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 .
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).
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Claims 1, 12, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of copending Application No. 19/211,024 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current pending claims are merely broader in scope than the copending claims of US Application 19/211,024 by eliminating features from the copending claims. Broadening a claim is obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant application: 19/210,987
Reference application: 19/211,024
Claim 1: A system to treat sleep disordered breathing, the system comprising:
a nerve stimulator configured to deliver stimulation energy to a phrenic nerve in a sleeping patient;
at least one sensor configured to sense one or more physical aspects that are indicative of a physiological condition of the patient, and
output one or more signals indicative of a respiratory cycle of the patient; and
a controller configured to:
receive the one or more signals,
determine, based on the one or more signals indicative of a respiratory cycle of the patient, a targeted period in the respiratory cycle, and
control the nerve stimulator or cause the nerve stimulator to be controlled to deliver the stimulation energy to the nerve based on the targeted period.
Claim 1: A system to treat sleep disordered breathing, the system comprising:
a nerve stimulator configured to deliver stimulation energy to a phrenic nerve in a patient that is sleeping;
at least one sensor configured to sense one or more physical aspects that are indicative of breaths taken by the patient and
output one or more signals representative of breathing characteristics of the patient; and
a controller that includes at least one hardware processor that is configured to perform operations comprising:
causing, via the a nerve stimulator, the stimulation energy to be delivered to the phrenic nerve of the patient,
wherein delivery of the stimulation energy is based on stimulation parameters that include at least a stimulation rate, a stimulation phase, a stimulation frequency, and a stimulation amplitude,
determining, based on breathing characteristics, a breathing rate for the patient,
setting, based on the breathing rate, the stimulation rate for a plurality of stimulation pulses to be delivered to the phrenic nerve of the patient over a period of time,
setting the stimulation phase for when, from onset of inspiration in a breathing cycle of the patient, the stimulation energy is to be delivered,
determining, while the patient is sleeping and based on the breathing characteristics, that the breathing characteristics have decreased below a threshold level,
controlling, the stimulation amplitude at which each of the plurality of stimulation pulses is delivered,
wherein multiple ones of the plurality of stimulation pulses have different stimulation amplitudes, and
based on determination that the breathing characteristics have decreased below a threshold level, adjusting the stimulation phase at which the stimulation energy is to be delivered to a new stimulation phase that is different from a prior stimulation phase.
Claim 12, the system of claim 11,
wherein the delay period is prior to onset of inspiration in the respiratory cycle of the patient.
Claim 2, the system of claim 1,
wherein stimulation phase is at a delay time that is, within the breathing cycle of the patient, prior to onset of inspiration.
Claim 16, the system of claim 13,
wherein the electrical energy pulses are biphasic.
Claim 4, the system of claim 1,
wherein each one of the plurality of stimulation pulses are a bi-phasic pulse pairs or mono-phasic pulses.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 9-13, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dieken et al. (US 2020/0147376).
In re claim 1, Dieken discloses a system to treat sleep disordered breathing [0069], the system comprising:
a nerve stimulator ((fig 6: 142, stimulation element) configured to deliver stimulation energy to a phrenic nerve (fig 6, 146; [0105]: “target nerve 146… phrenic nerve”) in a sleeping patient [0079];
at least one sensor [0141] configured to sense one or more physical aspects that are indicative of a physiological condition of the patient ([0140, 0157]), and
output one or more signals indicative of a respiratory cycle of the patient ([0151, 0157]); and
a controller ([0176]: “the pulse generator 1510 may be simplified to act as a single controller”) configured to:
receive the one or more signals ([0157]: “IPG receives sensor waveforms from the respiratory sensor”),
determine, based on the one or more signals indicative of a respiratory cycle of the patient, a targeted period in the respiratory cycle ([0089]: uses respiratory information to determine timing of the stimulation in the respiratory cycle; [0114]: synchronizes stimulation to the inspiratory phase of a respiratory cycle), and
control the nerve stimulator or cause the nerve stimulator to be controlled to deliver the stimulation energy to the nerve based on the targeted period ([0157]: last sentence).
In re claim 2, Dieken discloses wherein the sensor is at least one of a:
transthoracic impedance sensor [0141, 0161], an accelerometer [0141], a gyroscope, an auscultatory sensor, ultrasonic sensor (fig 35), a pressure sensor (fig 35), an optical sensor (fig 35), a pulse oximeter [0263], or a chemical sensor.
In re claim 3, Dieken discloses wherein the at least one sensor includes an acceleration sensor and a transthoracic impedance sensor (fig 35: 2252, combination of sensors; [0141]: “bio-impedance sensor, … accelerometer”).
In re claim 4, Dieken discloses wherein the at least one signal includes an output signal from the acceleration sensor [0244] and an output signal from the transthoracic impedance sensor [0161].
In re claim 6, Dieken discloses wherein the at least one sensor includes a transthoracic impedance sensor [0141, 0161].
In re claim 9, Dieken discloses wherein a common lead is used by
the at least one sensor to sense the one or more physical aspects ([0257]: last sentence) and
the nerve stimulator to deliver stimulation energy to the phrenic nerve ([0142]: last sentence; [0143]).
In re claim 10, Dieken discloses wherein
a first sensing lead is used by the at least one sensor to sense the one or more physical aspects (fig 29, 1437; [0156]) and
a second lead is included with the nerve stimulator to deliver stimulation energy to the phrenic nerve (fig 29: 1432, [0154], [0180]), the first lead and second lead being separate from one another (fig 29: 1432, 1437).
In re claim 11, Dieken discloses
wherein the targeted period is synchronized based on a determined onset of inspiration in the respiratory cycle [0157],
wherein the targeted period is determined by applying a delay period to the determined onset of inspiration ([0117]: last sentence; Note: Applicant’s instant drawings show the delay period to the onset of inspiration can be before inspiration or after inspiration (fig 31).
In re claim 12, Dieken discloses wherein the delay period is prior to onset of inspiration in the respiratory cycle of the patient [0117].
In re claim 13, Dieken discloses wherein the controlling the nerve stimulator includes delivering a train of electrical energy pulses to the nerve ([0083]: “on-going stimulation may be implemented via a duty cycle, train of pulses”).
In re claim 18, Dieken discloses wherein the controller is further configured to:
receive a command from a user interface communicatively connected to the controller ([0282]: “controller 3002 is electrically couplable to, and in communication with, … user interfaces”) indicative of the patient resting or sleeping ([0085]: patient starts a timer before falling asleep and once the timer is finished the patient is asleep and stimulation can start), and/or
receive a command from a user interface communicatively connected to the controller indicative of the patient interrupting resting or sleeping ([0085]: patient uses a remote to disable stimulation after waking up),
wherein the command is used by the controller to determine if the patient is asleep ([0085]: starting a timer shows the patient is not asleep but will be by the time the timer goes off, using a remote to disable stimulation shows the patient is not asleep).
In re claim 20, see above (In re claim 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. (US 2020/0147376) in view of Rondoni et al. (US 2022/0336098).
In re claim 5, Dieken lacks wherein the at least one sensor includes a 6-axis accelerometer that is configured to detect 3 transverse linear accelerations and 3 rotational accelerations, wherein the 6 signals are fused together for a chest acceleration signal, wherein the one or more signals indicative of the respiratory cycle of the patient includes the chest acceleration signal.
Rondoni teaches a system that can be used to provide stimulation therapy for sleep disordered breathing [0036]. The system uses an implantable medical device that can have an acceleration sensor that has a six-axis accelerometer [0052]. The six-axis accelerometer provides information along three linear and rotational axes [0071]. The acceleration sensor is used to sense physiological data that can determine respiration information based on movements of the chest [0075].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dieken by using a six-axis accelerometer to get a chest acceleration signal to determine respiratory information as taught by Rondoni as a six-axis accelerometer can be used to sense chest movements with more orientation and position data which be analyzed to provide respiratory information, including whether the patient is awake or asleep.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. (US 2020/0147376) in view of Thakur et al. (US 2017/0119317).
In re claim 7, Dieken lacks wherein the transthoracic impedance sensor includes a bipolar configuration of electrodes.
Thakur teaches a system that can receive a physiological signal from a patient (abstract) and uses a physiologic parameter generator circuit that can extract signal parameters from the physiological signals that can be indicative of sleep apnea [0059]. The physiological signal can include transthoracic impedance, with the impedance able to be sensed using a bipolar electrode configuration or a tripolar electrode configuration [0045].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dieken with having the transthoracic impedance signal measured by using a bipolar or tripolar electrode configuration as taught by Thakur, as these are known electrode configurations for sensing impedance and using the bipolar configuration would allow for the electrodes to be used for both sensing and stimulating while using the tripolar configuration would allow for the electrodes to either be sensing or stimulating [0045].
In re claim 8, see above (In re claim 7).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. (US 2020/0147376) in view of Falkenberg et al. (US 7,340,302).
In re claim 14, Dieken lacks
wherein the train is in a range of 0.2 to 2 seconds.
Falkenberg teaches a device that stimulates the phrenic nerve to minimize or prevent episodes of sleep apnea (col 2, ln 1-7). The phrenic nerve stimulation pulses can be varied during a pulse train (col 5, ln 12-15) and the pulse train can have a different duration depending on the phase of respiration it is being delivered with, such as 1 second during inspiration or 0.5 seconds during expiration (col 12, ln 23-28). The pulses delivered in the pulse train can have frequencies between 10 and 60 Hz and can vary during delivery of the pulse train (col 10, ln 13-16). The pulses delivered during the pulse train can be monophasic, biphasic, or other phase pulse types (col 10, ln 21-25).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dieken by having the pulse train duration and pulse frequency be within the specified ranges and by using biphasic pulses as taught by Falkenberg, as the train duration and frequency are known to be adjustable parameters during phrenic nerve stimulation and can be adjusted based on the user’s respiration or the desired outcome of stimulation. Additionally, the phase pulse type is known to be variable and biphasic pulses can be used to reduce risks of inappropriate cardiac stimulation (col 10, ln 24-25).
Additionally, it would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited values/ranges in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 15, see above (In re claim 14).
In re claim 16, see above (In re claim 14).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. (US 2020/0147376) in view of Orser et al. (WO 2023/230131).
In re claim 17, Dieken discloses wherein the controller is further configured to:
determine based on the one or more signals from the one or more sensors that breathing of the patient is insufficient [0089, 0157, 0189];
Dieken lacks
based on the determination, adjust the target period; and
control the nerve stimulator to deliver the stimulation energy to the nerve during the adjusted targeted period.
Orser teaches a system that can be used to apply electrical stimulation to a phrenic nerve to prevent or treat sleep apnea [00111]. The system has a sensing circuit which receives physiologic information from a sensor and a stimulation circuit which delivers the stimulation [0045]. The physiologic information can include information related to respiration and severity of disordered breathing. This information is also used to determine the duration of stimulation, when to start and stop stimulation, and to synchronize the stimulation with a specific portion of the respiratory cycle [0047].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dieken by using information from the sensors to determine when to start and stop stimulation as well as which part of the respiratory cycle stimulation should be delivered during as taught by Orser, as this would allow the nerve stimulator to deliver stimulation during precise portions of the respiratory cycle based on the user’s specific physiologic information which would allow the stimulation to more effectively treat the user’s disordered breathing.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. (US 2020/0147376) in view of Rondoni et al. (US 2023/0095780).
In re claim 19, Dieken lacks wherein establishing whether the patient is resting or sleeping comprises:
identifying a current time of day,
comparing the current time of the day with one or more pre-set time intervals,
the one or more pre-set time intervals being stored in a memory communicatively connected with, or part of, the controller and being indicative of one or more periods in the day during which the patient is considered as resting or sleeping.
Rondoni teaches a device to determine a sleep-wake status (abstract) and once a sleep state is detected, applying stimulation to a phrenic nerve [0284]. The sleep-wake status can detect sleep based off the time of day which can be selectable or based on patient data [0051]. Sleep time data is collected and includes duration of sleep, time that sleep started and ended, pauses in sleep and more [0057]. The sleep pattern data can be stored in a memory [0349].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dieken by determining the time of day and comparing it to other times to determine whether or not the patient was sleeping as taught by Rondoni, as this would allow for stimulation to be started automatically based on the patient’s sleep pattern including what time they typically fall asleep compared to the time, without the patient having to set a timer or a specified time period for treatment to occur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tehrani (US 11,266,838) teaches a system to treat sleep disordered breathing (col 2, ln 39-50) that delivers stimulation energy to a phrenic nerve (col 13, ln 6-7) from the onset of inspiration (col 26, ln 62-64). The stimulation is delivered at a delay time that is prior to the onset of inspiration (col 13, ln 17-18) and the stimulation pulses can be biphasic or monophasic (col 32, ln 1-2).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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