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 3/16/2026. As directed by the amendments, claims 1-3, 5, 7, 10-12, 14, and 17-18 were amended, and claim 8 was cancelled. Thus, claims 1-7 and 9-20 are currently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-5, 7, 9, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of Dunlop (WO 2023010173 A1).
Regarding claim 1, Vazales an adapter for a ventilation system, comprising: a junction (Fig. 1 where there is a junction from where the ports 15 and 17 branch from, being the central junction from which all three ports 11, 15, and 17 branch from), a first port fluidly coupled to the junction configured to interface with a ventilator piece (paragraph 0053 "The manifold 13 also includes a standard size ventilator connection port 15"), a second port configured to interface with a suction catheter system (paragraph 0053 "As shown, the closed suction cleaning device module 12 is removably coupled (e.g., via friction-fit coupling or mechanical interlocking coupling mechanisms) to the instrumentation port 17"), and a third port configured to interface with an intubation tube (paragraph 0053 "The distal port 11 of the manifold (e.g., a variable size connector) can be sized as appropriate to match the internal diameter of the endotracheal tube 14 to which it is being connected").
Vazales is silent wherein the junction comprises an integrated region including a sensor mount surface for directly releasably receiving a gas concentration sensor, and wherein the junction and first port have a first centerline axis that extends through each of the first port, the integrated region, and a junction length.
However, Dunlop teaches an integrated region including a sensor mount surface (Fig. 11b, the surface where sensor 51 attaches to is a sensor mount surface) for directly releasably receiving a gas concentration sensor (Fig. 11b shows a connector 50 which has a region integrated into the device to receive a gas sensor).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include an integrated region on the junction for releasably receiving a gas concentration sensor. Creating an integrated region on the adapter for the sensor allows for quicker and more precise measurements as the sensor is directly built into the adapter (page 13 paragraph 5 “the placement of connector 50 and sensor 51 at the expiratory limb (second connector 6), allows for a more accurate CO2 sample for the smallest patient for which this set up is used, namely for small mammals of mass 5kg to 10kg”).
Additionally, the product disclosed by the prior art could be reasonably arranged to arrive at the same function of the gas sensor measuring the air flowing through it while having 3 ports connected to 3 different sources. Reasonably, the modified device has the first port 15 located adjacent to the centerline axis of the junction. However, reasonably rearranging port 15 to be swapped with port 11 would still allow the adapter to function the same way and after this modification, the junction and first port would have centerline axis that extends through each of the first port, the integrated region, and a junction length. There is no evidence to show that the claimed arrangement and location of parts imparts any patentable distinction between the claimed product and that of the prior art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 and In re Kuhle, 526 F.2d 553, 188 USPQ 7. See also MPEP § 2144.
Regarding claim 2, modified Vazales teaches the adapter of claim 1.
Vazales further teaches a manifold, wherein the junction, the second port, and the third port branch off from the manifold to form separate channels (Fig. 1 where 13 is a manifold and the ports 11, 15, and 17 branch from the manifold), wherein the manifold is a one-piece, monolithic member (Fig. 1A shows a close up of the manifold 13 which demonstrates the manifold being a single-piece and monolithic).
Modified Vazales does not specifically teach wherein the junction, the integrated region, and the sensor mount surface are integrally formed as part of the one-piece, monolithic member.
However, it would be obvious for one reasonably skilled in the art to integrate these structures together as part of the one-piece monolithic member for the purpose of conserving space and material costs. It is not patently distinct to make these structures integrally formed. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). See also MPEP 2144.
Regarding claim 3, modified Vazales teaches the adapter of claim 2.
Vazales further teaches a cross sectional area of the manifold decreases from the integrated region of the junction through the junction length to the third port (paragraph 0053 "The distal port 11 of the manifold (e.g., a variable size connector) can be sized as appropriate to match the internal diameter of the endotracheal tube 14 to which it is being connected. The distal port 11 reversibly couples to the manifold 13 and is chosen from a variety of available sizes to accommodate endotracheal tubes of various diameters"; Port 11 can be sized to have a decreased area compared to the manifold 13 to accommodate a smaller tube; when Vazales is modified with the integrated region as taught by Dunlop above, then one skilled in the art would expect that the cross sectional area decreases when starting from the integrated region, then moving through the junction length of Vazales, and then moving towards the third port 11 when this port is chosen to be a smaller size that would reasonably have a decreased cross sectional area).
Regarding claim 4, modified Vazales teaches the adapter of claim 2.
Vazales further teaches wherein the junction and the second port branch off from the manifold substantially in parallel (Fig. 1 where the second port 17 and the junction are in parallel).
Regarding claim 5, modified Vazales teaches the adapter of claim 2.
Modified Vazales is silent wherein a first axial length of the junction length is less than a second axial length of the third port.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to construct the first axial length of the junction length to be less than the axial length of the third port. This would be an optimized modification so that the adapter can be constructed as small as possible.
Regarding claim 7, modified Vazales teaches the adapter of claim 1.
Dunlop further teaches wherein the integrated region further comprising the sensor mount surface interposed between a first clip and a second clip (Fig. 11b where connector 50 demonstrates two clips to accommodate the sensor), the first clip and the second clip releasably mounting the gas concentration sensor to the sensor mount surface (Fig. 11b demonstrates how the sensor 51 mounts to the connector 50 via the clips shown on connector 50), and a sensor window positioned in the sensor mount surface (page 13 paragraph 4 "Connector 50 has a side window").
Regarding claim 9, modified Vazales teaches the adapter of claim 2.
Vazales further teaches wherein the adapter is formed as a one-piece, monolithic structure by one of an injection molding process and a compression molding process (Fig. 1A where the manifold itself is the adapter and thereby demonstrates a single piece).
With regard to claim 9 which is a product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. There is no evidence to show that the claimed process imparts any patentable distinction between the claimed product and that of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113.
Regarding claim 17, Vazales teaches a method for an adapter, the method comprising: operating a ventilator to flow gas to a patient (paragraph 0010 “The method further comprises coupling a ventilator to the ventilator port of the endotracheal tube adapter or manifold and inserting a distal end of the suction catheter through at least a portion of an endotracheal tube to perform suctioning of the endotracheal tube and/or portions of the tracheobronchial tree beyond the endotracheal tube”), the ventilator fluidly coupled to the patient via the adapter (paragraph 0005 “The manifold may include a ventilator port adapted to couple to a standard ventilation source (e.g., ventilator or ventilation unit) so as to provide ventilation to a patient from the ventilator through the artificial airway”), a first port fluidly coupled to the junction configured to interface with a ventilator piece (paragraph 0053 "The manifold 13 also includes a standard size ventilator connection port 15"), a second port configured to interface with a suction catheter system (paragraph 0053 "As shown, the closed suction cleaning device module 12 is removably coupled (e.g., via friction-fit coupling or mechanical interlocking coupling mechanisms) to the instrumentation port 17"), and a third port configured to interface with an intubation tube (paragraph 0053 " The distal port 11 of the manifold (e.g., a variable size connector) can be sized as appropriate to match the internal diameter of the endotracheal tube 14 to which it is being connected").
Vazales is silent wherein the junction comprises an integrated region including a sensor mount surface for directly releasably receiving a gas concentration sensor, and wherein the junction and first port have a first centerline axis that extends through each of the first port, the integrated region, and a junction length.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include an integrated region on the junction for releasably receiving a gas concentration sensor. Creating an integrated region on the adapter for the sensor allows for quicker and more precise measurements as the sensor is directly built into the adapter (page 13 paragraph 5 “the placement of connector 50 and sensor 51 at the expiratory limb (second connector 6), allows for a more accurate CO2 sample for the smallest patient for which this set up is used, namely for small mammals of mass 5kg to 10kg”).
Additionally, the product disclosed by the prior art could be reasonably arranged to arrive at the same function of the gas sensor measuring the air flowing through it while having 3 ports connected to 3 different sources. Reasonably, the modified device has the first port 15 located adjacent to the centerline axis of the junction. However, reasonably rearranging port 15 to be swapped with port 11 would still allow the adapter to function the same way and after this modification, the junction and first port would have centerline axis that extends through each of the first port, the integrated region, and a junction length. There is no evidence to show that the claimed arrangement and location of parts imparts any patentable distinction between the claimed product and that of the prior art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 and In re Kuhle, 526 F.2d 553, 188 USPQ 7. See also MPEP § 2144.
Regarding claim 20, modified Vazales teaches the method of claim 17.
Vazales further teaches operating the suction catheter system, the suction catheter system fluidly coupled to the second port of the adapter (paragraph 0054 “When the manifold occluder 18 is in the open configuration, a closed suction catheter 19 of the closed suction cleaning device module 12, an endotracheal tube cleaning device [e.g., catheter], or other catheters, scopes, or instruments can be inserted into the endotracheal tube 14 through the manifold 13 [e.g., in through instrumentation port 17 and out through distal port 11]”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of Dunlop (WO 2023010173 A1) as applied to claim 1 and in further view of Kabumoto (US 20230277085 A1).
Regarding claim 6, modified Vazales teaches the adapter of claim 1.
Modified Vazales is silent on further comprising a heat guard coupled to the junction, the heat guard comprising a flexible extension and a guard frame configured to conform to the gas concentration sensor.
However, Kabumoto teaches a heat guard comprising a flexible extension and a guard frame configured to conform to the gas concentration sensor (paragraph 0032 “In particular, the first adapter-side engagement portion 34 is elastically deformed when the respiratory gas sensor 2 is attached to the compatible airway adaptor 3”; paragraph 0033 “In particular, the second adapter-side engagement portion 35 is elastically deformed when the respiratory gas sensor 2 is attached to the compatible airway adaptor 3”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include a heat guard coupled to the junction comprising a flexible extension and guard frame configured to the gas sensor. The flexible heat guard allows a user to adjust the exact positioning of the sensor for preferred comfortability or function. It would have been obvious to couple the heat guard to the junction to allow the sensor to interface with the integrated region while still being spaced away from the user.
Claims 10-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of McCormick (US 20220241528 A1) and Dunlop (WO 2023010173 A1).
Regarding claim 10, Vazales teaches a system comprising: the adapter comprising a junction (Fig. 1 where there is a junction from where the ports 15 and 17 branch from), a first port fluidly coupled to the junction configured to interface with the ventilator (paragraph 0053 "The manifold 13 also includes a standard size ventilator connection port 15"), a second port configured to interface with the suction catheter system (paragraph 0053 "As shown, the closed suction cleaning device module 12 is removably coupled (e.g., via friction-fit coupling or mechanical interlocking coupling mechanisms) to the instrumentation port 17”), and a third port configured to interface with the intubation tube (paragraph 0053 " The distal port 11 of the manifold (e.g., a variable size connector) can be sized as appropriate to match the internal diameter of the endotracheal tube 14 to which it is being connected").
Vazales is silent on a source of medical gas; a ventilator coupled to the source of medical gas; a gas concentration sensor coupled to the ventilator; a suction catheter system coupled to the ventilator; an intubation tube; and an adapter coupled to the ventilator, the gas concentration sensor, and the suction catheter system, and the intubation tube.
However, McCormick teaches a source of medical gas; a ventilator coupled to the source of medical gas (paragraph 0036 "A portable gas source 8 is connected to the portable ventilator 2 and a host gas source 12 is connected to the host 10. The portable ventilator 2 is configured to deliver ventilation gas to the patient 16 from either one of at least one portable gas source 8 and a host gas source 12"); a gas concentration sensor coupled to the ventilator (paragraph 0049 "Further, one or more of the controllers 20, 22 may receive information from sensors within the drive 4, such as O.sub.2 sensors, pressure sensors, flow sensors, valve position sensors, etc. Additionally, the ventilation controllers 20, 22 may be configured to variously control the user interfaces 21, 23 on the ventilator 2 and/or the host 10"); a suction catheter system coupled to the ventilator (paragraph 0038 "In other embodiments, the patient connection 14 may include any patient end connector configured to deliver appropriate ventilation or respiratory support to a patient, such as a mask, nasal cannula, etc"; the suction catheter would be an obvious inclusion for respiratory support); an intubation tube (paragraph 0063 "The endotracheal tube patient connection 14′ is connected to the inspiratory connection port 64 and the expiratory connection port 74 on the ventilator 2, and particularly on the interface housing 46 on the patient interface section 6"); and an adapter coupled to the ventilator, the gas concentration sensor, and the suction catheter system, and the intubation tube (paragraph 0039 “A flow of medical gas and/or other ventilation gases is provided through the inspiratory path 60 to the patient 16 through the patient connection 14 in an inspiratory phase of a ventilation cycle and expired gases are directed from the patient 16 through the patient connection 14 through the expiratory path 70 in an expiratory phase of the ventilation cycle”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include a system comprising medical gas, ventilator, suction catheter, intubation tube, and gas concentration sensor. The ports of Vazales are configured to attach to these system components, therefore it would have been obvious for the adapter to connect with these components in a system to be fully functional and achieve its intended use.
Vazales is silent wherein the junction comprises an integrated region including a sensor mount surface for directly releasably receiving a gas concentration sensor, and wherein the junction and first port have a first centerline axis that extends through each of the first port, the integrated region, and a junction length.
However, Dunlop teaches an integrated region including a sensor mount surface (Fig. 11b, the surface where sensor 51 attaches to is a sensor mount surface) for directly releasably receiving a gas concentration sensor (Fig. 11b shows a connector 50 which has a region integrated into the device to receive a gas sensor).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include an integrated region on the junction for releasably receiving a gas concentration sensor. Creating an integrated region on the adapter for the sensor allows for quicker and more precise measurements as the sensor is directly built into the adapter (page 13 paragraph 5 “the placement of connector 50 and sensor 51 at the expiratory limb (second connector 6), allows for a more accurate CO2 sample for the smallest patient for which this set up is used, namely for small mammals of mass 5kg to 10kg”).
Additionally, the product disclosed by the prior art could be reasonably arranged to arrive at the same function of the gas sensor measuring the air flowing through it while having 3 ports connected to 3 different sources. Reasonably, the modified device has the first port 15 located adjacent to the centerline axis of the junction. However, reasonably rearranging port 15 to be swapped with port 11 would still allow the adapter to function the same way and after this modification, the junction and first port would have centerline axis that extends through each of the first port, the integrated region, and a junction length. There is no evidence to show that the claimed arrangement and location of parts imparts any patentable distinction between the claimed product and that of the prior art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 and In re Kuhle, 526 F.2d 553, 188 USPQ 7. See also MPEP § 2144.
Regarding claim 11, modified Vazales teaches the system of claim 10.
Vazales further teaches the adapter further comprising a manifold wherein the junction, the second port, and the third port branch off from the manifold to form separate channels (Fig. 1 where 13 is a manifold and the ports 11, 15, and 17 branch from the manifold), wherein a cross sectional area of the manifold decreases from the integrated region of the junction to the third port (paragraph 0053 "The distal port 11 of the manifold (e.g., a variable size connector) can be sized as appropriate to match the internal diameter of the endotracheal tube 14 to which it is being connected. The distal port 11 reversibly couples to the manifold 13 and is chosen from a variety of available sizes to accommodate endotracheal tubes of various diameters"; Port 11 can be sized to have a decreased area compared to the manifold 13 to accommodate a smaller tube; when Vazales is modified with the integrated region as taught by Dunlop above, then one skilled in the art would expect that the cross sectional area decreases when starting from the integrated region, then moving through the junction length of Vazales, and then moving towards the third port 11 when this port is chosen to be a smaller size that would reasonably have a decreased cross sectional area), and wherein the junction and the second port branch off from the manifold substantially in parallel (Fig. 1 where the second port 17 and the junction are in parallel).
Regarding claim 12, modified Vazales teaches the system of claim 11.
Modified Vazales is silent wherein a first axial length of the junction length is less than a second axial length of the third port.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to construct the first axial length of the junction length to be less than the axial length of the third port. This would be an optimized modification so that the adapter can be constructed as small as possible.
Regarding claim 14, modified Vazales teaches the system of claim 10.
Dunlop further teaches wherein the integrated region further comprising the sensor mount surface interposed between a first clip and a second clip (Fig. 11b where connector 50 demonstrates two clips to accommodate the sensor), the first clip and the second clip releasably mounting the gas concentration sensor to the sensor mount surface (Fig. 11b demonstrates how the sensor 51 mounts to the connector 50 via the clips shown on connector 50), and a sensor window positioned in the sensor mount surface (page 13 paragraph 4 "Connector 50 has a side window").
Regarding claim 16, modified Vazales teaches the system of claim 11.
Dunlop further teaches wherein the manifold is a one-piece, monolithic member formed from one or more medical grade plastics (page 9 paragraph 13 “In this embodiment connector piece 1 is preferably made of a plastic material, such as polycarbonate or polypropylene").
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of McCormick (US 20220241528 A1) and Dunlop (WO 2023010173 A1) as applied to claim 10 and in further view of Kabumoto (US 20230277085 A1).
Regarding claim 13, modified Vazales teaches the system of claim 10.
Modified Vazales is silent on further comprising a heat guard coupled to the junction, the heat guard comprising a flexible extension and a guard frame configured to conform to the gas concentration sensor.
However, Kabumoto teaches a heat guard comprising a flexible extension and a guard frame configured to conform to the gas concentration sensor (paragraph 0032 “In particular, the first adapter-side engagement portion 34 is elastically deformed when the respiratory gas sensor 2 is attached to the compatible airway adaptor 3”; paragraph 0033 “In particular, the second adapter-side engagement portion 35 is elastically deformed when the respiratory gas sensor 2 is attached to the compatible airway adaptor 3”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include a heat guard coupled to the junction comprising a flexible extension and guard frame configured to the gas sensor. The flexible heat guard allows a user to adjust the exact positioning of the sensor for preferred comfortability or function. It would have been obvious to couple the heat guard to the junction to allow the sensor to interface with the integrated region while still being spaced away from the user.
Regarding claim 15, modified Vazales teaches the system of claim 10.
Modified Vazales is silent on the gas concentration sensor is an infrared sensor comprising an emitter and a detector, the emitter and the detector sealingly clamping around opposing sides of the integrated region.
However, Kabumoto teaches a gas concentration sensor that is an infrared sensor comprising an emitter and a detector (paragraph 0024 “The light emitting unit 42 and the light detecting unit 41 function as a respiratory gas detector that detects the state of the respiratory gas of the patient. The light emitting unit 42 can include a first light emitter that emits first infrared light and a second light emitter that emits second infrared light having a wavelength different from that of the first infrared light”) sealingly clamping around opposing sides of the integrated region (paragraph 0023 "As illustrated in FIG. 1, a sensor attachment portion 31 (see FIG. 5) is fitted to the fitting portion 23 in a state in which the respiratory gas sensor 2 is attached to the compatible airway adaptor 3. In this state, the light emitting unit 42 and the light detecting unit 41 face each other in the Y-axis direction through the respiratory gas passing through a respiratory gas ventilation passage 40").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include an infrared sensor with an emitter and detector that clamps around opposing sides of an integrated region. The use of the infrared emitter and detector allows for analysis of the carbon dioxide in the air, adding more vital signs regarding the respiratory status of the patients (paragraph 0025 “Therefore, the first infrared light is used as measurement light for measuring the concentration of carbon dioxide, while the second infrared light is used as reference light. A controller (not illustrated) provided in the respiratory gas sensor 2 can generate a vital signs signal indicating the state of the respiratory gas of the patient (concentration or partial pressure of carbon dioxide contained in respiratory gas) based on a ratio between an intensity of a first measurement signal output from the first light detector and an intensity of a second measurement signal output from the second light detector”). It would have been obvious for the sensor to clamp around opposing sides of an integrated region on the adaptor so that the sensor would not interfere with the air traveling through the adaptor (paragraph 007 “The respiratory gas sensor is attachable to the compatible airway adaptor in a state in which the compatible airway adaptor and the respiratory gas sensor do not interfere with each other”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of Dunlop (WO 2023010173 A1) as applied to claim 17 and in further view of McCormick (US 20220241528 A1).
Regarding claim 18, modified Vazales teaches the method of claim 17.
Dunlop further teaches operating the gas concentration sensor (page 13 paragraph 5 “Connector 50 is attached to the expiratory limb [second connector 6]. In this arrangement, because the MDS has been minimized by use of connector piece 1, the placement of connector 50 and sensor 51 at the expiratory limb [second connector 6], allows for a more accurate CO2 sample for the smallest patient for which this set up is used”), the gas concentration sensor fluidly coupled to the sensor mount surface of the integrated region of the adapter (Fig. 11b where connector 50 demonstrates two clips to accommodate the sensor 51, where this area enclosed by the clips is the sensor mount surface fluidly coupled to the sensor).
Modified Vazales is silent wherein the sensor is in electronic communication with a control system of the ventilator.
However, McCormick teaches the sensor in electronic communication with a control system of the ventilator (paragraph 0049 "Further, one or more of the controllers 20, 22 may receive information from sensors within the drive 4, such as O.sub.2 sensors, pressure sensors, flow sensors, valve position sensors, etc. Additionally, the ventilation controllers 20, 22 may be configured to variously control the user interfaces 21, 23 on the ventilator 2 and/or the host 10").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales to include a sensor in electronic communication with a ventilator. This increases the monitoring and alarming ability of the ventilator and allows for the ventilator settings to be adjusted based on the sensor data (paragraph 0063 “Thereby, patient physiological data is provided to the ventilator 2, which may be used by the controller 20 for controlling ventilation to the patient as well as for general patient monitoring and alarming. Patient physiological information based on the monitoring data may be displayed on the user interface section 21b, such as on the display 21c”).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vazales (US 20190336714 A1) in view of Dunlop (WO 2023010173 A1) and McCormick (US 20220241528 A1) as applied to claim 18 and in further view of Haveri (US 8353295 B2).
Regarding claim 19, modified Vazales is teaches the method of claim 18.
Modified Vazales is silent wherein operating the gas concentration sensor comprises measuring patient fractional concentration of inspired CO2, end tidal CO2, real-time CO2 concentration, and respiration rate.
However, Haveri teaches wherein the gas concentration sensor measures patient fractional concentration of inspired CO2, end tidal CO2, real time CO2 concentration, and respiration rate (claim 7 “The branching unit according to claim 4, wherein said airway adapter comprises a sampling chamber and an optical windows and is configured to receive a gas analyzer for measuring at least one gas component flowing through said sampling chamber”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Vazales so the gas sensor measures fractional CO2, end tidal CO2, real-time CO2 concentration, and respiration rate. These parameters provide valuable insights into the stability and health of the patient’s respiration and thus it would be obvious monitor these parameters (paragraph 11 “Respiratory acidosis occurs when the carbon dioxide is retained. The CO.sub.2 concentration reaches a maximum at the end of exhalation, which is called end-tidal carbon dioxide concentration or tension depending on whether it is expressed in fractional concentration or mmHg. End-tidal carbon dioxide reflects CO.sub.2 concentration of alveoli emptying last”; paragraph 17 “Furthermore respiration rates (RR) of smaller patients are higher, up to 150 breaths/minute or even more, which is well above the measurement range of the conventional sidestream gas measurement technology, compared to adult patients with RR less than 60 breaths/minute”).
Response to Arguments
Applicant argues on pages 8-9 that it is unclear how Dunlop’s connector 50 would combine with Vazales. Examiner respectfully disagrees with this argument. The Examiner states in the previous office action that the junction is where ports 15 and 17 branch from in Vazales, and so one skilled in the art would expect that this integrated region would be modified onto this junction region of Vazales. The new limitations amended into claim 1 are addressed in the modified rejection above, specifically…
Applicant argues on page 10 that it is unclear how Dunlop’s connector 50 would combine with Vazales while maintaining a monolithic structure. Examiner respectfully disagrees with this argument. Examiner would like to clarify that the modification made in the previous office actions intends add in just the integrated region from Dunlop’s connector into the adapter of Vazales. Making the modification in this way would still maintain the monolithic structure that is already taught by Vazales. Additionally, it would be obvious for one reasonably skilled in the art to integrate these structures together as part of the one-piece monolithic member for the purpose of conserving space and material costs as discussed in the modified rejection for claim 2 above.
Applicant argues on pages 10-11 that it is unclear how Vazales teaches claim 3. Examiner respectfully disagrees in light of the clarified rejection above. Specifically, the Examiner states in the previous office action that the junction is where ports 15 and 17 branch from in Vazales. Therefore, once modified with an integrated region as taught by Dunlop, and given the teachings of Vazales about the various sizing of the third port 11, Examiner maintains the rejection in light of the amendements to claim 3. Port 11 can be sized to have a decreased area compared to the manifold 13 to accommodate a smaller tube, so when Vazales is modified with the integrated region as taught by Dunlop above, then one skilled in the art would expect that the cross sectional area decreases when starting from the integrated region, then moving through the junction length of Vazales, and then moving towards the third port 11 when this port is chosen to be a smaller size that would reasonably have a decreased cross sectional area.
Applicant argues on page 11 that it would not be obvious to make the modifications described in claims 5 and 12. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Examiner maintains that one with ordinary skill in the art would still make the proposed modification so that the adapter can be constructed as small as possible, which would save on constructional and material costs and allows for easier storage.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKHIL A JAYAN whose telephone number is (571)272-6099. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 5712729034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AKHIL A JAYAN/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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