DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/3/2025 has been entered.
Response to Amendments
The Amendment filed 11/3/2025 has been entered. Claim 1 was amended, and claims 28-85 were canceled. Thus, claims 1-27 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 14, 16-17, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Landis et al. (US 2009/0101147 A1) in view of Tero (US 2011/0284001 A1) and White et al. (US 2016/0193438 A1), or alternatively over Landis in view of Tero, White, and Katahira (WO 03/050497 A1, see translation attached).
Regarding claim 1, Landis discloses a breath sensing device of a respiratory therapy system, the device configured to monitor patient breathing (a device for providing high flow therapy to a patient and which monitors their airway pressures) (abstract; para. [0030]), comprising:
a nasal cannula for breath sensing of a patient being provided high flow respiratory therapy (nasal cannula for delivering high flow therapy and measuring airway pressure) (abstract; para. [0030]), the nasal cannula comprising:
a cannula body having a first connector configured to receive a first flow of breathing gas and a second connector configured to receive a second flow of breathing gas (interface body 108, 308, 608 has gas delivery inlets 110, 310, 610 on both end portions to receive a flow of gas) (Figs. 1, 3, 6; para. [0034]);
a first nasal prong configured to deliver the first flow of breathing gas to a nare of the patient (left gas supply cannula 104, 304, 604 fits inside a nostril up to the flange) (Figs. 1, 3, 6; para. [0034]);
a second nasal prong configured to deliver the second flow of breathing gas to a nare of the patient (right gas supply cannula 104, 304, 604 fits inside a nostril up to the flange) (Figs. 1, 3, 6; para. [0034]);
a first sensing lumen having a distal end comprising a first sensing tip positioned externally along the first nasal prong such that, during patient inspiration and expiration, gas flows over the first nasal prong and the first sensing tip to create a pressure change within the first sensing lumen (left pressure cannula 106, 306, 606 tip positioned externally along the left gas supply cannula 104, 304, 604 to monitor airway pressure; as the left pressure cannula 106, 306, 606 tip is inside a patient’s nostril, gas during patient inspiration/expiration would flow over the cannula and tip to create a pressure change within the left pressure cannula 106, 306, 606) (Figs. 1, 3, 6; para. [0030]; para. [0034]);
and a first pressure sensor configured to detect gas flow over the sensing tip by detecting a first pressure in the first sensing lumen (as the pressure cannula 106, 306, 606 and pressure sensing conduits 112, 312, 612 are meant to be used to monitor pressure from a flow of gas, there would have to be a pressure sensor to detect that pressure from the gas flow) (Figs. 1, 3, 6; para. [0030]; para. [0034]).
Landis does not teach the first pressure sensor being positioned at a proximal end of the first sensing lumen opposite the first sensing tip.
However, Tero teaches a nasal interface device (Tero; abstract) including the first pressure sensor being positioned at a proximal end of the first sensing lumen opposite the first sensing tip (pressure measuring device 14 is on one end of the pressure tubing 108 opposite the end at the cannula) (Tero; Fig. 1; para. [0012]; para. [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis device such that the first pressure sensor is positioned at a proximal end of the first sensing lumen opposite the first sensing tip, as taught by Tero, for the purpose of providing the Landis device with a specific location for the pressure sensor which is suitable for measuring gas pressure from a patient and which one of ordinary skill in the art could feasibly assume to work reasonably well.
Alternatively, if Landis is not seen as disclosing a first pressure sensor is configured to detect gas flow over the sensing tip by detecting a first pressure in the first sensing lumen, White teaches an apparatus for providing flow therapy (White; para. [0001]) including a first pressure sensor is configured to detect gas flow over the sensing tip by detecting a first pressure in the first sensing lumen (a pressure line 23 with a pressure sensor 24 is used to detect a patient’s airway pressure in pressure line 23, which is then used to determine a patient’s respiratory flow rate at a nare, which is over a tip of the pressure line 23) (White; Figs. 1, 3, 13; para. [0548]; para. [0556]; para. [0574]; para. [0667]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis first pressure sensor such that the first pressure sensor is configured to detect gas flow over the sensing tip by detecting a first pressure in the first sensing lumen, as taught by White, for the purpose of enabling the device to determine whether a patient is taking in entrained ambient air, thereby indicating the breathing apparatus is not meeting the patient’s inspiratory demand (White; abstract; para. [0025]; para. [0032]).
Landis does not teach a controller configured to: (i) receive a pressure signal from the first pressure sensor indicative of the first sensing lumen pressure, the sensing lumen pressure indicative of the gas flow over the first nasal prong; (ii) convert the pressure signal into data; (iii) apply an algorithm to the data, wherein the algorithm is configured to: determine an average pressure in the data; determine maximum and minimum peaks in the data and/or filter the data; determine an average maximum peak over a period of time; determine an average minimum peak over a period of time; determine a pressure threshold as a percentage of the average maximum peak; and identify a breath when the pressure: crosses from below the average pressure to above the average pressure, then exceeds the average pressure by at least the pressure threshold, then reaches one of said maximum peaks, then crosses from above the average pressure to below the average pressure, then reaches one of said minimum peaks, then crosses from below the average pressure to above the average pressure; exclude non-breathing periods from the data; and (iv) send the data to the respiratory therapy system for determining a change to an operating parameter of the respiratory therapy system.
However, White further teaches including a controller configured to: (i) receive a pressure signal from the first pressure sensor indicative of the first sensing lumen pressure, the sensing lumen pressure indicative of the gas flow over the first nasal prong (controller 13 gets output from pressure sensor 24 in pressure line 23 for measuring the pressure over the cannula prong 18 in the patient’s nare, which is then used to determine a patient’s respiratory flow rate at a nare over the prong 18) (White; Figs. 1, 3, 13; para. [0548]; para. [0553]; paras. [0555-0556]; para. [0574]; para. [0667]); (ii) convert the pressure signal into data (pressure measurements from the pressure sensor are analyzed, and so data is created) (White; Figs. 1, 13; para. [0553]); (iii) apply an algorithm to the data, wherein the algorithm is configured to: determine an average pressure in the data (average/mean patient pressure determined from the pressure measured with the pressure line and pressure sensor) (White; para. [0026]; para. [0029]; para. [0667]); determine maximum and minimum peaks in the data and/or filter the data (minimum and maximum pressures can be determined over multiple breath cycles; mean pressure can be calculated according to an IIR median filter) (White; para. [0556]; para. [0567]; para. [0620]; para. [0639]; para. [0693]; para. [0765]); determine an average maximum peak over a period of time (average maximum pressure can be determined over multiple breath cycles) (White; para. [0765]); determine an average minimum peak over a period of time (average minimum pressure can be determined over multiple breath cycles) (White; para. [0556]; para. [0567]; para. [0693]); determine a pressure threshold as a percentage of the average maximum peak (for each therapy mechanism or mode, there can be maximum or minimum limits for each parameter setting, thresholds for particular parameter settings; as the average maximum peak is a parameter, there can be a minimum limit or a threshold associated with it that would be some percentage of the average maximum peak) (White; para. [0765]; para. [0989]); and identify a breath when the pressure: crosses from below the average pressure to above the average pressure, then exceeds the average pressure by at least the pressure threshold, then reaches one of said maximum peaks, then crosses from above the average pressure to below the average pressure, then reaches one of said minimum peaks, then crosses from below the average pressure to above the average pressure (the controller 13 can identify breath cycles, and when there is a new breath; controller 13 uses the measured pressure so as to be able to track pressure over a cycle, which would include when the pressure goes up from below a mean pressure, to at a mean pressure, to above a mean pressure by a threshold, to a maximum pressure during an expiratory breath and then when the pressure does down from the maximum pressure, to the mean pressure, to below a mean pressure, to a minimum pressure during an inspiratory breath, wherein the breathing cycle would then repeat) (White; Figs. 28-29, 35, 39-40; para. [0693]; para. [0765]); exclude non-breathing periods from the data (if the user is not wearing the interface, the pressure measurements are not taken) (White; Fig. 28; para. [0556]); and (iv) send the data to the respiratory therapy system for determining a change to an operating parameter of the respiratory therapy system (pressure measurements are used to determine a nasal flow or inspiratory/expiratory demand, and based on that determination the apparatus can alter the delivered gas flow rate or other parameters) (White; Figs. 28-29, 35, 39-40; para. [0556]; para. [0567]; para. [0754]; para. [0765]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis device to include a controller configured to: (i) receive a pressure signal from the first pressure sensor indicative of the first sensing lumen pressure, the sensing lumen pressure indicative of the gas flow over the first nasal prong; (ii) convert the pressure signal into data; (iii) apply an algorithm to the data, wherein the algorithm is configured to: determine an average pressure in the data; determine maximum and minimum peaks in the data and/or filter the data; determine an average maximum peak over a period of time; determine an average minimum peak over a period of time; determine a pressure threshold as a percentage of the average maximum peak; and identify a breath when the pressure: crosses from below the average pressure to above the average pressure, then exceeds the average pressure by at least the pressure threshold, then reaches one of said maximum peaks, then crosses from above the average pressure to below the average pressure, then reaches one of said minimum peaks, then crosses from below the average pressure to above the average pressure; exclude non-breathing periods from the data; and (iv) send the data to the respiratory therapy system for determining a change to an operating parameter of the respiratory therapy system, as taught by White, for the purpose of providing the device with a means to control and adjust the delivered flow depending upon measured pressures, thereby helping to ensure a patient’s inspiratory and expiratory demands are met (White; para. [0567]; para. [0751]; para. [0754]).
Alternatively, if White is not seen as definitively teaching determining a pressure threshold as a percentage of the average maximum peak, the pressure then exceeding the average pressure by at least the pressure threshold, Katahira teaches a pressure monitor for an airway (Katahira; translation, abstract) including determining a pressure threshold as a percentage of the average maximum peak (average value of a maximum pressure is calculated, and from there a lower limit value based on the average maximum pressure multiplied by a predetermined ratio) (Katahira; translation, page 3 third paragraph, page 4 first paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the White controller to determine a pressure threshold as a percentage of the average maximum peak, as taught by Katahira, for the purpose of allowing the system to recognize an abnormality and sound an alarm if needed (Katahira; translation, page 4 third and fourth paragraphs).
With this modification, the modified Landis would thus teach determining a pressure threshold as a percentage of the average maximum peak (in White, there can be maximum or minimum limits for each parameter setting, thresholds for particular parameter settings; as the White average maximum peak is a parameter, there can be a minimum limit or a threshold associated with it that would be some percentage of the average maximum peak; Katahira teaches such a threshold as a lower limit value based on the average maximum pressure multiplied by a predetermined ratio) (White, para. [0639], para. [0989]; Katahira, translation, page 3 third paragraph, page 4 first paragraph), the pressure then exceeding the average pressure by at least the pressure threshold (an allowable value for maximum pressure is met after the lower limit value of Katahira is exceeded, the Katahira lower limit value being some pressure above the White mean pressure) (White, Figs. 28-29, 35, 39-40, para. [0765], para. [0989]; Katahira, translation, page 3 third paragraph, page 4 first paragraph).
Regarding claim 3, the modified Landis teaches wherein the first sensing lumen comprises: a housing mounted on the cannula body (a left pressure sensing conduit 112, 312, 612 mounted on the interface body 108, 308, 608) (Landis; Figs. 1, 3, 6; para. [0034]), and a tube configured to enable fluid communication between the first sensing tip and the pressure sensor, wherein the tube is in fluid communication with the pressure sensor at the proximal end of the first sensing lumen, wherein the housing is fluidically connected to the tube (Tero pressure tubing 108 would enable fluid communication between the left Landis pressure sensing conduit 112, 312, 612, the left pressure cannula 106, 306, 606 tip, and the Tero pressure measuring device 14) (Landis, Figs. 1, 3, 6, para. [0034]; Tero, Fig. 1, para. [0012], para. [0031]).
Regarding claim 14, the modified Landis teaches the invention as previously claimed, but does not teach wherein the detected first pressure indicates a difference between an internal pressure within the first sensing lumen and ambient pressure of the surrounding environment (Landis monitors inhalation and exhalation pressure of the patient’s airway in the pressure sensing conduits 112, 312, 612 and pressure cannula 106, 306, 606 tips, which would be different from the ambient environment) (Landis; para. [0030]; para. [0034]).
Regarding claim 16, the modified Landis teaches wherein the first pressure sensor is configured to output a pressure signal indicative of the detected first sensing lumen pressure (Landis left pressure cannula 106, 306, 606 tip to monitor airway pressure with Tero pressure measuring device 14, and so would output a detected pressure signal using the Tero manometer 14 for the clinician to monitor) (Landis, Figs. 1, 3, 6, para. [0030], para. [0034]; Tero, Figs. 1, 5A, para. [0031]).
Regarding claim 17, the modified Landis teaches wherein the first sensing tip is angled relative to a longitudinal axis of the first sensing lumen (pressure cannula 106, 306 tip is angled relative to the rest of the pressure cannula 106, 306 along its longitudinal axis due to the curved shape) (Landis, Figs. 1, 3).
Regarding claim 22, the modified Landis teaches wherein the sensing tip is positioned on an exterior surface of the first nasal prong (a pressure cannula 106, 306, 606 tip is positioned on a respective gas supply cannula 104, 304, 604 exterior surface) (Landis; Figs. 1, 3, 6).
Regarding claim 23, the modified Landis teaches wherein the sensing tip is positioned on a dorsal side of the exterior surface of the first nasal prong (a pressure cannula 106, 306, 606 tip is positioned on a dorsal side of a respective gas supply cannula 104, 304, 604 exterior surface) (Landis; Figs. 1, 3, 6).
Regarding claim 24, the modified Landis teaches wherein the sensing tip is positioned proximally to a prong tip of the first nasal prong (a pressure cannula 106, 306, 606 tip is positioned proximally to a respective gas supply cannula 104, 304, 604 tip) (Landis; Figs. 1, 3, 6).
Regarding claim 25, the modified Landis teaches wherein the sensing tip is positioned on the nasal cannula such that the sensing tip resides within the nare of the patient while the cannula is in use (pressure cannula 106, 306, 606 tip is inside a patient’s nostril up to the flange when in use) (Landis; Figs. 1, 3, 6; para. [0034]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 1 above, and further in view of Aylsworth et al. (US 2005/0005942 A1).
Regarding claim 2, the modified Landis teaches the invention as previously claimed, including further comprising: a second sensing lumen having a second sensing tip positioned along the second nasal prong such that, during patient inspiration and expiration, gas flows over the second sensing tip to create a second pressure change within the second sensing lumen (right pressure cannula 106, 306, 606 tip positioned along the right gas supply cannula 104, 304, 604 to monitor airway pressure; as the right pressure cannula 106, 306, 606 tip is inside a patient’s nostril, gas during patient inspiration/expiration would flow over the tip to create a pressure change within the right pressure cannula 106, 306, 606) (Figs. 1, 3, 6; para. [0030]; para. [0034]), but does not teach a second pressure sensor configured to detect a second pressure in the second sensing lumen and positioned at a proximal end of the second sensing lumen opposite the second sensing tip.
However, Aylsworth teaches a system for measuring airflow through nares (Aylsworth; abstract) including a second pressure sensor configured to detect a second pressure in the second sensing lumen (second pressure sensor 160 coupled to the other of two nares 148 via a sensing tube to sense air pressure in that other nare; each nare has its own separate sensor and sensing tube) (Aylsworth; Fig. 6D; para. [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Landis device such that each nare has its own separate sensor and sensing tube, thereby including a second pressure sensor configured to detect a second pressure in the second sensing lumen, as taught by Aylsworth, for the purpose of being able to determine whether there is a difference in the airflow between the two nares (Aylsworth; para. [0049]).
With this modification, the modified Landis would thus teach the second pressure sensor positioned at a proximal end of the second sensing lumen opposite the second sensing tip (the Aylsworth second pressure sensor 160 would be positioned at the end of the pressure sensing tube opposite the end at the nasal cannula as taught by Tero) (Tero, Fig. 1, para. [0012], para. [0031]; Aylsworth, Fig. 6D, para. [0049]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 3 above, and further in view of Starr et al. (US 2005/0121033 A1, hereinafter Starr ‘033).
Regarding claim 4, the modified Landis teaches the invention as previously claimed, but does not teach wherein the tube has a length between about 5 mm and about 3 m.
However, Starr ‘033 teaches an apparatus for monitoring a patient’s respiratory status (Starr ‘033; abstract) wherein the tube has a length between about 5 mm and about 3 m (length of the conduit between the ports at the patient interface and the pressure sensor 134 can be approximately 7 feet, or 2.1336 meters) (Starr ‘033; Fig. 1; para. [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Landis device such that the tube has a length between about 5 mm and about 3 m, as taught by Starr ‘033, for the purpose of ensuring the pressure drop across the conduit is not too great (Starr ‘033; para. [0041]).
Claims 5 and 26 rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claims 1 and 3 above, and further in view of Allum et al. (US 2012/0325206 A1).
Regarding claim 5, the modified Landis teaches the invention as previously claimed, but is silent on wherein the tube has an internal diameter between about 0.25 mm and about 2.5 mm.
However, Allum teaches a mask for providing mechanical ventilation (Allum; abstract) wherein the tube has an internal diameter between about 0.25 mm and about 2.5 mm (pressure sensing lumen of bi-lumen 102 has an inner diameter or ID of about 0.5 mm to 2 mm) (Allum; Figs. 13-14; para. [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Landis sensing lumen such that the tube has an internal diameter between about 0.25 mm and about 2.5 mm, as taught by Allum, for the purpose of providing the tube with a specific suitable internal diameter which one of ordinary skill in the art could feasibly assume to work reasonably well for sensing air pressure from a patient interface, as well as which would allow for the tube to be of a reduced size capable of being routed around a patient’s ears to help hold the mask to the patient’s face (Allum; Fig. 14; para. [0067]).
Regarding claim 26, the modified Landis teaches wherein the sensing tip has an internal diameter between about 0.25 mm and 2.5 mm (modified Landis sensing lumen, which includes pressure cannula 106, 306, 606 tip, was modified by Allum to have an internal diameter or ID of about 0.5 mm to 2 mm) (Landis, Figs. 1, 3, 6, para. [0030], para. [0034]; Allum, Figs. 13-14, para. [0057]).
Claims 6-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 3 above, and further in view of Blackburn et al. (US 4,270,564).
Regarding claim 6, the modified Landis teaches the invention as previously claimed, but does not teach wherein a control gas flows from a flow generator through at least a portion of the tube in a direction from the proximal end to the sensing tip.
However, Blackburn teaches a purging system for removing moisture from gas lines in respiratory monitoring systems (Blackburn; col. 1, lines 4-7) wherein a control gas flows from a flow generator through at least a portion of the tube in a direction from the proximal end to the sensing tip (pump 107 produces an airflow illustrated by arrows with rectangle tails through the gas line in a reverse direction towards an inlet conduit 97 to force moisture out before reaching the end with the analyzer 27/flow meter 31) (Blackburn; Fig. 5; col. 6, lines 53-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis device to include a control gas flows from a flow generator through at least a portion of the tube in a direction from the proximal end to the sensing tip, as taught by Blackburn, for the purpose of enabling the device to remove moisture and foreign material from the gas line (Blackburn; abstract; col. 1, lines 4-7), thereby protecting the gas line from obstructions and/or contamination.
Regarding claim 7, the modified Landis teaches wherein the control gas collides with patient breath at a boundary region adjacent to the first sensing tip (when the Blackburn pump 107 generates the rectangle tail gas flow, that gas flow would move out of the Landis pressure cannula 106, 306, 606 tip in the patient’s nostril, and in doing so collide with the patient’s breath in their nostril at a region just outside the pressure cannula 106, 306, 606 tip) (Landis, Figs. 1, 3, 6, para. [0030], para. [0034]; Blackburn, Fig. 5, col. 6 lines 53-65).
Regarding claim 8, the modified Landis teaches wherein the control gas is delivered intermittently as a bolus flow (pump 107 produces a rectangle tail airflow intermittently, as determined by when moisture is sensed) (Blackburn; Fig. 5; col. 6, lines 53-65).
Regarding claim 10, the modified Landis teaches wherein the flow generator is a blower (pressure pump 107 pumps air) (Blackburn; Fig. 5; col. 6, lines 53-65).
Regarding claim 11, the modified Landis teaches wherein the nasal cannula is configured with the control gas so as to purge condensation from the first sensing lumen (Blackburn pump 107 generates the rectangle tail gas flow to remove moisture out the Landis pressure cannula 106, 306, 606 tip) (Landis, Figs. 1, 3, 6, para. [0030], para. [0034]; Blackburn, Fig. 5, abstract, col. 1 lines 4-7, col. 6 lines 53-65).
Regarding claim 12, the modified Landis teaches wherein the sensing lumen comprises a tee joint positioned along the tube and configured to convey the control gas into the tube from the flow generator (gas line connector 3 is tee shaped and positioned along conduits 99, 103 to convey the rectangle tail gas flow into the conduit 99 from pump 107) (Blackburn; Fig. 5; col. 4, lines 3-15; col. 6, lines 53-65).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, Katahira, and Blackburn as applied to claim 6 above, and further in view of Merilainen et al. (US 6,315,739 B1).
Regarding claim 9, the modified Landis teaches the invention as previously claimed, but is silent on wherein the control gas has a flow rate between about 0.1 mL/min and about 10 mL/min.
However, Merilainen teaches an apparatus for determining the pressure of a patient (Merilainen; abstract) wherein the control gas has a flow rate between about 0.1 mL/min and about 10 mL/min (infusion conduit 9 controls a flow of fluid from a fluid source 10 at one end to maintain patency of the conduit, i.e. preventing mucus from blocking the conduit, and measures pressure at its second end; infusion flow rate for gases is between 3-30 ml/min, preferably around 10 ml/min) (Merilainen; abstract; col. 3, lines 5-17; col. 4, lines 14-22, 30-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Landis control gas to have a flow rate between about 0.1 mL/min and about 10 mL/min, as taught by Merilainen, for the purpose of providing the device with a specific flow rate which one of ordinary skill in the art could feasibly assume to work reasonably well for removing mucus and moisture from tubing, as well as for the purpose of minimizing the pressure caused by the control or infusion gas flow (Merilainen; col. 4, lines 30-41).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 1 above, and further in view of Levitsky et al. (US 2015/0230731 A1).
Regarding claim 13, the modified Landis teaches the invention as previously claimed, but does not teach further comprising a temperature sensor configured to measure a breath temperature.
However, Levitsky teaches a system for sampling exhaled breath (Levitsky; abstract) including a temperature sensor configured to measure a breath temperature (thermistor for detecting air temperature changes caused by breathing) (Levitsky; para. [0079]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis device to include a temperature sensor configured to measure a breath temperature, as taught by Levitsky, for the purpose of allowing for the detection of when exactly the patient exhales, thereby enabling the supplied gas flow to be reduced for the minimum possible duration to cover the exhalations (Levitsky; para. [0079]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 14 above, and further in view of Starr et al. (US 6,017,315, hereinafter Starr ‘315).
Regarding claim 15, the modified Landis teaches the invention as previously claimed, but is silent on wherein the difference is about 1 Pa to about 5 Pa.
However, Starr ‘315 teaches a patient monitoring apparatus with a patient interface (Starr ‘315; abstract) wherein the difference is about 1 Pa to about 5 Pa (sensor 78 measures a pressure differential between the internal portion of the user interface and the ambient atmosphere due to patient inhalation and exhalation; the pressure differential ranges from about -2.3 to 2.3 cmH2O, or about -225.55 to 225.55 Pa) (Starr ‘315; Fig. 8; abstract; col. 6, lines 16-30; col. 12, lines 12-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis difference to be at least about 1 Pa to at least about 5 Pa, as taught by Starr ‘315, for the purpose of ensuring the device supplies a suitable pressure differential for the gas to flow through the circuit for the flow rate to be measured, and which is suitable for a patient’s inhalation and exhalation (Starr ‘315; col. 6, lines 31-41).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 17 above, and further in view of Hobson et al. (US 2019/0134336 A1).
Regarding claims 18-20, the modified Landis teaches the invention as previously claimed, but does not teach wherein the first sensing tip comprises a tip face at an angle other than 90 degrees relative to the longitudinal axis, wherein the angle is between about 30 degrees and about 60 degrees, wherein the angle is about 45 degrees.
However, Hobson teaches a nasal cannula arrangement (Hobson; abstract) wherein the first sensing tip comprises a tip face at an angle other than 90 degrees relative to the longitudinal axis, wherein the angle is between about 30 degrees and about 60 degrees, wherein the angle is about 45 degrees (angle X between lines A and B, which is the angle between the tip face at B and the rest of the prong along axis A, can range between 0 to 60 degrees) (Hobson; Fig. 9; para. [0116]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis sensing tip such that the first sensing tip comprises a tip face at an angle other than 90 degrees relative to the longitudinal axis, wherein the angle is between about 30 degrees and about 60 degrees, wherein the angle is about 45 degrees, as taught by Hobson, for the purpose of providing the most comfortable fit or position for a patient (Hobson; para. [0116]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, Katahira, and Hobson as applied to claim 18 above, and further in view of Tabrizchi (US 2013/0160772 A1).
Regarding claim 21, the modified Landis teaches the invention as previously claimed, but does not teach wherein the tip face has rounded, beveled, or chamfered edges.
However, Tabrizchi teaches a multi-functional cannula (Tabrizchi; abstract) wherein the tip face has rounded edges (nasal prong outer edge can be rounded) (Tabrizchi; para. [0017]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis tip face to have rounded edges, as taught by Tabrizchi, for the purpose of minimizing any irritation that may occur from the outer edge rubbing inside the user’s nasal passage (Tabrizchi; para. [0017]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Landis, Tero, White, and Katahira as applied to claim 1 above, and further in view of Evans et al. (US 2018/0064898 A1).
Regarding claim 27, the modified Landis teaches the invention as previously claimed, but is silent on wherein the first nasal prong has an internal diameter of about 1.0 to about 4.0 mm.
However, Evans teaches a nasal cannula (Evans; abstract) wherein the first nasal prong has an internal diameter of about 1.0 to about 4.0 mm (nasal prong 233 has an internal diameter of 4-5 mm) (Evans; Figs. 23G-23I; para. [0276]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Landis first nasal prong to have an internal diameter of about 1.0 to about 4.0 mm, as taught by Evans, for the purpose of providing the nasal prong with a specific suitable internal diameter which one of ordinary skill in the art could feasibly assume to work reasonably well for supplying gas to a patient’s nostrils.
Response to Arguments
Applicant's arguments filed 11/3/2025 have been fully considered but they are not persuasive.
On pages 7-8 in the “Rejections under 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections.
On page 11 in the second paragraph of the Applicant’s remarks, the Applicant argues that White is not concerned with flow direction and breath detection, as White’s pressure sensor cannot determine the direction of flow. However, the Examiner respectfully disagrees. White is concerned with flow direction and breath detection, as White tracks when an instantaneous pressure reading is above, below, or at a mean pressure to indicate a new inspiratory/expiratory breath in a breathing cycle. When the instantaneous pressure reading is below a mean pressure, then it is determined that there is currently an inspiratory flow. When the instantaneous pressure reading is above a mean pressure, then it is determined that there is currently an expiratory flow (White; para. [0693]; para. [0765]). Thus, the White reference can still be used to teach the Applicant’s invention as currently claimed.
Applicant’s arguments on page 11 in the third paragraph of the Applicant’s remarks with respect to the Gerrad reference have been considered but are moot in view of new grounds of rejection with new additional Katahira reference being used in the current rejection as discussed above.
On page 11 in the fourth paragraph of the Applicant’s remarks, the Applicant argues that the White and Gerrad references are not concerned with sensing the patient’s breathing patterns and conditions to measure a respiratory rate as claimed, e.g. by determining if changes in detected pressure are noise or actual breathing patterns, and as such cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sensing the patient’s breathing patterns and conditions to measure a respiratory rate as claimed, e.g. by determining if changes in detected pressure are noise or actual breathing patterns) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the current prior art of record can be used to teach the Applicant’s invention as currently claimed.
On page 11 in the last paragraph to page 12 in the third paragraph of the Applicant’s remarks, the Applicant argues that the other prior art of record (i.e. not the White or Gerrad references previously discussed above) cannot be used to teach the claimed controller and algorithm of claim 1, and thus claim 1 is allowable. However, the Examiner respectfully disagrees. The other prior art of record are not being used to teach the claimed controller and algorithm of claim 1. Rather, the White and Katahira references are used to teach those features as discussed in the 35 U.S.C. 103 rejection of claim 1 above. Thus, this argument is moot, and so the current combination of Landis, Tero, White, and Katahira references can be used to teach the Applicant’s invention as currently claimed in claim 1.
Conclusion
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785