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 .
Claim Objections
Claims 1, 15, and 20 are objected to because of the following informalities: the phrase “causing, via the a nerve stimulator” uses both “the” and “a”. Appropriate correction is required.
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 1-2, 4-5, 15, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tehrani (US 11,266,838).
In re claim 1, Tehrani discloses a system to treat sleep disordered breathing (col 2, ln 39-50), the system comprising:
a nerve stimulator configured to deliver stimulation energy to a phrenic nerve (col 13, ln 6-7) in a patient that is sleeping (col 23, ln 12-15);
at least one sensor configured to sense one or more physical aspects that are indicative of breaths taken by the patient (col 14, ln 1-6) and output one or more signals representative of breathing characteristics of the patient (col 25, ln 54-65; col 14, ln 16-23); and
a controller that includes at least one hardware processor that is configured to perform operations (col 16, ln 33-34) comprising:
causing, via the a nerve stimulator, the stimulation energy to be delivered to the phrenic nerve of the patient (col 15, ln 5; col 13, ln 30),
wherein delivery of the stimulation energy is based on stimulation parameters that include at least
a stimulation rate (col 16, ln 49-51),
a stimulation phase (col 35, ln 3-6; Under the guidelines of broadest reasonable interpretation, stimulation phase is being understood to correspond to the part of the breathing cycle that stimulation occurs during; see Applicant’s instant specification [00209]),
a stimulation frequency (col 17, ln 22-26), and
a stimulation amplitude (col 17, ln 22-26),
determining, based on breathing characteristics, a breathing rate for the patient (col 25, ln 60-65; col 26, ln 1-3),
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 (col 39, ln 9-15; col 31, ln 12-16, 39-51),
setting the stimulation phase for when, from onset of inspiration in a breathing cycle of the patient, the stimulation energy is to be delivered (col 26, ln 62-64),
determining, while the patient is sleeping and based on the breathing characteristics, that the breathing characteristics have decreased below a threshold level (col 25, ln 42-46),
controlling, the stimulation amplitude at which each of the plurality of stimulation pulses is delivered (col 31, ln 56-59), wherein multiple ones of the plurality of stimulation pulses have different stimulation amplitudes (col 31, ln 56-59; col 40, ln 3-7), 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 (col 31, ln 17-36: stimulation can be started at different times closer or further from onset on inspiration to control breathing; col 27, ln 31-36; col 28, ln 7-10).
In re claim 2, Tehrani discloses wherein stimulation phase is at a delay time that is, within the breathing cycle of the patient, prior to onset of inspiration (col 31, ln 17-18).
In re claim 4, Tehrani discloses wherein each one of the plurality of stimulation pulses are a bi-phasic pulse pairs or mono-phasic pulses (col 32, ln 1-2).
In re claim 5, Tehrani discloses wherein each of the plurality of stimulation pulses are in one of
a stimulation burst ramp portion (fig 12C: ramp portion: the diagonal line from the dashed line to the plateau portion),
a stimulation burst plateau portion (fig 12C: plateau portion: the horizontal line connecting the top of the ramp portion and the fall portion), and
a stimulation burst fall portion (fig 12C: fall portion: the vertical line from the end of the plateau portion),
wherein the stimulation burst ramp portion, the stimulation burst plateau portion, and the stimulation burst fall portion are each included in a stimulation train (fig 12C: each of the ramp, plateau, and fall portions are included in a train of pulses).
In re claim 15, see above (In re claim 1).
In re claim 17, see above (In re claim 5).
In re claim 20, see above (In re claim 1) and the following limitations:
a controller that includes at least one hardware processor that is configured to perform operations (col 16, ln 33-34) comprising:
synchronizing delivery of the stimulation energy to a natural respiratory cycle of the patient (col 26, ln 62-64) with a phase delay that is selected to improve ventilation of the patient (col 31, ln 17-21 and ln 47-48), and
selecting values for one or more parameters of the stimulation energy (col 31, ln 56-67) to capture the phrenic nerve as a result of stimulation thereof (col 31, ln 52-55).
Claim Rejections - 35 USC § 102/103
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.
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 8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tehrani (US 11, 266,838).
In re claim 8, Tehrani discloses wherein the stimulation burst plateau portion is shorter than the stimulation burst ramp portion (fig 12C: the burst ramp portion is longer than the burst plateau portion).
Additionally, insofar as this is not explicitly disclosed, even if Tehrani fails to disclose the recited limitation it would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide wherein the stimulation burst plateau portion, ramp portion, and fall portion can be modified to be shorter or longer than the other portions 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 10, Tehrani discloses wherein the stimulation burst ramp portion is longer than the stimulation burst fall portion (fig 12C: the ramp portion is longer than the fall portion).
Additionally, see above (In re claim 8).
In re claim 11, Tehrani discloses wherein a rate of change of amplitude over the stimulation burst ramp portion is lower than a rate of change of amplitude over the stimulation burst fall portion (col 29, ln 52-54; col 31, ln 58-59; fig 12C: the stimulation burst shows the ramp up and down of amplitude, the ramp portion takes longer to increase amplitude than the fall portion takes to decrease the amplitude, so the rate of change of amplitude for the stimulation burst ramp portion is lower).
It would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide wherein a rate of change of amplitude can be modified to be lower or higher than the stimulation burst ramp or fall portion 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 12, Tehrani discloses wherein a stimulation frequency at which the plurality of stimulation pulses of a given stimulation train are delivered is between 10Hz and 140Hz (col 31, ln 61-63).
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.
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.
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani (US 11,266,838).
In re claim 3, Tehrani lacks wherein the delay time is between 150 milliseconds prior to onset of inspiration to 120 milliseconds after the onset of inspiration.
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.
Additionally, Tehrani discloses wherein the delay time is prior to the onset of inspiration (col 31, ln 17-18) and is adjustable (fig 14B: D1, D2, D3). At the time the instant application was filed it would be obvious to try to provide wherein the delay time is between 150 milliseconds prior to the onset of inspiration to 120 milliseconds after the onset of inspiration. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed range of delay time is a known result yielding parameter in the art as also shown by Tehrani adjusting the delay time and since the claimed range is not disclosed as being crucial or unexpected.
In re claim 16, see above the proposed combination yielded In re claim 3.
Claims 6-7, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani (US 11,266,838) in view of Erickson (US 5,549,655).
In re claim 6, Tehrani lacks wherein the stimulation burst ramp portion occurs over a period of between 0.2 seconds to 1 second.
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.
Erickson teaches a device for treating sleep apnea (col 1, ln 8-10) that has a stimulation pulse with a stimulation rise time of 250ms, or 0.25s, a stimulation fall time of 125ms, or 0.125s (col 8, ln 24-29), and a total stimulation burst time of less than 2.5s (col 12, ln 9-11).
At the time the instant application was filed it would be obvious to try to provide the duration of the stimulation burst ramp, plateau, and fall portions to be within the specified ranges. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed range of stimulation burst ramp, plateau, and fall portion duration is not disclosed as being crucial or unexpected and Erickson teaches that the stimulation burst cannot exceed a specific duration.
In re claim 7, see above (In re claim 6)
In re claim 9, see above (In re claim 6).
In re claim 18, see above (In re claim 6 and In re claim 7).
Claims 13-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani (US 11,266,838) in view of Schulhauser et al. (US 2021/0290957).
In re claim 13, Tehrani lacks wherein a pulse width of each of the plurality of stimulation pulses of a given stimulation train is between 100 and 1000 microseconds.
Schulhauser teaches a system for delivering electrical stimulation to a phrenic nerve to treat sleep apnea [0008]. Different stimulation parameters, such as pulse width ranging from 60 to 1000 microseconds, can be used [0093].
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 Tehrani by using a pulse width between the specified range as taught by Schulhauser, as this range of pulse widths is known to be effective in stimulating the phrenic nerve for treating sleep apnea.
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.
At the time the instant application was filed it would be obvious to try to provide wherein the pulse width is between 100 and 1000 microseconds. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed range of pulse widths is not disclosed as being crucial or unexpected.
In re claim 14, Tehrani lacks wherein the stimulation amplitude of at least some of the plurality of stimulation pulses of a given stimulation train is between about 0.5 and 1.5 milli-Amperes.
Schulhauser teaches a system for delivering electrical stimulation to a phrenic nerve to treat sleep apnea [0008]. Different stimulation parameters, such as amplitude ranging from 0 mA to 3 mA, can be used [0086].
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 Tehrani by using a stimulation amplitude between the specified range as taught by Schulhauser, as this range of amplitude is known to be effective in stimulating the phrenic nerve for treating sleep apnea.
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.
At the time the instant application was filed it would be obvious to try to provide wherein the amplitude is between 0 and 1.5 mA. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed range of amplitude is not disclosed as being crucial or unexpected.
In re claim 19, see above (35 U.S.C. 102/103: In re claim 10) and the following limitations:
wherein all of the stimulation pulses in the stimulation burst ramp portion are at least 0.2milliamps, and
stimulation pulses in the stimulation burst plateau portion are between 0.5milliamps and 1.5milliamps,
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.
Tehrani discloses wherein the amplitude is ramped up and down during a stimulation burse (col 29, ln 52-54; col 31, ln 58-59), the stimulation burst ramp portion having an amplitude greater than 0 mA (fig 12C: diagonal line) and the burst plateau portion having an amplitude greater than the burst ramp portion (fig 12C: horizontal line connecting the stimulation ramp and fall portion). Schulhauser teaches having an amplitude between 0-3 mA [0086].
At the time the instant application was filed it would be obvious to try to provide wherein the stimulation pulses in the stimulation ramp portion will be at a lower amplitude than the stimulation pulses in the stimulation plateau portion with the stimulation ramp portion having an amplitude greater than 0 mA and a stimulation plateau portion having a stimulation amplitude higher than the ramp portion without exceeding the maximum possible amplitude. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed threshold for the burst ramp portion and for the stimulation plateau portion is not disclosed as being crucial or unexpected and additionally, the stimulation ramp portion provides stimulation pulses at smaller amplitude increments to avoid quick increases in amplitude that may wake the user up.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dieken et al. (US 2020/0147376) teaches a method for delivering stimulation to an upper airway nerve to treat sleep apnea (abstract) that uses sensors to sense respiratory information, including a respiratory rate [0232], and can use that information to determine an onset of inspiration and then trigger or terminate stimulation [0206].
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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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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