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 .
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.
Claims 1-12 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Steinhauer et al (US 2014/0000609), hereinafter Steinhauer in view of Choncholas et al (US 2007/0062529), hereinafter Choncholas.
Regarding claim 1, Steinhauer teaches a ventilation monitoring system (Abstract, a monitoring system for multiple medical ventilators, Fig. 1A, AB, Fig. 8) for use in monitoring ventilation of at least one patient being ventilated by a suitable ventilator device via an associated connected arrangement defining a flow path of gas including air or oxygen between the patient and the ventilator device (Paragraph 58, mechanically moves air in and out of the lungs of a patient, configured to monitor physiological statistics for the patients such as dynamic compliance, ventilation rate, PEEP, airway pressure, paragraph 128, during use of the system ventilators are in operation with respective patients, paragraph 192, ventilator associated with a patient); wherein the system comprises:
a ventilation data capturing device connected between a patient and a ventilator device is arranged to collect ventilation data (Fig. 8: 710, paragraph 88, paragraph 90, may capture audio data of a patient to facilitate in the care of the patient ) wherein the ventilator device and/or ventilation data capturing device comprise unique identifiers(Paragraph 149, identifies a configuration for each of the ventilators):
at least one remote processor (Paragraph data associated with a ventilator and a patient is accessed by data accessor 2710, paragraph 205, remote device 3220, paragraph 206, remote device is able to remotely communicate with the ventilator); and
at least one memory device coupled to the at least one remote processor (Paragraph 209, the computer readable and computer executable instructions reside in a memory), wherein the at least one memory device containing instructions which, when executed by the at least one remote processor (paragraph 209) are arranged to cause the at least one remote processor to:
associate and store in the at least one memory device, unique identifiers of at least two of an associated ventilator device, ventilation data capturing device, and the patient under a particular ventilation profile or ventilation file (Associates a ventilator with a patient, Fig. 31, step 2810, paragraph 10, the identification for each patient can include at least one of an account identification a patient name, patient care area, patient location, paragraph 139, the ventilator monitoring user interface can generate reports specific to a patient or ventilator, paragraph 155, report includes an identification of the patient and the patient’s ventilator);
collect or receive ventilation data from the ventilation data capturing device (paragraph 210, ventilator data, Fig. 28, step 2812, access streaming ventilator data);
data (paragraph 151, indicative ventilator settings report, ventilator history report, lung protection analytics report), status of the ventilator device determined from the received or collected, and commands collected from a remote device that is in communication with at least the ventilation data capturing device, wherein the output data comprising at least instructions/commands for actioning on the ventilator device associated with the ventilation data capturing device to allow suitable ventilation to be provided by the ventilator device to the patient. (Paragraph 174, suggesting protocol based on the analyzed aggregated data, paragraph 177, the protocol is customized according to a patient associated with the ventilator)
Steinhauer teaches a ventilation data capturing device connected between a patient and a ventilator device but does not teach it is arranged to collect ventilation data from at least the flow path between the patient and the ventilator device.
However, Choncholas teaches a ventilation monitoring device for use in monitoring ventilation of at least one patient being ventilated by a suitable ventilator device via an associated connected arrangement defining a flow path of gas including air or oxygen between the patient and the ventilator device (Abstract, Fig. 1, paragraph 34) and a ventilation capturing device connected between a patient and a ventilator device to collect ventilation data from at least the flow path between the patient and the ventilator device. (Paragraph 36, flow measurement unit 62 in gas module 64 to measure gas flow in patient limb)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included the measurement device of Choncholas in the ventilator monitoring system of Steinhauer in order to determine residual capacity of a patient connected to a ventilator without needing to move the patient (paragraph 9) in order to provide information about the pulmonary state of a patient over time. (paragraph 10)
Regarding claim 2, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, and Choncholas further teaches the ventilation monitoring system according to claim 1, wherein the ventilation data capturing device is connected in an in-line flow communication fashion in the flow path between the ventilator device and the patient. (See fig. 1, the monitoring device is located in the gas lines between the patient and ventilator)
Regarding claim 3, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, and Choncholas further teaches wherein the ventilation data includes at least pressure data indicative of and/or associated with a ventilation process between the patient and the ventilator device, (paragraph 36, pressure measurement unit 66)wherein the ventilation process includes the creation and/or generation of positive and/or negative pressure differentials between the airways and lungs of a patient to support and/or provide for inhalation and/or exhalation of the patient (paragraph 11, paragraph 35, the air and oxygen are provided it inspiratory limb of breathing circuit 32, during inspiration patient limb 36 provides breathing gas to the lungs, patient limb receives gas during expiration), and thus wherein the pressure data is indicative of gas pressure in the flow path between ventilator device and the patient. (paragraph 36, measures pressure in the patient limb)
Regarding claim 4, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 3,and Choncholas further teaches wherein the pressure data comprises pressure signals, or data indicative thereof, associated with the ventilation process, and wherein the ventilation data capturing device comprises one or more suitable sensors for sensing at least gas pressure associated with or indicative of the ventilation process and generating pressure signals in response to said sensing. (paragraph 36, pressure sensor 57, one of the pressure lines is connected to pressure measurement unit 66 to measure the pressure in patient limb 66)
Regarding claim 5, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, and Steinhauer teaches further teaches wherein the ventilation data capturing device (Fig. 7: 705) comprises a memory (Fig. 7:725), a communication module (Fig. 7: 712, 714)and a controller (Fig. 7: processor 720), wherein the controller is configured to transmit ventilation data collected by the ventilation data capturing device via the one or more sensors to the at least one remote processor, via the communication module, (Paragraph 89, receiver 712 and transmitter 714 similar to receivers and transmitter 112, 114, paragraph 65, receiver configured to receive communication from medical entity) and wherein the at least one remote processor is configured to:
analyze the ventilation data collected by the ventilation data capturing device (Paragraph 168, analyze medical device data, paragraph 169, ; and
generate output data, based on the analyzed ventilation data, wherein the output data comprises at least visual representations of the analyzed and/or collected ventilation data. (paragraph 170, reports analyzed aggregated data, paragraph 173, report is displayed)
Regarding claim 6, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 5, and Steinhauer further teaches wherein the output data comprises diagrams and/or graphs indicative of the ventilation process including pressure versus time diagrams; flow versus time diagrams; and/or air volume versus time diagrams. (Paragraph 155, provides graphs illustrating trends for settings and measured values of the patient report, measured values includes PEEP, peak expiratory flow rate, peak inspiratory flow rate)
Regarding claim 7, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 6, and Steinhauer further teaches wherein the analysis of the ventilation data includes performing process diagnostics on the ventilation data to extract set points of the ventilation process, wherein the set points are selected from a group comprising an inspiration: expiration ratio; peak inhalation pressure; exhalation pressure; and tidal volume. (Paragraph 155, includes information indicating an apnea interval, a bias flow, a compression volume, a demand flow, an average end tidal CO2, a flow cycle, a flow trigger, dynamic compliance, inverse ratio ventilation, PEEP, PEFR, PIFR, measured values illustrate trends in the values, Fig. 17H,)
Regarding claim 8, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, and Steinhauer teaches wherein the at least one remote processor is configured to collect or receive patient metadata including information indicative of one or more of the patient's gender, patient's age (paragraph 89, patient’s age, sex, height, weight), ventilation device details (paragraph 87, ventilator device details), and details of the patient circuit tubing selection.
Regarding claim 9, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 8, and Steinhauer further teaches wherein the at least one remote processor is further configured to: analyze the patient metadata (paragraph 154, provides an executive summary focused on historical data measures0; and generate output data, wherein the output data comprises at least visual representations of the analyzed patient metadata. (paragraph 139, may generate reports for display specific to a patient, paragraph 152)
Regarding claim 10, Steinhauer in view of Choncholas teaches the ventilation monitoring system of claim 1, and Steinhauer further teaches wherein the at least one remote processor is further configured to collect commands/instructions, from the remote device, for displaying on an on-site device associated with an on-site medical practitioner for actioning by the on-site medical practitioner on the ventilator device. (Paragraph 77, stream ventilator information in real-time via a handheld device, a clinician is able to view the snapshot of the ventilator information at the handheld device, paragraph 193, the clinician inputs data about weaning, change of ventilator))
Regarding claim 11, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1,and Steinhauer further teaches wherein the at least one remote processor is arranged to generate an alarm when the collected ventilation data is below or above a predefined threshold (paragraph 10, generates a notification when the statistic exceeds a threshold, paragraph 57, paragraph 138) , wherein the ventilation data includes information indicative of the gas pressure flowing from the ventilator device to the patient (Paragraph 146, pressure limit), wherein the gas pressure is indicative of whether the gas pressure is higher or lower than required for providing adequate ventilation to the patient. (paragraph 145, threshold for plateau pressure limit, paragraph 147, high peak inspiratory pressure limit)
Regarding claim 12, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to 7, and Steinhauer further teaches wherein the at least one remote processor is arranged to collect and store extracted, historic set points, (Paragraph 186, compared with historical data of another ventilator) and further wherein the at least one remote processor is arranged to compare, substantially in real-time, extracted historic set points of the patient with extracted, current set points, (Paragraph 186, compares associated historical data with oxygen level of the current ventilator) and when the extracted, current set points deviate from the extracted, historic set points of the patient, the at least one remote processor is arranged to generate a suitable alarm or alert message. (Paragraph 186, generates a ventilator avoidance report based on the comparison, paragraph 183, avoidance report)
Regarding claim 17, Steinhauer in view of Choncholas teaches a ventilation monitoring system according to claim 1, and Steinhauer further teaches for use in a method of monitoring ventilation of at least one patient. (Fig. 18, Fig. 20)
Regarding claim 18, Steinhauer teaches a computer-readable medium storing instructions thereon which are executable by at least one remote processor of a ventilation monitoring system ((Paragraph 209, the computer readable and computer executable instructions reside in a memory, Paragraph data associated with a ventilator and a patient is accessed by data accessor 2710, paragraph 205, remote device 3220, paragraph 206, remote device is able to remotely communicate with the ventilator), the ventilation monitoring system comprising:
a ventilation data capturing device connected between a patient and a ventilator device dedicated to and/or associated with the patient, (Fig. 8: 710, paragraph 88, paragraph 90, may capture audio data of a patient to facilitate in the care of the patient ) for providing ventilation support to the patient, (Paragraph 58, mechanically moves air in and out of the lungs of a patient)
a ventilation data capturing device connected between a patient and a ventilator device is arranged to collect ventilation data (Fig. 8: 710, paragraph 88, paragraph 90, may capture audio data of a patient to facilitate in the care of the patient ) wherein the ventilator device and/or ventilation data capturing device comprise unique identifiers(Paragraph 149, identifies a configuration for each of the ventilators):
wherein the instructions when executed by the at least one remote processor are arranged to cause the at least one remote processor to perform the operations of associating and storing in the computer readable-medium or at least one memory device, unique identifiers of at least two of an associated ventilator device, ventilation data capturing device, and the patient under a particular ventilation profile or ventilation file; (Associates a ventilator with a patient, Fig. 31, step 2810, paragraph 10, the identification for each patient can include at least one of an account identification a patient name, patient care area, patient location, paragraph 139, the ventilator monitoring user interface can generate reports specific to a patient or ventilator, paragraph 155, report includes an identification of the patient and the patient’s ventilator);
collecting ventilation data from the ventilation data capturing device; (paragraph 210, ventilator data, Fig. 28, step 2812, access streaming ventilator data) and
generating output data, the output data indicative of, or comprising, a status of the ventilator device, (Paragraph 140, example reports can include weaning summary, weaning details, medical ventilator settings, ventilator history reports) or generating output data based on at least one of the status of the ventilator device determined from the collected ventilation data, (paragraph 151, indicative ventilator settings report, ventilator history report, lung protection analytics report),received or collected ventilation data from the ventilation data capturing device, and commands collected from a remote device that is arranged to be in communication with at least the ventilation data capturing device,
wherein the output data comprising at least instructions or commands for actioning on the ventilator device associated with the ventilation data capturing device to allow suitable ventilation to be provided by the ventilator device to the patient. (Paragraph 174, suggesting protocol based on the analyzed aggregated data, paragraph 177, the protocol is customized according to a patient associated with the ventilator)
Steinhauer teaches a ventilation data capturing device connected between a patient and a ventilator device but does not teach it is arranged to collect ventilation data from at least the flow path between the patient and the ventilator device.
However, Choncholas teaches a ventilation monitoring device for use in monitoring ventilation of at least one patient being ventilated by a suitable ventilator device via an associated connected arrangement defining a flow path of gas including air or oxygen between the patient and the ventilator device (Abstract, Fig. 1, paragraph 34) and a ventilation capturing device connected between a patient and a ventilator device to collect ventilation data from at least the flow path between the patient and the ventilator device. (Paragraph 36, flow measurement unit 62 in gas module 64 to measure gas flow in patient limb)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included the measurement device of Choncholas in the ventilator monitoring system of Steinhauer in order to determine residual capacity of a patient connected to a ventilator without needing to move the patient (paragraph 9) in order to provide information about the pulmonary state of a patient over time. (paragraph 10)
Regarding claim 19, Steinhauer teaches Steinhauer teaches a ventilation monitoring system (Abstract, a monitoring system for multiple medical ventilators, Fig. 1A, AB, Fig. 8) for use in monitoring ventilation of at least one patient being ventilated by a suitable ventilator device via an associated connected arrangement defining a flow path of gas including air or oxygen between the patient and the ventilator device (Paragraph 58, mechanically moves air in and out of the lungs of a patient, configured to monitor physiological statistics for the patients such as dynamic compliance, ventilation rate, PEEP, airway pressure, paragraph 128, during use of the system ventilators are in operation with respective patients, paragraph 192, ventilator associated with a patient); wherein the system comprises:
the ventilator device (Fig. 1: ventilators 110), wherein the ventilator device comprises
a ventilation data capturing device connected between the patient and the ventilator device dedicated to and/or associated with the patient, (Fig. 8: 710, paragraph 88, paragraph 90, may capture audio data of a patient to facilitate in the care of the patient ) and
wherein the ventilator device and/or ventilation data capturing device comprise unique identifiers(Paragraph 149, identifies a configuration for each of the ventilators):
at least one remote processor (Paragraph data associated with a ventilator and a patient is accessed by data accessor 2710, paragraph 205, remote device 3220, paragraph 206, remote device is able to remotely communicate with the ventilator); and
at least one memory device coupled to the at least one remote processor (Paragraph 209, the computer readable and computer executable instructions reside in a memory), wherein the at least one memory device containing instructions which, when executed by the at least one remote processor (paragraph 209) are arranged to cause the at least one remote processor to:
associate and store in the at least one memory device, unique identifiers of at least two of an associated ventilator device, ventilation data capturing device, and the patient under a particular ventilation profile or ventilation file (Associates a ventilator with a patient, Fig. 31, step 2810, paragraph 10, the identification for each patient can include at least one of an account identification a patient name, patient care area, patient location, paragraph 139, the ventilator monitoring user interface can generate reports specific to a patient or ventilator, paragraph 155, report includes an identification of the patient and the patient’s ventilator);
collect or receive ventilation data from the ventilation data capturing device (paragraph 210, ventilator data, Fig. 28, step 2812, access streaming ventilator data) ; and
generate output data, based on the collected or received ventilation data, wherein the output data comprises or is indicative of a status of the ventilator device, (Paragraph 140, example reports can include weaning summary, weaning details, medical ventilator settings, ventilator history reports) or
generate output data based on at least one of the collected or received ventilation data (paragraph 151, indicative ventilator settings report, ventilator history report, lung protection analytics report), status of the ventilator device determined from the received or collected, and commands collected from a remote device that is in communication with at least the ventilation data capturing device, wherein the output data comprising at least instructions/commands for actioning on the ventilator device associated with the ventilation data capturing device to allow suitable ventilation to be provided by the ventilator device to the patient. (Paragraph 174, suggesting protocol based on the analyzed aggregated data, paragraph 177, the protocol is customized according to a patient associated with the ventilator)
Steinhauer teaches a ventilation data capturing device connected between a patient and a ventilator device but does not teach it is arranged to collect ventilation data from at least the flow path between the patient and the ventilator device. Steinhauer is silent as to the source of gas in the ventilator.
However, Choncholas teaches a ventilation monitoring device for use in monitoring ventilation of at least one patient being ventilated by a suitable ventilator device via an associated connected arrangement defining a flow path of gas including air or oxygen between the patient and the ventilator device (Abstract, Fig. 1, paragraph 34), a gas canister containing suitable gas for ventilation of the patient (paragraph 34, receives air from an appropriate source such as a cylinder of pressurized air) and a ventilation capturing device connected between a patient and a ventilator device to collect ventilation data from at least the flow path between the patient and the ventilator device. (Paragraph 36, flow measurement unit 62 in gas module 64 to measure gas flow in patient limb)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included the measurement device of Choncholas in the ventilator monitoring system of Steinhauer in order to determine residual capacity of a patient connected to a ventilator without needing to move the patient (paragraph 9) in order to provide information about the pulmonary state of a patient over time. (paragraph 10)
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Steinhauer in view of Choncholas, and further in view of Acker et al (US 2015/0320953), hereinafter Acker.
Regarding claim 13, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, and further teaches wherein in generating an output comprising the status of the ventilator device, wherein the ventilator device comprises a gas cylinder (Choncholas, paragraph 34, appropriate source such as a gas cylinder or manifold) and a gas mask connectable to the gas cylinder (Choncholas, Fig. 1: patient is connected to air an oxygen via tubing), but does not teach the at least one remote processor is arranged to determine, substantially in real-time, an amount of gas remaining in the ventilator device based on a flow rate of gas travelling from the ventilator device to the patient over a period of time.
However, Acker teaches systems for delivery of therapeutic gas (Abstract) wherein the device communicates a run-time to empty for a particular gas source and indicates a criticality on a status display (Paragraph 201) based on a flow rate of gas traveling from the ventilator device to a patient over a period of time. (Paragraph 7, the run time to empty is calculated from a gas flow rate value communicated from the therapeutic gas flow controller)
Therefore, the combination of Steinhauer in view of Choncholas and Acker teaches remote processor is arranged to determine, substantially in real-time, an amount of gas remaining in the ventilator device based on a flow rate of gas travelling from the ventilator device to the patient over a period of time.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Steinhauer in view of Choncholas with the ability to determine an amount of gas remaining the ventilator based on the flow rate as taught by Acker in order to notify the user of the remaining run time. (paragraph 201)
Regarding claim 14, Steinhauer in view of Choncholas and Acker teaches the ventilation monitoring system according to claim 13, and Acker further teaches wherein if the amount of gas remaining in the ventilator device falls below a predetermined threshold, the at least one remote processor is arranged to generate a suitable alarm or alert message.(paragraph 210, a high level alarm may indicate that a half hour remains)
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Steinhauer in view of Choncholas, and further in view of Gottlib et al (US 2008/0053441), hereinafter Gottlib.
Regarding claim 15, Steinhauer in view of Choncholas teaches the ventilation monitoring system according to claim 1, but does not teach wherein in generating an output comprising the status of the ventilator device, the at least one remote processor is arranged to determine, substantially in real-time, an operating condition of the ventilator device by determining whether there is a flow of gas or a reduction of flow of gas from the ventilator device to the patient, wherein the absence of or reduction of a flow of gas between the ventilator device and the patient is indicative that the ventilation device is not functioning.
However, Gottlib teaches a system of detecting faults in a breathing assistance device (Fig. 1, Abstract) which is arranged to determine, substantially in real-time, an operating condition of the ventilator device by determining whether there is a flow of gas or a reduction of flow of gas from the ventilator device to the patient, wherein the absence of or reduction of a flow of gas between the ventilator device and the patient is indicative that the ventilation device is not functioning.(Fig. 4, paragraph 59, detect a fault by the comparison of the filtered flow rate value with the flow rate threshold value and determine a fault conditions exists)
It would have been obvious to a person of ordinary skill in the art to have provided the system of Steinhauer with determining the ventilation device is not functioning based on a low flow rate as taught by Gottlib in order to notify a person that there is an issue with the ventilation device. (paragraph 61)
Regarding claim 16, Steinhauer in view of Choncholas and Gottlib teaches the ventilation monitoring system according to 15 and Gottlib further teaches wherein in the absence of or reduction of a flow of gas between the ventilator device and the patient, the at least one remote processor is arranged to generate a suitable alarm or alert message. (Paragraph 61, an alert)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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, Brandy Lee can be reached at 571-270-7410. 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.
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785