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
The amendment filed 8/1/2025 has been entered. Claims 1-20 remain pending.
Claim Objections
Claim 1, and claims 2-11 by dependency are objected to because of the following informalities:
Claim 1 recites “the color corresponding to coupled airway device”, line 24-26. This should read --the color corresponding to the coupled airway device”.
Appropriate correction is required.
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy et al. (US 10478586 B2), hereafter McCarthy, in view of Sherman et al. (US 11596753 B2), hereafter Sherman, further in view of Hietala (US 20210109084 A1), further in view of Karlsson et al. (US 20090143996 A1), hereafter Karlsson.
Regarding claim 1, McCarthy discloses a rescue breath apparatus (ventilator system 10), comprising: a set of multiple airway devices (mask body 46A, 46B, 46C; Fig. 2), the airway devices being configured to be placed on a face of a human patient (mask 14, which includes mask body 46A/B/C, is placed on the face region 26 of a patient 24; Fig. 1), wherein the set includes at least two airway devices having different sizes intended for different size human faces (infant-sized mask body 46A, child-sized mask body 46B, adult-sized mask body 46C; col. 13 ln 11-24), and wherein the set includes at least two airway devices with different classifications of airway protection (airway devices can also include endotracheal tubes which is a protected airway device; col. 20 ln 60-67, col. 21 ln 41-46); a set of adapters (mask inlets 48A, 48B, 48C; Fig. 2), individual adapters being coupled to individual airway devices (adapters 48A/B/C are coupled to airway devices 46A/B/C; Fig. 2), wherein each adapter is color coded according to the airway device to which the adapter is coupled (mask inlet can have a predetermined color based on the size or intended use of the mask, col. 16 line 15-17), and wherein the color code of the adapter indicates a size of the airway device (mask inlet color can be based on the size of the mask, col. 16 line 15-17); an air/oxygen source (air/oxygen source 16; Fig. 1); a ventilator system coupled to the air/oxygen source (ventilator device 21 connected to air/oxygen source 16; Fig. 2), the ventilator system comprising: a connector configured to couple to the adapter associated with an airway device selected for the patient (connector 44; Fig. 2); wherein the ventilator system is configured to provide air/oxygen to the patient through the selected airway device coupled to the ventilator system (ventilator system delivers air/oxygen to the patient via mask, col. 6 ln 54-59), a controller comprising a computer processor, the controller being configured to determine a rate and volume of rescue breaths provided by the ventilator system (processor maintains flow of air/oxygen at a desired breath volume and rate; col. 9 ln 63-col. 10 ln 7) based on the size of the coupled airway device (rate and volume are automatically set as a function of a size of mask coupled to the system, abstract ln 3-6, col. 13 ln 33-col. 14 ln 8).
McCarthy does not disclose differentiating between a classification of airway protection for the airway device.
Sherman teaches an automatic ventilator system (title) which differentiates between protected and unprotected airways (col. 12 ln 11-20) for the purpose of delivering breaths in accordance with CPR guidelines for protected and unprotected airways (CPR tube mode for protected airway, col. 12 ln 41-50 and CPR mask mode for unprotected airway, col. 13 ln 47-57).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of McCarthy to differentiate between a classification of the airway protection as taught by Sherman for the purpose of delivering breaths in accordance with CPR guidelines for protected and unprotected airways (CPR tube mode for protected airway, Sherman col. 12 ln 41-50 and CPR mask mode for unprotected airway, Sherman col. 13 ln 47-57).
The modified McCarthy does not disclose a handpiece comprising a color sensor, wherein the color sensor is configured to determine a color of the adapter coupled to the connector; the color corresponding to the coupled airway device.
Hietala teaches a handpiece (housing 22; Fig. 3-4) comprising a color sensor (color detector 48; Fig. 4), wherein the color sensor is configured to determine a color of the adapter coupled to the connector (color sensor 48 determines a color of the airway adapter 8 coupled to connector 19; Fig. 3-4); the color corresponding to the coupled airway device (controller identifies a neonatal, pediatric, or adult airway adapter based on color indicator detected by color sensor; par. 0026-0027).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the apparatus of McCarthy to include a color sensor as taught by Hietala for the purpose of automatically identifying the type of airway adapter connected to the apparatus (Hietala par. 0020 ln 1-9). The addition of a color sensor also provides the benefit of being able to authenticate a component attached to the apparatus to avoid the use of an uncertified or counterfeit component (Hietala par. 0020 ln 12-18).
The modified McCarthy discloses the controller being configured to determine a rate and volume of rescue breaths according to the color detected by the color sensor, the color corresponding to the coupled airway device (controller determines a rate and volume according to the type of airway device, McCarthy abstract ln 3-6, col. 13 ln 33-col. 14 ln 8; type of airway device is determined according to a corresponding color detected by the color sensor, Hietala par. 0026-0027).
The modified McCarthy does not disclose the handpiece configured to be positioned around the connector and the adapter when the connector is coupled to the adapter.
Karlsson teaches a handpiece (16; Fig. 3-4) configured to be positioned around the connector and the adapter (23, 24; Fig. 3-4) when the connector is coupled to the adapter (16 is positioned around 23 and 24 which are coupled; Fig. 3-4) for the purpose of including multiple sensors to measure a value at the connector as well as the adapter (handpiece 16 includes a sensor 26 to measure a value at 23 and a flow sensor 18 to measure a value at 24; Fig. 3, par. 0030-0031).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the handpiece of the modified McCarthy to be positioned around the connector and adapter as taught by Karlsson for the purpose of including multiple sensors to measure a value at the connector as well as the adapter (Karlsson Fig. 3, par. 0030-0031).
Regarding claim 2, the modified McCarthy discloses the apparatus of claim 1 (shown above), wherein the different sizes of airway devices are intended for human faces selected from the following different sizes of human faces: adult, child, and infant (infant-sized mask body 46A, child-sized mask body 46B, adult-sized mask body 46C; McCarthy col. 13 ln 11-24).
Regarding claim 3, the modified McCarthy discloses the apparatus of claim 1 (shown above), wherein the classification of airway protection is either a protected airway device or an unprotected airway device (Sherman col. 12 ln 11-20).
Regarding claim 4, the modified McCarthy discloses the apparatus of claim 3 (shown above), wherein the protected airway device is an endotracheal (ET) tube (protected airway can be endotracheal tube; Sherman col. 12 ln 11-20).
Regarding claim 5, the modified McCarthy discloses the apparatus of claim 3 (shown above), wherein the unprotected airway device is a cardiopulmonary resuscitation (CPR) mask (masks 14A/B/C with mask bodies 46A/B/C; McCarthy Fig. 2).
Regarding claim 6, the modified McCarthy discloses the apparatus of claim 1 (shown above), further comprising a compression pad configured to be positioned on a chest of the patient (compression sensor 450; McCarthy Fig. 16), the compression pad having a sensor configured to detect chest compressions being performed on the patient (compression sensor detects application chest compressions; McCarthy col. 28 ln 9-27).
Regarding claim 7, the modified McCarthy discloses the apparatus of claim 6 (shown above), wherein the controller is configured to determine whether air/oxygen is provided to the patient based on chest compressions being detected by the sensor in the compression pad (controller stops respirations when compressions are detected and resumes respiration when compressions stop; McCarthy col. 28 ln 15-27).
Regarding claim 8, the modified McCarthy discloses the apparatus of claim 7 (shown above), wherein the controller is configured to inhibit air/oxygen being provided to the patient when a chest compression is detected by the sensor (controller stops respirations when compressions are detected; McCarthy col. 28 ln 15-23) and the classification of airway protection for the coupled airway device indicates the airway device is an unprotected airway device (for a patient with an unprotected airway the ventilator delivers breaths after a predetermined period of chest compressions; Sherman col 17 ln 17-20, claim 12).
Regarding claim 9, the modified McCarthy discloses the apparatus of claim 1 (shown above), wherein the controller is configured to determine a safe pressure limit for the rescue breaths provided by the ventilator system based on the size of the coupled airway device (maximum pressure limit is automatically set as a function of a size of the mask; McCarthy abstract ln 1-6, col. 2 ln 52-58) and the classification of airway protection (pressure limit for protected airway is 60 cmH2O and for unprotected airway is 30 cmH2O; Sherman col. 12 ln 41-col. 13 ln 2, col. 13 ln 47-col. 14 ln 6) for the coupled airway device indicated by the color determined by the color sensor (controller identifies the type of coupled airway device based on color indicator detected by color sensor; Hietala par. 0026-0027).
Regarding claim 10, the modified McCarthy discloses the apparatus of claim 1 (shown above), wherein the controller is configured to determine a rate of positive pressure rescue breaths versus a rate passive exhalation provided by the ventilator system based on the size of the coupled airway device (inspiratory and expiratory time is determined as a function of the size of the mask; McCarthy col. 4 ln 22-26) and the classification of airway protection (inspiration expiration ratio is determined by airway protection status; Sherman col. 12 ln 41-61, col. 13 ln 47-col. 14 ln 1) for the coupled airway device indicated by the color determined by the color sensor (controller identifies the type of coupled airway device based on color indicator detected by color sensor; Hietala par. 0026-0027).
Regarding claim 11, the modified McCarthy discloses the apparatus of claim 1 (shown above), wherein at least one of the airway devices is a continuous flow oxygen mask (a continuous high-flow oxygen mask can be used to deliver supplemental oxygen, McCarthy col. 28 ln 60-col. 29 ln 3), and wherein the controller is configured to provide a continuous flow of oxygen based on the color determined by the color sensor indicating the airway device is the continuous flow oxygen mask (supplemental oxygen mode is automatically activated to provide continuous oxygen when the keying mechanism detects a supplemental oxygen mask, McCarthy col. 29 ln 14-21).
Regarding claim 12, McCarthy discloses a method, comprising: detecting an airway device selected from a set of multiple airway devices (ventilator mask of difference sizes are detected; col. 2 ln 27-46), the airway device being positioned on a face of a human patient (ventilator masks fit upon human faces; col. 2 ln 27-32), and wherein the set of multiple airway devices includes at least two airway devices having different sizes intended for different size human faces (ventilator masks fit upon a different range of sizes of human faces; col. 2 ln 27-32); determining, by a controller coupled to the ventilator system, a rate and volume of rescue breaths to be provided by the ventilator system (processor maintains flow of air/oxygen at a desired breath volume and rate; col. 9 ln 63-col. 10 ln 7) based on a size for the airway device coupled to the ventilator system (rate and volume are automatically set as a function of a size of mask coupled to the system; abstract ln 3-6, col. 13 ln 33-col. 14 ln 8), wherein the controller includes a computer processor (a processor is used to maintain flow of air/oxygen at a desired breath volume and rate; col. 9 ln 63-col. 10 ln 7); and providing, by the ventilator system, air/oxygen from an air/oxygen source to the patient through the airway device coupled to the ventilator system (ventilator system delivers air/oxygen to the patient via mask, col. 6 ln 54-59), the air/oxygen being provided according to the determined rate and volume of rescue breaths (processor maintains flow of air/oxygen at a desired breath volume and rate; col. 9 ln 63-col. 10 ln 7).
McCarthy does not disclose differentiating between at least two airway devices with different classifications of airway protection for the airway device.
Sherman teaches an automatic ventilator system (title) which differentiates between protected and unprotected airways (operating mode is selected between protected airway, such as an endotracheal tube and unprotected airway, such as a mask; col. 12 ln 11-20) for the purpose of delivering breaths in accordance with CPR guidelines for protected and unprotected airways (CPR tube mode for protected airway, col. 12 ln 41-50 and CPR mask mode for unprotected airway, col. 13 ln 47-57).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of McCarthy to differentiate between a classification of the airway protection as taught by Sherman for the purpose of delivering breaths in accordance with CPR guidelines for protected and unprotected airways (CPR tube mode for protected airway, Sherman col. 12 ln 41-50 and CPR mask mode for unprotected airway, Sherman col. 13 ln 47-57).
The modified McCarthy does not disclose detecting, by a color sensor located in a handpiece of a ventilator system, a color of an adapter coupled to a connector, wherein the color of the adapter is detected by a color sensor positioned in the handpiece, wherein the adapter is coupled to an airway device; the color detected by the color sensor corresponds to the coupled airway device.
Hietala teaches a handpiece (housing 22; Fig. 3-4) comprising a color sensor (color detector 48; Fig. 4), wherein the color sensor is configured to determine a color of the adapter coupled to the connector (color sensor 48 determines a color of the airway adapter 8 coupled to connector 19; Fig. 3-4); the color corresponding to the coupled airway device (controller identifies a neonatal, pediatric, or adult airway adapter based on color indicator detected by color sensor; par. 0026-0027).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the method of McCarthy to include a color sensor as taught by Hietala for the purpose of automatically identifying the type of airway adapter connected to the apparatus (Hietala par. 0020 ln 1-9). The addition of a color sensor also provides the benefit of being able to authenticate a component attached to the apparatus to avoid the use of an uncertified or counterfeit component (Hietala par. 0020 ln 12-18).
The modified McCarthy discloses determining a rate and volume of rescue breaths to be provided by the ventilator system according to the color detected by the color sensor that corresponds to the coupled airway device (controller determines a rate and volume of rescue breaths according to the type of airway device, McCarthy abstract ln 3-6, col. 13 ln 33-col. 14 ln 8; type of airway device is determined according to a corresponding color detected by the color sensor, Hietala par. 0026-0027).
The modified McCarthy does not disclose an adapter is coupled to a connector inside of the handpiece.
Karlsson teaches a handpiece (16; Fig. 3-4) configured to be positioned around the connector and the adapter (23, 24; Fig. 3-4) when the connector is coupled to the adapter (16 is positioned around 23 and 24 which are coupled; Fig. 3-4) for the purpose of including multiple sensors to measure a value at the connector as well as the adapter (handpiece 16 includes a sensor 26 to measure a value at 23 and a flow sensor 18 to measure a value at 24; Fig. 3, par. 0030-0031).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the handpiece of the modified McCarthy to be positioned around the connector and adapter as taught by Karlsson for the purpose of including multiple sensors to measure a value at the connector as well as the adapter (Karlsson Fig. 3, par. 0030-0031).
Regarding claim 13, the modified McCarthy discloses the method of claim 12 (shown above), wherein the different sizes of airway devices in the set are intended for human faces selected from the following different sizes of human faces: adult, child, and infant (infant-sized mask body 46A, child-sized mask body 46B, adult-sized mask body 46C; McCarthy col. 13 ln 11-24).
Regarding claim 14, the modified McCarthy discloses the method of claim 12 (shown above), wherein the classification of airway protection is either a protected airway device or an unprotected airway device (Sherman col. 12 ln 11-20).
Regarding claim 15, the modified McCarthy discloses the method of claim 12 (shown above), further comprising detecting, by a sensor positioned in a compression pad placed on a chest of the patient, chest compressions being performed on the patient (compression sensor detects application chest compressions; McCarthy col. 28 ln 9-27).
Regarding claim 16, the modified McCarthy discloses the method of claim 15 (shown above), further comprising determining, by the controller, whether air/oxygen is provided to the patient based on chest compressions being detected by the sensor in the compression pad (controller stops respirations when compressions are detected and resumes respiration when compressions stop; McCarthy col. 28 ln 15-27).
Regarding claim 17, the modified McCarthy discloses the method of claim 16 (shown above), further comprising inhibiting, by the controller, air/oxygen being provided to the patient when a chest compression is detected by the sensor (controller stops respirations when compressions are detected; McCarthy col. 28 ln 15-23) and the classification of airway protection for the coupled airway device indicates the airway device is an unprotected airway device (for a patient with an unprotected airway the ventilator delivers breaths after a predetermined period of chest compressions; Sherman col 17 ln 17-20, claim 12).
Regarding claim 18, the modified McCarthy discloses the method of claim 12 (shown above), further comprising determining, by the controller, a safe pressure limit for the rescue breaths provided by the ventilator system based on the size of the coupled airway device (maximum pressure limit is automatically set as a function of a size of the mask; McCarthy abstract ln 1-6, col. 2 ln 52-58) and the classification of airway protection (pressure limit for protected airway is 60 cmH2O and for unprotected airway is 30 cmH2O; Sherman col. 12 ln 41-col. 13 ln 2, col. 13 ln 47-col. 14 ln 6) for the coupled airway device indicated by the color determined by the color sensor (controller identifies the type of coupled airway device based on color indicator detected by color sensor; Hietala par. 0026-0027).
Regarding claim 19, the modified McCarthy discloses the method of claim 12 (shown above), further comprising determining, by the controller, a rate of positive pressure rescue breaths versus a rate passive exhalation provided by the ventilator system based on the size of the coupled airway device (inspiratory and expiratory time is determined as a function of the size of the mask; McCarthy col. 4 ln 22-26) and the classification of airway protection (inspiration expiration ratio is determined by airway protection status; Sherman col. 12 ln 41-61, col. 13 ln 47-col. 14 ln 1) for the coupled airway device indicated by the color determined by the color sensor (controller identifies the type of coupled airway device based on color indicator detected by color sensor; Hietala par. 0026-0027).
Regarding claim 20, the modified McCarthy discloses the method of claim 12 (shown above), further comprising providing a continuous flow of oxygen based on the color detected by the color sensor corresponding to the airway device being a continuous flow oxygen mask (supplemental oxygen mode is automatically activated to provide continuous oxygen when the keying mechanism detects a supplemental oxygen mask, McCarthy col. 29 ln 14-21).
Response to Arguments
Applicant's arguments filed 8/1/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In particular, Applicant argues that McCarthy, Sherman, Hietala, and Karlsson, individually, do not teach or suggest determining a rate and volume of rescue breaths according to the color detected. However, McCarthy in combination with Hietala teaches this limitation, as shown in the rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785