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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/3/24, 12/16/24 and 3/9/26 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 19/272,733 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 6, 8, 15 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sosa et al. (US 2014/0081369, hereinafter Sosa)
Regarding claims 1 and 21, Sosa discloses an apparatus for electrical stimulation of tissue (FIG.4A, par. 0003, 0103). The apparatus comprises a first pair of electrodes configured to contact a person (1022, 1024, FIG.10B) and to convey a first AC current between the first pair of electrodes through tissue of the person (FIG. 10B, par. 0121, 0123, 0124) and a second pair of electrodes configured to contact the person (1032, 1034, FIG.10B) and to convey a second AC current between the second pair of electrodes and through tissue of the person (FIG. 10B, par. 0121, 0123, 0124). The first pair of electrodes and the second pair of electrodes are configured to be positioned on the person such that the first AC current and the second AC current are simultaneously and bilaterally conveyed through a target tissue of the person, the first AC current and the second AC current configured to stimulate the target tissue (par. 0124 “…for System 1002 of FIG. 10B, two or more high frequency pluses with a small frequency difference (1-500 Hz) are superimposed through simultaneous stimulation, through multiple electrodes, to generate an excitation signal at a lower frequency than any of the high frequency superimposed pulse streams."). Furthermore, Sosa discloses the first AC current has a first frequency and the second AC current has a second frequency wherein the first frequency and the second frequency are both greater than 1000 Hz (FIG.10B, par. 0122). The current conveyed through the target tissue has a frequency different from the first frequency and different from the second frequency, such that the current conveyed through the target tissue has a frequency equivalent to a frequency difference between the first frequency and the second frequency, wherein the frequency difference is less than 200 Hz (par. 0124)
Regarding claim 6, Sosa discloses the first pair of electrodes and the second pair of electrodes are in one of: an interleaved configuration, a nested configuration, or a nearest neighbor configuration (nearest neighbor configuration, See FIG. 4A showing electrode pairs 142 next to each other).
Regarding claim 8, a controller 320 is configured to control/set stimulation parameters (par. 0119).
Regarding claim 15, fig. 3B shows a single, continuous housing in which the controller is housed and the electrodes are located on an exterior surface.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7, 37, 39 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Sosa in view of Toth et al. (US 2019/0134396, hereinafter Toth).
Regarding claims 7 and 37, Sosa, as described above, discloses the applicant’s basic invention, including a housing to be affixed to tissue and the electrodes being battery-powered (par. 0024) but is silent as to their being separate batteries for each pair of electrodes. Toth discloses an apparatus for electrical stimulation of tissue (see abstract) and thus is analogous art with Sosa. Toth discloses that each module may include its own battery, such that a first battery powers the first pair of electrodes and a second battery powers the second pair of electrodes, wherein the first battery does not supply power to the second pair of electrodes, and wherein the second battery does not supply power to the first pair of electrodes (various electrodes having their own power source module for various parts of the body, par. 0075 "In aspects, the physiologic monitoring system may include one or more modules, and each module may include a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, microcircuit, and an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, etc.), signal conditioning circuitry, communication circuitry, one or more sensors, or the like, configured to generate one or more signals (e.g., physiologic and/or physical signals), stimulus, etc.”). Therefore, it would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to modify Sosa to have included the method of using multiple electronic modules and separate batteries as taught by Toth since it allows for providing various, separate types of stimulation (FIG.12a)
Regarding claim 39, Toth is silent as to including the electrodes on patches. Toth further discloses at least one patch configured to adhere to skin of the person, the at least one patch comprising the first pair of electrodes and the second
pair of electrodes and at least one electrical connection configured to couple the first battery and the second battery with the at least one patch (FIG.12a, par. 0174).
Furthermore, the at least one patch comprises a first patch and a second patch, wherein the first patch comprises the first pair of electrodes, and wherein the second patch comprises the second pair of electrodes (par. 0165, Fig.12a, par. 0174). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Sosa to substitute the patches of Toth as the patches would function equivalently as the structure of Sosa.
Regarding claim 47, Sosa discloses a wireless communication system which can be used to deliver any information desired by a user (par. 0129).
Claims 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sosa in view of Mashiach et al. (US 2014/0039579, hereinafter Mashiach).
Regarding claims 9 and 26, Sosa, as described above, discloses the applicant’s basic invention but is silent as to setting the first frequency and the second frequency to a base frequency value, setting the first frequency to a different frequency value that is different from the base frequency value within a first time period in response to a determination that an event has occurred, maintaining the first frequency at the different frequency value and the second frequency at the base frequency value for a second time period after the first time period, and reverting the first frequency to the base frequency value within a third time period after the second time period. Mashiach discloses an apparatus for electrical stimulation (par. 0113) and thus is analogous art with Sosa. Mashiach discloses a controller is configured to set the parameters of the first AC current and the second AC current by: setting the first frequency and the second frequency to a base frequency value; in response to a determination that an event has occurred, setting the first frequency to a different frequency value that is different from the base frequency value within a first time period after the event; maintaining the first frequency at the different frequency value and the second frequency at the base frequency value for a second time period after the first time period; and reverting the first frequency to the base frequency value within a third time period after the second time period (i.e., change
frequency over the course of the treatment over time, par. 0193). Therefore, it would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to have modified Sosa to include the method of adjusting the treatment frequency over time as required for the treatment as taught by Mashiach since it allows for timing the frequency as per the physiological events of the subject (par. 0193).
Claims 10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sosa in view of Scheiner et al. (US 2020/0282215, hereinafter Scheiner).
Regarding claim 10, Sosa, as described above, discloses the applicant’s basic invention, including a first pair of electrodes (considered a first electrode array) and a second pair of electrodes (considered a second electrode array) but is silent as to determining a subset of the first electrode array and a subset of the second electrode array that, when activated, causes stimulation of the target tissue, activating the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes the first pair of electrodes, and activating the subset of the second electrode array without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes the second pair of electrodes. Scheiner discloses an apparatus for electrical stimulation (par. 0022) and thus is analogous art with Sosa. Scheiner discloses determining a subset of the first electrode array and a subset of the second electrode array that, when activated, causes stimulation of the target tissue, activating the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes the first pair of electrodes, and activating the subset of the second electrode array without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes the second pair of electrodes (i.e., specifically selecting required electrodes for the treatment and activate stimulation, see fig. 1 and 5 and par. 0028 "The multiple distal electrodes 30 may be used to deliver bilateral or unilateral stimulation to the GG 42 and/or the GH 46 muscles via the medial branch of the HGN or branches thereof, also referred to herein as the "medial HGN." Distal electrodes 30 may be switchably coupled to output circuitry of pulse generator 12 to enable delivery of electrical stimulation pulses in a manner that selectively activates the right and left protrusor muscles in a cyclical or alternating pattern to avoid muscle fatigue while maintaining upper airway patency. Additionally or alternatively, electrical stimulation may be delivered to selectively activate the GG 42 and/or GH 46 muscles or portions thereof during unilateral stimulation of the left or right protrusor muscles." Par. 0035 "The multiple distal electrodes 30 may be used to deliver bilateral or unilateral stimulation to the GG 42 and/or the GH 46 muscles via the medial branch of the HGN or branches thereof, also referred to herein as the "medial HGN." Distal electrodes 30 may be switchably coupled to output circuitry of pulse generator 12 to enable delivery of electrical stimulation pulses in a manner that selectively activates the right and left protrusor muscles in a cyclical or alternating pattern to avoid muscle fatigue while maintaining upper airway patency. Additionally or alternatively, electrical stimulation may be delivered to selectively activate the GG 42 and/or GH 46 muscles or portions thereof during unilateral stimulation of the left or right protrusor muscles."; par. 0038 "Bipolar electrode pairs may be selected one at a time or may be selected two or more at time to allow overlapping stimulation of two or more different portions of the protrusor muscles. Overlapping stimulation times of two portions of the protrusor muscles, for example left and right or proximal and distal may maintain a forward position of the tongue and allow a ramping up and ramping down of the electrical stimulation being delivered to two different portions of the protrusor muscles."). Therefore, it would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to have modified Sosa to include the method of selectively activating any set of electrodes as required for the treatment as per Scheiner since it allows for delivery of stimulation to different portions of the muscles of the tongue to avoid fatigue (par. 0038).
Regarding claim 12, Sosa is further silent as to including an EMG sensor to set parameters based on muscle tone. Scheiner further discloses an electromyography (EMG) sensor configured to provide sensor data, wherein the controller is further configured to determine, based on the EMG sensor data, a muscle tone of the patient and wherein the controller sets the parameters based on the muscle tone of the person (par. 0025, 0070-0073). Therefore, it would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to have modified Sosa to include an EMG sensor to set the current parameters based on muscle tone as per Scheiner since it allows for personalized delivery of stimulation to the patient to best treat the current conditions of the patient.
Regarding claim 13, Sosa is further silent as to including an EEG sensor to set parameters. Scheiner further discloses an electroencephalogram (EEG) sensor configured to provide sensor data, wherein the controller is further configured to determine, based on the EEG sensor data, a sleep state of the person (par. 0078)
and wherein the controller sets the parameters of the first AC current and the second AC current based on the sleep state of the person (par. 0079 and 0081). Therefore, it would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to have modified Sosa to include an EEG sensor to set the current parameters as per Scheiner since it allows for personalized delivery of stimulation to the patient to best treat the current conditions of the patient.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sosa in view of Srivastava et al. (US 2018/0229040, hereinafter Srivastava).
Regarding claim 14, Sosa, as described above, discloses the applicant’s basic invention, including a controller but is silent as to determining a respiration rate based on PPG sensor data and setting the stimulation parameters based on the respiration rate. Srivastana discloses an apparatus for electrical stimulation (see abstract) and thus is analogous art with Sosa. Srivastana discloses determining a sleep state of the patient for therapy parameters (abstract) and further discloses a sleep monitoring circuit 302, which represents an example of sleep monitoring circuit 202 (Fig.3, par. 0049) and
a photoplethysmography (PPG) sensor configured to provide sensor data (par. 0057). Srivastana discloses determining respiration rate based on PPG sensor data (par. 0050). It would have been obvious to a person of ordinary skill in the art before the applicant’s effective filing date to modify Sosa in to use a PPG sensor to determine the
respiration rate as per Srivastana since it allows for personalized delivery of stimulation to the patient to best treat the current conditions of the patient.
Allowable Subject Matter
Claims 16, 28, 34, 36 and 60 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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