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 Objections
Claim 15 is objected to because of the following informalities: line 2 appears to have a typographical error in “a control a control system comprising…”. The limitation should be amended to remove the redundant words as follows: “.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-7, 9, 15-17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ansay et al. (US 2017/0296766 A1), hereafter Ansay.
Regarding Claim 1, Ansay discloses a method for analyzing user interface leakage (fig. 3, abstract), comprising: receiving, at a computing device (fig. 2, 10 [0020]), motion data associated with orientation of a user interface ([0018-0019] data associated with positioning and movement of the patient’s head and mask is acquired) worn by a user during a sleep session (fig. 1, user interface 3 is worn during sleep [0016]); analyzing the motion data to identify leak data (fig. 3, 21, [0027]), the leak data indicative of at least one unintentional leak from the user interface (fig. 3, 20 [0027]); and generating a notification based at least in part on the leak data ([0034] a report is generated on leakage signals), the notification indicative of the presence of the at least one unintentional leak ([0034]).
Regarding Claim 6, Ansay discloses a method of claim 1, further comprising determining, based at least in part on the leak data, a corrective action for reducing the at least one unintentional leak (fig. 3, 25 [0031] the amount of gas supplied to the user is modified to account for the leak), wherein the notification includes an indication to perform the corrective action ([0034] actions to be considered are suggested to medical staff).
Regarding Claim 7, Ansay discloses a method of claim 6, wherein the corrective action includes i) an adjustment of the user interface; ii) an adjustment of one or more straps of the user interface; iii) a replacement of a replaceable component of the user interface with a new replaceable component; iv) a replacement of a select component of the user interface with an alternate style of the select component; v) a replacement of the user interface with an alternate type of the user interface; vi) a replacement of the user interface with an alternate size of the user interface; vii) a grooming action associated with a face of the user; viii) an adjustment of one or more parameters of a respiratory therapy device fluidly coupled to the user interface (fig. 3, 25 [0031] the amount of gas delivered by the therapy device is adjusted in response to detecting a leak caused by patient motion); or ix) any combination of i-viii (examiner’s note: the remaining limitations are treated as optional).
Regarding Claim 9, Ansay discloses a method of claim 1, wherein analyzing the motion data to identify the leak data includes identifying the at least one unintentional leak when the motion data deviates from a baseline signal by at least a threshold value, wherein the baseline signal is based at least in part on a portion of historical motion data assumed to be associated with low leakage or no leakage, the historical motion data associated with a prior sleep session ([0029] the movement data may represent a stereotyped mouth movement, which indicates the presence of apnea [0028] and is understood to be data derived from prior sleep data in order to have been considered stereotyped; if the movement data deviates from a predetermined threshold, the gas supply is modified to compensate for the unintended leak).
Regarding Claim 15, Ansay discloses a system comprising: a control system (fig. 2, device 5 is a control system [0019]) comprising one or more processors (fig. 2, 10 [0020]); and a memory having stored thereon machine readable instructions (fig. 2, microprocessor 20 is understood to have a memory with machine readable instructions in order to be able to process the signals [0020-0021]); wherein the control system is coupled to the memory (fig. 2 [0020]), and the method of claim 1 is implemented when the machine executable instructions in the memory are executed by at least one of the one or more processors of the control system ([0021]).
Regarding Claim 16, Ansay discloses a computer program product embodied on a non-transitory computer readable medium and comprising instructions which, when executed by a computer, cause the computer to carry out the method of claim 1 ([0020] microprocessor 20 is understood to include the instructions necessary to perform the steps of claim 1).
Regarding Claim 17, Ansay discloses a system (fig. 1, abstract) comprising: one or more motion sensors (fig. 2, 8 [0019]) coupled to a user interface (fig. 1, 3, [0016]) worn by a user during a sleep session ([0016]), the user interface fluidly coupled to a respiratory therapy device for providing a flow of air from the respiratory therapy device to a respiratory system of the user (fig. 3 [0016]); one or more processors (fig. 2, 10 [0020]); and a non-transitory computer-readable storage medium containing instructions which, when executed on the one or more processors, cause the one or more processors to perform operations ([0020-0021] the processor 10 is understood to include instructions to analyzing the signals received) including: receiving, at a computing device, motion data associated with orientation of the user interface ([0018-0019]); analyzing the motion data to identify leak data (fig. 3 [0030]), the leak data indicative of at least one unintentional leak from the user interface ([0030]); and generating a notification based at least in part on the leak data, the notification indicative of the presence of the at least one unintentional leak ([0034] a report is generated to include the leak data).
Regarding Claim 21, Ansay discloses a system of claim 17, wherein analyzing the motion data to identify the leak data includes identifying the at least one unintentional leak when the motion data deviates from a baseline signal by at least a threshold value, wherein the baseline signal is based at least in part on (i) a portion of historical motion data assumed to be associated with low leakage or no leakage, the historical motion data associated with a prior sleep session ([0029] the movement data may represent a stereotyped mouth movement, which indicates the presence of apnea [0028] and is understood to be data derived from prior sleep data in order to have been considered stereotyped; if the movement data deviates from a predetermined threshold, the gas supply is modified to compensate for the unintended leak); (ii) an extracted first portion of the motion data assumed to be associated with low leakage or no leakage; or (iii) both (i) and (ii) (examiner’s note: (ii) and (iii) are considered optional limitations).
In an alternative rejection, Claims 1-3, 6-7, and 15-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lawrenson (US 10471226 B2), hereafter Lawrenson.
Regarding Claim 1, Lawrenson discloses a method for analyzing user interface leakage (col. 3 line 66-col. 4 line 5), comprising: receiving, at a computing device (fig. 1B control unit 34, col. 8 line 47), motion data (fig. 2, displacement sensor 32 sends position information to detection unit 30, col. 9 lines 6-10) associated with orientation of a user interface (fig. 2, 10, col. 9 lines 13-14) worn by a user during a sleep session (col. 9 lines 42-45); analyzing the motion data to identify leak data (col. 9 lines 18-21, the control unit monitors for displacement changes in the mask which would result in a leak), the leak data indicative of at least one unintentional leak from the user interface (the displacement of the mask during sleep would result in an unintended leak); and generating a notification based at least in part on the leak data, the notification indicative of the presence of the at least one unintentional leak (col. 9 lines 21-23, the displacement sensor sends a notification in the form of a signal to the control unit).
Regarding Claim 2, Lawrenson discloses a method of claim 1, wherein receiving the motion data includes receiving the motion data from one or more accelerometers coupled to the user interface (col. 5 lines 32-35, the displacement sensor can be an accelerometer).
Regarding Claim 3, Lawrenson discloses a method of claim 2, wherein the one or more accelerometers includes i) an accelerometer directly coupled to the user interface (col. 5 lines 32-35, the accelerometer is arranged on or in the sealing portion of the patient interface); ii) an accelerometer coupled to a connector coupled to the user interface; iii) an accelerometer coupled to a conduit coupled to the user interface; or iv) any combination of i-iii (examiner’s note: the remaining limitations are treated as optional and not required by the claim).
Regarding Claim 6, Lawrenson discloses a method of claim 1, further comprising determining, based at least in part on the leak data, a corrective action for reducing the at least one unintentional leak, wherein the notification includes an indication to perform the corrective action (col. 9 lines 21-26, the control unit actuates one or more actuators to adjust the position of the user interface).
Regarding Claim 7, Lawrenson discloses a method of claim 6, wherein the corrective action includes i) an adjustment of the user interface (col. 9 lines 21-26, the control units actuates actuators to adjust the position of the user interface) ii) an adjustment of one or more straps of the user interface; iii) a replacement of a replaceable component of the user interface with a new replaceable component; iv) a replacement of a select component of the user interface with an alternate style of the select component; v) a replacement of the user interface with an alternate type of the user interface; vi) a replacement of the user interface with an alternate size of the user interface; vii) a grooming action associated with a face of the user; viii) an adjustment of one or more parameters of a respiratory therapy device fluidly coupled to the user interface; or ix) any combination of i-viii (examiner’s note: the remaining limitations are treated as optional and not required by the claim).
Regarding Claim 15, Lawrenson discloses a system (fig. 2, col. 8 lines 51-53) comprising: a control a control system comprising one or more processors (fig. 2, 35, col. 8 line 47, is understood to have at least one processor for signal processing, col. 10 line 6); and a memory having stored thereon machine readable instructions (col. 9 lines 26-31, the control unit 34 is understood to have a memory having machine readable instructions stored in order to perform the calculations needed to then readjust the patient interface); wherein the control system is coupled to the memory (the memory is understood to be a component of the control system), and the method of claim 1 is implemented when the machine executable instructions in the memory are executed by at least one of the one or more processors of the control system (see claim 1 above).
Regarding Claim 16, Lawrenson discloses a computer program product embodied on a non-transitory computer readable medium and comprising instructions (understood to be a portion of the control unit in order for the control unit to perform the functions of calculating a magnitude and force of direction to be applied by the actuators, col. 9 lines 20-38) which, when executed by a computer, cause the computer to carry out the method of claim 1 (see claim 1 above).
Regarding Claim 17, Lawrenson discloses a system comprising: one or more motion sensors (fig. 2, 32, col. 8 line 53) coupled to a user interface (fig. 2, 32 is shown schematically coupled to input interface 40, which is arranged on the user interface 10, col. 9 lines 13-14) worn by a user during a sleep session (col. 9 lines 42-45), the user interface fluidly coupled to a respiratory therapy device for providing a flow of air from the respiratory therapy device to a respiratory system of the user (col. 8 lines 31-35); one or more processors (col. 9 lines 31-38, control unit 34 may have a processing unit); and a non-transitory computer-readable storage medium containing instructions which, when executed on the one or more processors, cause the one or more processors to perform operations (col. 9 lines 26-31, the control unit 34 is understood to have storage which contains instructions to perform the described operations of calculating a magnitude and direction of force required to be applied by actuators in response to receiving displacement sensor signals) including: receiving, at a computing device, motion data associated with orientation of the user interface (col. 9 lines 21-22); analyzing the motion data to identify leak data (col. 9 lines 18-21, the control unit monitors for displacement changes in the mask which would result in a leak), the leak data indicative of at least one unintentional leak from the user interface (the displacement of the mask during sleep would result in an unintended leak); and generating a notification based at least in part on the leak data, the notification indicative of the presence of the at least one unintentional leak (col. 9 lines 21-23, the displacement sensor sends a notification in the form of a signal to the control unit).
Regarding Claim 18, Lawrenson discloses a system of claim 17, wherein the one or more motion sensors includes one or more accelerometers (col. 5 lines 32-35, the displacement sensor can be an accelerometer), wherein receiving the motion data includes receiving the motion data from the one or more accelerometers (col. 9 lines 21-26), and wherein the one or more accelerometers includes i) an accelerometer directly coupled to the user interface (col. 5 lines 32-35, the accelerometer is arranged on or in the sealing portion of the patient interface); ii) an accelerometer coupled to a connector coupled to the user interface; iii) an accelerometer coupled to a conduit coupled to the user interface; or iv) any combination of i-iii (examiner’s note: the remaining limitations are treated as optional and not required by the claim).
Claim Rejections - 35 USC § 103
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 2-3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ansay in view of Seddon et al. (US 2020/0276367 A1), hereafter Seddon.
Regarding Claim 2, Ansay discloses a method of claim 1, but is silent on wherein receiving the motion data includes receiving the motion data from one or more accelerometers coupled to the user interface ([0019] uses a movement measuring device incorporated by reference to EP 1716387, which discloses a distance measuring device).
Seddon teaches the use of an accelerometer (fig. 2, 144 [0053]) to monitor motion of a pressure device to determine whether motion is occurring, and provide a leak determination manager (fig. 2, 154) with information on motion to adjust parameters for one or more leak alarms ([0059]). The leak determination manager is used to provide an alarm to the user if a leak occurs ([0065]) and increases an alarm threshold if motion is occurring ([0083]) to avoid excess alarming that the user may ignore ([0084]). Seddon discloses a user interface (fig. 4B, 312 [0045] negative pressure wound therapy (NPWT) device) that may be worn while sleeping ([0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace Ansay’s motion sensor with Seddon’s accelerometer, since Seddon teaches that accelerometers can be used to detect motion in pressure devices in relation to leak detection ([0048]).
Regarding Claim 3, Ansay as modified discloses a method of claim 2, wherein the one or more accelerometers includes i) an accelerometer directly coupled to the user interface (as modified by Seddon, the accelerometer is positioned in the user interface portion of the device, Seddon fig. 1, 100 [0063]); ii) an accelerometer coupled to a connector coupled to the user interface; iii) an accelerometer coupled to a conduit coupled to the user interface; or iv) any combination of i-iii (examiner’s note: the remaining limitations are treated as optional).
Regarding Claim 18, Ansay discloses a system of claim 17, but is silent on wherein the one or more motion sensors includes one or more accelerometers ([0019] uses a movement measuring device incorporated by reference to EP 1716387, which discloses a distance measuring device), wherein receiving the motion data includes receiving the motion data from the one or more accelerometers, and wherein the one or more accelerometers includes i) an accelerometer directly coupled to the user interface; ii) an accelerometer coupled to a connector coupled to the user interface; iii) an accelerometer coupled to a conduit coupled to the user interface; or iv) any combination of i-iii.
Seddon teaches the use of an accelerometer (fig. 2, 144 [0053]) to monitor motion of a pressure device to determine whether motion is occurring, and provide a leak determination manager (fig. 2, 154) with information on motion to adjust parameters for one or more leak alarms ([0059]). The leak determination manager is used to provide an alarm to the user if a leak occurs ([0065]) and increases an alarm threshold if motion is occurring ([0083]) to avoid excess alarming that the user may ignore ([0084]). Seddon discloses a user interface (fig. 4B, 312 [0045] negative pressure wound therapy (NPWT) device) that may be worn while sleeping ([0083]). The accelerometer is positioned in the user interface portion of the device (fig. 1, 100 [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace Ansay’s motion sensor with Seddon’s accelerometer, since Seddon teaches that accelerometers can be used to detect motion in pressure devices in relation to leak detection ([0048]), as well as to place the accelerometer on the user interface, in order to detect motion in the user interface (Seddon [0063]).
Claim 8 is rejected under 35 U.S.C. 103 as unpatentable over Ansay in view of Byron et al. (US 2015/0301521 A1), hereafter Byron.
Regarding Claim 8, Ansay discloses a method of claim 1, wherein analyzing the motion data to identify the leak data includes: identifying the at least one unintentional leak when the motion data deviates from the baseline signal by at least a threshold value ([0029] a threshold is established to determine if a movement measurement signal variation exceeds a value indicating a weak leak).
Ansay does not explicitly disclose extracting a first portion of the motion data assumed to be associated with low leakage or no leakage; generating a baseline signal based at least in part on the first portion of the motion data.
However, Byron teaches calibrating an accelerometer by detecting a zero level of the accelerometer ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to extract a first portion of the motion data assumed to be associated with low leakage or no leakage, in the form calibrating as taught by Byron, in order to remove the 1G acceleration of gravity from the accelerometer signal (Byron [0105]). It then would have been obvious to make the baseline the calibrated motion data signal to remove acceleration due to gravity in Ansay’s device.
Claims 13 and 24 are rejected under 35 U.S.C. 103 as unpatentable over Ansay in view of Hong et al. (US 2005/0021270 A1), hereafter Hong.
Regarding 13, Ansay discloses a method of claim 1, wherein analyzing the motion data includes: determining average motion data from the motion data ([0028] stereotyped mouth movement); identifying a deviation in orientation of the user interface from the average orientation based at least in part on the motion data ([0029]); and identifying the at least one unintentional leak based at least in part on the identified deviation ([0029]).
Ansay does not disclose the average motion data indicative of an average orientation of the user interface with respect to the face of the user, and the deviation being greater than a threshold value (a deviation greater than a threshold is disclosed as an alternative means of detection that the stereotyped mouth movement).
Hong teaches that using a movement average for an accelerometer acts as a low-pass filter to remove an irregular constant related to a constant which changes each time power is applied to the sensor, as well as to account for gravitational acceleration (see [0050] and [0046]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ansay’s method to determine average motion data indicative of an average orientation of the user interface with respect to the face of the user, since Hong teaches that filtering can be completed using an average value. It additionally would have been obvious to additionally apply Ansay’s threshold to the averaged motion data deviation, in order to distinguish between motion signals that would only cause a temporary, weak leakage (Ansay [0029]).
Regarding Claim 24, Ansay discloses a system of claim 17, wherein analyzing the motion data includes: determining average motion data from the motion data ([0028] stereotyped mouth movement), identifying a deviation in orientation of the user interface from the average orientation based at least in part on the motion data ([0029]); and identifying the at least one unintentional leak based at least in part on the identified deviation ([0029]).
Ansay does not disclose the average motion data indicative of an average orientation of the user interface with respect to the face of the user, and the deviation being greater than a threshold value (a deviation greater than a threshold is disclosed as an alternative means of detection that the stereotyped mouth movement).
Hong teaches that using a movement average for an accelerometer acts as a low-pass filter to remove an irregular constant related to a constant which changes each time power is applied to the sensor, as well as to account for gravitational acceleration (see [0050] and [0046]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ansay’s method to determine average motion data indicative of an average orientation of the user interface with respect to the face of the user, since Hong teaches that filtering can be completed using an average value. It additionally would have been obvious to additionally apply Ansay’s threshold to the averaged motion data deviation, in order to distinguish between motion signals that would only cause a temporary, weak leakage (Ansay [0029]).
Claims 4-5 and 19-20 are rejected under 35 U.S.C. 103 as unpatentable over Lawrenson.
Regarding Claim 4, Lawrenson discloses a method of claim 2, but is silent on further comprising receiving additional sensor data indicative of relative movement of the user interface with respect to the one or more accelerometers during the sleep session, wherein analyzing the motion data to identify the leak data is based at least in part on the additional sensor data.
However, Lawrenson does disclose an alternative sensor for detecting motion of the user interface with respect to the user (col. 8 lines 57-61, the displacement sensor may be an optical sensor or an accelerometer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to additionally include an optical sensor to detect movement of the user interface with respect to the accelerometer, wherein analyzing the leak data is based at least in part on the additional sensor, since it would have been obvious to include an additional sensor for the benefit of redundancy in the event of the failure of the primary accelerometer sensor, and leaking can affect the efficacy of the respiratory therapy (Lawrenson col. 4 lines 6-8).
Regarding Claim 5, Lawrenson as modified discloses a method of claim 4, wherein the additional sensor data is light sensor data (col. 8 lines 57-58) of an encoded visual element associated with the user interface (col. 10 lines 48-53), wherein the light sensor data is indicative of the orientation of the user interface (col. 10 lines 53-57).
Regarding Claim 19, Lawrenson discloses a system of claim 17, but is silent on wherein the operations further include: receiving additional sensor data indicative of relative movement of the user interface with respect to the one or more accelerometers during the sleep session, wherein analyzing the motion data to identify the leak data is based at least in part on the additional sensor data.
However, Lawrenson does disclose an alternative sensor for detecting motion of the user interface with respect to the user (col. 8 lines 57-61, the displacement sensor may be an optical sensor or an accelerometer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to additionally include an optical sensor to detect movement of the user interface with respect to the accelerometer, wherein analyzing the leak data is based at least in part on the additional sensor, since it would have been obvious to include an additional sensor for the benefit of redundancy in the event of the failure of the primary accelerometer sensor, and leaking can affect the efficacy of the respiratory therapy (Lawrenson col. 4 lines 6-8).
Regarding Claim 20, Lawrenson as modified discloses a system of claim 19, wherein the additional sensor data is light sensor data (col. 8 lines 57-58) of an encoded visual element associated with the user interface (col. 10 lines 48-53), wherein the light sensor data is indicative of the orientation of the user interface (col. 10 lines 53-57).
Allowable Subject Matter
Claims 10-12, 14, 22-23, and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 10, both Ansay and Lawrenson disclose a method of claim 1, but are silent on wherein analyzing the motion data includes: extracting frequency-domain motion data from the motion data, the frequency-domain motion data including (i) frequency-domain linear acceleration data; (ii) frequency-domain rotational acceleration data; (iii) or (i) and (ii); and identifying the at least one unintentional leak based at least in part on the frequency-domain motion data.
There does not appear to be prior art of record which discloses, alone or in combination, extracting either frequency-domain linear acceleration and/or rotational acceleration data from the motion data in relation to an orientation of a user interface.
Thus, claim 10 would be allowed over the prior art. Claims 11-12 would be allowed as depending on claim 10.
Claims 22-23 are allowed for the same reasons as claim 10.
Regarding Claim 14, Ansay and Lawrenson each disclose a method of claim 1, but are silent on wherein analyzing the motion data to identify leak data includes: extracting a plurality of motion data features from the motion data, including at least i) a user interface orientation displacement feature (which has been interpreted to mean a value indicative of a shift in the orientation of the user interface according to original specification [0170]), and ii) a frequency-domain motion deviation feature (which has been interpreted to mean “a value indicative of a difference in intensity with which one or more frequencies are represented in the received motion data and a baseline” according to specification [0170]); identifying the at least one unintentional leak based at least in part on the user interface orientation displacement feature and the frequency-domain motion deviation feature.
There does not appear to be prior art of record that includes all of the limitations of parent claim 1 in addition to the above limitations. Thus, claim 14 would be allowed over the prior art.
Claim 25 would be allowed for the same reasons as claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2021/0316175 A1 [0035] uses a user’s motion and orientation data using an accelerometer to correlate with leakage.
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/SARA K TOICH/ Examiner, Art Unit 3785
/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785
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