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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/12/25 has been entered.
Response to Amendment
The amendments made to claims 36 and 43 in the response filed 8/12/25 are acknowledged.
Claims 36-43, 46, and 52-55 are now pending in the application, with claims 52-55 remaining as previously withdrawn.
Claims 36-43 and 46 are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 36-43 and 46 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. (Applicant’s arguments on p. 7-9 regarding Koh and Barker failing to teach the newly added limitations in claim 36 are moot in view of new reference Lynn; Applicant’s arguments on p. 9-11 regarding Meer and Mashiach failing to make up for the deficiencies of Koh and Barker are moot in view of new reference Lynn provided to address the newly added limitations in claim 36).
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.
Claim(s) 36, 37, 40-42, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashyam US 2014/0135868 A1 in view of Lynn US 2006/0155206 A1.
Regarding claim 36, Bashyam discloses a method for treating sleep apnea in a patient ([0029], method for treatment of OSA), comprising: receiving from:
one or more first sensors, one or more first signals indicative of the patient's respiratory rate ([0062], piezoelectric film sensor detects intrinsic respiratory cycle by sensing rhythmic movements in mouth cavity),
one or more second sensors, one or more second signals indicative of the patient's position ([0060], accelerometer sensor determines patient’s position and activity), and
one or more third sensors, one or more third signals indicative of the patient's audio output ([0063], EMG acquisition and detection sub-system for detecting increase or decrease in genioglossus muscle activity, which can affect the patient’s audio output; [00198]-[00199] of the instant specification indicates the use of EMG signals for audio signals);
determining a need for therapy; and based on the determination, causing an electrical therapy signal to be delivered, via one or more electrodes, to at least a portion of the patient's upper airway to address a breathing obstruction in the patient ([0074], [0077], the sensor information is used in a closed loop control of the onset or offset of the stimulator device based on the signal level and state of the patient; [0067]-[0068], the base of the tongue, which is in the oral/upper part of the pharynx airway, is stimulated via electrodes 603).
Bashyam is silent on the determining a need for therapy being determining that a positive slope of the one or more first, second, and/or third signals decreases successively during each of at least two successive respiratory cycles of the patient.
However, Lynn teaches a method for detecting apnea via sensors ([0062], identification of specific cluster patterns indicative of sleep apnea; [0071], recognition of apnea clusters derived from sensors), wherein determining a need for therapy comprises determining that a positive slope of an analogous signal decreases successively during each of at least two successive respiratory cycles of the patient ([0186], during upper airway obstruction, inspiration is slowed to a greater degree than exhalation, and [0197], patients with obstructive sleep apnea will have a fall in the slopes of fundamental inspiration objects; fig. 12 shows the successive decrease in the positive inhalation slope, specifically starting at the Transition Object through the Apnea Object, where the slope of each rise becomes less steep; [0085], data obtained may be employed to initiate therapeutic activities, including stimulation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the step of determining a need for therapy of Bashyam to be determining that a positive slope of the one or more first, second, and/or third signals decreases successively during each of at least two successive respiratory cycles of the patient, as taught by Lynn, allowing Bashyam to indicate the type of disordered breathing as breathing obstruction based on the claimed breathing pattern and stimulate accordingly.
Regarding claim 37, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses the one or more first sensors include at least one of a capacitive proximity detector, piezoelectric sensor ([0062]), optical sensor, microphone, or respiration sensor,
the one or more second sensors include an accelerometer ([0060]), and
the one or more third sensors include at least one of a respiration sensor, acoustic sensor, vibration sensor, microphone, electromyogram sensor ([0063]), or radar device.
Regarding claim 40, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses initiating, adjusting, and/or terminating the electrical therapy signal based at least in part on the one or more first, second, and third signals ([0064], the sensor information is used in a closed loop control of the onset or offset of the stimulator device).
Regarding claim 41, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses controlling at least one of a type, a timing, a frequency ([0076], sensor information from the piezoelectric film can be analyzed to synchronize the stimulation therapy to the patient’s intrinsic respiratory activity), a duration, or a magnitude of the electrical therapy signal based at least in part on the one or more first, second, and third signals.
Regarding claim 42, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses the breathing obstruction results from obstructive sleep apnea (OSA) ([0031], the stimulator system and method is for treatment of OSA) and/or hypopnea.
Regarding claim 46, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses adjusting the electrical therapy signal based at least in part on the one or more first, second, and/or third signals, wherein the adjusted electrical therapy signal corrects the breathing obstruction and/or wakes the patient ([0059]-[0063], the type of disordered breathing can be characterized by properties such as patient position, respiratory cycle, and muscle activity, which are sensed by the sensors of the invention; [0074]-[0077], this sensed information is used to adjust therapy, such as the axis of stimulation, synchronization to respiratory activity, and initiating stimulation; [0029], OSA is treated by the stimulation).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashyam US 2014/0135868 A1 in view of Lynn US 2006/0155206 A1 further in view of Meer US 4,830,008.
Regarding claim 38, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam in view of Lynn is silent on the one or more electrodes including the one or more first sensors.
However, Meer teaches a method of treating sleep apnea (col. 1, lines 12-15) comprising one or more electrodes that include one or more first sensors (col. 4, lines 32-35 and 41-46, wherein effector/stimulating electrodes are simultaneously used as sensors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the one or more electrodes of Bashyam in view of Lynn to include the one or more first sensors, as taught by Meer, since using a single electrode for multiple purposes (stimulating and sensing) reduces the amount of separate electrical components needed, making the device more simple and comfortable for the user.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashyam US 2014/0135868 A1 in view of Lynn US 2006/0155206 A1 further in view of Mashiach et al. US 2011/0152965 A1.
Regarding claim 39, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam in view of Lynn is silent on receiving, from one or more fourth sensors, one or more fourth signals indicative of the patient's oxygen saturation level, wherein the one or more fourth sensors include at least one of an oxygen saturation sensor, heart rate sensor, or respiration sensor.
However, Mashiach teaches a method of treating sleep apnea ([0001]) comprising receiving, from one or more fourth sensors, one or more fourth signals indicative of the patient's oxygen saturation level, wherein the one or more fourth sensors include at least one of an oxygen saturation sensor ([0060], [0070], additional sensors may include sensors that measure oxygen saturation), heart rate sensor, or respiration sensor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the method of Bashyam in view of Lynn with the step of receiving, from one or more fourth sensors, one or more fourth signals indicative of the patient's oxygen saturation level, wherein the one or more fourth sensors include at least one of an oxygen saturation sensor, heart rate sensor, or respiration sensor, as taught by Mashiach, to monitor changes in the oxygen level of the blood.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashyam US 2014/0135868 A1 in view of Lynn US 2006/0155206 A1 further in view of Barker US 4,365,636.
Regarding claim 43, Bashyam in view of Lynn discloses the claimed invention as discussed above.
Bashyam further discloses causing the electrical therapy signal to be delivered based on the determination of the state of the patient ([0077], the sensor information is used in a closed loop control of the onset or offset of the stimulator device based on the signal level and state of the patient).
Bashyam in view of Lynn is silent on the determination of the state of the patient being determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period.
However, Barker teaches a method of monitoring patient respiration for detection of apnea (col. 1, lines 7-14) comprising determination of the state of the patient being determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period (claim 1, the method includes monitoring a respiration waveform and forming instantaneous magnitude of said waveform at continuous time intervals, continuously forming the difference between each value to form a slope value, forming a threshold value, comparing each subsequent slope value with the threshold value, and activating an alarm when the slope values are less than the threshold value; in other words, the slope value represents the variation in the magnitude of each subsequent data point, since the slope value is calculated as the difference between each subsequent data point; then, this slope value (variation in magnitude) is compared to a threshold (i.e., the claimed “amount”)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Bashyam in view of Lynn such that the determination of the state of the patient is accomplished by determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period, as taught by Barker, as this approach allows for self adjustment of the detection parameters for changing conditions of respiration (col. 2, lines 44-48).
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.
Claims 36-42 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-24, 37, 38, and 43 of copending Application No. 17/322,576 in view of Bashyam US 2014/0135868 A1 further in view of Lynn US 2006/0155206 A1.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 36 of the instant application, the conflicting patent claims a method for treating sleep apnea in a patient, comprising: receiving from: one or more first sensors, one or more first signals indicative of the patient's respiratory behavior, one or more second sensors, one or more second signals indicative of the patient's position, and one or more third sensors, one or more third signals indicative of the patient's audio output; causing an electrical therapy signal to be delivered, via one or more electrodes, to at least a portion of the patient's upper airway to address a breathing obstruction in the patient (claim 32).
The conflicting patent is silent on the respiratory behavior being respiratory rate.
However, Bashyam teaches a method for treating sleep apnea in a patient ([0029], method for treatment of OSA), comprising: receiving from: one or more first sensors, one or more first signals indicative of the patient's respiratory rate ([0062], piezoelectric film sensor detects intrinsic respiratory cycle by sensing rhythmic movements in mouth cavity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the respiratory behavior of the conflicting patent to be respiratory rate, as taught by Bashyam, as respiratory rate is representative of the respiratory cycle, which is highly informative for detecting apnea.
The conflicting patent in view of Bashyam is silent on determining that a positive slope of the one or more first, second, and/or third signals decreases successively during each of at least two successive respiratory cycles of the patient; and based on the determination, causing the electrical therapy signal to be delivered.
However, Lynn teaches a method for detecting apnea via sensors ([0062], identification of specific cluster patterns indicative of sleep apnea; [0071], recognition of apnea clusters derived from sensors), comprising determining that a positive slope of an analogous signal decreases successively during each of at least two successive respiratory cycles of the patient, and based on the determination, causing the electrical therapy signal to be delivered ([0186], during upper airway obstruction, inspiration is slowed to a greater degree than exhalation, and [0197], patients with obstructive sleep apnea will have a fall in the slopes of fundamental inspiration objects; fig. 12 shows the successive decrease in the positive inhalation slope, specifically starting at the Transition Object through the Apnea Object, where the slope of each rise becomes less steep; [0085], data obtained may be employed to initiate therapeutic activities, including stimulation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the step of determining a need for therapy of the conflicting patent in view of Bashyam to be determining that a positive slope of the one or more first, second, and/or third signals decreases successively during each of at least two successive respiratory cycles of the patient, and based on the determination, causing the electrical therapy signal to be delivered, as taught by Lynn, allowing for indication of the type of disordered breathing as breathing obstruction based on the claimed breathing pattern and stimulate accordingly.
Regarding claim 37 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
The conflicting patent further claims the entirety of the claim (see claim 43).
Regarding claim 38 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
The conflicting patent further claims the entirety of the claim (see claim 33 and 34).
Regarding claim 39 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
The conflicting patent further claims the entirety of the claim (see claim 37 and 38).
Regarding claim 40 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
Bashyam further teaches initiating, adjusting, and/or terminating the electrical therapy signal based at least in part on the one or more first, second, and third signals ([0064], the sensor information is used in a closed loop control of the onset or offset of the stimulator device), to allow the patient’s state to inform whether therapy is delivered.
Regarding claim 41 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
Bashyam further teaches controlling at least one of a type, a timing, a frequency ([0076], sensor information from the piezoelectric film can be analyzed to synchronize the stimulation therapy to the patient’s intrinsic respiratory activity), a duration, or a magnitude of the electrical therapy signal based at least in part on the one or more first, second, and third signals, to allow the patient’s state to inform the therapy sequence.
Regarding claim 42 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
The conflicting patent further claims the entirety of the claim (claim 32, where sleep apnea is inherently caused by a breathing obstruction).
Regarding claim 46 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
Bashyam further teaches adjusting the electrical therapy signal based at least in part on the one or more first, second, and/or third signals, wherein the adjusted electrical therapy signal corrects the breathing obstruction and/or wakes the patient ([0059]-[0063], the type of disordered breathing can be characterized by properties such as patient position, respiratory cycle, and muscle activity, which are sensed by the sensors of the invention; [0074]-[0077], this sensed information is used to adjust therapy, such as the axis of stimulation, synchronization to respiratory activity, and initiating stimulation; [0029], OSA is treated by the stimulation), to allow the patient’s state to inform the therapy configuration.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-24, 37, 38, and 43 of copending Application No. 17/322,576 in view of Bashyam US 2014/0135868 A1 further in view of Lynn US 2006/0155206 A1 and Barker US 4,365,636.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 43 of the instant application, the conflicting patent in view of Bashyam further in view of Lynn discloses the claimed invention as discussed above.
Bashyam further teaches causing the electrical therapy signal to be delivered based on the determination of the state of the patient ([0077], the sensor information is used in a closed loop control of the onset or offset of the stimulator device based on the signal level and state of the patient), to allow the patient’s state to inform the therapy sequence.
The conflicting patent in view of Bashyam further in view of Lynn is silent on the determination of the state of the patient being determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period.
However, Barker teaches a method of monitoring patient respiration for detection of apnea (col. 1, lines 7-14) comprising determination of the state of the patient being determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period (claim 1, the method includes monitoring a respiration waveform and forming instantaneous magnitude of said waveform at continuous time intervals, continuously forming the difference between each value to form a slope value, forming a threshold value, comparing each subsequent slope value with the threshold value, and activating an alarm when the slope values are less than the threshold value; in other words, the slope value represents the variation in the magnitude of each subsequent data point, since the slope value is calculated as the difference between each subsequent data point; then, this slope value (variation in magnitude) is compared to a threshold (i.e., the claimed “amount”)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of the conflicting patent in view of Bashyam further in view of Lynn such that the determination of the state of the patient is accomplished by determining that a magnitude of the one or more first, second, and/or third signals is varying by more than an amount during a time period, as taught by Barker, as this approach allows for self adjustment of the detection parameters for changing conditions of respiration (col. 2, lines 44-48).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786