DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 21 rejected on the ground of non-statutory double patenting as being unpatentable over Claims 92 and 103 of U.S. Patent No. 20110264164 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of claim 92 and 103 of U.S. Patent No. 20110264164 A1 encompasses the scope of claim 21. Claims 92 of U.S. Patent No. 20110264164 A1 encompasses a physiological sensor, an implantable pulse generator, and an automatic therapy manager that: a) determines a sleep state over a period of time, b) applies therapy in a sleep state, and c) suspends therapy in an awake state (Claim 103 mentions the suspension of operations in a first state from an awake schedule parameter).
Claims 25 and 26 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 92 of U.S. Patent No. 20110264164 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of claim 92 and 103 of U.S. Patent No. 20110264164 A1 encompasses the scope of claims 25 and 26. Claims 92 of U.S. Patent No. 20110264164 A1 discloses wherein a sensor comprises a body activity sensor or a body posture sensor.
Claim 39 and is rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 92, 101, and 103 of U.S. Patent No. 20110264164 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of claim 92, 101, and 103 of U.S. Patent No. 20110264164 A1 encompasses the scope of claim 34. Claims 92 of U.S. Patent No. 20110264164 A1 encompasses a physiological sensor, an implantable pulse generator, and an automatic therapy manager that: a) determines a sleep state over a period of time, b) applies therapy in a sleep state, and c) suspends therapy in an awake state (Claim 103 mentions the suspension of operations in a first state from an awake schedule parameter). Additionally, claim 101 discloses the probabilistic model for sensing based on a dynamic schedule. Additionally, claim 92 recites where one of the sensors is a body activity sensor.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 32, which is dependent from claim 30, recites “wherein the automatic therapy manager is configured to increment the level of stimulation therapy to increase an efficacy of the stimulation therapy”. Claim 30 recites, “wherein the automatic therapy manager is configured to increment… a level of stimulation therapy…”. Therefore, the only additional limitation of claim 32 is “to increase an efficacy of the stimulation therapy.” This limitation is merely an effect or result achieved from increased stimulation (i.e. intended use language), and does not further limit the scope of the claimed system from claim 30. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26, 38, and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 26, 38, and 39, the claims recite “[the sensor] is polled based on a probabilistic model.” It is unclear what is meant by the recited language in the claim. For Examination purposes, it will be interpreted that “polled” means the data used in the probabilistic model is acquired from the sensor at specific times.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 22, 24, 25, and 27-36 are rejected under pre-AIA 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bolea et al. (US 20080103545 A1, “Bolea”).
Regarding claim 21, Bolea teaches a system for treating sleep disordered breathing (Abstract: "Devices, systems and methods for nerve stimulation for obstructive sleep apnea (OSA) therapy.") comprising: at least one sensor (Fig. 1; par. [0046]: "one or more sensors 74") to sense physiologic parameters of a patient (Fig. 3; para. [0053]: "respiration sensors 74); and an implantable pulse generator (para. [0196] mentions a closed-loop system for using the respiratory sensor to control stimulation settings: "For example, the closed-loop process 400 may include the initial step of sensing respiration 350 using bio-Z, for example, and optionally sensing other parameters 360 indicative of respiration or other physiologic process. The sensed signal indicative of respiration (or other parameter) may be signal processed 370 to derive a usable signal and desired fiducials. A trigger algorithm 380, which will be discussed in greater detail below, may then be applied to the processed signal to control delivery of the stimulation signal 390.") and including an automatic therapy manager (para. [0258]: "The Default Algorithm block represents one or more pre-set trigger algorithms pre-programmed into the INS or physician programmer. The default algorithm used at a specific point in time while delivering therapy may be selected from a library of pre-set algorithms. The selection of the algorithm can be made automatically by the INS based on: patient sleep position (position sensor), heart rate (detectable through the impedance measuring system) or respiration rate.") configured to: determine an awake state or a sleep state of the patient based on the sensed physiologic parameters (para. [0057]: " The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. ") including determining whether sleep-indicative behavior is present for a specified period of time (para. [0057]: "Alternatively, data corresponding to a patient's motion may be evaluated over a long period of time, such as, for example, the first few months of treatment, for indications of improvement in a patient's quality of life."); apply stimulation therapy to an airway patency-related tissue (para. [0049]: "Stimulus may be delivered to one or more of a variety of nerve sites to activate one muscle or muscle groups controlling patency of the upper airway.") in response to determining the sleep state; and suspend stimulation therapy in response to determining the awake state. (para. [0057]: "In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake.").
Regarding claim 22, Bolea teaches the system of claim 21 (see above), wherein the sleep-indicative behavior comprises body motion. (para. [0057]: " The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake.").
Regarding claim 24, Bolea teaches the system of claim 21 (see above), wherein the physiologic parameters include at least one of body motion, body posture, heart rate, or respiratory rate (para. [0070]: "Generally, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link. The respiratory sensor(s) may detect respiration directly or a surrogate thereof. The respiratory sensor(s) may measure, for example, respiratory airflow, respiratory effort (e.g., diaphragmatic or thoracic movement), intra-pleural pressure, lung impedance, respiratory drive, upper airway EMG, changes in tissue impedance in and around the lung(s) including the lungs, diaphragm and/or liver, acoustic airflow or any of a number other parameters indicative of respiration.").
Regarding claim 25, Bolea teaches the system of claim 21 (see above), wherein the at least one sensor comprises a body activity sensor. (para. [0056]: " In one embodiment, INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient. The activity sensor may detect motion of a patient by any suitable means available to those of ordinary skill in the art.").
Regarding claim 27, Bolea teaches the system of claim 25 (see above), wherein the body activity sensor comprises an accelerometer. (para. [0056]: "The activity sensor may detect motion of a patient by any suitable means available to those of ordinary skill in the art. For example, a patient's motion may be detected by, for example, using an internal accelerometer.").
Regarding claim 28, Bolea teaches the system of claim 21 (see above), wherein the at least one sensor comprises an acoustic sensor. (para. [0070]: "The respiratory sensor(s) may detect respiration directly or a surrogate thereof. The respiratory sensor(s) may measure, for example… acoustic airflow or any of a number other parameters indicative of respiration.").
Regarding claim 29, Bolea teaches the system of claim 21 (see above), wherein the at least one sensor comprises at least one of an airflow sensor, a pressure sensor, a volume sensor, a temperature sensor, a mechanical strain sensor, or an effort sensor. (para. [0306]: "The respiration sensor may comprise any one or combination of devices capable of detecting inspiration. The following are examples… a flow sensor; a pressure sensor in combination with a mask to measure flow; and a temperature sensor to detect the difference between cool inspired air versus warmed expired air.").
Regarding claim 30, Bolea teaches the system of claim 21 (see above), wherein the automatic therapy manager is configured to increment or decrement a level of stimulation therapy based on the sensed physiologic parameters. (para. [0224]: "The data may also be used to control stimulus in a closed loop fashion by, for example, increasing stimulus intensity during periods of increased apnea and hypopnea occurrence or decreasing stimulus intensity during periods of decreased apnea and hypopnea occurrence (which may be observed if a muscle conditioning effect is seen with chronic use). Further, the data may be used to turn stimulus on (e.g., when apnea or hypopnea events start occurring or when motion artifact is absent) or to turn stimulus off (e.g., when no apnea or hypopnea events are occurring over a present time period or when motion artifact is predominant).").
Regarding claim 31, Bolea teaches the system of claim 30 (see above), wherein the automatic therapy manager is configured to decrement the level of stimulation therapy in the event that the patient is experiencing discomfort. (para. [0303]: "Further, onset and removal of stimulation can be graded to manage patient discomfort from abruptness. Grading may comprise pulse width control, signal amplitude control or a combination thereof.").
Regarding claim 32, Bolea teaches the system of claim 30 (see above), wherein the automatic therapy manager is configured to increment the level of stimulation therapy to increase an efficacy of the stimulation therapy (para. [0051]: “The patient controller 40 may also have programmability to adjust stimulus parameters (e.g., amplitude) within a pre-set range determined by the physician in order to improve efficacy and/or to reduce sensory perception, for example.”; para. [0244]: “The data may be subsequently transmitted or downloaded to the physician programmer 30. The data may be used to determine therapeutic efficacy (e.g., apnea hypopnea index, amount of REM sleep, etc.) and/or to titrate stimulus parameters using the physician programmer 30. The data may also be used to control stimulus in a closed loop fashion by, for example, increasing stimulus intensity during periods of increased apnea and hypopnea occurrence or decreasing stimulus intensity during periods of decreased apnea and hypopnea occurrence (which may be observed if a muscle conditioning effect is seen with chronic use).”).
Regarding claim 33, Bolea teaches the system of claim 30 (see above), wherein the automatic therapy manager is configured to increment or decrement the level of stimulation therapy based on patient feedback. (para. [0051]: "The patient controller 40 may comprise control circuitry and associated user interface to allow the patient to control the system via a wireless telemetry link while at home, for example. The patient controller 40 may include a power switch 42 to turn the system on and slowly ramp up when the patient goes to sleep at night, and turn it off when the patient wakes in the morning. A snooze switch 44 may be used to temporarily put the INS 50 in standby mode during which electrical stimulus is paused for a preprogrammed period of time to allow the patient to temporarily wake, after which the INS 50 turns back on and ramps up to the desired stimulus level… The patient controller 40 may also have programmability to adjust stimulus parameters (e.g., amplitude) within a pre-set range determined by the physician in order to improve efficacy and/or to reduce sensory perception, for example.").
Regarding independent claim 34, Bolea teaches a system for treating sleep disordered breathing (Abstract: "Devices, systems and methods for nerve stimulation for obstructive sleep apnea (OSA) therapy.") comprising: an accelerometer to sense physiologic parameters of a patient (para. [0056]: "The activity sensor may detect motion of a patient by any suitable means available to those of ordinary skill in the art. For example, a patient's motion may be detected by, for example, using an internal accelerometer."); and an implantable pulse generator (para. [0196] mentions a closed-loop system for using the respiratory sensor to control stimulation settings: "For example, the closed-loop process 400 may include the initial step of sensing respiration 350 using bio-Z, for example, and optionally sensing other parameters 360 indicative of respiration or other physiologic process. The sensed signal indicative of respiration (or other parameter) may be signal processed 370 to derive a usable signal and desired fiducials. A trigger algorithm 380, which will be discussed in greater detail below, may then be applied to the processed signal to control delivery of the stimulation signal 390.") in communication with the accelerometer (para. [0056]) and including an automatic therapy manager (para. [0258]: "The Default Algorithm block represents one or more pre-set trigger algorithms pre-programmed into the INS or physician programmer. The default algorithm used at a specific point in time while delivering therapy may be selected from a library of pre-set algorithms. The selection of the algorithm can be made automatically by the INS based on: patient sleep position (position sensor), heart rate (detectable through the impedance measuring system) or respiration rate.") configured to: determine an awake state or a sleep state of the patient based on the sensed physiologic parameters (para. [0057]: " The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. ") including determining whether sleep-indicative behavior is present for a specified period of time (para. [0057]: "Alternatively, data corresponding to a patient's motion may be evaluated over a long period of time, such as, for example, the first few months of treatment, for indications of improvement in a patient's quality of life."); apply stimulation therapy to an airway patency-related tissue (para. [0049]: "Stimulus may be delivered to one or more of a variety of nerve sites to activate one muscle or muscle groups controlling patency of the upper airway.") in response to determining the sleep state; and suspend stimulation therapy in response to determining the awake state. (para. [0057]: "In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake.").
Regarding claim 35, Bolea teaches the system of claim 34 (see above), wherein the sleep state is detected in response to detecting inactivity meeting a threshold for the specified period of time. (para. [0057]: "The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake.").
Regarding claim 36, Bolea teaches the system of claim 34 (see above), wherein the awake state is detected in response to detecting inactivity failing to meet a threshold. (para. [0057]: "The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake.").
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 23, 26, and 37-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bolea et al. (US 20080103545 A1, “Bolea”) in view of Stahmann et al. (US 7680537 B2, "Stahmann").
Regarding claim 23, Bolea teaches the system of claim 21 (see 102 rejection above). However, Bolea does not expressly disclose wherein the sleep-indicative behavior comprises posture.
Stahmann, in the same field of endeavor of treating respiratory disorders, discloses a therapy system using electrical stimulation. Stahmann discloses wherein the sleep-indicative behavior comprises posture. (Table 2: " Posture may be used to determine if the patient is asleep and may predispose the patient to disordered breathing. Posture may be a condition predisposing the patient to episodes of disordered breathing.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bolea to further include the posture as a sleep-indicative behavior. One of ordinary skill would have recognized that posture is a contextual indicator of sleep that can be used to predict disordered breathing (see Stahmann para. (37)). Therefore, it would have been obvious for one of ordinary skill to modify the system of Bolea to include a posture indicator since Stahmann demonstrates using posture to indicate disordered breathing. This would improve the accuracy of predicting and treating sleep disordered breathing.
Regarding claim 26, Bolea teaches the system of claim 25 (see 102 rejection above). However, Bolea does not expressly disclose wherein the body activity sensor is polled based on a probabilistic model in which the sensing is performed according to a dynamic schedule based on an amount of body activity measured at a particular sensing time.
Stahmann discloses wherein the body activity sensor (para. (122): "the cardiac rhythm management system 710 also includes an accelerometer mounted within the housing of the cardiac rhythm management system 710 for sensing patient activity.") is polled based on a probabilistic model (abstract: "One or more patient conditions are detected and used to predict disordered breathing."; Fig. 1; 120; the invention of Stahmann uses physiological data to predict disordered breathing. The method or approach is considered a model; para. (11): “A prediction engine is coupled to the detector system and is configured to predict disordered breathing based on the one or more detected conditions.”) in which the sensing is performed according to a dynamic schedule (para. (65): "Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.") based on an amount of body activity (para. (124): " Two additional signals, the patient's activity level and proximity to bed, are used to verify the prediction of disordered breathing. After a prediction of disordered breathing, the cardiac rhythm management system delivers an appropriate cardiac therapy to mitigate the disordered breathing.") measured at a particular sensing time. (para. (65): ") Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bolea to further include the probabilistic model based on body activity of the user, as disclosed by Stahmann. One of ordinary skill would have recognized that body motion is indicative of disordered breathing, and using body motion would improve the predictive capabilities of disordered breathing. Therefore, it would have been obvious for one of ordinary skill to modify the system of Bolea to include predictive capabilities for disordered breathing based on body motion since Stahmann discloses the efficacy in doing so.
Regarding claim 37, Bolea discloses the system of claim 34 (see 102 rejection above). Bolea further discloses suspending stimulation therapy in response to a change in body activity (para. [0057]: "For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake."). However, Bolea does not expressly disclose wherein the physiologic parameters comprise posture.
Stahmann discloses wherein the physiologic parameters comprise posture (para. (63): "A further example of a condition predisposing a patient to hypopnea or apnea is body posture. A supine posture is more likely to result in obstruction of the upper airway and can be used to predict episodes of obstructive hypopnea and apnea. Posture and/or torso orientation sensing may be accomplished, for example, using an implantable multiaxis accelerometer.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bolea to further include posture as a sleep-indicative behavior used to suspend therapy stimulation. One of ordinary skill would have recognized that posture is a contextual indicator of sleep that can be used to predict disordered breathing (see Stahmann para. (37)). Therefore, it would have been obvious for one of ordinary skill to modify the system of Bolea to include a posture indicator since Stahmann demonstrates using posture to indicate disordered breathing. Further, one of ordinary skill would have recognized that it is a simple substitution of indicators since Bolea discloses using body activity to suspend therapy. It would have been obvious to use posture instead since Stahmann discloses using posture as a sleep indicator.
Regarding claim 38, Bolea discloses the system of claim 34 (see 102 rejection above). However, Bolea does not disclose wherein the accelerometer is polled based on a probabilistic model in which the sensing is performed according to a dynamic schedule based on an amount of body activity measured at a particular sensing time.
Stahmann discloses wherein an accelerometer (para. (122): "the cardiac rhythm management system 710 also includes an accelerometer mounted within the housing of the cardiac rhythm management system 710 for sensing patient activity.") is polled based on a probabilistic model (abstract: "One or more patient conditions are detected and used to predict disordered breathing."; Fig. 1; 120; the invention of Stahmann uses physiological data to predict disordered breathing. The method or approach is considered a model) in which the sensing is performed according to a dynamic schedule (para. (65): "Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.") based on an amount of body activity (para. (124): " Two additional signals, the patient's activity level and proximity to bed, are used to verify the prediction of disordered breathing. After a prediction of disordered breathing, the cardiac rhythm management system delivers an appropriate cardiac therapy to mitigate the disordered breathing.") measured at a particular sensing time. (para. (65): ") Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bolea to further include the probabilistic model based on body activity of the user, as disclosed by Stahmann. One of ordinary skill would have recognized that body motion is indicative of disordered breathing, and using body motion would improve the predictive capabilities of disordered breathing. Therefore, it would have been obvious for one of ordinary skill to modify the system of Bolea to include predictive capabilities for disordered breathing based on body motion since Stahmann discloses the efficacy in doing so.
Regarding independent claim 39, Bolea discloses a system for treating sleep disordered breathing (Abstract: "Devices, systems and methods for nerve stimulation for obstructive sleep apnea (OSA) therapy.")comprising: at least one sensor to sense physiologic parameters of a patient, the at least one sensor comprising a body activity sensor (para. [0056]: " In one embodiment, INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient. The activity sensor may detect motion of a patient by any suitable means available to those of ordinary skill in the art.") and an implantable pulse generator (para. [0196] mentions a closed-loop system for using the respiratory sensor to control stimulation settings: "For example, the closed-loop process 400 may include the initial step of sensing respiration 350 using bio-Z, for example, and optionally sensing other parameters 360 indicative of respiration or other physiologic process. The sensed signal indicative of respiration (or other parameter) may be signal processed 370 to derive a usable signal and desired fiducials. A trigger algorithm 380, which will be discussed in greater detail below, may then be applied to the processed signal to control delivery of the stimulation signal 390.") in communication with the accelerometer (para. [0056]) and including an automatic therapy manager (para. [0258]: "The Default Algorithm block represents one or more pre-set trigger algorithms pre-programmed into the INS or physician programmer. The default algorithm used at a specific point in time while delivering therapy may be selected from a library of pre-set algorithms. The selection of the algorithm can be made automatically by the INS based on: patient sleep position (position sensor), heart rate (detectable through the impedance measuring system) or respiration rate.") configured to: determine an awake state or a sleep state of the patient based on the sensed physiologic parameters (para. [0057]: " The data corresponding to a patient's detected motion may be stored, evaluated, and utilized in any of a number of various ways. In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. ") including determining whether sleep-indicative behavior is present for a specified period of time (para. [0057]: "Alternatively, data corresponding to a patient's motion may be evaluated over a long period of time, such as, for example, the first few months of treatment, for indications of improvement in a patient's quality of life.") in response to determining the sleep state, monitor sleep disordered breathing via the sensed physiologic parameters (para. [0180]: "By way of example, not limitation, the following bio-Z vectors may be effective for monitoring respiration and/or for measuring artifacts for subsequent removal of the artifact from the respiration signal."; The Z-vectors describe parameters of the motion of the sensor electrodes; these vectors are considered to be physiological parameters); in response to determining sleep disordered breathing is occurring, apply stimulation therapy to an airway patency-related tissue (para. [0049]: " Stimulus may be delivered to one or more of a variety of nerve sites to activate one muscle or muscle groups controlling patency of the upper airway. For example, stimulation of the genioglossus muscle via the hypoglossal nerve."; Stimulation is applied to treat sleep apnea when it is detected by various sensors, such as electrodes 74 (Fig. 1)); and suspend stimulation therapy in response to determining the awake state. (para. [0057]: "In one embodiment, data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the pre-determined threshold, it may be assumed that the patient is awake. The activity sensor therefore may be used to facilitate selectively applying treatment when the patient is detected to be sleeping and/or inhibiting treatment when the patient is detected to be awake."). However, Bolea does not disclose wherein the body activity sensor is polled based on a probabilistic model in which the sensing is performed according to a dynamic schedule based on an amount of body activity measured at a particular sensing time.
Stahmann discloses wherein the body activity sensor (para. (122): "the cardiac rhythm management system 710 also includes an accelerometer mounted within the housing of the cardiac rhythm management system 710 for sensing patient activity.") is polled based on a probabilistic model (abstract: "One or more patient conditions are detected and used to predict disordered breathing."; Fig. 1; 120; the invention of Stahmann uses physiological data to predict disordered breathing. The method or approach is considered a model) in which the sensing is performed according to a dynamic schedule (para. (65): "Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.") based on an amount of body activity (para. (124): " Two additional signals, the patient's activity level and proximity to bed, are used to verify the prediction of disordered breathing. After a prediction of disordered breathing, the cardiac rhythm management system delivers an appropriate cardiac therapy to mitigate the disordered breathing.") measured at a particular sensing time. (para. (65): ") Conditions that predispose the patient to disordered breathing 320 are conditions that indicate the likelihood that one or more episodes of disordered breathing will occur during the next time period, such as over the course of the night or other sleep period. Based on predisposing conditions 320, an onset of disordered breathing may be predicted 312 to occur within a time window that may include several hours, for example, eight hours.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bolea to further include the probabilistic model based on body activity of the user, as disclosed by Stahmann. One of ordinary skill would have recognized that body motion is indicative of disordered breathing, and using body motion would improve the predictive capabilities of disordered breathing. Therefore, it would have been obvious for one of ordinary skill to modify the system of Bolea to include predictive capabilities for disordered breathing based on body motion since Stahmann discloses the efficacy in doing so.
Regarding claim 40, Bolea, in combination with Stahmann, discloses the system of claim 39 (see above). Bolea further discloses wherein the stimulation therapy is applied synchronous with inspiration. (para. [0326]: "Another screening technique involves the use of an oral appliance with sub-lingual surface electrodes contacting the base of the tongue or fine wire electrodes inserted into the genioglossus muscle to stimulate the tongue protruder muscle(s) synchronous with respiration during a sleep study.")
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) and 8am – noon (F).
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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