DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the amendment filed on December 5, 2025. As directed by the amendment: claims 1, 3, 5-6, and 8 have been amended, claims 7 and 9 have been cancelled, and no claims have been added. Thus, claims 1, 3-6, 8, and 10-11 are presently pending in this application.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 3 and 8 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 claim 3, the limitation “a humidity of the breathing circuit, a temperature of the breathing circuit” is unclear in how a flow sensor that uses a pressure differential across a diaphragm can additionally detect humidity and temperature. It appears a humidity and/or temperature sensor would be required and is missing from the claims.
Regarding claim 8, the limitation “determine a difference between the first pressure differential and the second pressure differential is due to condensation; generate a condensation message indicating a presence of water condensation in the first flow sensor or the second flow sensor; and provide the condensation message to a display device coupled to the anesthesia device” is unclear if the condensation related values are detected by only the differential pressure or by a combination of the differential pressure and a high humidity environment that is detected by a humidity and temperature sensor as suggested in the specification (specification paragraph [0031]).
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claim(s) 1, 3-5, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman et al. (US 2012/0272957) in view of Sarihan (US 5,515,735), Dong (US 2021/0290883), and O’Hara (US 2008/0202606).
Regarding claim 1, Chapman discloses an anesthesia device (fig. 1, respiratory support system 10 which provides anesthetic gas via a vaporizer, see [0035]) comprising:
a ventilator system (fig. 1, 40);
a vaporizer system (fig. 1, vaporizer 32) operably connected to the ventilator system (fig. 1, vaporizer 32 and ventilator 40 both feed into breathing circuit 14);
a breathing circuit (fig. 1, 14) connected to the vaporizer system and configured to receive vaporized anesthetic agent from the vaporizer system (fig. 1, vaporizer 32 feeds into breathing circuit 14), the breathing circuit includes an inspiratory section (fig. 1, inspiratory gases 16) configured to carry inhalation gasses from the ventilator system to a patient (fig. 1, ventilator 40 feeds into 14 and into inspiratory gases section 16) and an expiratory section (fig. 1, expired gases 18) configured to carry gasses from the patient back to the ventilator (fig. 1, 18 feeds back towards ventilator 40);
a first flow sensor disposed within the inspiratory section (fig. 1, respiratory gas monitor 42 includes a flow sensor for providing processor 36 with flow to the patient, see [0025]); and
a processor (fig. 1, digital signal processor 36) to:
obtain usage information from the first flow sensor coupled to the anesthesia device ([0025] states that flow sensor in gas monitor 42 is provided with an indication of gas to and from the patient);
Chapman does not expressly disclose a first flow sensor including a diaphragm configured to oscillate as gases flow through.
However, Sarihan teaches of a flow sensor (figs. 1-2, flow sensor device 10) which uses a pressure differential found across a diaphragm to find a flow value (col. 2, lines 24-30).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the flow sensor of Chapman with the flow sensor as taught by Sarihan as a simple substitution of known elements to obtain a predictable result of allowing flow measurement of the gas being delivered to the patient that would function.
Chapman does not expressly disclose the processor determining usage information exceeds a predetermined limit, the processor generating an alert indicating the first flow sensor is to be replaced if the usage information exceeds a predetermined limit, and where the usage information comprises a pressure differential across the diaphragm of the first flow sensor.
However, Dong teaches of a medical ventilator system that determines a type of failure according to a predetermined limit (figs. 5A-5D, where each pattern corresponds to a type of failure) and the ventilator can subsequently generate an alert by causing an alarm to sound and/or sending the measured values to a display ([0041]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the processor of Chapman with the program for accuracy verification as taught by Dong regarding the determination of failure and alerting for the replacement of the flow sensor to assist in providing a more accurate flow estimate ([0005]).
Chapman does not expressly disclose the usage information comprising a number of times the diaphragm oscillates.
However, O’Hara teaches of a device to monitor diaphragm condition which uses a control unit (fig. 2B, 250) with a processor (fig. 2B, 255), memory (fig. 2B, 260), and input output port (fig. 2B, 265) to monitor a high number of open/close cycles, which are a back and forth oscillating movement, and subsequently indicate the diaphragm is nearing the end of its life ([0029]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the diaphragm of the modified Chapman device with the diaphragm monitoring device as taught by O’Hara for the purpose of maintaining accurate measurements by monitoring the condition of the diaphragm without visually inspecting the device (O’Hara [0006]).
Regarding claim 3, the modified device of Chapman reads on the limitations of claim 1 and further reads on the usage information further comprising a temperature of the breathing circuit (Dong [0009] states sensor failure is also considered when a temperature element is damaged, this inherently means temperature is also considered).
Regarding claim 4, the modified device of Chapman reads on the limitations of claim 1 and further reads on the first flow sensor comprising a storage device (O’Hara fig. 2B, 260) to store a number of movements of a diaphragm of the first flow sensor (O’Hara [0029] states that open/close cycles are monitored)
Regarding claim 5, the modified device of Chapman presented in claim 1 above reads on the limitations of claim 1 in addition to the processor provides an alert to a display device coupled to the anesthesia device (Dong [0037] states the system is connected to a display for displaying ventilatory information such as alerts where the display may be Chapman fig. 1, display 66).
Regarding claim 10, the modified device of Chapman reads on the limitations of claim 1 and further reads on the processor providing a differential pressure (Sarihan col. 2, lines 24-30 states that flow is derived from differential pressure) from the first flow sensor to a display (Chapman fig. 3, shows that pressure and flow values are displayed on display 66).
Regarding claim 11, the modified device of Chapman reads on the limitations of claim 1 and further reads on the processor provides usage information via a display device (Chapman fig. 3, can display alarms, see [0053], in addition to ventilatory information, see [0057]), including a number of movements of a diaphragm (O’Hara [0035] states the control unit can transmit data from the diaphragm storage, and Dong [0037] states the display can display ventilatory data which inherently means it can display diaphragm usage data).
8. Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman in view of Sarihan and Dong as applied to claim 1 above and further in view of Acker et al. (US 2017/0216551).
Regarding claim 6, the modified device of Chapman presented in claim 1 above reads on the limitations of claim 1, but is silent on a second flow sensor.
However, Acker teaches of anesthesia delivery system (fig. 3) which compares a first and second breathing gas flow rate measurement to one another ([0008]) and can identify a disruption or fault if one or more sensor provides inaccurate or mismatched readings ([0022]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to duplicate the flow sensor of the modified device of Chapman and provide the program for comparing flow sensors as taught by Acker for the purpose of detecting faults within the flow sensors ([0049] states that during faults/disruptions an alert indicating the type of disruption and the current delivery method is provided to the user).
The further modified device of Chapman reads on a second flow sensor (Acker [0017] states that a second flow sensor can be located at the ventilator for comparison with a first flow sensor), wherein the processor is to: obtain a first pressure values from the first flow sensor and a second pressure value from the second flow sensor (Sarihan col. 2, lines 24-30 states that differential pressure is used to determine flow); determine that the first pressure value and the second pressure value indicate that the first pressure sensor or the second pressure sensor is operating outside of a predetermined accuracy range (Acker [0022] states that a fault can be detected if one or more sensors provide mismatched readings, where the accuracy range is the value determined by the other sensor); and generate a second alert indicating the first pressure sensor or the second pressure sensor is to be replaced (Acker [0049] states that when a disruption is detected an alert, visual or audio, is provided to the user).
Regarding claim 8, the modified device of Franke presented in claim 6 above reads on the limitations of claim 1 and further reads on the processor is to: detect a pressure differential from a first and second flow sensor (Sarihan col. 2, lines 24-30 states that differential pressure is used to determine flow), determine if the pressure differential is due to condensation (Dong [0009] considers temperature, and Dong [0028] further considers condensation as a cause of failure), generate a condensation message (Dong [0009] states a message is generated due to failure and condensation is a possible failure implying that the message may be a condensation message); and provide the condensation message to a display device coupled to the anesthesia device (Dong [0037] states the system is connected to a display for displaying ventilatory information such as alerts).
Response to Arguments
9. Applicant’s arguments with respect to claim(s) claims 1, 3-6, and 10-11 have been considered but are moot because the 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.
10. In response to Applicant’s arguments regarding dependent claim 8 on page 7 paragraphs 1-2, Applicant states that Dong does not state that the comparison between a flow sensor and modeled exhalation flow can determine if condensation is present and further does not provide a condensation specific message. However, Dong specifies in paragraphs [0056]-[0057] that saturation of the flow sensor caused by the accumulation of water can be detected (see Dong fig. 5D, large measured flow spikes 514 measured by the flow sensor can be caused by water contacted the flow element [0056]). Further, Dong in paragraph [0059] states that a specific failure can be detected if the measured exhalation flow matches the patterns described in figs. 5A-5D (see [0056]-[0057] which states that fig. 5D corresponds to inaccurate measurements due to water contacting the flow element of the flow sensor) which indicates of high humidity/condensation causing water droplets.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tappehorn et al. (US 2021/0370008) discloses a connection with a volume flow sensor that makes use of a flow sensor (fig. 1, 90) with a diaphragm (fig. 3, 2).
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785