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
Acknowledgment is made of applicant’s claim for priority to Application No. (61/648,799) filed on the May 18, 2012.
Status of the Claims
This office action is responsive to the claims filed on January 21, 2026. As directed by claims: no claims have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-22 are presently pending in the application.
Response to Arguments
Applicant argues on page 7-8 of the remarks that the 103-rejection on made does not read on the limitations of claim 1. Examiner respectfully disagrees. In the independent claim 1, Examiner states that Sweeny does not specifically teach that “comparing, by the controller, the current breath flow parameter to an equivalent baseline flow parameter; determining, by the controller, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state.” Examiner then looks at Rahman to teach that a parameter can be compared with a threshold determined previously they use that data to determine or indicate a certain sleep/awake state. This modified does not teach specifically comparing the current flow parameter of the patient measured to baseline parameter that was measured previously. However, Kotmel teaches that it known in the art to compare the current patient's data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously (para. 0026). Kotmel specifically teaches that EPD device can compare current measurement data to baseline or previous values, and compare individual compartments to whole lung data. Such display may be graphical, numerical or any other type. The multiple sets of information may be displayed simultaneously or individually, wherein viewing is controlled by the user. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the therapy apparatus and processor of Sweeney to being able to compare the current patients data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously as taught by Kotmel as it is known in the art that comparison are used for the purpose of being able to use the data and allow be able to see what needs to be changed for the patient (para. 0026).
Applicant’s arguments with respect to claim(s) 4, 10, 15, 20-21 and the rest of the claims that are dependent from the independent claim have been considered but are not persuasive as addressed above. Previous prior art rejections stand on the merit.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1, 4, 10, 12, 15 and 20-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sweeney et al. (US 20110253136 A1), hereafter as Sweeney in view of Ramanan et al. (US 20120179061 A1), hereafter as Ramanan, Kotmel et al. (US 20030051733 A1), hereafter as Kotmel and Foote et al. (US 20140283831 A1), hereafter as Foote.
Regrading Claim 1, Sweeney discloses a method of operating a breathing apparatus (Fig. 1) using a controller (controller 120; Fig. 1; para. 0054, 0062-0067 ) the method comprising:
providing fluid to a patient (by the nasal cannula 108; Fig. 1; para. 0042-0043, 0059);
measuring, by a sensor(sensors 114, 115, 116, 117, 131, 132, 134, flow sensors; Fig. 1; para. 0052, 0060, 0075), a current breath flow parameter of a patient (sensors; Fig. 1; claims 6 and 10: Examiner notes: That Sweeney teaches that the processor is measuring and control the flow rate which is a parameter of flow to the patient).
Sweeny does not disclose specifically that comparing, by the controller, the current breath flow parameter to an equivalent baseline flow parameter; determining, by the controller, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state.
However, Ramanan teaches comparing, by the controller, the current breath flow parameter (before 110; Fig, 20) to an equivalent baseline breath flow parameter of the patient (Fig. 20; para. 0163-0318, 0435; the flow rate is controlled with threshold parameters); determining, by the controller, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter (Fig. 20), a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state (para. 0436-0437; Ramanan teaches that after the comparison sleep is detected and then changing the parameter depending if they are sleep or not);
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Sweeney to include comparing, by the controller, the current breath flow parameter to an equivalent baseline flow parameter of the patient measured previously; determining, by the controller, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state as taught by Ramanan for the purpose therapeutic pressure levels may be automatically adjusted in response to the detection of sleep conditions that may be suitable for treatment (para . 0436-0437).
Modified Sweeney does not specifically teach comparing the current flow parameter of the patient measured previously.
However, Kotmel teaches that it known in the art to compare the current patient’s data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously(para. 0026).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the therapy apparatus and processor of Sweeney to being able to compare the current patients data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously as taught by Kotmel as it is known in the art that comparison are used for the purpose of being able to use the data and allow be able to see what needs to be changed for the patient (para. 0026).
Modified Sweeney does not specifically teach then controlling, by the controller, a humidity of the fluid to the patient based on the sleep state of the patient.
However, Foote teaches controlling, by the controller, a humidity of the fluid to the patient based on the sleep state of the patient (para. 0213-0219).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Ramanan to include the ability to control, by the controller, a humidity of the fluid to the patient based on the sleep state of the patient as taught by Foote for the purpose of improve the patient's feeling of comfort. Similarly, the humidity and delivered air temperature may also be optimized to suit the patient during such conditions (para. 0213).
Regarding Claim 4, Modified Sweeney discloses the method according to claim 1, further comprising controlling a flow rate of the fluid to the patient based on the sleep state of the patient (para 0091-0092).
Regarding Claim 10, Modified Sweeney discloses the method according claim 1,
wherein the current breath flow breath flow parameter comprises respiratory rate and tidal volume (para. 0065 and 0067).
Regarding Claim 12, Sweeney a breathing apparatus to provide fluid flow to a patient (Fig. 1) comprising:
a blower (blower 104; Fig. 1; para. 0038, 0042, 0052, 0054, 0059-0063);
at least one sensor (sensors 114, 115, 116, 117, 131, 132, 134, flow sensors; Fig. 1; para. 0052, 0060, 0075);
and a controller (controller 120; Fig. 1; para. 0054, 0062-0067 ) configured (this limitation is functional) to:
operate the blower (para. 0060) to generate fluid flow to the patient (by the nasal cannula 108; Fig. 1; para. 0042-0043, 0059);
measure using the at least one sensor a current breath flow parameter of the patient using the breathing apparatus (para. 0060-0062; Claim 6 and 10; sensors; Fig. 1: Examiner notes: That Sweeney teaches that the processor is measuring and control the flow rate which is a parameter of flow to the patient);
compare the breath flow parameter to a baseline breath flow parameter (para. 0088; Examiner notes: the flow rate is controlled with predetermined profile),
Sweeny does not disclose specifically that compare the current breath flow parameter to an equivalent baseline breath flow parameter; determine, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state.
However, Ramanan teaches compare the current breath flow parameter to an equivalent baseline breath flow parameter (before 110; Fig, 20) to an equivalent baseline breath flow parameter of the patient (Fig. 20; para. 0163-0318, 0435; the flow rate is controlled with threshold parameters); ; determine, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state (para. 0436-0437; Fig. 11; Fig. 20; Ramanan teaches that after the comparison sleep is detected and then changing the parameter depending if they are sleep or not);
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Sweeney to include comparing, by the controller, the current breath flow parameter to an equivalent baseline flow parameter of the patient measured previously; determining, by the controller, based on a comparison of the current breath flow parameter to the equivalent baseline breath flow parameter, a current breathing parameter that indicates a sleep state of the patient, wherein the sleep state is either an awake state or an asleep state as taught by Ramanan for the purpose therapeutic pressure levels may be automatically adjusted in response to the detection of sleep conditions that may be suitable for treatment (para . 0436-0437).
Modified Sweeney does not specifically teach comparing the current flow parameter of the patient measured previously.
However, Kotmel teaches that it known in the art to compare the current patient’s data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously(para. 0026).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the therapy apparatus and processor of Sweeney to being able to compare the current patients data of different parameters to an equivalent baseline breath flow parameter of the patient measured previously as taught by Kotmel as it is known in the art that comparison are used for the purpose of being able to use the data and allow be able to see what needs to be changed for the patient (para. 0026).
Modified Sweeney does not specifically teach control a humidity of the fluid flow to the patient based on the sleep state of the patient.
However, Foote teaches controlling a humidity of the fluid flow to the patient based on the sleep state of the patient. (para. 0213-0219).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Ramanan to include the ability to control, by the controller, a humidity of the fluid to the patient based on the sleep state of the patient as taught by Foote for the purpose of improve the patient's feeling of comfort. Similarly, the humidity and delivered air temperature may also be optimized to suit the patient during such conditions (para. 0213).
Regarding Claim 21, Modified Sweeney discloses the breathing apparatus according to claim 12, wherein the current breath flow parameter comprises respiratory rate and tidal volume (para. 0065 and 0067).
Claim(s) 2-3, 5-9 11, 13-14, 16, 17-19 and 22 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Sweeney, Ramanan, Kotmel, Foote, as applied to claims 1, 4, 12, and 15, in view of Rapoport et al. (US 20060102179 A1), hereafter as Rapoport.
Regarding Claim 2, Modified Sweeney discloses the method according to claim 1, further comprising providing a first humidity level at a state (claim 1 and 3) and a second humidity level at a second state (Claim 3, 10).
Sweeney does not disclose when the first humidity level is when the person is awake and the second when the person is awake.
However, Rapoport teaches a system that detects when a patient is asleep/awake and adjust the pressure thereon (para. 0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects when a patient is asleep/awake as taught by Rapoport for the purpose of identifying a patient sleeping pattern and knowing when adjust the parameter needed by the patient.
Regarding Claim 3, Modified Sweeney discloses the method according to claim 2, Sweeney further discloses wherein: the first humidity level is higher than the second humidity level; or the first humidity level is lower than the second humidity level (Claim 21; teaches that the two levels are different meaning one has to be either higher or lower).
Regarding Claim 5, Modified Sweeney the method according to claim 4, further comprising providing a first humidity level at a state (claim 1 and 3) and a second humidity level at a second state (Claim 3, 10).
Sweeney does not disclose when the first humidity level is when the person is awake and the second when the person is awake.
However, Rapoport teaches a system that detects when a patient is asleep/awake and adjust the pressure thereon (para. 0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects when a patient is asleep/awake as taught by Rapoport for the purpose of identifying a patient sleeping pattern and knowing when adjust the parameter needed by the patient.
Regarding Claim 6, Modified Sweeney the method according to claim 5, further wherein: the first humidity level and the first flow rate is higher than the second humidity level and the second flow rate; or the first humidity level and the first flow rate is lower than the second humidity level and the second flow rate (Claim 21; teaches that the two levels are different meaning one has to be either higher or lower).
Regarding Claim 7, Modified Sweeney the method according to claim 3, further comprising comparing the current breathing parameter to a former breathing parameter (para. 0062; Sweeney).
Regarding Claim 8, Modified Sweeney the method according to claim 7, wherein controlling the humidity of the fluid to the patient further comprises: ramping up from the first humidity level to the second humidity level or ramping down from the second humidity level to the first humidity level (para. 0075; Examiner notes: the humidity/temperature is ramped up to desired range due to the sensors 132, and 134; Fig. 1).
Regarding Claim 9, Modified Sweeney discloses the method according to claim 6, further comprising comparing the current breathing parameter to a former breathing parameter, wherein controlling the humidity and the flow rate of the fluid to the patient comprises: ramping up from the first humidity level and the first flow rate to the second humidity level and the second flow rate (para. 0075; Examiner notes: the humidity/temperature is ramped up to desired range due to the sensors 132, and 134; Fig. 1).
Regarding Claim 11, Modified Sweeney the method according to claim 1,
Sweeney does not specifically teach wherein a baseline breath flow parameter is measured when the patient is in the sleep state or the awake state.
However, Rapoport teaches a baseline breath flow parameter is measured when the patient is in the sleep state or the awake state (para. 0057-0058; Fig 12: Examiner notes: the processing arrangement 24 may utilize a predetermined algorithm for adjusting the pressure after the state of the patient has been identified).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects a baseline breath flow parameter is measured when the patient is in the sleep state or the awake state as taught by Rapoport for the purpose of adjusting the pressure supplied to the patient based on the state (para. 0056).
Regarding Claim 13, Modified Sweeney the breathing apparatus according to claim 12, wherein the controller (controller 120; Fig. 1; para. 0054, 0062-0067) configured a first humidity level at a state (claim 1 and 3) and a second humidity level at a second state (Claim 3, 10).
Sweeney does not disclose when the first humidity level is when the person is awake and the second when the person is awake.
However, Rapoport teaches a system that detects when a patient is asleep/awake and adjust the pressure thereon (para. 0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects when a patient is asleep/awake as taught by Rapoport for the purpose of identifying a patient sleeping pattern and knowing when adjust the parameter needed by the patient.
Regarding Claim 14, Modified Sweeney the breathing apparatus according to claim 13, wherein: the first humidity level is higher than the second humidity level; or the first humidity level is lower than the second humidity level (Claim 21; teaches that the two levels are different meaning one has to be either higher or lower).
Regarding Claim 15, Modified Sweeney the breathing apparatus according to claim 14, wherein the controller (controller 120; Fig. 1; para. 0054, 0062-0067) is further configured to control a flow rate of the fluid flow to the patient based on the sleep state of the patient (para. 0091-0092).
Regarding Claim 16, Modified Sweeney discloses the breathing apparatus according to claim 15, wherein the controller (controller 120; Fig. 1; para. 0054, 0062-0067) is further configured to provide a first humidity level at a state (claim 1 and 3) and a second humidity level at a second state (Claim 3, 10).
Sweeney does not disclose when the first humidity level is when the person is awake and the second when the person is awake.
However, Rapoport teaches a system that detects when a patient is asleep/awake and adjust the pressure thereon (para. 0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects when a patient is asleep/awake as taught by Rapoport for the purpose of identifying a patient sleeping pattern and knowing when adjust the parameter needed by the patient.
Regarding Claim 17, Modified Sweeney discloses the breathing apparatus according to claim 16, wherein: the first humidity level and the first flow rate is higher than the second humidity level and the second flow rate; or the first humidity level and the first flow rate is lower than the second humidity level and the second flow rate (Claim 21; teaches that the two levels are different meaning one has to be either higher or lower).
Regarding Claim 18, Modified Sweeney discloses the breathing apparatus according claim 14, wherein the controller (controller 120; Fig. 1; para. 0054, 0062-0067) is further configured to compare the current breathing parameter to a former breathing parameter(para. 0062; Sweeney).
Regarding Claim 19, Modified Sweeney the breathing apparatus according to claim 18, wherein controlling (controller 120; Fig. 1; para. 0054, 0062-0067) the humidity and the flow rate of the fluid to the patient comprises: ramping up from the first humidity level to the second humidity level and/or ramping down from the second humidity level to the first humidity level (para. 0075; Examiner notes: the humidity/temperature is ramped up to desired range due to the sensors 132, and 134; Fig. 1).
Regarding Claim 20, Modified Sweeney discloses the breathing apparatus according to claim 16, wherein the controller (controller 120; Fig. 1; para. 0054, 0062-0067) is further configured to compare the current breathing parameter to a former breathing parameter and wherein controlling the humidity and the flow rate of the fluid to the patient comprises: ramping up from the first humidity level and the first flow rate to the second humidity level and the second flow rate (para. 0075; Examiner notes: the humidity/temperature is ramped up to desired range due to the sensors 132, and 134; Fig. 1).
Regarding Claim 22, Modified Sweeney discloses the breathing apparatus according to claim 12, Sweeney does not specifically teach wherein a equivalent baseline breath flow parameter is measured when the patient is in the sleep state or the awake state.
However, Rapoport teaches a baseline breath flow parameter is measured when the patient is in the sleep state or the awake state (para. 0057-0058; Fig 12: Examiner notes: the processing arrangement 24 may utilize a predetermined algorithm for adjusting the pressure after the state of the patient has been identified).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Sweeney to include a system that detects a baseline breath flow parameter is measured when the patient is in the sleep state or the awake state as taught by Rapoport for the purpose of adjusting the pressure supplied to the patient based on the state (para. 0056).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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