 6, Lines 20-30; “As can be seen, the CPU 56 has sufficient information to carry out the proper calculations, that is, it knows the flow of breathing gas from the gas delivery device by means of flow transducer 46 (Q.sub.i,) and the concentration of NO in the NO/nitrogen supply by means of NO sensor 65 (.gamma..sub.NOcut). With that information, CPU 56 can calculate the desired flow (Q.sub.del) from the proportional control valve 24 that needs to be provided to the confluence 50 to mix with the gas from the gas delivery system to produce the desired or set concentration (.gamma..sub.NOset) established by the user through input device 58.” Column 6, Lines 40-55; “By this equation, the CPU 56 can make extremely rapid, such as 20 millisecond, changes to the flow delivered from proportional control valve 24 (Q.sub.del) in order to maintain the concentration of the flow delivered to the patient at the desired level as determined by the user (.gamma..sub.set).” Column 6, Line 60 thru Column 7, Line 15; “By knowing the flow from the gas delivery system by means of flow transducer 46 and the concentration of NO in the main supply from NO sensor 65, a derivation is made by the CPU 56 and the proportional control valve 24 is adjusted to provide then calculated flow of NO/nitrogen to arrive at the desired concentration set by the user in the breathing gas actually administered to the patient.” Column 7, Lines 45-55) of NO/N2 gaseous mixture (10) passing through the at least one main solenoid (24), characterized in that: the at least one main solenoid valve (24) is a proportional solenoid valve (“proportional control valve 24 … the valve may be a digital controlled valve rather that analog and which is controlled by timing its on/off cycles to effect the desired flow through the proportional control of flow therethrough.” Column 4, Lines 35-50; “Control signals are transmitted from CPU 56 to proportional control valve 18, shutoff valve 14, purge valve 20, and proportional valve 24 via signal lines 66, 68, 70, and 72 respectively.” Column 6, Lines 15-20; “By knowing the flow from the gas delivery system by means of flow transducer 46 and the concentration of NO in the main supply from NO sensor 65, a derivation is made by the CPU 56 and the proportional control valve 24 is adjusted to provide then calculated flow of NO/nitrogen to arrive at the desired concentration set by the user in the breathing gas actually administered to the patient.” Column 7, Lines 40-56) and is configured to function in a given operating range (“to arrive at the desired concentration”), and the operating means (56) are configured to control the at least one main solenoid (24) in a pulsed mode (“breath-by-breath basis”; “As an alternate, the system may operate on a breath-by-breath basis, that is, the system can take a reading of the flow, or a portion thereof, from the gas delivery system at each breath and calculate the desired flow of NO/nitrogen for delivery at the next breath. Although such delivery is less rapid than the instantaneous equation, slower flow transducers and control valves may by employed and thus less expensive components used in the system. … With the breath-by-breath analysis, however, the flow transducer 46 may detect the start and end of a breath, or selected portion thereof, integrate to determine the total or fixed selected volume of the breath, and adjust the proportional control valve 24 to provide the set or desired concentration of NO at the next breath.” Column 7, Lines 10-35) so as to deliver successive gas pulses.
Yet, Bathe does not expressly disclose the “degrees of opening between 0 and 100%”, “a first operating range corresponding to degrees of opening of the main solenoid valve (42) of between 0 and x% where: 0 < x% ≤ 10%” nor “a second operating range corresponding to degrees of opening of the main solenoid valve (42) > x%”.
Taube teaches the operation of proportional valves to have degrees of opening and different operational ranges was known. Explicitly, Taube teaches “The term “proportional solenoid valve” or simply “proportional solenoid” is used to refer to a type of solenoid valve device in which two or more gasses from two or more inputs can be controlled in a manner that allows each input to be directed to the output proportionally so that, for example, one input may be set to 30% of full flow while the other input may be set to 70% full flow. This proportionality can be controlled either by signals that cause the valves to open and close in proportion to one another, or by signals that individually select the degree to which each valve is open or closed.” (Para 0035). In operation of a proportional valve, Taube teaches the valve can be set from 0 to 100% degrees of “full flow”, whereby the specific valuation can be selected to control the operation of the valve.
Consequently, considering the teachings of Taube to modify Bathe, the at least one main solenoid valve (24) of Bathe can be set to the various degrees of “full flow” to control the opening of the proportional valve in order to control the desired concentration of NO delivered to the patient.
Although Bathe as modified by Taube does not expressly disclose one operating value of between 0 and 10% and another operating value of greater than 10%, the specific valuations are obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired concentration of NO to be delivered to the patient.
As Applicant has not asserted the specific valuation of less than 10% and greater than 10% provide a particular advantage, solve a stated problem or serve a particular purpose, the use of the specific valuation appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Bathe, as the specific valuation of operating degrees would yield the predictable results of permitting the ability of the desired concentration of NO to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the at least one main solenoid valve of Bathe to operate at the operational values of between 0 and 10% and greater than 10%, a known result effective variable in order to achieve the desired concentration of NO to be delivered to the patient.
As to Claim 3, the modified Bathe, specifically Taube teaches the operational values of between 0 and 10% and greater than 10% were known in order to achieve the desired concentration of NO to be delivered to the patient.
Yet, the modified Bathe does not expressly disclose the operational ranges to be between 0 and 5%.
Although Bathe as modified by Taube does not expressly disclose one operating value of between 0 and 5% and another operating value of greater than 5%, the specific valuations are obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired concentration of NO to be delivered to the patient.
As Applicant has not asserted the specific valuation of less than 5% and greater than 5% provide a particular advantage, solve a stated problem or serve a particular purpose, the use of the specific valuation appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Bathe, as the specific valuation of operating degrees would yield the predictable results of permitting the ability of the desired concentration of NO to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the at least one main solenoid valve of Bathe to operate at the operational values of between 0 and 5% and greater than 5%, a known result effective variable in order to achieve the desired concentration of NO to be delivered to the patient.
As to Claim 4, the modified Bathe, specifically Bathe discloses the operating means (56) is configured to fix or adjust a duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35) or amplitude (“inspired tidal volume of gas (V.sub.t,insp.)” Column 7, Lines 10-35) of each gas pulse delivered in the pulse mode (“breath-by-breath basis”), in order to control the flow rate (“By this equation, the CPU 56 can make extremely rapid, such as 20 millisecond, changes to the flow delivered from proportional control valve 24 (Q.sub.del) in order to maintain the concentration of the flow delivered to the patient at the desired level as determined by the user (.gamma..sub.set).” Column 6, Line 60 thru Column 7, Line 15; “By knowing the flow from the gas delivery system by means of flow transducer 46 and the concentration of NO in the main supply from NO sensor 65, a derivation is made by the CPU 56 and the proportional control valve 24 is adjusted to provide then calculated flow of NO/nitrogen to arrive at the desired concentration set by the user in the breathing gas actually administered to the patient.” Column 7, Lines 45-55) of the gas passing through the at least one main solenoid valve (24).
As to Claim 5, the modified Bathe, specifically Bathe discloses the operating means (56) is configured to adjust a pulse duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35) of each pulse by controlling the duration (operation of the valve 24) of opening the proportional solenoid valve (24).
As to Claim 6, the modified Bathe, specifically Bathe discloses the operating means (56) is configured to adjust a pulse duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35) of each pulse by controlling the amplitude (“inspired tidal volume of gas (V.sub.t,insp.)” Column 7, Lines 10-35) of each pulse by controlling the degree of opening of the proportional solenoid valve (24).
As to Claim 7, the modified Bathe, specifically Bathe discloses the duration of opening of the proportional solenoid valve (24) proportional solenoid valve (24) is between 5 and 200 msec – explicitly 20 milliseconds (“By this equation, the CPU 56 can make extremely rapid, such as 20 millisecond, changes to the flow delivered from proportional control valve 24 (Q.sub.del) in order to maintain the concentration of the flow delivered to the patient at the desired level as determined by the user (.gamma..sub.set).” Column 6, Line 60 thru Column 7, Line 15).
As to Claim 8, the modified Bathe, specifically Bathe discloses the operating means (56) is configured to control the proportional solenoid valve (24) to deliver successive gas pulses (“breath-by-breath basis”) in which each gas pulse has a non-zero pulse duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35) during which the proportional solenoid valve (24) is in a partially open position with a degree of opening, such that less than 10%, so as to allow a given quality of NO/N2 mixture (via 10) to pass through during the pulse duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35).
As to Claim 9, the modified Bathe, specifically Bathe discloses pulse time period of each gas pulse is a non-zero pulse duration (“time of inspiration (t.sub.insp.)” Column 7, Lines 10-35).
As to Claim 10, the modified Bathe, specifically Bathe discloses the duration of opening of the proportional solenoid valve (24) is between 5 and 200 msec – explicitly 20 milliseconds (“By this equation, the CPU 56 can make extremely rapid, such as 20 millisecond, changes to the flow delivered from proportional control valve 24 (Q.sub.del) in order to maintain the concentration of the flow delivered to the patient at the desired level as determined by the user (.gamma..sub.set).” Column 6, Line 60 thru Column 7, Line 15).
As to Claim 15, Bathe discloses an installation for supplying NO (“Nitric Oxide Delivery System” Title) to a patient (42, “The patient limb 40, obviously, leads to the patient indicated by the block 42.” Column 5, Lines 1-15), comprising at least one source (10, “Suffice at this point is to state that the proportional control valve 18 provides a predetermined flow of nitrogen through a suitable conduit into the conduit to be mixed with the NO/nitrogen gas from cylinder 10 and which then enters the shutoff valve 14.” Column 4, Lines 1-15) of NO/N2 mixture, a medical ventilator (via 30, “Delivery adaptor 28 is preferably a one piece reusable device and which has an inlet 30 which receives the gas delivered from the gas delivery system. As indicated, that gas delivery system may be a mechanical means providing a varying flow such as a ventilator, may be gas continuously supplied by a gas proportioning device for spontaneous ventilation or may be gases supplied to a bag for manual ventilation.” Column 4, Line 60 thru Column 5, Line 5; “In the operation of the present NO delivery system, therefore, the inlet 30 is connected to a gas delivery system, whether that gas delivery system is a mechanical ventilator or gas proportioning device or other means of supplying a breathing gas to a patient.” Column 6, Lines 20-30) configured to supply a respiratory gas containing oxygen (“a certain concentration of oxygen”, “Accordingly, the flow from the gas delivery means enters the inlet 30 at a flow rate Q.sub.i and at a certain concentration of oxygen .gamma.O.sub.2i and is mixed in the main passage of delivery adapter 28 with the NO/nitrogen gas from proportional control valve 24 at confluence 50.” Column 5, Lines 30-45), a patient circuit (28, “The delivery adaptor 28 has a main passage 32 therethrough and which receives the gas from the gas delivery device through inlet 30 for delivery to a patient. The gas actually delivered to the patient is transmitted via a patient wye piece 34 having an inspiratory limb 36 and an expiratory limb 38 of conventional design. The patient limb 40, obviously, leads to the patient indicated by the block 42.” Column 5, Lines 1-15) to which the at least one source of NO/N2 mixture (10) and the medical ventilator (via 30) for supplying the patient circuit (34 via 40) with NO/N2 gaseous mixture (via 10) and respiratory gas containing oxygen (“a certain concentration of oxygen” via 30), respectively are fluidly connected, and a flow rate sensor (46, “As can be seen from FIG. 1, a flow transducer 46 is also included in the delivery adapter 28 and which detects the flow of gas from the gas delivery system. The inlet 44 is positioned downstream in the delivery adapter 28 from flow transducer 46. Flow transducer 46 may be of a variety of technologies, including pneumotach, hot wire anemometer, thermal flow sensor, variable orifice, thermal time-of-flight, rotating vane and the like. Included, obviously, are flow transducers that actually measure pressure, such as a pressure drop though an orifice, in order to determine flow.” Column 5, Lines 10-25) arranged on the patient circuit (28) and configured to determine and supply the operating means (56, “A signal processing means, such as a CPU 56 is provided to solve certain equations and algorithms to operate the nitric oxide delivery system. CPU 56 receives a signal from an input device 58 indicative of the concentration the user desires to be administered to the patient. CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64. Another input to CPU 56 is provided by the NO sensor 65 through signal line 67. The NO sensor 65 senses the concentration of NO in the supply cylinder 10 so that the user can verify that the proper supply is being utilized or, alternatively, the CPU 56 may use that input to adjust the system to adapt for any concentrations of NO in the supply within certain limits. … Control signals are transmitted from CPU 56 to proportional control valve 18, shutoff valve 14, purge valve 20, and proportional valve 24 via signal lines 66, 68, 70, and 72 respectively.” Column 5, Line 55 thru Column 6, Line 20) of the NO delivery apparatus (Figure 1) at least one measurement signal (via 60, “CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64.” Column 5, Line 55 thru Column 6, Line 5) representative of the gas flow rate within the patient circuit (28).
Regarding the features of the apparatus, Bathe discloses an apparatus (Figure 1) for supplying NO (“Nitric Oxide Delivery System” Title), comprising: a main gas circuit (defined by the flow of gas from 10 to 42, wherein 10 – “In the FIG. 1, a supply of nitric oxide is provided in the form of a cylinder 10 of gas.” Column 3, Lines 40-60, “Suffice at this point is to state that the proportional control valve 18 provides a predetermined flow of nitrogen through a suitable conduit into the conduit to be mixed with the NO/nitrogen gas from cylinder 10 and which then enters the shutoff valve 14.” Column 4, Lines 1-15, “For example, the cylinder 10 may be supplying a concentration of nitric oxide that is too high for the particular flows in the system and therefore the concentration may be reduced to a more desirable level. If, of course, the supply of nitric oxide from cylinder 10 is suitable for the particular application, the addition of supplemental nitrogen is unnecessary.” Column 4, Lines 10-25; and wherein 42 – “The patient limb 40, obviously, leads to the patient indicated by the block 42.” Column 5, Lines 1-15) for conveying an NO/N2 gaseous mixture (10, “Suffice at this point is to state that the proportional control valve 18 provides a predetermined flow of nitrogen through a suitable conduit into the conduit to be mixed with the NO/nitrogen gas from cylinder 10 and which then enters the shutoff valve 14.” Column 4, Lines 1-15), flow rate control means (via operation of 24, “A further proportional control valve 24 is positioned with suitable conduit to receive the NO/nitrogen gas from the purge valve 20. Typical of such proportional control valves for both the proportional control valve 18 in the nitrogen supply system and the proportional control valve 24 in the NO/nitrogen stream may be obtained commercially from various companies, including MKS Instruments, Inc. of Andover, Mass. and which provide electronic control of gases.” Column 4, Line 35-50; “A flow sensor 26 is located in the downstream conduit from proportional control valve 24 and senses the flow from such valve.” Column 4, Lines 50-60; “A further inlet 44 is formed in the delivery adaptor 28 and which receives the NO/nitrogen gas from the proportional control valve 24 through flow sensor 26.” Column 5, Lines 10-25) comprising at least one main solenoid valve (24, “A flow sensor 26 is located in the downstream conduit from proportional control valve 24 and senses the flow from such valve.” Column 4, Lines 50-60) arranged on the main gas circuit (defined by the flow of gas from 10 to 42), and operating means (56, “A signal processing means, such as a CPU 56 is provided to solve certain equations and algorithms to operate the nitric oxide delivery system. CPU 56 receives a signal from an input device 58 indicative of the concentration the user desires to be administered to the patient. CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64. Another input to CPU 56 is provided by the NO sensor 65 through signal line 67. The NO sensor 65 senses the concentration of NO in the supply cylinder 10 so that the user can verify that the proper supply is being utilized or, alternatively, the CPU 56 may use that input to adjust the system to adapt for any concentrations of NO in the supply within certain limits. … Control signals are transmitted from CPU 56 to proportional control valve 18, shutoff valve 14, purge valve 20, and proportional valve 24 via signal lines 66, 68, 70, and 72 respectively.” Column 5, Line 55 thru Column 6, Line 20) configured to control the at least one main solenoid (24) in order to control the flow rate (“CPU 56 also receives signals from the flow transducer 46 indicative of the flow of gas delivered by the gas delivery system, Q.sub.i through a signal line 60 and also receives signals indicative of the concentration of NO, as well as NO.sub.2 and O.sub.2 from gas sensor bench 52 via a signal line 62 and a signal from flow sensor 26 indicative of the flow from proportional control valve 24, Q.sub.del, respectively via a signal line 64.” Column 5, Line 60 thru Column 6, Line 5; “As the gas is delivered from the gas delivery system, its flow is sensed by the flow transducer 46 in delivery adapter 28 and a signal is transmitted indicative of that flow to the CPU 56.” Column 6, Lines 20-30; “As can be seen, the CPU 56 has sufficient information to carry out the proper calculations, that is, it knows the flow of breathing gas from the gas delivery device by means of flow transducer 46 (Q.sub.i,) and the concentration of NO in the NO/nitrogen supply by means of NO sensor 65 (.gamma..sub.NOcut). With that information, CPU 56 can calculate the desired flow (Q.sub.del) from the proportional control valve 24 that needs to be provided to the confluence 50 to mix with the gas from the gas delivery system to produce the desired or set concentration (.gamma..sub.NOset) established by the user through input device 58.” Column 6, Lines 40-55; “By this equation, the CPU 56 can make extremely rapid, such as 20 millisecond, changes to the flow delivered from proportional control valve 24 (Q.sub.del) in order to maintain the concentration of the flow delivered to the patient at the desired level as determined by the user (.gamma..sub.set).” Column 6, Line 60 thru Column 7, Line 15; “By knowing the flow from the gas delivery system by means of flow transducer 46 and the concentration of NO in the main supply from NO sensor 65, a derivation is made by the CPU 56 and the proportional control valve 24 is adjusted to provide then calculated flow of NO/nitrogen to arrive at the desired concentration set by the user in the breathing gas actually administered to the patient.” Column 7, Lines 45-55) of NO/N2 gaseous mixture (10) passing through the at least one main solenoid (24), characterized in that: the at least one main solenoid valve (24) is a proportional solenoid valve (“proportional control valve 24 … the valve may be a digital controlled valve rather that analog and which is controlled by timing its on/off cycles to effect the desired flow through the proportional control of flow therethrough.” Column 4, Lines 35-50; “Control signals are transmitted from CPU 56 to proportional control valve 18, shutoff valve 14, purge valve 20, and proportional valve 24 via signal lines 66, 68, 70, and 72 respectively.” Column 6, Lines 15-20; “By knowing the flow from the gas delivery system by means of flow transducer 46 and the concentration of NO in the main supply from NO sensor 65, a derivation is made by the CPU 56 and the proportional control valve 24 is adjusted to provide then calculated flow of NO/nitrogen to arrive at the desired concentration set by the user in the breathing gas actually administered to the patient.” Column 7, Lines 40-56) and is configured to function in a given operating range (“to arrive at the desired concentration”), and the operating means (56) are configured to control the at least one main solenoid (24) in a pulsed mode (“breath-by-breath basis”; “As an alternate, the system may operate on a breath-by-breath basis, that is, the system can take a reading of the flow, or a portion thereof, from the gas delivery system at each breath and calculate the desired flow of NO/nitrogen for delivery at the next breath. Although such delivery is less rapid than the instantaneous equation, slower flow transducers and control valves may by employed and thus less expensive components used in the system. … With the breath-by-breath analysis, however, the flow transducer 46 may detect the start and end of a breath, or selected portion thereof, integrate to determine the total or fixed selected volume of the breath, and adjust the proportional control valve 24 to provide the set or desired concentration of NO at the next breath.” Column 7, Lines 10-35) so as to deliver successive gas pulses.
Yet, Bathe does not expressly disclose the “degrees of opening between 0 and 100%”, “a first operating range corresponding to degrees of opening of the main solenoid valve (42) of between 0 and x% where: 0 < x% ≤ 10%” nor “a second operating range corresponding to degrees of opening of the main solenoid valve (42) > x%”.
Taube teaches the operation of proportional valves to have degrees of opening and different operational ranges was known. Explicitly, Taube teaches “The term “proportional solenoid valve” or simply “proportional solenoid” is used to refer to a type of solenoid valve device in which two or more gasses from two or more inputs can be controlled in a manner that allows each input to be directed to the output proportionally so that, for example, one input may be set to 30% of full flow while the other input may be set to 70% full flow. This proportionality can be controlled either by signals that cause the valves to open and close in proportion to one another, or by signals that individually select the degree to which each valve is open or closed.” (Para 0035). In operation of a proportional valve, Taube teaches the valve can be set from 0 to 100% degrees of “full flow”, whereby the specific valuation can be selected to control the operation of the valve.
Consequently, considering the teachings of Taube to modify Bathe, the at least one main solenoid valve (24) of Bathe can be set to the various degrees of “full flow” to control the opening of the proportional valve in order to control the desired concentration of NO delivered to the patient.
Although Bathe as modified by Taube does not expressly disclose one operating value of between 0 and 10% and another operating value of greater than 10%, the specific valuations are obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired concentration of NO to be delivered to the patient.
As Applicant has not asserted the specific valuation of less than 10% and greater than 10% provide a particular advantage, solve a stated problem or serve a particular purpose, the use of the specific valuation appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Bathe, as the specific valuation of operating degrees would yield the predictable results of permitting the ability of the desired concentration of NO to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the at least one main solenoid valve of Bathe to operate at the operational values of between 0 and 10% and greater than 10%, a known result effective variable in order to achieve the desired concentration of NO to be delivered to the patient.
Allowable Subject Matter
Claims 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims AND upon overcoming the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art made of record does not appear to disclose, teach, or fairly suggest the specific construction arrangement of the NO apparatus as claimed in Claim 11, and its dependents, to include the features of a bypass circuit which is fluidically connected to the main gas circuit, upstream AND downstream of the flow rate control means and comprises a secondary flow rate control means comprising an all or nothing secondary solenoid valve and a fixed flow rate device. Thus, Claims 11-14 are deemed allowable over the prior art made of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boulanger (11,964,107) shares a common assignee/inventor with the instant application, and appears to disclose a NO delivery system; yet, at this time there does not appear to be an applicable double patenting rejection.
Higenbottam (5,839,433) discloses an NO delivery system which deliveries NO gas to the patient in pulses (Column 6, Lines 40 thru Column 7, Line 10; and Column 11, Lines 45-60); yet, does not disclose the features of the proportional solenoid valve having a specific operating degree of opening.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
