DETAILED ACTION
This office action is in response to the claims filed 6/30/2023. Claims 1-19 are presenting pending in this application.
Drawings
The drawings are objected to for the following informalities:
The unlabeled rectangular box(es) shown in the drawings (e.g. evaporator (52) in figs 4-8 and filter (13) in figs 5-8) should be provided with descriptive text labels
37 C.F.R. 1.84(q) states, “Lead lines. Lead lines are those lines between the reference characters and the details referred to. Such lines may be straight or curved and should be as short as possible. They must originate in the immediate proximity of the reference character and extend to the feature indicated. Lead lines must not cross each other. Lead lines are required for each reference character except for those which indicate the surface or cross section on which they are placed. Such a reference character must be underlined to make it clear that a lead line has not been left out by mistake.” Lead lines are required for all reference characters in the drawings, and in in the case where the reference character indicates the surface or cross section on which they are placed (e.g. reference characters 3, 4, 22, 52), the reference character is required to be underlined.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-19 is/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 pre-AIA the applicant regards as the invention.
Regarding claim 1, lines 3-4 recite, “an intake branch at an inspiratory phase . . . and an exhaust branch at an expiratory phase”. It is unclear what structural element is being recited by the limitation “an inspiratory phase” and “an expiratory phase”, as it is unclear how the intake branch and the exhaust branch are connected to a user’s breathing cycle, and because the claim does not use inferential language, would appear to positively recite part of the human body in combination with the structure of the claimed invention, as the inspiratory and expiratory branches would be required to connect to a patient in order to receive an inspiratory or expiratory phase of a patient.
Regarding claims 4 and 6, lines 1-2 of claim 4 and lines 2-3 of claim 6 recites, “wherein the flow monitor is a one-way flow sensor; the flow monitor comprises: a first flow sensor and a second flow sensor”. It is unclear whether the limitation is interpreted so that the flow monitor comprises at least three flow sensors (i.e. a one-way flow sensor, a first flow sensor, and a second flow sensor), whether both the first and second flow sensors are required to configured as one-way flow sensors, or whether either the first and/or second flow sensor may be a one-way flow sensor.
Claim 5 recites the limitations "the first flow", “the drive gas”, “the second flow” and “the mixed gas” in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
Claim 7 recites the limitation “the first flow” in line 13, and “the second flow” in line 13. There is insufficient antecedent basis for these limitations in the claim. Line 13 recites, “the third flow”; it is unclear whether the limitation refers back to the previously recited third flow of the third gas recited in line 6, the third flow of the fifth gas recited in line 10, or both the previously recited third flows. For purposes of examination, it is considered that the third flow is considered to refer back to the third flow of both the third gas and the fifth gas.
Claim 8 recites the limitation “the drive gas” in line 8; and “the superfluous mixed gas” in lines 12-13. There is insufficient antecedent basis for these limitations in the claim.
Claim 9 recites the limitation “the drive gas” in lines 5, 8, and 17; and “the first gas” in lines 5 and 10. There is insufficient antecedent basis for these limitations in the claim.
Claim 10 recites the limitation “the drive gas” in lines 6, 8, and 15; and “the first gas” in line 7. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 11, the phrase "may" 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).
Regarding claim 18, line 4 recites, “the third flow”; it is unclear whether the limitation refers back to the previously recited third flow of the third gas recited in claim 17, line 7, the third flow of the fifth gas recited in claim 17, line 12, or both the previously recited third flows. For purposes of examination, it is considered that the third flow is considered to refer back to the third flow of both the third gas and the fifth gas.
Claim 19 recites the limitation “the respiratory tidal volume” in line 2. There is insufficient antecedent basis for these limitations in the claim. It is suggested to amend the claim to recite --the expiratory tidal volume--, as it appears that the tidal volume for one respiratory cycle it calculated by adding the inspiratory tidal volume to the expiratory tidal volume.
Claims 2-3 and 12-17 are rejected for being either directly or indirectly depending from a rejected claim base.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
The following claim(s) appear to positively recite part of the human body in combination with the structure of the claimed invention:
Claim 1, lines 3-4, “an intake branch at an inspiratory phase, a respiratory container, and an exhaust branch at an expiratory phase”.
Claim 2, lines 3-10, “at the inspiratory phase, a first gas in the respiratory container is driven to the patient-end respiratory system by means of a drive gas transmitted in the intake branch, and is transmitted to a patient interface through the patient-end respiratory system, and a first flow of the drive gas in the respiratory container is measured by the flow monitor; at the expiratory phase, an exhaled gas is received from the patient interface and is transmitted to the respiratory container through the patient-end respiratory system, a superfluous mixed gas in the respiratory container is exhausted through the exhaust branch, and a second flow of the mixed gas is measured by the flow monitor;”.
Claim 5, lines 1-4, “wherein at the inspiratory phase, the first flow of the drive gas in the respiratory container is measured by the first flow sensor; and at the expiratory phase, the second flow of the mixed gas is measured by the second flow sensor”.
Claim 6, lines 11-14, “at the inspiratory phase, the first flow of the drive gas in the respiratory container is measured by means of the first flow sensor and the first one-way valve; and at the expiratory phase, the second flow of the mixed gas is measured by means of the second flow sensor and the second one-way valve”.
Claim 7, lines 4-11, “at the inspiratory phase, a second gas is received through the fresh gas interface and is transmitted to the evaporator to bring a third gas out, and the third gas is transmitted to the patient interface through the patient-end respiratory system; a third flow of the third gas delivered through the gas delivery branch is measured by the third flow sensor; at the expiratory phase, a fourth gas is received through the fresh gas interface and is transmitted to the evaporator to bring a fifth gas out, and the fifth gas is transmitted to the respiratory container through the patient-end respiratory system; a third flow of the fifth gas delivered through the gas delivery branch is measured by the third flow sensor;”.
Claim 8, lines 8-13, “at the inspiratory phase, the drive gas is transmitted to the inspiratory branch through a drive gas interface, and the first gas in the respiratory container is driven to the inspiratory branch and is transmitted from the inspiratory branch to the patient interface; and at the expiratory phase, the exhaled gas is received from the patient interface and is transmitted to the respiratory container through the expiratory branch, and the superfluous mixed gas in the respiratory container is exhausted through the exhaust branch.”.
Claim 9, lines 8-16, “at the inspiratory phase, the drive gas is transmitted to the gas mask through the intake branch, the gas bag shrinks and deforms under the action of a drive gas pressure in the gas mask, the first gas is compressed to be transmitted to the patient interface through the patient-end respiratory system, and the third gas is transmitted through the gas transmission branch and is transmitted to the patient interface through the patient-end respiratory system; at the expiratory phase, the exhaled gas is received from the patient interface and is transmitted to the gas bag through the patient-end respiratory system, and the fifth gas is received from the gas delivery branch and is transmitted to the gas bag through the patient-end respiratory system;”.
Claim 10, lines 6-14, “at the inspiratory phase, the drive gas is transmitted to the exchange cavity through the intake branch, the first gas in the exchange cavity is transmitted to the patient interface through the patient-end respiratory system under a pushing action of the drive gas pressure, and the third gas is transmitted through the gas transmission branch and is transmitted to the patient interface through the patient-end respiratory system; at the expiratory phase, the exhaled gas is received from the patient interface and is transmitted to the exchange cavity through the patient-end respiratory system, and the fifth gas is received from the gas delivery branch and is transmitted to the exchange cavity through the patient-end respiratory system;”.
Applicant needs to clearly state using inferential language (e.g. configured to, adapted to, etc.) so that the human anatomy is not claimed.
Claims 3-4 and 11 are rejected for being either directly or indirectly depending from a rejected claim base.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 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.
Claim(s) 1, 3-5, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinonen et al (2010/0078018).
Regarding claim 1, Heinonen discloses a patient-end respiratory system (2) (breathing circuit), a machine-end respiratory system (1) (ventilator) (para [0024]), a flow monitor (8, 10, 12) (flow sensors) (para [0026]) and a processor (40) (leak analyzer) (para [0024]), wherein the machine-end respiratory system (1) comprises: an intake branch at an inspiratory phase (branch connected to flow sensor (8)), a respiratory container (14) (bottle), and an exhaust branch at an expiratory phase (branch connected to flow sensor (10) and branch connected to flow sensor (12)); the intake branch and the exhaust branch are both connected to the respiratory container (14) via the flow monitor (8, 10), and the respiratory container (14) is connected to the patient-end respiratory system (1) (as shown in fig 1, gas flow added for inspiration is added to intake branch connected to flow sensor (8), and expiratory gases are vented from exhaust branch connected to flow sensor (10) (para [0026]).
Regarding claim 3, Heinonen discloses the flow monitor is a bidirectional flow sensor (flow sensors (8, 10) can be combined to a single sensor connected at an outlet (16) of the bottle (14), and therefore the single sensor would be a bidirectional flow sensor configured to measure both an inspiratory flow and an expiratory flow) (para [0026]).
Regarding claim 4, Heinonen discloses the flow monitor (8, 10) is a one-way flow sensor; the flow monitor comprises: a first flow sensor (8) and a second flow sensor (10); the first flow sensor (8) is connected to the intake branch, and the second flow sensor (10) is connected to the exhaust branch (first flow sensor (8) measures a gas flow for an inspiration and a second flow sensor (10) measures a gas flow for an expiration, and therefore each flow sensor (8, 10) is a one-way flow sensor configured to measure an inspiration and expiration flow, respectively) (para [0026]).
Regarding claim 5, Heinonen discloses that at the inspiratory phase, the first flow of the drive gas in the respiratory container is measured by the first flow sensor (8); and at the expiratory phase, the second flow of the mixed gas is measured by the second flow sensor (10) (para [0026]).
Regarding claim 11, Heinonen discloses the flow monitor (8, 10) may be arranged at a junction of the intake branch and the exhaust branch (flow sensors (8, 10) can be combined to a single sensor connected at an outlet (16) of the bottle (14), and therefore the single sensor would be a bidirectional flow sensor arranged at a junction of the intake branch and the exhaust branch at the outlet of the bottle (14)) (para [0027]]).
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 of this title, 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heinonen as applied to claim 1 above, and further in view of Brandt et al (2018/0221606).
Regarding claim 2, Heinonen discloses the processor (40) is connected to the flow monitor (8, 10, 12) (by signal lines (101, 102, 103), respectively) (para [0035]); wherein at the inspiratory phase, a first gas in the respiratory container (14) is driven to the patient-end respiratory system (2) by means of a drive gas transmitted in the intake branch, and is transmitted to a patient interface (28) (endotracheal tube) through the patient-end respiratory system (2) (para [0027]), and a first flow of the drive gas in the respiratory container (14) is measured by the flow monitor (8) (para [0026]); at the expiratory phase, an exhaled gas is received from the patient interface (28) and is transmitted to the respiratory container (14) through the patient-end respiratory system (2) (para [0027]), a superfluous mixed gas in the respiratory container (14) is exhausted through the exhaust branch, and a second flow of the mixed gas is measured by the flow monitor (12) (para [0037]); wherein the processor is configured to determine how much gas was added to the patient-end respiratory system (2) during inhalation and how much gas was added to the patient-end respiratory system (2) during exhalation for one respiratory cycle on the basis of the first flow and the second flow (para [0037]).
Heinonen does not disclose the processor is configured to calculate a tidal volume for one respiratory cycle on the basis of the first flow and the second flow.
However, Brandt teaches a ventilation device including a respiratory container (18) (bag in a bottle system) and an inspiratory branch configured to deliver air from air inlet (26) to respiratory container (18) (para [0040]), a flow sensor (36) configured to measure a flow in the inspiratory branch (para [0044]), and a processor (38) (control unit) (para [0043]), and wherein the processor (38) is configured to calculate a tidal volume for one respiratory cycle based on a flow measured by the flow sensor (36) (processor (38) measures a flow sensor signal of the flow sensor (36) and determines a tidal volume from this (para [0061]), and because the flow sensor (36) has a bidirectional configuration (para [0044]), is configured to determine the tidal volume based on the first and second flow).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Heinonen so that the controller is configured to calculate a tidal volume for one respiratory cycle on the basis of the first flow and the second flow as taught by Brandt in order to allow the device to calculate a tidal volume and compare it with a preset tidal volume set point to provide a new set point of the first flow to deliver the preset tidal volume (Brandt, para [0061]) .
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heinonen and Brandt et al as applied to claim 2 above, and further in view of Kollmeyer et al (2008/0196720).
Regarding claim 6, modified Heinonen discloses the flow monitor is a one-way flow sensor; the flow monitor comprises: a first flow sensor (8) and a second flow sensor (12) and the intake branch and the exhaust branch are both connected to the respiratory container (14) via the first flow sensor (8), and the second flow sensor (12) (Heinonen, fig 1, para [0025]).
Heinonen does not disclose a first one-way valve and a second one-way valve, wherein the first one-way valve is configured to transmit the drive gas to the respiratory container; and the second one-way valve is configured to transmit the mixed gas to the exhaust branch.
However, Kollmeyer teaches a ventilator device including a respiratory container (136) (bellows assembly) (para [0031]), an exhaust branch (branch connected to pop-off valve (152) and exhalation valve (148)) (para [0034]), a first one-way valve (130) (check valve) (para [0031]), and a second one-way valve (152) (pop-off valve), the one-way valve (152) configured to transmit a mixed exhalation gas to the exhaust branch (para [0034]), wherein the first one-way valve (130) is configured to transmit a drive gas to the respiratory container (136) (para [0031]); and the second one-way valve (152) is configured to transmit the mixed gas to the exhaust branch (para [0134]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Heinonen by providing a first one-way valve and a second one-way valve, wherein the first one-way valve is configured to transmit the drive gas to the respiratory container; and the second one-way valve is configured to transmit the mixed gas to the exhaust branch as taught by Kollmeyer in order to control the flow of drive gas during an inhalation (Kollmeyer, para [0031]) and to control the pressure of the medical gas in the respiratory container during exhalation (Kollmeyer, para [0034]). The now-modified Heinonen’s device is considered to disclose that the intake branch and the exhaust branch are both connected to the respiratory container via the first flow sensor, the first one-way valve, the second flow sensor and the second one-way valve (as shown in fig 1 of Heinonen, the intake branch and the exhaust branch are both connected to the respiratory container (14) via the first flow sensor (8) and the second flow sensor (12), and as shown in fig 1 of Kollmeyer, the intake branch and the exhaust branch are both connected to the respiratory container (136) via the first one-way valve (130) and the second one-way valve (152)); the first one-way valve (130 of Kollmeyer) is connected to the first flow sensor (8 of Heinonen) (both the first one-way valve (130 of Kollmeyer) and the first flow sensor (8 of Heinonen) are disposed in the intake branch), and the second one-way valve (152 of Kollmeyer) is connected to the second flow sensor (12 of Kollmeyer) (both the second one-way valve (152 of Kollmeyer) and the second flow sensor (12 of Heinonen) are disposed in the exhaust branch); at the inspiratory phase, the first flow of the drive gas in the respiratory container is measured by means of the first flow sensor (8 of Heinonen) and the first one-way valve (130 of Kollmeyer) (Heinonen, para [0026]); and at the expiratory phase, the second flow of the mixed gas is measured by means of the second flow sensor (12 of Heinonen) and the second one-way valve (152 of Kollmeyer) (Heinonen, para [0026]).
Claim(s) 12-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heinonen in view of Brandt et al.
Regarding claim 12, Heinonen discloses a device whose ordinary use discloses a respiratory ventilation method with the steps of: at an inspiratory phase, driving a first gas in a respiratory container (14) to a patient-end respiratory system (2) by means of a drive gas transmitted in an intake branch (branch containing flow monitor (8)) (para [0025]), and transmitting the first gas to a patient interface (28) (endotracheal tube) through the patient-end respiratory system (2) (para [0027]); measuring a first flow of the drive gas in the respiratory container (14) by a flow monitor (8) (para [0026]); at an expiratory phase, receiving an exhaled gas from a patient interface (28) and transmitting the exhaled gas to the respiratory container (14) through the patient-end respiratory system (2) (para [0027]), and exhausting a superfluous mixed gas from the respiratory container (14) through an exhaust branch (para [0026]); measuring a second flow of the mixed gas by the flow monitor (12) (para [0037]); wherein the processor is configured to determine how much gas was added to the patient-end respiratory system (2) during inhalation and how much gas was added to the patient-end respiratory system (2) during exhalation for one respiratory cycle on the basis of the first flow and the second flow (para [0037]).
Heinonen does not disclose the processor is configured to calculate a tidal volume for one respiratory cycle on the basis of the first flow and the second flow.
However, Brandt teaches a ventilation device including a respiratory container (18) (bag in a bottle system) and an inspiratory branch configured to deliver air from air inlet (26) to respiratory container (18) (para [0040]), a flow sensor (36) configured to measure a flow in the inspiratory branch (para [0044]), and a processor (38) (control unit) (para [0043]), and wherein the processor (38) is configured to calculate a tidal volume for one respiratory cycle based on a flow measured by the flow sensor (36) (processor (38) measures a flow sensor signal of the flow sensor (36) and determines a tidal volume from this (para [0061]), and because the flow sensor (36) has a bidirectional configuration (para [0044]), is configured to determine the tidal volume based on the first and second flow).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Heinonen so that the controller is configured to calculate a tidal volume for one respiratory cycle on the basis of the first flow and the second flow as taught by Brandt in order to allow the device to calculate a tidal volume and compare it with a preset tidal volume set point to provide a new set point of the first flow to deliver the preset tidal volume (Brandt, para [0061]) .
Regarding claim 13, Heinonen discloses the flow monitor comprises a first flow sensor (8) and a second flow sensor (12) (para [0025]); measuring a first flow of the drive gas in the respiratory container (14) by a flow monitor comprises: measuring the first flow of the drive gas in the respiratory container (14) by the first flow sensor (8) (para [0026]); and measuring a second flow of the mixed gas by the flow monitor (12) comprises: measuring the second flow of the mixed gas by the second flow sensor (12) (para [0037]).
Regarding claim 14, the modified Heinonen’s reference discloses calculating a tidal volume for one respiratory cycle on the basis of the first flow and the second flow comprises: obtaining the tidal volume for one respiratory cycle by using the first flow as an inspiratory tidal volume and using the second flow as an expiratory tidal volume (tidal volume is determined by a flow signal from (36 of Brandt) (Brandt, para [0061]), and flow sensor (36 of Brandt) has a bidirectional configuration (Brandt, para [0044]), and therefore is configured to obtaining the tidal volume for one respiratory cycle by using the first flow as an inspiratory tidal volume and using the second flow as an expiratory tidal volume).
Regarding claim 17, Heinonen discloses the patient-end respiratory system comprises a gas delivery branch; (branch containing flow sensor (38) (para [0032]), the method further comprises: at the inspiratory phase, receiving a second gas (input of evaporator (37)) through a fresh gas interface (line connecting sensors (35, 36) to anesthetic agent supply (37)) in the gas delivery branch and transmitting the second gas to an evaporator (37) in the gas delivery branch to bring a third gas (output of evaporator (37)) out, and transmitting the third gas to the patient interface (28) through the patient-end respiratory system (2) (para [0032]); measuring, by the third flow sensor (38), a third flow of the third gas delivered through the gas delivery branch (para [0032]); at the expiratory phase, receiving a fourth gas (input of evaporator (37)) through the fresh gas interface and transmitting the fourth gas to the evaporator (37) to bring a fifth gas (output of evaporator (37)) out (para [0032]), and transmitting the fifth gas to the respiratory container (14) through the patient-end respiratory system (2); and measuring, by the third flow sensor (38), a third flow of the fifth gas delivered through the gas delivery branch (para [0032]).
Allowable Subject Matter
Claims 7-10, 15-16, and 18-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Heinonen et al and Brandt et al disclose the limitations of claims 1 and 12, and Heinonen further discloses a gas delivery branch (branch containing flow sensor (38)); the gas delivery branch is provided with a third flow sensor (38), a fresh gas interface (line connecting sensors (35, 36) to anesthetic agent supply (37)) and an evaporator (37) (anesthetic agent supply (37) may be an evaporator) (para [0032]); at the inspiratory phase, a second gas (input of evaporator (37)) is received through the fresh gas interface and is transmitted to the evaporator (37) to bring a third gas (output of evaporator (37)) out, and the third gas is transmitted to the patient interface (28) through the patient-end respiratory system (2); a third flow of the third gas delivered through the gas delivery branch is measured by the third flow sensor (38) (para [0032]); at the expiratory phase, a fourth gas (input of evaporator (37)) is received through the fresh gas interface and is transmitted to the evaporator (37) to bring a fifth gas (output of evaporator (37)) out, and the fifth gas is transmitted to the respiratory container (14) through the patient-end respiratory system (2); a third flow of the fifth gas delivered through the gas delivery branch is measured by the third flow sensor (the amount of the fresh breathing gas delivered into the breathing circuit 2 during the breath cycle is determined using the flow sensor signal of the signal line 104 received from the flow sensor (3)), wherein the processor (40) is configured to calculate a tidal volume for one respiratory on the basis of the first flow and the second flow (Brandt, para [0061]); and Heinonen et al (5,490,499) teaches a respiratory device including a respiratory container (16) configured to deliver a gas to a user (col 5, ln 42-55) and a gas delivery branch (27) (duct) configured to deliver fresh gas, wherein a tidal volume can be calculated based on a third flow of a third gas delivered through the gas delivery branch during an inspiratory phase (the effect of a fresh gas flow on the tidal volume to be delivered to a patient can be preferably compensated by subtracting from a desired tidal volume the volume of a fresh gas flowing during the course of inspiration) (col 5, ln 59-62).
However, neither Heinonen et al, Brandt et al, Heinonen et al, nor the other prior art of record, disclose the processor is configured to calculate a tidal volume for one respiratory cycle on the basis of the first flow, the second flow and a third flow of the fifth gas as recited in claims 7 and 18, and obtaining an expiratory tidal volume by subtracting the fresh gas flow from the second flow, and obtaining the tidal volume for one respiratory cycle by adding the inspiratory tidal volume to the expiratory tidal volume as recited in claim 15, as while the prior art of record discloses calculating a tidal volume based on a third flow of a third gas delivered during inhalation (Heinonen, col 5, ln 59-62), the prior art does not disclose calculating a tidal volume based on a third flow of a fifth gas delivered during exhalation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Khoury (2018/0160970), Hendrickson (6,125,848), Sarkela et al (2019/0358418), Tham (5,857,458), and Levy et al (4,340,044) disclose respiratory devices including a respiratory container with a bellows or bag and/or a processor to calculate a tidal volume.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS Y SUL whose telephone number is (571)270-5260. The examiner can normally be reached Monday-Friday 9 am-5:30 pm EST.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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