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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT/IB2022/054869 filed May 25, 2022 and to U.S. Provisional App. No. 63/192,964 filed May 25, 2021.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on September 3, 2024. As directed by the amendment: claims 1-3, 5-14, and 18-20 have been amended; and claims 4, 15-17, 21-22, 24, 26-27, and 30-35 have been cancelled. Thus, claims 1-3, 5-14, 18-20, 23, 25, and 28-29 are presently pending in this application.
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.
Claim(s) 1-3, 5-14, 18-20, 23, 25, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell et al. (U.S. Pub. No. 2019/0336711; hereinafter: “O’Donnell”) in view of Bath et al. (U.S. Pub. No. 2020/0114098; hereinafter: “Bath”) .
Regarding Claim 1, O’Donnell discloses a respiratory apparatus that is configured to provide a flow of gases to a user for respiratory therapy comprising: a gases (¶¶ 0085, 0115), wherein the flow generator is motor-driven (158; Fig. 1; ¶¶ 0085, 0115); a flow path (¶ 0083) for the flow of gases through the respiratory apparatus to a gases outlet (at 22; Fig. 3; ¶ 0083) of the respiratory apparatus; a humidifier (14, 16; Fig. 3) that is operable to heat and humidify the flow of gases (¶¶ 0081, 0083, 0088), the humidifier comprising a removable humidification chamber (14; Fig. 3) in the flow path (¶¶ 0083, 0091); a flow rate sensor configured to generate a flow rate signal of the flow of gases in the flow path (¶¶ 0086-0087, 0094-0096, 0115-0116, 0127) and a controller (150, 152; Fig. 7) that is operatively connected to the flow generator and operable to control a flow rate of the flow of gases by controlling a motor speed of the flow generator (Fig. 7, 8; ¶¶ 0116-0121), wherein the controller is configured during operation to execute a leak detection process for detecting leaks in the flow path by: initiating a first-stage leak evaluation comprising comparing the pressure variable to a first leak threshold, the first leak threshold representing a possible leak condition (¶¶ 0012-0017, 0023-0025, 0027, 0033-0035); and initiating a second-stage leak evaluation if the pressure variable is below the first leak threshold thereby indicating a possible leak, the second-stage leak evaluation comprising: increasing the motor speed of the flow generator from a current motor speed to a higher motor speed, comparing a new pressure variable at the higher motor speed to the first leak threshold and a second leak threshold, the second leak threshold representing a definite leak condition (¶¶ 0012-0017, 0023-0025, 0027, 0033-0035), and then: generating a leak alarm (¶¶ 0099, 0115, 0123) and exiting the second-stage leak evaluation if the new pressure variable is below the second leak threshold thereby confirming the possible leak as a definite leak (Fig. 8-11; ¶¶ 0116-0136); or exiting the second-stage leak evaluation without generating an alarm if the new pressure variable is above the first leak threshold and second leak threshold thereby resolving the possible leak as no leak (Fig. 8-11; ¶¶ 0116-0136); or repeating the second-stage leak evaluation at a further higher motor speed or speeds until the possible leak is confirmed as a leak or resolved as no leak (Fig. 8-11; ¶¶ 0116-0136).
O’Donnell does not specifically disclose the respiratory apparatus comprising a pressure sensor configured to generate a pressure variable representing a sensed pressure characteristic of the flow of gases in the flow path.
Bath teaches a respiratory apparatus that is configured to provide a flow of gases to a user for respiratory therapy comprising a controller (4230; Fig. 4C) that is operatively connected to a flow generator (4140, 4142, 4144; Fig. 4A, 4B) and operable to control a flow rate of the flow of gases by controlling a motor speed (4144; Fig. 4B) of the flow generator (Fig. 4A, 4B; ¶¶ 0150-0152, 0161) and a pressure sensor (4272; Fig. 4C) configured to generate a pressure variable representing a sensed pressure characteristic of the flow of gases in a flow path (¶¶ 0159, 0160, 0198-0200, 0203-0205) for the purpose of relating the flow rate of the flow of gases in the flow path with the pressure therein to determine the possibility of a leak (¶¶ 0198-0200, 0203-0205).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify respiratory apparatus of O’Donnell to include the pressure sensor configured to generate the pressure variable representing the sensed pressure characteristic of the flow of gases in the flow path as taught by Bath for the purpose of relating the flow rate of the flow of gases in the flow path with the pressure therein to determine the possibility of a leak (See Bath: ¶¶ 0198-0200, 0203-0205).
Regarding Claim 2, the modified device of O’Donnell discloses wherein the first-stage leak evaluation comprises comparing the pressure variable to the first leak threshold and second leak threshold, and wherein the controller is configured to initiate the second- stage leak evaluation if the pressure variable is below the first leak threshold and above the second leak threshold thereby indicating a possible leak (See O’Donnell: ¶¶ 0012-0017, 0023-0025, 0027, 0033-0035, See Bath: ¶¶ 0198-0200, 0203-0205; Examiner notes: the modified device of O’Donnell discloses relating the flow rate of the flow of gases in the flow path with the pressure therein for leak detection.).
Regarding Claim 3, the modified device of O’Donnell discloses wherein the first-stage leak evaluation comprises comparing the pressure variable to the second leak threshold, and wherein the controller is configured to generate a leak alarm if the pressure variable is below the second leak threshold (See O’Donnell: ¶¶ 0099, 0115, 0123, See Bath: ¶¶ 0198-0200, 0203-0205; Examiner notes: the modified device of O’Donnell discloses relating the flow rate of the flow of gases in the flow path with the pressure therein for leak detection.).
Regarding Claim 5, the modified device of O’Donnell discloses wherein exit conditions comprise generating a leak alarm or initiating a second-stage leak evaluation to resolve a possible leak as a definite leak or no leak (See O’Donnell: Fig. 8-11; ¶¶ 0116-0136).
Regarding Claim 6, the modified device of O’Donnell discloses wherein, in the second-stage leak evaluation, increasing the motor speed of the flow generator comprises increasing the motor speed by a set increment to a first motor speed or to a second speeds, wherein the second motor speed is higher than the first motor speed (See O’Donnell: ¶¶ 0012-0017, 0023-0025, 0027, 0033-0035, 0040-0042, 0048-0052, 0096-0101, 0110-0112, 0126-0132).
Regarding Claim 7, the modified device of O’Donnell discloses wherein, in the second-stage leak evaluation, the controller is configured to hold the flow generator at the higher motor speed for a predetermined time period while comparing the new pressure variable to the first leak threshold and/or the second leak threshold to resolve the possible leak as a definite leak or no leak (¶¶ 0012-0017, 0023-0025, 0027, 0033-0035, 0040-0042, 0048-0052, 0096-0101, 0110-0112, 0126-0132; Examiner notes: the modified device of O’Donnell discloses relating the flow rate of the flow of gases in the flow path with the pressure therein for leak detection.).
Regarding Claim 8, the modified device of O’Donnell discloses wherein the controller is configured to repeat the second-stage leak evaluation at a second second
Regarding Claim 9, the modified device of O’Donnell discloses wherein the controller is configured to exit the second-stage leak evaluation depending on a comparison of the current motor speed to a motor speed threshold (See O’Donnell: ¶¶ 0012-0017, 0023-0025, 0027, 0033-0035, 0040-0042, 0048-0052, 0096-0101, 0110-0112, 0126-0132).
Regarding Claim 10, the modified device of O’Donnell discloses wherein the controller is configured to exit the second-stage leak evaluation if the current higher motor speed operating during the second-stage leak evaluation not below a motor speed threshold (See O’Donnell: ¶¶ 0012-0017, 0023-0025, 0027, 0033-0035, 0040-0042, 0048-0052, 0096-0101, 0110-0112, 0126-0132).
Regarding Claim 11, the modified device of O’Donnell discloses wherein the controller is configured to adjust the first leak threshold if the second-stage leak evaluation is exited without generating an alarm (See O’Donnell: ¶¶ 0045, 0100, 0109-0110).
Regarding Claim 12, the modified device of O’Donnell discloses wherein the controller is configured to adjust the first leak threshold by reducing the first leak threshold associated with the flow rate and/or motor speed operating during the first-stage leak evaluation(See O’Donnell: ¶¶ 0045, 0100, 0109-0110) .
Regarding Claim 13, the modified device of O’Donnell discloses wherein values of the first leak threshold and the second leak threshold are at least partly dependent on or a function of the flow rate and/or motor speed operating during comparison (See O’Donnell: ¶¶ 0023-0025, 0041-0042, 0116-0136).
Regarding Claim 14, the modified device of O’Donnell discloses wherein the first leak threshold and the second leak threshold are extracted from respective pressure-flow characteristic curves and/or representative look-up tables designating the first leak threshold and the second leak threshold for a range of flow rates and/or motor speeds (See O’Donnell: ¶¶ 0023-0025, 0041-0042, 0116-0136, See Bath: ¶¶ 0198-0200, 0203-0205; Examiner notes: the modified device of O’Donnell discloses relating the flow rate of the flow of gases in the flow path with the pressure therein for leak detection.).
Regarding Claim 18, the modified device of O’Donnell discloses wherein the controller is configured to initiate one or more alarm actions when generating a leak alarm (See O’Donnell: ¶¶ 0099, 0116-0136).
Regarding Claim 19, the modified device of O’Donnell discloses wherein the one or more alarm actions comprise freezing the flow rate and/or motor speed of the flow generator to current operating settings (See O’Donnell: ¶¶ 0099, 0116-0136).
Regarding Claim 20, the modified device of O’Donnell discloses wherein the one or more alarm actions comprise generating a notification or indication of the leak on a display of the respiratory apparatus (See O’Donnell: ¶¶ 0099, 0116-0136).
Regarding Claim 23, the modified device of O’Donnell discloses wherein the controller is operable to detect one or more different types of leaks in the flow path of the respiratory apparatus, each different type of leak having its own respective first and second leak thresholds (See O’Donnell: ¶¶ 0099, 0116-0136).
Regarding Claim 25, the modified device of O’Donnell discloses wherein, after an alarm is generated, the controller is configured to disable the alarm and revert to normal operation if the pressure variable rises above the second leak threshold or an alternative resolution leak threshold for a minimum time period (See O’Donnell: Fig. 8-11; ¶¶ 0099, 0116-0136).
Regarding Claim 28, the modified device of O’Donnell discloses wherein the humidifier of the respiratory apparatus further comprises a heater plate that is operable to heat the removable humidification chamber, and wherein the controller is further configured to execute a heater plate check process to further confirm or validate a definite leak identified in the second-stage leak evaluation before generating the leak alarm (See O’Donnell: ¶¶ 0053, 0081-0088).
Regarding Claim 29, the modified device of O’Donnell discloses wherein the heater plate check process comprises applying a power or temperature process to the heater plate and evaluating heating rate or and/or cooling rate of the heater plate against one or more thresholds based on a temperature sensor of or associated with the heater plate to thereby determine presence or absence of a humidification chamber being in thermal contact with the heater plate, the absence of the humidification chamber validating a definite leak condition (See O’Donnell: ¶¶ 0053, 0081-0088).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. 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.
/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
Prosecution Insights