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 .
Status of the Claims
This Office Action is in responsive to the preliminary amendment filed on 3/4/2024. As directed by the Preliminary amendment, claims 2-3, 5-7, 12, 14, 16, 18-19, 21-22, 24, 26, and 31 were amended, and claims 4, 8-11, 13, 15, 20, 23, 25, and 32-47 were cancelled. Thus, claims 1-3, 5-7, 12, 14, 16-19, 21-22, 24, and 26-31 are currently pending in this application.
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 3, 6-7, 12, 14, 16-19, 21-22, 24, and 26-31 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 portion” recited three times in lines 3 and 4 is confusing, as it is unclear whether these recitations are meant to be the same or different limitations.
Regarding claim 6, the limitation “optionally” in line 5 is confusing, as it is unclear whether the following limitation is required or not for the claimed invention.
Claim 7 recites the limitations "the current flow generator output" in lines 2-3 and “the current flow” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitation “the motor” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the current motor speed” in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitations “an upper motor speed limit” in lines 2-3 and “a lower motor speed limit” in lines 3-4 confusing, as it is unclear whether these recitations are meant to be the same as or different from “an upper motor speed limit” and “a lower motor speed limit” of claim 12.
Claim 16 recites the limitation “the comparison” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the limitations “a cannot reach flow rate alarm associated with the flow rate set point” in lines 3 and 5 are confusing, as it is unclear whether these limitations are meant to be the same as or different from “a cannot reach flow rate set point alarm” in claim 17.
Regarding claim 19, the limitation “a cannot reach flow rate set point alarm” in line 4 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a cannot reach flow rate set point alarm” in claim 17 and/or “a cannot reach flow rate alarm associated with the flow rate set point” in claim 18.
Regarding claim 21, the limitation “at least one alarm condition” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “at least one alarm condition” in claim 16.
Regarding claim 22, the limitation “about 5% to about 20% or about 10%” in line 3 is confusing, as the metes and bound of the value is unclear (i.e. is the claim reciting about 5%-about 20% or about 10%? Or is the claim reciting about 5%-20% or about 5%-10%?). Moreover, the term “ about” in line 3 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the proportion of the flow rate set point is indefinite.
Regarding claim 24, the limitation “a cannot reach flow rate set point alarm” in line 4 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a cannot reach flow rate set point alarm” in claim 17.
Regarding claim 26, the limitation “at least one alarm condition” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “at least one alarm condition” in claim 16.
Regarding claim 28, the limitation “about 5% to about 20% or about 10%” in line 2 is confusing, as the metes and bound of the value is unclear (i.e. is the claim reciting about 5%-about 20% or about 10%? Or is the claim reciting about 5%-20% or about 5%-10%?). Moreover, the term “ about” in line 3 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the proportion of the flow rate set point is indefinite.
Claim 30 recites the limitation “the motor speed” in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “a safe threshold rate” in lines 3-4 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a safe threshold rate” in line 3.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Starr et al. (US 2005/0121033 A1) in view of Bowman et al. (US 2016/0243325 A1).
Regarding claim 1, Starr discloses a breathing apparatus (apparatus for monitoring a patient’s respiratory status during the delivery of gases) (abstract), the breathing apparatus comprising:
a flow generator (supply of gas 110) (Fig. 1; para. [0034]), a flow path, the flow path configured to provide a flow of breathable gas to a patient (path through connector 108 and conduit 102 with lumen 103 for the gas from the gas supply 110 to travel to the patient) (Fig. 1; paras. [0034-0035]; para. [0042]), a controller (processor 136 configured to determine respiratory variables) (Fig. 1; para. [0038]), and wherein the controller is configured to:
determine a variable indicative of conductance of the flow path (resistance to flow is determined) (para. [0044]; para. [0088]),
determine a predicted flow rate for the flow path based on: the variable indicative of conductance of the flow path, the allowable flow generator output (quantitative flow for all other times is determined with the calculated resistance and the pressure measured, the pressure resulting from the flow of supplement gas through the lumen 103 from source 110) (Fig. 1; para. [0044]; paras. [0090-0091]).
Starr does not disclose the controller configured to control the flow generator by controlling a flow generator output to the flow generator, wherein the flow generator output is within an allowable flow generator output range, to provide the flow of breathable gas; determine a predicted maximum flow rate and/or a predicted minimum flow rate based on the allowable flow generator output range.
However, Bowman teaches a system adapted to regulate pressure of a flow of breathable gas (Bowman; abstract) wherein the controller is configured to control the flow generator by controlling a flow generator output to the flow generator (controller 300 may control the speed of motor 210 and fan 208) (Bowman; Fig. 1; para. [0037]), wherein the flow generator output is within an allowable flow generator output range, to provide the flow of breathable gas (ranges of motor speeds can be used to provide the flow) (Bowman; Figs. 7, 9-10; para. [0075]); determine a predicted maximum flow rate and/or a predicted minimum flow rate based on the allowable flow generator output range (each range of speeds has a minimum flow and maximum flow calculated, corresponding to the peaks and valleys of the graphed flow curve) (Bowman; Fig. 7; para. [0075]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Starr controller to be configured to control the flow generator by controlling a flow generator output to the flow generator, wherein the flow generator output is within an allowable flow generator output range, to provide the flow of breathable gas; determine a predicted maximum flow rate and/or a predicted minimum flow rate based on the allowable flow generator output range, as taught by Bowman, for the purpose of enabling a more accurate estimation of flow to be provided for multiple speeds (Bowman; para. [0078]).
Regarding claim 2, the modified Starr teaches wherein the flow generator output comprises one or more of a motor speed, a motor current, and a pressure of the gases in the flow path (in Starr, the quantitative flow is calculated with pressure measured by the pressure sensor 134; in Bowman, motor speed is used to determine flow, and the motor speed can in turn be determined from current of the motor 210) (Starr, Fig. 1, paras. [0090-0091]; Bowman, Figs. 7 and 9-10, para. [0040], para. [0046], para. [0075]).
Regarding claim 3, as best understood, the modified Starr teaches wherein the variable indicative of conductance of the flow path is, or is based on one or more of a resistance to flow of the flow path, or a portion of the flow path, and a pressure drop along the flow path, or a portion of the flow path (pressure drop of the gas through lumen 103 and resistance along the length of conduit 102) (Starr; para. [0044]).
Regarding claim 5, the modified Starr teaches wherein the breathing apparatus comprises a flow sensor configured to measure a flow rate of the flow of breathable gas to a patient (flow sensor 146 to measure the flow of oxygen delivered to a patient) (Starr; Fig. 1; para. [0052]).
Regarding claim 6, as best understood, the modified Starr teaches wherein the variable indicative of conductance of the flow path is based on a variable indicative of conductance of the flow path at a previous time step (the calculated resistance is determined first, and then subsequently used for determining the quantitative flow for all other times; resistance is along the length of conduit 102) (Starr; Fig. 1; para. [0044]; paras. [0090-0091]).
Regarding claim 7, as best understood, the modified Starr teaches wherein the variable indicative of conductance of the flow path is based on the current flow generator output and a current flow rate (resistance is determined from the pressure drop sensed by the pressure sensor 134 and the oxygen flow rate at a time when patient flow is zero) (Starr; Fig. 1; para. [0044]; paras. [0088-89]).
Claims 12-14, 16-19, 21-22, 24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Starr in view of Bowman as applied to claim 1 above, and further in view of Xu et al. (US 2022/0143356 A1).
Regarding claim 12, as best understood, the modified Starr teaches the invention as previously claimed, including wherein the allowable flow generator output range is an allowable motor speed range, wherein the allowable motor speed range comprises an upper motor speed limit and/or a lower motor speed limit (each range of speeds has a corresponding peak and valley as graphed, and thus has an upper and lower speed limit for a respective range) (Bowman; Fig. 7; para. [0075]), but does not teach wherein the controller is configured to control the motor to provide, or attempt to provide, the flow of breathable gas to the patient at a flow rate set point.
However, Xu teaches a system with a blower and air pathway (Xu; abstract) wherein the controller is configured to control the motor to provide, or attempt to provide, the flow of breathable gas to the patient at a flow rate set point (desired air flow rate as set by a user is provided via the controller adjusting the blower accordingly) (Xu; para. [0031]; para. [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Starr controller to be configured to control the motor to provide, or attempt to provide, the flow of breathable gas to the patient at a flow rate set point, as taught by Xu, for the purpose of enabling a user to have control over the flow rate delivered (Xu; para. [0031]), and thereby allow a user to have control over the flow of the device as needed or desired.
Regarding claim 14, as best understood, the modified Starr teaches wherein the predicted maximum flow rate is based on the current motor speed and/or an upper motor speed limit and the predicted minimum flow rate is based on the current motor speed and/or a lower motor speed limit (each range of speeds has a corresponding peak and valley for flow rates as graphed, which corresponds to the upper and lower speed limit for a respective range that occurs at a time) (Bowman; Fig. 7; para. [0075]).
Regarding claim 16, as best understood, the modified Starr teaches wherein the controller is configured to compare the predicted maximum flow rate and/or the predicted minimum flow rate, and a flow rate set point, and based on the comparison generate at least one alarm condition (in Bowman, the flow rate peak and valley for a speed range is calculated; in Xu, is the desired air flow is different than the air flow, and alarm is sounded; in the modified Starr device, the Xu comparison would use the Bowman calculated flow rates as compared to the Xu desired set flow rate) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claim 17, the modified Starr teaches wherein the at least one alarm condition comprises a cannot reach flow rate set point alarm (alarm sounded when the desired air flow set by the user cannot be provided) (Xu; para. [0045]).
Regarding claim 18, as best understood, the modified Starr teaches wherein the cannot reach flow rate set point alarm comprises: a cannot reach flow rate alarm associated with the flow rate set point being above the maximum predicted flow rate, and/or a cannot reach flow rate alarm associated with the flow rate set point being below the minimum predicted flow rate (in Xu, alarm sounded when the desired air flow set by the user cannot be provided; in Bowman, the flow rate for a speed range has both a peak and a valley; thus, in the modified Starr device, when the Bowman calculated flow rate range for a speed, which includes both the peak and the valley, is outside of the Xu desired set flow rate (i.e. the flow rate being above or below the desired flow rate), the Xu alarm would be sounded) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claim 19, as best understood, the modified Starr teaches wherein the controller is configured to determine a condition where the flow rate set point cannot be reached, based on the predicted maximum flow rate and the flow rate set point, and in response, the controller is configured to generate a cannot reach flow rate set point alarm (in Xu, alarm sounded when the desired air flow set by the user cannot be provided; in Bowman, the flow rate for a speed range has a peak; thus, in the modified Starr device, when the Bowman calculated flow rate range for a speed, which includes the peak flow rate, is outside of the Xu desired set flow rate, the Xu alarm would be sounded by the controller) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claim 21, as best understood, the modified Starr teaches wherein the controller is configured to generate at least one alarm condition when the flow rate set point is greater than the predicted maximum flow rate by more than an alarm threshold (in Xu, if the air flow is different from the desired air flow by 5% or 10%, then the alarm is sounded; thus, in the modified Starr device, when the Bowman calculated flow rate range for a speed, which includes the peak and valley flow rates, is below the Xu desired set flow rate by 5% or 10%, the Xu alarm would be sounded by the controller) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claim 22, as best understood, the modified Starr teaches wherein the alarm threshold is a proportion of the flow rate set point, wherein the proportion of the flow rate set point is about 5% to about 20% or about 10% of the flow rate set point (if the air flow is different from the desired air flow by 5% or 10%, then the alarm is sounded) (Xu; para. [0045]).
Regarding claim 24, as best understood, the modified Starr teaches wherein the controller is configured to determine a condition where flow rate set point cannot be reached, based on the predicted minimum flow rate and the flow rate set point, and in response the controller is configured to generate a cannot reach flow rate set point alarm (in Xu, alarm sounded when the desired air flow set by the user cannot be provided; in Bowman, the flow rate for a speed range has a valley; thus, in the modified Starr device, when the Bowman calculated flow rate range for a speed, which includes the valley flow rate, is outside of the Xu desired set flow rate, the Xu alarm would be sounded by the controller) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claim 26, as best understood, the modified Starr teaches wherein the controller is configured to generate at least one alarm condition when the flow rate set point is less than the predicted minimum flow rate by more than an alarm threshold (in Xu, if the air flow is different from the desired air flow by 5% or 10%, then the alarm is sounded; thus, in the modified Starr device, when the Bowman calculated flow rate range for a speed, which includes the peak and valley flow rates, is above the Xu desired set flow rate by 5% or 10%, the Xu alarm would be sounded by the controller) (Bowman, Fig. 7, para. [0075]; Xu, para. [0045]).
Regarding claims 27-28, as best understood, the modified Starr teaches wherein the alarm threshold is a proportion of the flow rate set point, wherein the proportion of the flow rate set point is about 5% to about 20% or about 10% of the flow rate set point (if the air flow is different from the desired air flow by 5% or 10%, then the alarm is sounded) (Xu; para. [0045]).
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Starr in view of Bowman and Xu as applied to claim 16 above, and further in view of Nightingale et al. (US 2013/0133656 A1).
Regarding claim 29, the modified Starr teaches the invention as previously claimed, including the controller controls the motor speed to a predetermined safe motor speed (each of the motor speed ranges with a baseline motor speed 410 would be safe for a user, as they are for providing appropriate flows to a patient; these motor speed ranges have predetermined functions associated with them, and so would be predetermined motor speeds) (Bowman; Figs. 7, 9-10; paras. [0075-0076]; para. [0098]), but does not teach wherein in response to the generation of the at least one alarm condition, the controller controls the motor speed to a predetermined safe motor speed.
However, Nightingale teaches an apparatus for controlling pressure delivery of a flow of gas to a patient (Nightingale; abstract) wherein in response to the generation of the at least one alarm condition, the controller controls the motor speed to a safe motor speed (when the flow exceeds or is below a desired flow range, the motor speed can be increased or decreased; the motor speed would be safe for a user, as it is for reaching the desired flow range for the user) (Nightingale; para. [0052]; paras. [0083-0084]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Starr controller such that wherein in response to the generation of the at least one alarm condition, the controller controls the motor speed to a safe motor speed, as taught by Nightingale, for the purpose of achieving a desired flow range (Nightingale; para. [0052]; paras. [0083-0084]).
With this modification, the modified Starr device would thus teach wherein in response to the generation of the at least one alarm condition (if the air flow is different from the desired air flow by 5% or 10%, then the alarm is sounded) (Xu; para. [0045]), the controller controls the motor speed to a predetermined safe motor speed (in Nightingale, when the flow exceeds or is below a desired flow range, the motor speed can be increased or decreased; Bowman can have any number of baseline motor speed ranges with associated predetermined functions possible, and so the change in motor speed by Nightingale can be accounted for with Bowman predetermined speeds and functions) (Bowman, Figs. 7 and 9-10, paras. [0075-0077]; Nightingale, paras. [0083-0084]).
Regarding claim 30, as best understood, the modified Starr teaches wherein the controller controls the motor speed to the predetermined safe motor speed until the predicted maximum flow rate is greater than a safe threshold flow rate, and/or the predicted minimum flow rate is less than a safe threshold flow rate (if the Bowman motor speed was adjusted from a first motor speed down to a second lower motor speed to meet a Nightingale desired flow range, then the calculated peak and valley flow rates of the first motor speed would be greater than the second motor speed’s calculated baseline, peak, and valley flow rates; if the Bowman motor speed was adjusted from a first motor speed up to a second higher motor speed to meet a Nightingale desired flow range, then the calculated peak and valley flow rates of the first motor speed would be lesser than the second motor speed’s calculated baseline, peak, and valley flow rates) (Bowman, Figs. 7 and 9-10, paras. [0075-0077]; Nightingale, paras. [0083-0084]).
Regarding claim 31, the modified Starr teaches wherein the controller controls the motor speed to the predetermined safe motor speed until the flow rate set point is less than the predicted maximum flow rate, and/or the flow rate set point is greater than the predicted minimum flow rate (if the Bowman motor speed was adjusted from a first motor speed down to a second lower motor speed to meet a Nightingale desired flow range, then the desired flow range would be less than the calculated peak and valley flow rates of the first motor speed; if the Bowman motor speed was adjusted from a first motor speed up to a second higher motor speed to meet a Nightingale desired flow range, then the desired flow range would be greater than the calculated peak and valley flow rates of the first motor speed) (Bowman, Figs. 7 and 9-10, paras. [0075-0077]; Nightingale, paras. [0083-0084]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10,799,656 B2 by Berry Ann et al. is considered to be relevant as it discloses a device to deliver breathable gas to a patient that has an equation to predict flow rate using conductance and pressure variables.
US 2015/0144130 A1 by O’Donnell et al. is considered to be relevant as it discloses a respiratory assistance device that changes from one motor speed to another predetermined motor speed to see if the resulting flow rate indicates a leak or blockage.
US 2011/0060700 A1 by Durtschi et al. is considered to be relevant as it discloses a medical gas system that determines if a measured flow rate is within a predetermined range or normal operating flow rates.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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, 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.
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.
/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785