DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 02/18/2026. As directed by the amendment, claim(s) 1, 5-6 and 8 have been amended, claim(s) 19-20 have been cancelled and claims 23-29 have been added. As such, claims 1, 4-8, 16-17 and 21-29 are pending in the instant application.
Response to Arguments
Applicant's arguments, see pages 8-10 of Remarks, filed 02/18/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
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.
Claim(s) 1, 4-8, 16-17 and 21-29 are 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.
Claim 1, lines 23-27, recites “…in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), increasing the final nasal gas pressure (Pnset); in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), decreasing the final nasal gas pressure (Pnset)…” However, the claim limitation is not supported within the specification. The specification recites “If the calculated minimum fragment Frnin is smaller than the determined measured, effective, internal, minimum gas flow Fint,min, the control device 28 reduces the final nasal gas pressure Pnset and sets it (step 85; step b)). If the calculated minimum fragment F min is greater than the determined measured, effective, internal, minimum gas flow F,int,min, the control device 28 increases the final nasal gas pressure Pnset and sets it (step 86; step b)) (see [0115]-[0116])” which is the opposite of what is written in the claims. The claims states if the calculated minimum gas flow is less than the minimum measured gas flow, the final gas pressure is to be increased whereas the specification says it is to be decreased. Furthermore, it would not be obvious to one of ordinary skill in the art to increase the final gas pressure if the measured gas flow is already greater than the calculated gas flow. As such, the claim subject matter is not described in the specification in a way that is reasonably conveyed to one skilled in the art. Claim 23 is rejected for similar reasons to claim 1 as they hold similar claim limitations.
Claims 4-8, 16-17, 21-22 and 24-29 are rejected as they depend from and therefore incorporate the claimed subject matter rejected under this statute.
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, 4-8, 16-17 and 21-29 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.
Claim 1, lines 23-27, recites “…in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), increasing the final nasal gas pressure (Pnset); in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), decreasing the final nasal gas pressure (Pnset)…” However, the specification recites “If the calculated minimum fragment Frnin is smaller than the determined measured, effective, internal, minimum gas flow Fint,min, the control device 28 reduces the final nasal gas pressure Pnset and sets it (step 85; step b)). If the calculated minimum fragment F min is greater than the determined measured, effective, internal, minimum gas flow F,int,min, the control device 28 increases the final nasal gas pressure Pnset and sets it (step 86; step b)) (see [0115]-[0116])” which is the opposite of what is written in the claims. The claims states if the calculated minimum gas flow is less than the minimum measured gas flow, the final gas pressure is to be increased whereas the specification says it is to be decreased. Therefore, it is unclear what is meant by the claim limitations, especially as it would not be obvious to one of ordinary skill in the art to increase the final gas pressure if the measured gas flow is already greater than the calculated gas flow. For examination purposes, as best understood, the claim will read as “…in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), decrease the final nasal gas pressure (Pnset); in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), increase the final nasal gas pressure (Pnset)…” Claim 23 is rejected for similar reasons to claim 1 as they hold similar claim limitations.
Claims 4-8, 16-17, 21-22 and 24-29 are rejected as they depend from and therefore incorporate the claimed subject matter rejected under this statute.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 6-7, 23-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1).
Regarding claim 1, O’Connor teaches a method for operating a flow apparatus (CPAP apparatus 10, see Fig. 1; CPAP apparatus 10 comprises a controllable air blower or flow generator 12 as seen in Fig. 1 and [0037]), wherein the flow apparatus is arranged to deliver a conditioned gas into a connected tubing system (air delivery hose 16, see Fig. 1) (“The respiratory mask system 14 includes an air delivery hose 16 that connects the respiratory mask system 14 to the flow generator 12 to supply breathable gas through the respiratory mask system 14 to the patient.” See [0037] and Fig. 1), and the flow apparatus has a control device (processor 20, servo-control circuit 26 and controller 32, see Fig. 1) with a storage unit (the controller has a storage medium to implement the methodologies as seen in [0041]) and a pressure controller for controlling a gas pressure (processor 20 is to determine a plurality of air flow characteristics (see [0044] and to control the flow generator 12 to maintain pressure within the mask system 14 as seen in [0045]), as well as a computer system (servo-control circuit 26, see Fig. 1; [0056] of the specification discusses a computer system as a computer algorithm used to execute a method automatically. Servo-control circuit 26 aids in maintenance of a pressure in the mask within error limits as seen in [0045]), wherein the method comprises:
determining a pressure approximation (Pn) by calculating at least one differential pressure approximation (dPsch) in the connected tubing system, the pressure approximation (Pn) being based on one or more stored internal gas flow values (Fint) and one or more stored internal gas pressure values (Pint) (O’Connor teaches flow generator 14 delivering a particular flow value (Fi) in step 604 in which a pressure value (Pi) will be measured in step 606 and associated with the flow value as seen in Fig. 6 and [0094]. Furthermore, both values will be recorded into an impedance data table 608 as seen in Fig. 6 and [0094] and [0098]. O’Connor further teaches using impedance table to aid in estimating pressure at the mask (see [0098]), as well as, the recorded values may be used to derive a quadratic equation to calculate the pressure drop as seen in [0102] (which is equivalent to applicant using a mathematical equation to calibrate dPsch in [0099]). Using the pressure drop and a pressure measured within the blower, the pressure within the mask can be calculated using the equation Pmask = Pblower – Pdrop (which is similar to applicant’s equation of pressure approximation: Pn= Pint - dPsch as seen in [0097]-[0098])), wherein the pressure approximation (Pn) and the at least one differential pressure approximation (dPsch) are determined without the connected tubing system connected to a patient (during impedance learn mode 602, the patient is prompted to remove the patient interface before going through the method as seen in Fig. 6 and [0097], and therefore is not connected to the air delivery hose 16);
specifying a final nasal gas pressure (PnSet) in the pressure controller (A target pressure for the mask can be set using the controller as seen in [0098]);
controlling the flow apparatus with the aid of the pressure controller to adjust a nasal gas pressure (Pnasal) at the flow apparatus towards the final nasal gas pressure (PnSet) (O’Connor teaches servo-controlling the flow generator (the flow generator will be adjusting a nasal gas pressure) by adjusting for Pdrop towards a target pressure for the mask as seen in [0098]), based on the pressure approximation (Pn) (the pressure control is carried out based on Pdrop and Pblower which is used in the pressure approximation equation above for Pmask); and
delivering the conditioned gas from the flow apparatus into the connected tubing system (the flow generator 12 is to supply a controllable source of breathable gas through air delivery hose 16 as seen in [0038]).
but does not teach a ventilator;
calculating a minimum gas flow (Fmin) through the connected tubing system;
determining whether the calculated minimum gas flow (Fmin) is less than or greater than a minimum measured internal gas flow value (Fnt.min);
in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), increasing the final nasal gas pressure (Pnset);
in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), decreasing the final nasal gas pressure (Pnset).
However, Scholler teaches a ventilator for carrying out CPAP ventilation as seen in [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by O’Connor to replace the CPAP apparatus with the ventilator taught by Scholler as the ventilator can carry out CPAP ventilation or APAP ventilation (see [0030]) allowing for different therapies.
However, Kiritake teaches calculating a minimum gas flow (Fmin) through the connected tubing system (Kiritake teaches determining a bottom flow rate of an oxygen-concentrated gas based on an equation as seen in [0017]. Kiritake further teaches a patient inhaling the oxygen-concentrated gas from the device as seen in Fig. 3 and [0021], and therefore there is a tubing system to connect the device to the patient);
determining whether the calculated minimum gas flow (Fmin) is less than or greater than a minimum measured internal gas flow value (Fnt.min);
in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), increasing the gas pressure;
in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), decreasing the gas pressure; (see 112(a) and 112(b) rejections above; Kiritake teaches a flow rate sensor 302 with a function to measure a bottom flow rate and a control device 401 is used to control an increase or decrease of the amount of pressurized air supplied from the compressor 103 when the peak flow rate value or bottom flow rate value per a predetermined time exceeds a predetermined range of a threshold value as seen in Fig. 1 and [0017] and [0035]-[0036]. As such, Kiritake teaches comparing the measured bottom flow rate with the calculated bottom flow rate threshold and adjusting pressure depending on the comparison, wherein if the measured flow rate is higher, the pressurized air is to be decreased and if the measured flow rate is lower, the pressurized air is to be increased to be within the threshold value).
O’Connor teaches “control of treatment of the patient typically requires that certain prescribed levels of pressure be delivered to the patient's airway (see [0090])” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by O’Connor in view of Scholler to include the flow sensor and controller as taught by Kiritake to aid in controlling the pressure to have the proper flow rate for treatment (see [0017] and [0067]).
Regarding claim 4, modified O’Connor teaches the method of claim 1, and O’Connor further teaches wherein the at least one differential pressure approximation (dPscb) in the connected tubing system is calculated with aid of a mathematical function (O’Connor further teaches using the recorded flow values to derive a quadratic equation to calculate the pressure drop as seen in [0102] (which is equivalent to applicant using a mathematical equation to calibrate dPsch in [0099])).
Regarding claim 6, modified O’Connor teaches the method of claim 1, and O’Connor further teaches wherein a maximum mean gas flow (Fmax) is provided through the connected tubing system (flow generator 12 supplies a controllable source of breathable gas through the air delivery hose 16 that can get up to a flow of 100 L/min as seen in [0038]-[0039]), and wherein the maximum mean gas flow (Fmax) is set to a value between 10 and 200 litres per minute (“The flow generator 12 is capable of delivering the source of breathable gas at a flow up to about 100 L/min.” see [0039]).
Regarding claim 6, modified O’Connor teaches the method of claim 4, and O’Connor further teaches wherein a maximum mean gas flow (Fmax) is provided through the connected tubing system (flow generator 12 supplies a controllable source of breathable gas through the air delivery hose 16 that can get up to a flow of 100 L/min as seen in [0038]-[0039]), and wherein the maximum mean gas flow (Fmax) is set to a value between 10 and 200 litres per minute (“The flow generator 12 is capable of delivering the source of breathable gas at a flow up to about 100 L/min.” see [0039]).
Regarding claim 7, modified O’Connor teaches the method of claim 1, and O’Connor further teaches wherein a nasal gas flow (Fnasal) is controlled as an inner cascade of the nasal gas pressure (Pnasal) (O’Connor teaches flow generator 12 to deliver a nasal gas flow to the mask as seen in Figs. 1-3, and the nasal gas pressure is measured by pressure sensor 44 as seen in Figs. 2-3, wherein the flow control is the inner cascade. Especially since the pressure for the mask can be adjusted by controlling the flow generator as seen in [0098]).
Regarding claim 7, modified O’Connor teaches the method of claim 4, and O’Connor further teaches wherein a nasal gas flow (Fnasal) is controlled as an inner cascade of the nasal gas pressure (Pnasal) (O’Connor teaches flow generator 12 to deliver a nasal gas flow to the mask as seen in Figs. 1-3, and the nasal gas pressure is measured by pressure sensor 44 as seen in Figs. 2-3, wherein the flow control is the inner cascade. Especially since the pressure for the mask can be adjusted by controlling the flow generator as seen in [0098]).
Regarding claim 23, O’Connor teaches a flow apparatus (CPAP apparatus 10, see Fig. 1; CPAP apparatus 10 comprises a controllable air blower or flow generator 12 as seen in Fig. 1 and [0037]) comprising:
a control device (processor 20, servo-control circuit 26 and controller 32, see Fig. 1) with a storage unit (the controller has a storage medium to implement the methodologies as seen in [0041]) and a pressure controller for controlling a gas pressure (processor 20 is to determine a plurality of air flow characteristics (see [0044] and to control the flow generator 12 to maintain pressure within the mask system 14 as seen in [0045]), as well as a computer system (servo-control circuit 26, see Fig. 1; [0056] of the specification discusses a computer system as a computer algorithm used to execute a method automatically. Servo-control circuit 26 aids in maintenance of a pressure in the mask within error limits as seen in [0045]), wherein the flow apparatus is arranged to deliver a conditioned gas into a connected tubing system (air delivery hose 16, see Fig. 1) (“The respiratory mask system 14 includes an air delivery hose 16 that connects the respiratory mask system 14 to the flow generator 12 to supply breathable gas through the respiratory mask system 14 to the patient.” See [0037] and Fig. 1), and configured to:
determine a pressure approximation (Pn) by calculating at least one differential pressure approximation (dPsch) in the connected tubing system, the pressure approximation (Pn) being based on one or more stored internal gas flow values (Fint) and one or more stored internal gas pressure values (Pint) (O’Connor teaches flow generator 14 delivering a particular flow value (Fi) in step 604 in which a pressure value (Pi) will be measured in step 606 and associated with the flow value as seen in Fig. 6 and [0094]. Furthermore, both values will be recorded into an impedance data table 608 as seen in Fig. 6 and [0094] and [0098]. O’Connor further teaches using impedance table to aid in estimating pressure at the mask (see [0098]), as well as, the recorded values may be used to derive a quadratic equation to calculate the pressure drop as seen in [0102] (which is equivalent to applicant using a mathematical equation to calibrate dPsch in [0099]). Using the pressure drop and a pressure measured within the blower, the pressure within the mask can be calculated using the equation Pmask = Pblower – Pdrop (which is similar to applicant’s equation of pressure approximation: Pn= Pint - dPsch as seen in [0097]-[0098])), wherein the pressure approximation (Pn) and the at least one differential pressure approximation (dPsch) are determined without the connected tubing system being connected to a patient (during impedance learn mode 602, the patient is prompted to remove the patient interface before going through the method as seen in Fig. 6 and [0097], and therefore is not connected to the air delivery hose 16);
specify a final nasal gas pressure (Pnset) in the pressure controller (A target pressure for the mask can be set using the controller as seen in [0098]);
control the flow apparatus with aid of the pressure controller to adjust a nasal gas pressure (Pnasai) at the ventilator towards the final nasal gas pressure (Pnset) (O’Connor teaches servo-controlling the flow generator (the flow generator will be adjusting a nasal gas pressure) by adjusting for Pdrop towards a target pressure for the mask as seen in [0098]) based on the pressure approximation (Pn) (the pressure control is carried out based on Pdrop and Pblower which is used in the pressure approximation equation above for Pmask); and
deliver the conditioned gas from the ventilator into the connected tubing system (the flow generator 12 is to supply a controllable source of breathable gas through air delivery hose 16 as seen in [0038]).
but does not teach a ventilator;
calculating a minimum gas flow (Fmin) through the connected tubing system;
determine whether the calculated minimum gas flow (Fmin) is less than or greater than a minimum measured internal gas flow value (Fint,min);
in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fint,min), increase the final nasal gas pressure (Pnset);
in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint,min), decrease the final nasal gas pressure (Pnset).
However, Scholler teaches a ventilator for carrying out CPAP ventilation as seen in [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flow apparatus taught by O’Connor to replace the CPAP apparatus with the ventilator taught by Scholler as the ventilator can carry out CPAP ventilation or APAP ventilation (see [0030]) allowing for different therapies.
However, Kiritake teaches calculating a minimum gas flow (Fmin) through the connected tubing system (Kiritake teaches determining a bottom flow rate of an oxygen-concentrated gas based on an equation as seen in [0017]. Kiritake further teaches a patient inhaling the oxygen-concentrated gas from the device as seen in Fig. 3 and [0021], and therefore there is a tubing system to connect the device to the patient);
determining whether the calculated minimum gas flow (Fmin) is less than or greater than a minimum measured internal gas flow value (Fnt.min);
in response to the calculated minimum gas flow (Fmin) being less than the minimum measured internal gas flow value (Fnt.min), increasing the gas pressure;
in response to the calculated minimum gas flow (Fmin) being greater than the minimum measured internal gas flow value (Fint.min), decreasing the gas pressure; (see 112(a) and 112(b) rejections above; Kiritake teaches a flow rate sensor 302 with a function to measure a bottom flow rate and a control device 401 is used to control an increase or decrease of the amount of pressurized air supplied from the compressor 103 when the peak flow rate value or bottom flow rate value per a predetermined time exceeds a predetermined range of a threshold value as seen in Fig. 1 and [0017] and [0035]-[0036]. As such, Kiritake teaches comparing the measured bottom flow rate with the calculated bottom flow rate threshold and adjusting pressure depending on the comparison, wherein if the measured flow rate is higher, the pressurized air is to be decreased and if the measured flow rate is lower, the pressurized air is to be increased to be within the threshold value).
O’Connor teaches “control of treatment of the patient typically requires that certain prescribed levels of pressure be delivered to the patient's airway (see [0090])” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by O’Connor in view of Scholler to include the flow sensor and controller as taught by Kiritake to aid in controlling the pressure to have the proper flow rate for treatment (see [0017] and [0067]).
Regarding claim 24, modified O’Connor teaches the ventilator of claim 23, and O’Connor further teaches wherein the at least one differential pressure approximation (dPsch) in the connected tubing system is calculated with aid of a mathematical function. (O’Connor further teaches using the recorded flow values to derive a quadratic equation to calculate the pressure drop as seen in [0102] (which is equivalent to applicant using a mathematical equation to calibrate dPsch in [0099])).
Regarding claim 26, modified O’Connor teaches the ventilator of claim 23, and O’Connor further teaches wherein a nasal gas flow (Fnasal) is controlled as an inner cascade of the nasal gas pressure (Pnasal) (O’Connor teaches flow generator 12 to deliver a nasal gas flow to the mask as seen in Figs. 1-3, and the nasal gas pressure is measured by pressure sensor 44 as seen in Figs. 2-3, wherein the flow control is the inner cascade. Especially since the pressure for the mask can be adjusted by controlling the flow generator as seen in [0098]).
Claim(s) 5 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1), as applied to claim(s) 1/23 above, and further in view of Kane (US 20120298108 A1).
Regarding claim 5, O’Connor in view of Scholler teaches the method of claim 1, and Kiritake further teaches wherein the minimum gas flow (Fmin) is calculated (Kiritake teaches determining a bottom flow rate of an oxygen-concentrated gas based on an equation as seen in [0017])
but does not teach wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Vd is dead space which is calculated with aid of an ideal body weight of a patient and a Radford constant, and k is a factor between 0.05 and 2, and Te is an expiration time.
However, Kane teaches wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Vd is the dead space which is calculated with the aid of an ideal body weight of a patient and a Radford constant, and k is a factor between 0.05 and 2, or equates 0.33, and Te is an expiration time (Kane teaches using the Otis equation in order to solve for various parameters such as breath rate frequency and alveolar ventilation to control things such as the minimum work of breathing (paragraph [0012]) and minimum IPAP value (paragraph [0071]), the equation includes variables such as those in the applicant’s claimed equation, including dead space volume (“Vd”), a k factor (“a”), expiratory time (“RCe”), and body weight (paragraphs [0011]-[0019]); applicant’s specification describes the minimum gas flow rate as being used with the aid of established theories such as the Otis theory (paragraphs [0024]-[0025] and [0031]). As both Kane and the applicant’s claimed equation (interpreted in light of the specification in paragraphs 24-25 and 31) are based on the Otis equation, Kane is seen to necessarily recite the same variables and equation calculation as that claimed by the applicant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to use the method of ventilation and equation as taught by Kane to provide a target tidal volume (and thus minimum gas flow) using a closed loop system (see [0057]) for a feedback system to respond to the patient’s breathe rate to reduce patient’s work of breathing (see [0010]). Kane teaches providing a target tidal volume in which the relationship between flow and tidal volume is shown in Fig. 2 (see [0030]). Kane further teaches using the Otis equation to calculate a breath rate associated with the minimum work of breathing as seen in [0011]. One of ordinary skill in the art would recognize a target tidal volume would include having a minimal gas flow due to wanting a minimum work of breathing that allows a patient to have adequate ventilation without unneeded pressure to the lungs.
In the event that applicant is not convinced that Kane teaches the applicant’s claimed equation from claim 5, it is noted Kane has a recognized desire/need for a minimum gas flow to a patient, involve substantially similar variables to that of the applicant’s claimed equation and have only a finite number of identified, predictable solutions based on those variables, and one having ordinary skill in the art could have pursued the known predicable solutions of the equation for the desired minimum gas flow with a reasonable expectation of success.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to try different combinations of equations with the finite number of variables described in Kane paragraphs 11-19 and arrive at the applicant’s claimed equation of claim 5 in order to provide the minimum flow rate to reduce patient’s work of breathing.
Regarding claim 5, modified O’Connor teaches the method of claim 4, and Kiritake further teaches wherein the minimum gas flow (Fmin) is calculated (Kiritake teaches determining a bottom flow rate of an oxygen-concentrated gas based on an equation as seen in [0017])
but does not teach wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Vd is dead space which is calculated with aid of an ideal body weight of a patient and a Radford constant, and k is a factor between 0.05 and 2, and Te is an expiration time.
However, Kane teaches wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Vd is the dead space which is calculated with the aid of an ideal body weight of a patient and a Radford constant, and k is a factor between 0.05 and 2, or equates 0.33, and Te is an expiration time (Kane teaches using the Otis equation in order to solve for various parameters such as breath rate frequency and alveolar ventilation to control things such as the minimum work of breathing (paragraph [0012]) and minimum IPAP value (paragraph [0071]), the equation includes variables such as those in the applicant’s claimed equation, including dead space volume (“Vd”), a k factor (“a”), expiratory time (“RCe”), and body weight (paragraphs [0011]-[0019]); applicant’s specification describes the minimum gas flow rate as being used with the aid of established theories such as the Otis theory (paragraphs [0024]-[0025] and [0031]). As both Kane and the applicant’s claimed equation (interpreted in light of the specification in paragraphs 24-25 and 31) are based on the Otis equation, Kane is seen to necessarily recite the same variables and equation calculation as that claimed by the applicant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to use the method of ventilation and equation as taught by Kane to provide a target tidal volume (and thus minimum gas flow) using a closed loop system (see [0057]) for a feedback system to respond to the patient’s breathe rate to reduce patient’s work of breathing (see [0010]). Kane teaches providing a target tidal volume in which the relationship between flow and tidal volume is shown in Fig. 2 (see [0030]). Kane further teaches using the Otis equation to calculate a breath rate associated with the minimum work of breathing as seen in [0011]. One of ordinary skill in the art would recognize a target tidal volume would include having a minimal gas flow due to wanting a minimum work of breathing that allows a patient to have adequate ventilation without unneeded pressure to the lungs.
In the event that applicant is not convinced that Kane teaches the applicant’s claimed equation from claim 5, it is noted Kane has a recognized desire/need for a minimum gas flow to a patient, involve substantially similar variables to that of the applicant’s claimed equation and have only a finite number of identified, predictable solutions based on those variables, and one having ordinary skill in the art could have pursued the known predicable solutions of the equation for the desired minimum gas flow with a reasonable expectation of success.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to try different combinations of equations with the finite number of variables described in Kane paragraphs 11-19 and arrive at the applicant’s claimed equation of claim 5 in order to provide the minimum flow rate to reduce patient’s work of breathing.
Regarding claim 25, modified O’Connor teaches the ventilator of claim 23, and Kiritake further teaches wherein the minimum gas flow (Fmin) is calculated (Kiritake teaches determining a bottom flow rate of an oxygen-concentrated gas based on an equation as seen in [0017])
but does not teach wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Va is dead space which is calculated with aid of an ideal body weight of the patient and a Radford constant, and k is a factor between 0.05 and 2, and Te is an expiration time.
However, Kane teaches wherein the minimum gas flow (Fmin) is calculated in the computer system using:
F
m
i
n
=
V
d
k
*
T
e
wherein Vd is the dead space which is calculated with the aid of an ideal body weight of a patient and a Radford constant, and k is a factor between 0.05 and 2, or equates 0.33, and Te is an expiration time (Kane teaches using the Otis equation in order to solve for various parameters such as breath rate frequency and alveolar ventilation to control things such as the minimum work of breathing (paragraph [0012]) and minimum IPAP value (paragraph [0071]), the equation includes variables such as those in the applicant’s claimed equation, including dead space volume (“Vd”), a k factor (“a”), expiratory time (“RCe”), and body weight (paragraphs [0011]-[0019]); applicant’s specification describes the minimum gas flow rate as being used with the aid of established theories such as the Otis theory (paragraphs [0024]-[0025] and [0031]). As both Kane and the applicant’s claimed equation (interpreted in light of the specification in paragraphs 24-25 and 31) are based on the Otis equation, Kane is seen to necessarily recite the same variables and equation calculation as that claimed by the applicant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by modified O’Connor to use the method of ventilation and equation as taught by Kane to provide a target tidal volume (and thus minimum gas flow) using a closed loop system (see [0057]) for a feedback system to respond to the patient’s breathe rate to reduce patient’s work of breathing (see [0010]). Kane teaches providing a target tidal volume in which the relationship between flow and tidal volume is shown in Fig. 2 (see [0030]). Kane further teaches using the Otis equation to calculate a breath rate associated with the minimum work of breathing as seen in [0011]. One of ordinary skill in the art would recognize a target tidal volume would include having a minimal gas flow due to wanting a minimum work of breathing that allows a patient to have adequate ventilation without unneeded pressure to the lungs.
In the event that applicant is not convinced that Kane teaches the applicant’s claimed equation from claim 5, it is noted Kane has a recognized desire/need for a minimum gas flow to a patient, involve substantially similar variables to that of the applicant’s claimed equation and have only a finite number of identified, predictable solutions based on those variables, and one having ordinary skill in the art could have pursued the known predicable solutions of the equation for the desired minimum gas flow with a reasonable expectation of success.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to try different combinations of equations with the finite number of variables described in Kane paragraphs 11-19 and arrive at the applicant’s claimed equation of claim 5 in order to provide the minimum flow rate to reduce patient’s work of breathing.
Claim(s) 8 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1), as applied to claim(s) 1/23 above, and further in view of Perine (US 20100078023 A1) and Baker (US 20090320836 A1).
Regarding claim 8, modified O’Connor teaches the method of claim 1, but does not teach the final nasal gas pressure (Paset) is increased or decreased based on the basis of a measured blood gas value, selected from a group consisting of a carbon dioxide value, and an oxygen saturation value.
However, Baker teaches wherein the final gas pressure (PnSet) is increased or decreased on the basis of a measured blood gas value, selected from a group consisting of a carbon dioxide value and an oxygen saturation value (“…oxygen delivery may be adjusted based on a patient's estimated blood oxygen saturation level (SpO.sub.2), a ventilator rate may be adjusted based on end tidal carbon dioxide (EtCO.sub.2), continuous positive airway pressure (CPAP) may be adjusted based on SpO.sub.2…” see [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to adjust pressure base on blood oxygen saturation as taught by Baker to control various physiologic parameters while delivering oxygen to prevent over oxygenation.
Regarding claim 8, modified O’Connor teaches the method of claim 4, but does not teach the final nasal gas pressure (Paset) is increased or decreased based on the basis of a measured blood gas value, selected from a group consisting of a carbon dioxide value, and an oxygen saturation value.
However, Baker teaches wherein the final gas pressure (PnSet) is increased or decreased on the basis of a measured blood gas value, selected from a group consisting of a carbon dioxide value and an oxygen saturation value (“…oxygen delivery may be adjusted based on a patient's estimated blood oxygen saturation level (SpO.sub.2), a ventilator rate may be adjusted based on end tidal carbon dioxide (EtCO.sub.2), continuous positive airway pressure (CPAP) may be adjusted based on SpO.sub.2…” see [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to adjust pressure base on blood oxygen saturation as taught by Baker to control various physiologic parameters while delivering oxygen to prevent over oxygenation.
Regarding claim 29, modified O’Connor teaches the ventilator of claim 23, but does not wherein the final nasal gas pressure (Pnset) is increased or decreased based on a measured blood gas value, selected from a group consisting of a carbon dioxide value, and an oxygen saturation value.
However, Baker teaches wherein the final nasal gas pressure (Pnset) is increased or decreased based on a measured blood gas value, selected from a group consisting of a carbon dioxide value, and an oxygen saturation value (“…oxygen delivery may be adjusted based on a patient's estimated blood oxygen saturation level (SpO.sub.2), a ventilator rate may be adjusted based on end tidal carbon dioxide (EtCO.sub.2), continuous positive airway pressure (CPAP) may be adjusted based on SpO.sub.2…” see [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by modified O’Connor to adjust pressure base on blood oxygen saturation as taught by Baker to control various physiologic parameters while delivering oxygen to prevent over oxygenation.
Claim(s) 16-17 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1), as applied to claim(s) 1/23 above, and further in view of White (US 20160193438 A1).
Regarding claim 16, modified O’Connor teaches the method of claim 1, but does not teach wherein the ventilator comprises a humidifier and the method further comprises humidifying the conditioned gas using the humidifier.
However, White teaches wherein the ventilator (flow therapy apparatus 10, see Fig. 1; White teaches the phrase “flow therapy apparatus” intended to mean any apparatus, system or device, that is capable of providing or controlling the delivery of a flow or stream of gases to a user for therapeutic purposes including a ventilator as seen in [0400]) comprises a humidifier (humidifier 12, see Fig. 1) and the method further comprises humidifying the conditioned gas using the humidifier (“…operating the humidifier 12 to humidify and/or heat the generated gasflow…” see [0493] and [0583]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to include a humidifier to humidify the conditioned gas as taught by White for increase patient comfort during treatment (see [0583]).
Regarding claim 17, modified O’Connor teaches the method of claim 16, but does not teach further comprising setting a temperature of the conditioned gas via a temperature control system.
However, White further teaches further comprising setting a temperature of the conditioned gas via a temperature control system (humidifier 12 and controller 13, see Fig. 1) (controller 13 is used to control the heater plate 70 in humidifier 12 to heat the gas to a desired temperature as seen in Fig. 70b and [0944]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to include the controller as taught by White to have a desired gas temperature for the required level of therapy and/or comfort for the patient (see [0944]).
Regarding claim 27, modified O’Connor teaches the ventilator of claim 23, but does not teach further comprising a humidifier, wherein the control device is further configured to control the humidifier to humidify the conditioned gas.
However, White teaches comprising a humidifier (humidifier 12, see Fig. 1), wherein the control device is further configured to control the humidifier to humidify the conditioned gas (“…operating the humidifier 12 to humidify and/or heat the generated gasflow…” see [0493] and [0583]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by modified O’Connor to include a humidifier to humidify the conditioned gas as taught by White for increase patient comfort during treatment (see [0583]).
Regarding claim 28, modified O’Connor teaches the ventilator of claim 23, but does not teach further comprising a temperature control system, wherein the control device is further configured to control a temperature of the conditioned gas using the temperature control system.
However, White teaches comprising a temperature control system (humidifier 12 and controller 13, see Fig. 1), wherein the control device is further configured to control a temperature of the conditioned gas using the temperature control system (controller 13 is used to control the heater plate 70 in humidifier 12 to heat the gas to a desired temperature as seen in Fig. 70b and [0944]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by modified O’Connor to include the controller as taught by White to have a desired gas temperature for the required level of therapy and/or comfort for the patient (see [0944]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1), as applied to claim 1 above, and further in view Hill (US 6401713 B1)
Regarding claim 21, modified O’Connor teaches the method of claim 1, but does not teach further comprising receiving a user input to switch between automatic pressure control and constant pressure control.
However, Hill teaches comprising receiving a user input (input/output device 52, see Fig. 1) to switch between automatic pressure control and constant pressure control (Hill teaches manually setting initial pressure and final pressure via the input/output device or having it be automated as seen in Col. 6, lines 14-26).
O’Connor further teaches automatic pressure control as seen in [0094], [0099] and [0108]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to include the controller and input/output device taught by Hill to allow a user to either have an automated mode or a manual mode that allows the user to set the variables for great degree of flexibility (see Col. 6, lines 14-26).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20040118403 A1) in view of Scholler (US 20080058665 A1) and Kiritake (US 20100071698 A1), as applied to claim 1 above, and further in view Genger (US 20040016432 A1).
Regarding claim 22, modified O’Connor teaches the method of claim 1, but does not teach wherein the final nasal gas pressure (PnSet) is limited to a value between 0 mbar and 10 mbar.
However, Genger further teaches wherein the final nasal gas pressure (PnSet) is limited to a value between 2 mbar and 20 mbar (Genger teaches air pressure of 2 to 20 mbar in the sleeping person’s airways of sleeping person 14 receiving air through a nasal air cannula 1 as seen in Fig. 1 and [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified O’Connor to have the nasal gas pressure be between 2 to 20 mbar as taught by Genger as a pressure known in the art to be used with nose or face masks (see [0004]).
However, Genger does not explicitly disclose the pitch being between 0 and 10 mbar
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 nasal gas pressure of Genger from between 2 and 20 mbar to between 2 mbar and 10 mbar as applicant appears to have placed no criticality on the claimed range (see [0048], indicating the final nasal gas pressure is “preferably” within the claimed range) 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785