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 8/3/2026. As directed by the amendment, claims 1, 11, 12, 14 and 15 have been amended. Claims 1-3 and 5-21 are pending in the instant application.
Applicant has amended the claims to provide antecedent basis; the previous rejection under 35 USC 112(b)/second paragraph is withdrawn.
Response to Arguments
Applicant's arguments filed 8/3/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on pages 11-12 of Remarks that the tablet of Freeman is “separated from the ventilation device” and “relies on remote management via a tablet” rather than “a direct structural link” and asserts that “any such modification to have the system of Freeman incorporated into a single device with a structural connection between the sensor and process[or] with the display device arranged as claimed…would require significant modification…and would certainly change the basic principle of operation thereof, which requires remote operation.”
The Examiner disagrees with Applicant’s arguments on several points. First, the Examiner respectfully notes that the claims do not require the (entire) electronic unit to be not separated/incorporated into a single structure with the sensor; indeed, the claims require the sensor and the electronic unit to have a “disconnectable” connection, such that some degree of separability is inferred. Second, the “direct connection” in the claims is not required to be e.g. a mounted attachment; it reads on a direct wired connection between two electrical components. Since the elements of the claimed electronic unit are not required to be e.g. enclosed within a single housing, much less one mounted on/incorporated with the sensor, the tablet of Freeman in combination with the wired, detachable sensor electronic connection taught by Freeman and Bronner continues to read on the newly-added limitations. Third, 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). Freeman teaches providing feedback in different locations (para [0101]), including the tablet and a local electronically-driven display for indicating ventilation (Freeman Fig. 2; paras [0118-119]), and Bronner teaches the inclusion of a direct structural mounting link between a sensor housing and an associated electronic circuit housing, where Bronner further teaches the associated electronic circuit housing may include a processor and a display for processing and displaying flow data as discussed in the updated rejection below (with Duval-Arnould demonstrating the obviousness of a parallel orientation of such a display and Khoury demonstrating the obviousness of a perpendicular orientation of such a display). Including such an arrangement in Freeman would require some degree of modification, but the modification would not have been unachievable by an artisan through routine experimentation because it is already taught by Bronner (and see also the other BMV-sensor-mounted displays cited below), nor would it “change the basic principle of operation” of Freeman, because providing an electronic unit comprising a sensor data processor and a display attached/mounted to the sensor of Freeman as taught by Bronner (and Duval-Arnould OR Khoury) would not preclude the remote capabilities of the device of modified Freeman; rather, it would simply add enhanced local functionality, e.g. in the event that the remote device is unavailable and/or for redundancy of indicating flow, so that a local operator at the BVM device of modified Freeman is fully apprised of the details of the flow, regardless of the presence and/or location of the tablet/remote device.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the alternative new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For purposes of compact prosecution, the alternative rejections made below demonstrate that parallel OR perpendicular display devices mounted directly on BMV sensors were already known in the BVM art before the effective filing date of the claimed invention.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
Claims 1 and 15, lines 5-6 of each claim, should read either “perform a measurement of real-time air flow rates” or “perform a measurement in real-time of air flow rates”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 15-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 12 and 15 (and thus their dependent claims), the scope of “the display device is oriented parallel or perpendicular to the sensor” is unclear, since no axes and/or dimensional frames of reference for the display device or the sensor are provided in the claims. As best understood from e.g. instant Figs. 1-2, for purposes of examination, the claims will be interpreted as reading “a planar face of the display device is oriented parallel or perpendicular to a direction of air flow through the sensor”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 5-21 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2012/0302910 A1; hereinafter “Freeman”) in view of Kuenzler et al. (US 2009/0234240 A1; hereinafter “Kuenzler”), Hillsman (US 6,273,088 B1; hereinafter “Hillsman”), Bronner et al. (WO 2014/183747; hereinafter “Bronner,” wherein the citations below refer to the national stage publication of the WIPO document, US 2016/0074604 A1), and Hedrich (DE 102011081923 A1; hereinafter “Hedrich,” wherein the citations below refer to the translation provided with the Office Action mailed 10/22/2024), and, in the alternative, further in view of Duval-Arnould et al. (US 2015/0096559 A1; hereinafter “Duval-Arnould”) OR Khoury et al. (FR 2988004 A1; hereinafter “Khoury”).
Regarding claims 1 and 17, Freeman discloses/suggests a device for diagnosing a ventilatory effectiveness of a patient under a manual respiratory assistance performed by a user operating a system for ventilating the patient comprising a flexible bag (ventilation bag body 212) (para [0113]) or a self-inflating bag (Figs. 1-2; paras [0099-101], [0109-111], [0127], [0147], [0154], [0167], [0173], [0176], [0189-194]), the device including:
a two-way airflow/volume sensor (airflow sensor 204) configured to be plugged between said ventilating system and a patient interface (mask 202) (Fig. 2; airflow sensor 204 may be friction fit over [an extension of the neck 210 and an extension of the mask 202], allowing the airflow sensor to be added conveniently to a system that is not designed initially to have an airflow sensor, para [0114]) to perform a measurement in real-time air flow rates during insufflation and during expiration (paras [0006], [0049], [0063], [0115], [0163]);
an electronic unit (tablet 116 and/or the electronics for operating light(s) 208) comprising an electronic circuitry (electronic circuitry, e.g. within tablet 116 and/or in conjunction with light(s) 208) configured to receive and process data relating to the air flow rates measured by the sensor (Figs. 1 and 16; paras [0093], [0100-101], [0107-111], [0118-119], [0127-137], [0144-149], [0171-176], [0189-195], [0221-223]), the electronic circuitry including:
a user interface comprising a display device and configured to receive input data (graphical display…input mechanism such as a keyboard or a touchscreen, para [0093]; pointing device such as a mouse or trackball, para [0223]; light 208 is shown connected to the sensor 204 and may be used to provide feedback…both rate and volume, paras [0118-119]; computing device, using all of the entered information, may then generate a protocol for treating the victim, para [0109]; computing device may provide feedback or coaching when the performance falls out of line with a defined protocol, or may provide feedback to maintain the performance in line with the protocol, para [00111]);
a data processor (processor) configured to determine and adjust in real-time, ideal values for ventilatory parameters for an optimal ventilation of said patient, and configured to determine and adjust in real-time, for each ventilatory parameter, a minimum or maximum threshold (an appropriate provision of ventilation, para [0100]; protocol for treating the victim, para [0109]; protocol for ventilation rate, para [0107]; target tidal volume, para [0036]; target VEMV-CO2…target ventilation rate and minute volume, para [0178]; optimal…ventilation rate, para [0155]; optimal tidal volume, para [0183]; the computing device may update the protocol as care is being provided, para [0111]; protocol…customized for [t]he particular victim, para [0129]; a dynamic protocol that changes as the treatment of the victim continues…the protocol may change over time…[c]hanges may be made to the protocol as treatment continues, paras [0147-149]; computing device may update the protocol as care is being provided…rate of required ventilation may change, para [0111]; the range that is indicated as an optimal or an acceptable respiratory rate can change based on information from one or more physiological sensors, para [0155]; maximum ventilation pressure, para [0013]; minimum ventilation volume, para [0175]; maximum ventilated lung volume, para [0179]; threshold is calculated individually for each patient, para [0190]; calculation results are compared to a threshold, para [0202]; wherein it would have been reasonably suggested and/or obvious to an artisan before the effective filing date of the claimed invention for the determination of an appropriate protocol/target parameters disclosed by Freeman to include determining and updating a target value for each of the parameters above and determining and updating appropriate min and/or max threshold values for each of said target values, in order to predictably provide for ideal ventilation to be delivered even as a patient’s status changes with dynamic margins of error to avoid constant alarms while also taking into account the patient’s status (e.g. higher margin of errors if patient is more stable, narrower if less stable, see Kuenzler para [0072]), using a common process for determining appropriate ranges, i.e. determining a target value and adding and/or subtracting from that value to give a range of acceptable values/margin of error (see Hillsman Fig. 3A, col. 11, lines 50-62)) and in case a measured value of a ventilatory parameter becomes higher than a corresponding maximum threshold or lower than a corresponding minimum threshold, generate an alarm and/or display on the display device a piece of information on one or more ventilatory parameters to be modified or corrections to be carried out to achieve the optimal ventilation (Freeman Fig. 15; provide feedback or coaching when performance falls out of line with a defined protocol, para [0111]; rescuer is being prompted to increase or decrease their rate or volume of ventilation, para [0119]; data compared against a protocol for providing ventilation, and determination may be made with respect to whether the ventilation is being properly or improperly applied relative to that protocol…provide feedback, paras [00127-128]; tablet compares the received inputs to the appropriate protocol…[w]here the inputs do not match the protocol so that corrective action by the caregivers is required, the tablet may provide instructions, causing the ventilator to announce instructions, para [0147]; a visual indicator of ranges that indicate adequate versus sub-optimal ventilation…an indication of whether the user should increase or decrease the rate of respiration could be provided, para [0154]; telling a rescuer to squeeze the ventilation bag hard or softer, or faster or slower, para [0167]; end-tidal or minute-volume CO2 data is compared against a protocol…a range of values considered as providing proper ventilation can be used to determine whether the victim is being appropriately ventilated, over ventilated or under ventilated… computing device provides feedback…to guide the rescuer regarding when and with how much force to squeeze a ventilation bag…increase or decrease the depth of the CPR compressions, paras [00174-177]; provide guidance to the rescuer regarding proper ventilation, para [0181]; rescuer can be advised to increase ventilation…decrease ventilation, para [0191]; indicator can be provided to show the extent to which a resecure is squeezing the ventilation bag such that the rescuer can aim to keep the indicator within the appropriate ventilation range…graphically represent tidal volume…yellow representing tidal volume that is too low, green as correct within a range of ± 20 of desire range, and red indicating too much volume, para [0194]),
an electrical power supply (electronic circuity as discussed above necessarily requires an electrical power supply to function; see e.g. para [0150], which discusses powering down, which infers an electrical power source), and
wherein a connection directly connects the sensor to the electronic unit (the sensor described above can be joined with a computer, tablet…by a wired [i.e. direct electrical] connection, para [0167]) such that the display device is oriented parallel or perpendicular to the sensor (Freeman Fig. 1, where the display device is oriented parallel to the sensor when both the display and sensor are oriented upright, and where the display device is oriented perpendicular to the sensor when the display is closed flat on a flat surface and the sensor is upright).
Freeman does not explicitly disclose that the airflow/volume sensor is a single use or autoclavable thermal mass temperature gradient sensor, and Freeman is silent regarding the electronic circuitry including a disconnectable electromechanical connection to the two-way thermal mass temperature gradient sensor. However, Bronner demonstrates that it was well known in the art of flow/volume sensors for CPR systems such as that of Freeman to include a single use or autoclavable mass sensor (flow tube 2 comprising section 9/mass or volume flow sensor 10) (Figs. 5-7; paras [0009] and [0083]; flow tube…can either be disposed of after use or cleaned, disinfected and reused, para [0049], where autoclaving was a standard means for sterilization in the medical field before the effective filing date of the claimed invention and thus would have been an obvious means by which to achieve the cleaning/disinfection taught by Bronner) and for associated electronic circuitry (within plug-on part 3/circuit boards 27,28 and including data processing and displaying from a display device integrated into cover 30, which includes planar surfaces both parallel and perpendicular to the flow through the sensor) (Fig. 8; paras [0017], [0021], [0031], [0034-35], [0047-49], [0055-58], [0087]) to include a disconnectable electromechanical connection (comprising connector socket that receives the upper end of circuit board 11) (Figs. 5-7; para [0087]) to the two-way mass sensor (paras [0009-11]), and Hedrich demonstrates that it was well known in the art of flow/volume mass sensors for use in respiratory devices to be specifically thermal mass temperature gradient sensors (abstract on page 1 to the first full para on page 3 and the fifth para on page 5). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the airflow/volume sensor of Freeman to be a single use or autoclavable thermal mass temperature gradient sensor, and the electronic circuitry of Freeman to include a disconnectable electromechanical connection to the two-way thermal mass sensor as taught by Bronner and Hedrich, in order to provide the predictable result of a known (and thus easily sourced) type of airflow/volume sensor with typical plug-in detachable wire connection, i.e. one that is easily detachable from associated electronics to enable disposable or sterilization of the sensor portion (Bronner para [0049]) and particularly one that is capable of accurately measuring dynamically changing and water-saturated air flows (Hedrich page 8, fourth full para) and has a high measuring sensitivity, high dynamic range, fast response time and a relatively low energy consumption (Hedrich page 6, second full para).
In the alternative, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Freeman to include an electronic unit that includes the same functionality discussed above in a push-on part as taught by Bronner, with the display taught on the push-on part of Bronner located on one of the parallel or perpendicular walls of the push-on device, see e.g. Bronner Fig. 8 (paras [0017], [0021], [0031], [0034-35], [0047-49], [0055-58], [0087]), such that the display is oriented parallel or perpendicular to flow through the sensor, because it was well-known in the BVM sensor art before the effective filing date of the claimed invention for BVM-sensor-mounted displays to be oriented either parallel, see Duval-Arnould digital display 134 in Fig. 2, or perpendicular, see Khoury visible display face 430 in Fig. 4, in order to predictably provide a BVM-mounted sensor processor and display to enhance the local functionality of the local sensor display of Freeman, e.g. in the event that the remote device is unavailable and/or for redundancy of indicating flow, so that a local operator at the BVM device is fully apprised of the details of the flow, regardless of the presence and/or location of the tablet/remote device.
Regarding claim 2, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 1, wherein modified Freeman further discloses/teaches wherein the display device is a screen (e.g. touchscreen, Freeman para [0093]; and see also Bronner and Duval-Arnould OR Khoury regarding sensor-mounted screens) and electrical power supply being a battery because it was standard across all arts before the effective filing date of the claimed invention for a tablet to be battery powered, and Bronner further teaches including a battery for powering electronics associated with a flow sensor (para [0020]), such that a power supply being a battery within the push-on electronic unit taught by Bronner as discussed above regarding claim 1 would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide the predictable result of utilizing a standard, portable means for powering the modular electronic circuitry.
Regarding claim 3, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 1, wherein modified Freeman further renders obvious the device being configured to display an inspired volume and an expired volume on the display device in a form of a bar graph, divided into three portions respectively indicating whether the inspired volume or expired volume is insufficient, effective or excessive (Freeman Fig. 15; paras [0127], [0163], [0194] and claim 29; see also Bronner Fig. 9, para [0090]), because it would have been obvious to an artisan before the effective filing date of the claimed invention to display relevant data using standard, easily comprehended graphical representations.
Regarding claim 5, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 1, wherein modified Freeman further discloses/teaches wherein the electronic circuitry is configured to identify during a breathing phase of the patient if the patient is in an inspiration phase or in an expiration phase or in an end-expiration phase, by analyzing the data from the sensor (Freeman paras [0171-172]).
Regarding claim 6, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 1, wherein modified Freeman further discloses/teaches wherein the user interface is configured to allow physical and/or physiological characteristics of the patient to be input into the electronic circuitry, and/or characteristics relating to the ventilation, including a type of ventilation, a type of ventilation device and/or a type of ventilation interface to be input (Freeman paras [0108-109], attaches an oxygen source…manual rescuer input, para [0111], paras [0167], [0183], patient’s height, girth, weight and gender…input into the computing device by the rescuer, para [0195]; see also Bronner Fig. 9, para [0090]).
Regarding claim 7, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 6, wherein modified Freeman further discloses/teaches wherein the physical and/or physiological characteristics of the patient or physiological parameters of the patient measured by the sensor comprise at least two from the following characteristics or parameters: size of the patient (Freeman para [0144]), lung capacity of the patient (Freeman para [0190]), pulmonary compliance of the patient (Freeman para [0014]), pulmonary resistance of the patient (Freeman para [0206]), expiratory time constant of the patient (Freeman para [0127]), positive end-expiratory pressure of the patient (Freeman para [0013]), a concentration of CO2 in the expired air of the patient (Freeman paras [0163] and [0172]).
Regarding claim 8, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 7, wherein modified Freeman further discloses/teaches wherein the data processor is further configured to, throughout a duration of a ventilatory assistance provided to the patient, in each ventilation cycle, analyze said characteristics and the physiological parameters measured, in each ventilation cycle, by the sensor, in order to deduce therefrom the ideal values for ventilatory parameters for the optimal ventilation of said patient, and for each ventilatory parameter, the minimum and/or maximum threshold (see claim 1 discussion above and Freeman paras [0109-111], [0120], 0144-149], [0155], [0183-184], [0190], and [0195]).
Regarding claim 9, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 8, wherein modified Freeman further discloses/teaches wherein the ventilatory parameters include at least two from the following parameters: insufflated volume (Freeman para [0127]), expired volume (Freeman para [0127]), tidal volume (Freeman para [0013]), leak volume (Freeman para [0202]), ventilatory frequency (Freeman para [0146]) and insufflation pressure (Freeman para [0006]).
Regarding claim 10, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 8, wherein the data processor is configured to receive measured values for the ventilatory parameters and to compare them to said thresholds, throughout the duration of the ventilatory assistance provided to the patient, in each ventilation cycle (see claim 1 discussion above, and e.g. Freeman para [0147], where treatment (and comparing the received inputs to the appropriate protocol/target) continues, i.e. over multiple ventilation cycles).
Regarding claim 11, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches a ventilation system for providing respiratory assistance to a patient, including the device for diagnosing the effectiveness of the ventilation of the patient as claimed in claim 1 (see claim 1 discussion above), and a manual ventilation device chosen from the group consisting of: a flexible bag and a self-inflating bag (ventilation bag body 212) (Freeman para [0113]), and a ventilation interface chosen from the group consisting of: an invasive ventilation via tracheotomy or tracheal tube (ET tube), and a non-invasive ventilation via a mask (mask 202) (Freeman Fig. 2; intubation, paras [0121] and [0211]), the two-way thermal mass sensor being located between the ventilation device and the ventilation interface, wherein the two-way thermal mass sensor is immediately downstream of the ventilation interface (Freeman Fig. 2 when flow sensor 204 is modified to be a thermal mass flow sensor as discussed above regarding claim 1; see also Bronner Fig. 9, Duval-Arnould Fig. 2 OR Khoury Fig. 1).
Regarding claim 12, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches a method for determining a ventilatory effectiveness of a patient under manual ventilation performed by a user operating a manual ventilation system for providing respiratory assistance to the patient provided with a patient interface, the manual ventilation system including a flexible bag or a self-inflating bag operated by the user, the method comprising:
measuring in real-time air flow rates during insufflation and during expiration with a diagnosing device including a single use or autoclavable two-way thermal mass sensor located between the manual ventilation system and the patient interface and directly connected via a disconnectable electro-mechanical connection to an electronic unit comprising electronic circuitry configured to receive and process data relating to the air flow rates measured via a measurement performed by the sensor, the electronic circuitry including a user interface and a data processor;
determining ideal values for ventilatory parameters for an optimal ventilation of said patient, and for each ventilatory parameter, a minimum and/or maximum threshold;
measuring in real-time the ventilatory parameters of the patient;
comparing measured values for the ventilatory parameters to said thresholds, respectively;
for each ventilatory parameter, in case of a value of a measured ventilatory parameter higher than a corresponding determined maximum threshold or lower than a corresponding determined minimum threshold, informing the user of a correction to be carried out during operation of the manual ventilating system to achieve an optimal ventilation of the patient by generating a corresponding information on the user interface,
wherein the user interface comprises a display device oriented parallel or perpendicular to the sensor (see claim 1 discussion above, when the device is operated as configured as discussed above regarding claim 1, it performs the instant method).
Regarding claim 13, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the method as claimed in claim 12, wherein the ventilatory parameters include at least two from the following parameters: insufflated volume, expired volume, tidal volume, leak volume, ventilatory frequency and insufflation pressure (see claim 9 above).
Regarding claim 15, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches a device for diagnosing a ventilatory effectiveness of a patient under manual respiratory assistance performed by a user operating manually a ventilation system comprising a flexible bag or self-inflating bag operated by the user, the device including:
a two-way thermal mass sensor configured to perform a measurement in real-time air flow rates during insufflation and during expiration;
an electronic unit comprising an electronic circuitry configured to receive and process data relating to the air flow rates measured by the sensor, the electronic circuitry including:
a user interface including a display device,
a data processor configured to analyze said data, determine the effectiveness of the ventilation in real-time, and manage alarms;
a disconnectable electromechanical connection configured to connect the thermal mass sensor and heating element (see below) to the electronic circuitry and
an electrical power supply,
wherein the connection directly connects the sensor to the electronic unit such that the display device is oriented parallel or perpendicular to the sensor,
wherein modified Freeman is taught by Hedrich to include a heating element (condensate heater 30) (e.g. Hedrich Fig. 2, abstract) connectable to the circuitry via the connection above for heating the two-way thermal mass sensor, in order to provide the benefits of the modified sensor discussed above regarding claim 1.
Regarding claim 16, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claim 15, wherein modified Freeman is taught by Hedrich to include wherein the heating element is configured to be controlled by the electronic circuitry to heat the sensor at a predefined temperature above 20°C (condensate heater 30 can be configured to heat the sensor chip to a temperature greater than 50 deg C, fifth full para on Hedrich page 14).
Regarding claims 18 and 20, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claims 1 and 15, wherein Freeman further discloses/teaches a CO2 sensor within the device and configured to measure a concentration of CO2 in expired air of the patient ([t]he airflow sensor may also include sensors for measuring gas concentration, such as carbon dioxide, para [0162]; ventilation data may include…information about…the carbon-dioxide content included in the air…used to calculate an end-tidal CO2…provides an indication of the level of carbon dioxide in the air exhaled from the body, paras [0171-172]; and see also Khoury carbon dioxide rate sensor 7 in Fig. 2 thereof).
Regarding claims 19 and 21, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the device as claimed in claims 1 and 15, wherein Freeman further discloses/teaches a pressure sensor within the device ([t]he system includes an airflow sensor in the airflow path…and a pressure sensor in the airflow path, para [0006]; the system includes a sensor such as…[a] pressure sensor that detects manual or mechanical CPR compresssions, para [0210]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury as applied to claim 12 above, and further in view of Jonsson et al. (SE 506521 C2; hereinafter “Jonsson,” wherein the citations below refer to the translation provided with the Office Action mailed 10/22/2024).
Regarding claim 14, Freeman in view of Kuenzler, Hillsman, Bronner and Hedrich, and alternatively Duval-Arnould OR Khoury, teaches the method as claimed in claim 12, wherein modified Freeman further discloses/teaches wherein the display device is a screen and an inspired volume and an expired volume are displayed on a screen in a form of a bar graph, indicating whether the inspired volume or expired volume is insufficient, effective or excessive/the insufflated volume is displayed on the screen (see claim 3 discussion above); but modified Freeman is silent regarding the bar graph/insufflated volume being updated in a period of less than 100 ms. However, Jonsson demonstrates that it was well known in the art of displaying ventilation data before the effective filing date of the claimed invention for said data to be collected and immediately displayed, wherein the collection (and thus updated display) occurs in a period of less than 100 ms (the flow and pressure signals are continuously displayed on the computer screen after they have been converted to analogue to digital at a frequency of 50 Hz (second full para from the bottom of page 5, where 50 Hz is 20 ms). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Freeman to include wherein the bar graph/insufflated volume being updated in a period of less than 100 ms as taught by Jonsson, in order to provide the predictable result of collecting and displaying the sensor data very quickly for accurate assessment of parameters in real time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding BVM-sensor and/or thermal mass sensor-mounted displays: previously-cited Olin (Fig. 1A-B, display 112); Aziz (US 2006/0107745 A1); Al-Ali (US 2015/0238722 A1); Berg et al. (US 2017/0049978 A1); Han (WO 2015/041396 A1); Lee et al. (KR 20140040935 A); Yamamori et al. (EP 0728441 A2); Palatnik (US 2007/0261698 A1).
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 KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
