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 on June 16, 2026 have been fully considered but they are not persuasive.
In regard to Applicant’s arguments, applicant amends claims 2, 12, and 18 to state the following: “compare the monitored gravity vector with a threshold, and based upon the comparison and independent of any determination of patient posture, 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.”
Furthermore, Applicant presents the argument that Wang - col. 4, lines 36-43 and col. 16, lines 19-34 (a portion of the claimed references used to reject the previously claimed subject matter), does not describe therapy controlled based directly upon a comparison of a monitored gravity vector with a threshold, but rather teaches making a determination of the patient’s posture, and solely adjusting stimulation therapy based upon the patient’s posture. Moreover, Applicant states that even assuming Wang teaches comparing the gravity vector threshold values/regions, Wang discloses a “gravity-vector-to-posture determination process followed by posture-based therapy control”, which Applicant states is different from the amended claim subject matter, which monitors the gravity vector, compares it with a threshold, and prompts performance of the operational mode based on the comparison and independent of any determination of posture. The examiner respectfully disagrees.
First, as stated in col. 4, lines 36-43, col. 5, lines 1-10, col. 11, lines 24-32 and 66-67, col. 12, lines 1-12 , col. 15, lines 48-67, and col. 16, lines 1-7 and 19-34, the accelerometer sensors are used to generate the G vector, which is compared to specific threshold regions to determine the patient’s posture, and following this determination, the cardiac stimulation is adjusted.
Furthermore, although the amended claim states that the monitored gravity vector (which is compared to threshold), is independent to any determination of the patient’s posture, the monitored gravity vector as stated in Applicant’s specification is derived specifically from the implantable sensor 32, which is directly associated with the posture of a patient. This is stated in para [0019] of Applicant’s specification: “The implantable sensor 32 can assume various forms, and is generally configured for implantation into a patient and to at least sense a parameter indicative of a posture of the patient….. The posture module 34 receives information from the implantable sensor 32 and is programmed (or is connected to a separate module that is programmed) to recognize or identify or determine a current posture of the patient based, at least in part, upon information from the implantable sensor 32. In some embodiments, the posture module 34 is programmed (or is connected to a separate module that is programmed) to effect (or not effect) one or more control routines or the like relating to operation of the system 20.”
Moreover, although Applicant states support from para [0069]-[0070] of the specification for the amended claim subject matter, which contains the following statement: “In other embodiments, the posture module 34 does not detect or determine posture (nor does any other module or engine of the system 20), but tracks the gravity vector of the implantable sensor 32 over time. With these and related embodiments, the posture module 34 is programmed or configured to allow a user (e.g., patient, caregiver, etc.) to define certain gravity vector orientations relative to the implantable sensor 32 (or relative to the IPG assembly 52 where the implantable sensor 32 is carried in the housing of the IPG assembly 52) that can be associated with different operations modes”, the gravity vector of the implantable sensor 32 is directly associated with patient’s posture. Therefore, the comparison of the monitored gravity vector to a threshold for initiating the performance of an operational mode is not independent of patient’s posture.
As a result, in view of the following amendments, claims 2, 12, and 18 are rejected under 35 U.S.C.112(a) as failing to comply with the written description requirement in addition to the previous 35 U.S.C. 103 rejections, which will be more thoroughly addressed 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.
Claims 2, 12, and 18 are 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 claims 2, 12, and 18, the amended subject matter stating “ comparing the monitored gravity vector with a threshold, and based upon the comparison and independent of any determination of patient posture, prompt performance of an operational mode…”, para [0069]-[0070] of the specification states that in some embodiments, the posture module does not detect or determine posture, but tracks the gravity vector of the implantable sensor 32 over time. Furthermore, para [0070] states that a change in the monitored gravity vector is sufficient to prompt ramping down of the delivered therapy level, but as stated in para [0019], the gravity vector of the implantable sensor 32 is based directly on the patient’s posture, therefore the gravity vector (which is compared to the threshold for control of the stimulation system) cannot be independent of the patient’s posture.
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 and independent of any determination of patient posture, 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, and independent of any determination of patient posture, 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 24-32 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 1-7 and lines 19-34). See explanation regarding amended claim subject matter above. For examination purposes, the amended subject matter is interpreted as the gravity vector (G vector) is used independently to determine the patient’s 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 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 and independent of any determination of patient posture, 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 and independent of any determination of patient posture, 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, 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 1-7 and 19-34). See explanation regarding amended claim subject matter above. For examination purposes, the amended subject matter is interpreted as the gravity vector (G vector) is used independently to determine the patient’s 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 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 18-19 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, the delivery of therapy being activated independent of any determination of a posture of the patient.
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, the delivery of therapy being activated independent of any determination of a posture of the patient (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 24-32 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 1-7 and lines 19-34). See explanation regarding amended claim subject matter above. For examination purposes, the amended subject matter is interpreted as the gravity vector (G vector) is used independently to determine the patient’s 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 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).
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).
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.
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.
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, NIKETA PATEL can be reached at 571-272-4156. 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.
/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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