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 .
Response to Arguments
Applicant’s arguments, filed December 16, 2025, with respect to the Information disclosure statement, the specification objection, the 35 U.S.C. 112(b) rejection, and the rejection(s) of claim 1 under 35 U.S.C. 102(a)(1) and claims 2-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the previous objection(s) and rejection(s) have been withdrawn. However, upon further search and consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification lacks an adequate written description for the following claim limitations:
Regarding claim 20, the term “programmed to never determine a current posture of a patient” is unsupported. Para [0068-0069] of the specification states that in some alternative examples of the invention, the posture module can be configured or programmed to not detect current posture of a patient, but can instead detect gross change in posture. Furthermore, the posture module in some embodiments does not detect or determine posture, but instead tracks the gravity vector over time.
In the case of not detecting posture, it is unclear how the system can be configured to never determining a current posture of a patient, since the monitored gravity vector is associated patient information related to posture and provides therapy based on the gravity vector associated with the patient’s posture being in a predetermined range. Furthermore, there is no disclosure of “never” determining a current posture of the patient.
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 2, 4-5, 7, and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0160282 A1 to Dieken et al. ( hereinafter “Dieken”) in view of US 2013/0289652 A1 to Skelton et al. (hereinafter “Skelton”) and US 7,471,290 B2 to Wang et al. (hereinafter “Wang”).
Regarding claim 2, Dieken teaches:
A care/therapy system (para 0044, lines 1-6) comprising:
an implantable sensor configured for implantation into a patient (para 0017 and para 0037) and to generate information indicative of a gravity vector (para 0111);
an implantable medical device/implantable pulse generator for delivering stimulation therapy to the patient (para 0051 and claim 12),
a monitoring module/posture information engine for monitoring the gravity vector over time (para 0111-0113), a therapy module/stimulation manager (see fig. 17, para 0199-0200) for prompting operation of the IMD in delivering stimulation therapy (see para 0141, para 0198, and para 0200-0201), but does not explicitly disclose wherein
the therapy module is programmed to perform at least one therapy regimen in which stimulation therapy is delivered to the patient at a predetermined level.
However, Skelton teaches wherein the therapy module is programmed to perform at least one therapy regimen in which stimulation therapy is delivered to the patient based on a predetermined or previously stored therapy parameter/predetermined level) (fig. 4, para 0050, lines 1-9, para 0066, lines 1-9), but does not disclose wherein the system is programmed to, during performance of the at least one therapy regimen:
compare the monitored gravity vector with a threshold, and
based upon the comparison, prompt performance of an operational mode in which the stimulation therapy delivered to the patient is ramped down from the predetermined level to a ramped down level.
However, Wang teaches methods and systems for detecting a posture of a patient, and utilizing the posture to control medical devices for the detection and treatment of medical disorders (abstract). The system (figs. 1-3) teaches comparing the monitored gravity vector (G vector) with a threshold,
and,
based upon the comparison, prompt performance of an operational mode in which the stimulation therapy delivered to the patient is ramped down from the predetermined level to a ramped down level (see fig. 10, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”, col. 11, lines 66-67, col. 12, lines 1-12 and 39-49, col. 13: “The lead system 1110 is used to detect electrical signals produced by the heart 1190 and to provide electrical energy to the heart 1190 under certain predetermined conditions to treat cardiac arrhythmias.”, and col. 16, lines 19-34).
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 teachings of Dieken with the teachings of Skelton and Wang to arrive at the claimed invention. Such modification would improve the system by ensuring the stimulation therapy provides accurate stimulation treatment to the patient, ultimately preventing undesirable side-effects while providing more beneficial stimulation treatment.
Regarding claim 4, Dieken as modified teaches:
The care system of claim 2, wherein the system comprises calculating a gravity vector and an acceleration vector to determine the posture of a patient (para 0111 and para 0193), and wherein detection of a sleep and/or activity is detected when the magnitude of the measured acceleration meets or exceeds a threshold (para 0113), but does not explicitly disclose wherein the system is programmed to prompt performance of the operational mode based, at least in part, upon a change in the monitored gravity vector that exceeds a threshold magnitude.
However, in another example of the invention, Dieken discloses wherein the system is programmed to prompt performance of the operational mode (through entering an inversion detection state and adjusting stimulation) based upon a change in posture and/or motion artifact exceeding a threshold (para 0111, para 0198, para 0217, and para 0223).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dieken to utilize the gravity vector as opposed to the acceleration vector in order to arrive at the claimed invention. Doing so would improve the system by ensuring the patient is in the appropriate position to receive proper sleep therapy stimulation treatment.
Regarding claim 5, Dieken as modified teaches the care system of claim 2 containing a gravity vector (see para 0111 and para 0193), but does not disclose wherein the system is programmed to prompt performance of the operational mode based, at least in part, upon the monitored gravity vector falling within a predetermined range.
However, Wang teaches methods and systems for detecting a posture of a patient, and utilizing the posture to control medical devices for the detection and treatment of medical disorders (abstract). The system (figs. 1-3) teaches comparing the monitored gravity vector (G vector) with a predetermined range/threshold region(s) in order to determine the patient’s position, and based on this position, prompt performance (by providing stimulation therapy/pacing to the patient - see figs. 8A-8C, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”, col. 11, 24-50 and 66-67, col. 12, lines 1-12 and 39-49, col. 13: “The lead system 1110 is used to detect electrical signals produced by the heart 1190 and to provide electrical energy to the heart 1190 under certain predetermined conditions to treat cardiac arrhythmias.”, and col. 16, lines 19-34).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dieken with the teachings of Wang to arrive at the claimed invention. Doing so would improve the system by ensuring the patient is in the appropriate position to receive proper sleep therapy stimulation treatment. Furthermore, utilizing the stimulation range of Wang would improve the system by ensuring the patient’s stimulation is automatically adjusted within a safe stimulation range.
Regarding claim 7, Dieken as modified teaches the care system of claim 2 containing a gravity vector (para 0111 and para 0193), but does not disclose wherein the operational mode further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level to the predetermined level based, at least in part, upon a comparison of the monitored gravity vector with a predetermined range.
However, Wang teaches wherein the operation of the device further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level (adjusted based on changes in a patient’s posture) based at least in part, upon a comparison of the monitored gravity vector with a predetermined range (see fig. 10, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”), but does not explicitly disclose wherein the operational mode further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level to the predetermined level.
However, Skelton teaches wherein the operational mode further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level (or adjusted) based on a previously stored therapy parameter/predetermined level based upon a comparison of a monitored acceleration vector with a predetermined range (which is determined by the clinician) of a detected accelerometer output (para 0066-0067).
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 system of Dieken to utilize the system of Wang and the predetermined parameters of Skelton to arrive at the claimed invention. Doing so would improve the system by ensuring the patient is in the appropriate position to receive proper sleep therapy stimulation treatment.
Regarding claim 9, Dieken as modified teaches the care system of claim 2, wherein the system is programmed to automatically initiate the operational mode without referencing a determined posture of the patient (see para 0187, para 0216, and claim 10). Changes in the number of apnea-hypopnea events can cause automatic changes to the stimulation therapy/initiate the operational mode.
Regarding claim 10, Dieken as modified teaches the care system of claim 2 containing a gravity vector (see para 0111 and para 0193), and wherein the system is configured to automatically adjust stimulation/initiate the operational mode based on a patient’s body position using the magnitude of acceleration from an acceleration sensor (para 0113, 0195-0196, and para 0198), but does not explicitly disclose wherein the system is programmed to automatically initiate the operational mode based solely on the monitored gravity vector.
However, Wang teaches wherein the system is programmed to automatically initiate the operational mode (provide pacing therapy) based solely on the monitored gravity vector/G vector(used to determine the patient’s posture and to provide stimulation therapy to the patient – see figs. 8A-8C, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”, and col. 10, lines 51-67).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dieken with the teachings of Wang to arrive at the claimed invention. Doing so would improve the system by ensuring the patient is in the appropriate position to receive proper sleep therapy stimulation treatment.
Regarding claim 11, Dieken as modified teaches the care system of claim 2, wherein the system is programmed to prompt performance of the operational mode (enabling/disabling stimulation) further based upon detected motion of the patient (para 0222).
Regarding claim 12, Dieken teaches:
A care/therapy system (para 0044, lines 1-6) comprising:
an implantable sensor configured for implantation into a patient (para 0017 and para 0037) and to generate information indicative of a gravity vector (para 0111);
an implantable medical device/implantable pulse generator for delivering stimulation therapy to the patient (para 0051 and claim 12),
a monitoring module/posture information engine for monitoring the gravity vector over time (para 0111-0113), a therapy module/stimulation manager (see fig. 17, para 0199-0200) for prompting operation of the IMD in delivering stimulation therapy (see para 0141, para 0198, and para 0200-0201), but does not explicitly disclose wherein
the therapy module is programmed to perform at least one therapy regimen in which stimulation therapy is delivered to the patient at a predetermined level.
However, Skelton teaches wherein the therapy module is programmed to perform at least one therapy regimen in which stimulation therapy is delivered to the patient based on a predetermined or previously stored therapy parameter/predetermined level) (fig. 4, para 0050, lines 1-9, para 0066, lines 1-9), and wherein the posture is determined by detecting a gravity vector (see para 0111), but does not explicitly disclose
comparing the monitored gravity vector with a threshold, and
based upon the comparison, prompt performance of the at least one therapy regimen.
However, Wang teaches methods and systems for detecting a posture of a patient, and utilizing the posture to control medical devices for the detection and treatment of medical disorders (abstract). The system (figs. 1-3) teaches comparing the monitored gravity vector (G vector) with a threshold,
and,
based upon the comparison, prompt performance of at least one therapy regimen/providing therapy or stimulation to the patient (see figs. 8A-8C, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”, col. 11, lines 24-50, col. 12, lines 39-49, col. 13: “The lead system 1110 is used to detect electrical signals produced by the heart 1190 and to provide electrical energy to the heart 1190 under certain predetermined conditions to treat cardiac arrhythmias.”, and col. 16, lines 19-34).
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 teachings of Dieken with the teachings of Skelton and Wang to arrive at the claimed invention. Such modification would improve the system by ensuring the stimulation therapy provides accurate stimulation treatment to the patient, ultimately preventing undesirable side-effects while providing more beneficial stimulation treatment.
Regarding claim 14, Dieken as modified teaches the care system of claim 12, wherein the prompted performance of the at least one therapy regimen includes ramping the stimulation therapy delivered to the patient from zero stimulation to the predetermined level (or clinician-configurable limits) (para 0123, lines 1-14 and para 0216).
Regarding claim 15, Dieken as modified teaches the care system of claim 12, wherein the system is programmed to prompt performance (operating and/or adjusting stimulation) of the at least one therapy regimen further based upon detected motion of the patient (para 0198, and para 0217).
Regarding claim 16, Dieken as modified teaches the care system of claim 15, wherein the system is programmed to prompt performance of the at least one therapy regimen (adjusting stimulation for each different posture position) based upon the detected motion of the patient indicating no or minimal movements (small movements relating to different posture positions) over a defined time period/during a treatment period (para 0193, lines 1-5 and para 0217).
Regarding claim 17, Dieken as modified teaches the care system of claim 15, wherein the system is programmed to assign at least one gravity vector orientation relative to the implantable sensor/accelerometer (para 0193: “manual parameter 1414 can be used to perform calibration, such as via measuring a gravity vector in at least two known patient orientations, of the accelerometer orientation.”) with at least one operational mode (calibration function used to compensate for an unknown orientation of the accelerometer located in the patient’s body – see para 0193).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dieken in view of Skelton and Wang, and further in view of US 2008/0021504 A1 to McCabe et al. (hereinafter “McCabe”).
Regarding claim 6, Dieken as modified teaches the care system of claim 2, but does not disclose wherein the ramped down level (adjusting) is a pause in delivery of any stimulation therapy.
However, McCabe teaches a method for adjusting and/or titrating neurostimulation based detected cardiac activity (abstract). The system (fig. 4) contains a stimulation control circuit that is configured to withhold/pause or adjust the stimulation therapy when a cardiac arrythmia is occurring (abstract and para 0059).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dieken with the teachings of McCabe to arrive at the claimed invention, since such modification would improve the system by preventing strong stimulation from being applied to the patient when in a light sleep state, ensuring that the stronger stimulation/ramped up stimulation is appropriately applied to the patient during a heavily sedated state (in which a sleep breathing episode is likely to occur).
Claims 3, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken in view of Skelton and Wang, and further in view of US 2018/0064372 A1 to Van Beest.
Regarding claim 3, Dieken as modified teaches the care system of claim 2 containing a gravity vector (see para 0111 and para 0193), wherein the system is programmed to prompt performance of the operational mode (providing stimulation and/or adjusting stimulation) (para 0217), and wherein detection of a sleep and/or activity is detected when the magnitude of the measured acceleration meets or exceeds a threshold (para 0113), but does not explicitly disclose prompting performance of the at least one therapy regimen when the monitored gravity vector has maintained a designated relationship with respect to the threshold for a predetermined period of time.
However, Van Beest teaches a method and apparatus for sleep posture correction (see title and abstract, lines 1-4). The system (fig. 1) is configured to alert a patient of improper sleep posture (through the use of an alarm or stimulation signal) by increasing the number of alarms from a lower limit at the beginning of use to an upper limit when the patient’s sleep posture is out of a predetermined body posture range after a predetermined period of time (abstract, para 0023, 0028, 0030, 0048, 0065, 0090, 0092, 0139, and para 0160).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dieken with the method of Van Beest to arrive at the claimed invention. Such modification would improve the system by ensuring stimulation is applied to the patient during the appropriate time (during a deep sleep state), ensuring that the stronger stimulation/ramped up stimulation is appropriately applied to the patient during a heavily sedated state in which a sleep breathing episode is likely to occur.
Regarding claim 8, Dieken as modified teaches the care system of claim 7 containing a gravity vector (see para 0111 and para 0193) wherein the system is programmed to initiate ramping up of the stimulation therapy delivered to the patient from the ramped down level (or adjusted – see para 0195 and para 0196), but does not disclose wherein the system is programmed to initiate ramping up of the stimulation therapy delivered to the patient from the ramped down level to the predetermined level once the monitored gravity vector has remained within the predetermined range for a predetermined period of time.
However, Skelton teaches wherein the operational mode further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level (or adjusted) based on a previously stored therapy parameter/predetermined level based upon a comparison of a monitored acceleration vector with a predetermined range of a detected accelerometer output (which is determined by the clinician) (col. 14, lines 66-67 and col. 15, lines 1-19). Skelton does not disclose adjusting the ramped-down level to a predetermined level once the monitored vector has remained within the predetermined range for a predetermined period of time.
However, Van Beest teaches a method and apparatus for sleep posture correction (see title and abstract, lines 1-4). The system (fig. 1) is configured to alert a patient of improper sleep posture (through the use of an alarm or stimulation signal) by increasing the number of alarms from a lower limit at the beginning of use to an upper limit when the patient’s sleep posture is out of a predetermined body posture range after a predetermined period of time (abstract, para 0023, 0028, 0030, 0048, 0065, 0090, 0092, 0139, and para 0160).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dieken with the method of Van Beest to arrive at the claimed invention. Such modification would improve the system by ensuring stimulation is applied to the patient during the appropriate time (during a deep sleep state), ensuring that the stronger stimulation/ramped up stimulation is appropriately applied to the patient during a heavily sedated state in which a sleep breathing episode is likely to occur.
Regarding claim 13, Dieken as modified teaches the care system of claim 12 containing a gravity vector (see para 0111 and para 0193), wherein the system is programmed to prompt performance of the at least one therapy regimen (providing stimulation and/or adjusting stimulation – see para 0217), and wherein detection of a sleep and/or activity is detected when the magnitude of the measured acceleration meets or exceeds a threshold (para 0113), but does not explicitly disclose prompting performance of the at least one therapy regimen when the monitored gravity vector has maintained a designated relationship with respect to the threshold for a predetermined period of time.
However, Van Beest teaches a method and apparatus for sleep posture correction (see title and abstract, lines 1-4). The system (fig. 1) is configured to alert a patient of improper sleep posture (through the use of an alarm or stimulation signal) by increasing the number of alarms from a lower limit at the beginning of use to an upper limit when the patient’s sleep posture is out of a predetermined body posture range after a predetermined period of time (abstract, para 0023, 0028, 0030, 0048, 0065, 0090, 0092, 0139, and para 0160).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dieken with the method of Van Beest to arrive at the claimed invention. Such modification would improve the system by ensuring stimulation is applied to the patient during the appropriate time (during a deep sleep state), ensuring that the stronger stimulation/ramped up stimulation is appropriately applied to the patient during a heavily sedated state in which a sleep breathing episode is likely to occur.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken in view of US 9,776,008 B2 to Skelton et al. (hereinafter “Skelton’008”) and to Wang.
Regarding claim 18, Dieken teaches:
A care/therapy system (para 0044, lines 1-6) comprising:
an implantable sensor configured for implantation into a patient (para 0017 and para 0037) and to generate information indicative of a gravity vector (para 0111);
an implantable medical device/implantable pulse generator for delivering stimulation therapy to the patient (para 0051 and claim 12),
a monitoring module/posture information engine for monitoring the gravity vector over time (para 0111-0113), a therapy module/stimulation manager (see fig. 17, para 0199-0200) for prompting operation of the IMD in delivering stimulation therapy (see para 0141, para 0198, and para 0200-0201), but does not disclose wherein the system is programmed to activate delivery of therapy during a defined time period when no or minimal motion by the patient is detected and the monitored gravity vector is within a predetermined range.
However, Skelton’008 teaches techniques related to classifying a posture state of a patient (see abstract, lines 1-2). The system (fig. 1) is programmed to activate delivery of therapy during a defined time period when no or minimal motion by the patient is detected (see claim 44), but does not explicitly disclose wherein the monitored gravity vector is within a predetermined range.
However, Wang teaches wherein the operation of the device further includes the stimulation therapy delivered to the patient being ramped up from the ramped down level (adjusted based on changes in a patient’s posture) based at least in part, upon a comparison of the monitored gravity vector with a predetermined range (see fig. 10, col. 1, lines 10-16 and 21-29, col. 4, lines 36-43: “In another implementation, cardiac pacing may be adjusted if a sudden change in the patient's posture is detected. In yet another implementation, cardiac and/or other types of therapy may be adjusted to accommodate the patient's sleep/wake cycle as determined, at least in part, by the patient posture. For example, a cardiac pacing rate may be decreased from a waking rate to a lower sleeping rate to account for the decreased hemodynamic need of the patient during sleep.”).
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 system of Dieken with the teachings of Skelton’008 and Wang to arrive at the claimed invention. Such modification would improve the system by preventing strong stimulation from being applied to the patient during incorrect time periods (during non-sleep states), ensuring that the stimulation is appropriately activated and applied to the patient, preventing muscle fatigue from occurring as a result of excess stimulation.
Regarding claim 19, Dieken as modified teaches the care system of claim 18, wherein the system is programmed to make changes in a stimulation therapy (adjusting the stimulation) delivered to the patient based on repeating changes in the monitored gravity vector (para 0087, para 0091, para 0111, para 0114, para 0116, para 0126-0127, para 0130-0131, and para 0217). Due to the system using more than one sensor in order to monitor/track cardiac information and respiratory information to obtain the heart rate variability of a patient, and to track the different positions and orientations of the patient during different sleep stages, the accelerometer sensor is continuously updated and monitored, therefore repeatedly changing the gravity vector, which also provides changes/adjustments in the stimulation therapy, due to the posture at least partially being determined from the gravity vector ( which originates from the filtered axes of the accelerometer sensor).
Regarding claim 20, Dieken as modified teaches the care system of claim 18, but does not disclose wherein the system is programmed to -never determine a current posture of the patient.
However, Wang teaches wherein the system can be configured to only track posture information over time (col. 3, lines 59-67 and col. 4, lines 1-30). As noted in earlier rejections, Wang teaches that this is based on a gravity vector, which according to Applicant is an alternative to determining “current posture.”
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 system of Dieken with the teachings of Wang to arrive at the claimed invention, since such modification would allow for a comprehensive assessment of the patient’s well-being in order to determine if the patient’s health is declining, improving, etc., and provides an accurate indication of health problems they can be experiencing (such as sleep apnea).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Christopherson et al. (US 2011/0264164 A1) teaches a system and method for automatically applying stimulation therapy for treating sleep disorder breathing (abstract and para 0002).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/K.J.W./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792