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 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.
Claim(s) 1, 3-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schwarz et al. (U.S. Patent Application Publication No. 2023/0191111) hereinafter referred to as Schwarz.
Regarding claim 1, Schwarz teaches a device for treating sleep apnea, comprising:
a stand (the examiner is relying upon a plain and simple definition provided by Merriam-Webster, see attached references: “a frame on or in which something may be placed for support”, therefore, frame element 801, Fig. 9I)
a chin and neck support (¶[0086] support interpreted as pad, 4, in Fig. 3A chin pad, also usable on neck ¶[0177], ¶[0179], and ¶[0198] lower lip and neck combined therefore chin and neck, see also ¶¶[0121-0131] which teach a variety of additional support materials such as a rigid mask which can comprise any of the shapes of the pads and have the active elements integrated therein);
an applicator integrated into the chin and neck support configured to provide High-Intensity Focused Electromagnetic Technology (HIFEM) therapy and Radio Frequency (RF) therapy (¶[0024], ¶¶[0201-0202] active elements/electrodes elements 13 provide RF energy and electric current, including provided by a coil ¶[0136], ¶¶[0138-0139]); and
a control panel configured to adjust an intensity of the delivered HIFEM and RF therapies in real-time (¶[0165] control unit enabling adjustment of treatment parameters of each active element and providing information to the operator, and human machine interface), wherein the applicator is configured to provide HIFEM therapy by delivering HIFEM energy to a patient’s mouth, throat, and neck (¶[0198] lower lip and neck combined therefore mouth, chin, and neck) to stimulate and strengthen muscles associated with the patient’s breathing (¶[0014], ¶[0137], muscles “associated with breathing” includes any muscles targetable in the mouth, chin, and neck, see also ¶[0200] “configured for treatment of the sleep apnea and/or snoring” with the submentum pad disclosed in ¶[0198] combined with a neck pad) and wherein the applicator is further configured to provide RF therapy by delivering RF energy to reduce fat tissue in the patient’s airway (¶[0147] fat removing with the RF therapy, ¶[0177]).
Regarding claim 3, Schwarz as modified teaches the device of claim 1.
Schwarz teaches further comprising: one or more HIFEM and RF generators, each HIFEM generator configured to generate HIFEM energy for providing the HIFEM therapy to the patient’s mouth, throat and neck, and each RF generator configured to generate RF energy for providing RF therapy to the patient’s airway (¶[0024], ¶¶[0201-0202] active elements/electrodes elements 13 provide RF energy and electric current, including provided by a coil ¶[0136], ¶¶[0138-0139], ¶[0200]).
Regarding claim 4, Schwarz as modified teaches the device of claim 1.
Schwarz further teaches wherein the applicator is configured to deliver the HIFEM and RF energy concurrently to the muscles and fat tissues in the airway of the user of the device (¶[0147], ¶[0370] simultaneous energy delivery).
Regarding claim 5, Schwarz as modified teaches the device of claim 1.
Schwarz further teaches wherein the chin and neck support is selected based on the length and width of the user’s neck and jaw to enhance the user’s comfort and the effectiveness of treatment (¶[0176], replicating shapes of underlying anatomy ¶[0205]).
Regarding claim 6, Schwarz as modified teaches the device of claim 4.
Schwarz further teaches wherein applicator is configured to concurrently deliver the HIFEM energy pulsed at between 1Hz to 500 Hz (¶[0138]) with a continuous application of RF energy in the range of 1 MHz to 3 MHz (¶[0066]).
Regarding claim 7, Schwarz as modified teaches the device of claim 1.
Schwarz further teaches wherein the chin and neck support and the applicator are each curved to maintain a uniform distance to the neck throughout an HIFEM and RF energy application zone (¶[0128] avoid deflection of the pads by supporting the pads conformally against the skin of the user using rigid or semi rigid additional supports).
Regarding claim 8, Schwarz as modified teaches the device of claim 1.
Schwarz further teaches wherein the control panel comprises a patient-operated button configured to terminate the delivery of the HIFEM and RF energy, when the patient experiences discomfort during treatment (¶[0073] emergency stop button for heat sensitive patients).
Regarding claim 9, Schwarz as modified teaches the device of claim 1.
Schwarz further teaches wherein the applicator is configured to deliver the HIFEM energy and RF energy for a duration of 10 to 30 minutes long, depending on the patient’s comfort level (¶[0384]).
Regarding claim 10, 12, the claim is directed to a method comprising substantially the same subject matter as claims 1, 3-5, 8 and are rejected under substantially the same sections of Schwarz.
Schwarz additionall teaches adjusting the intensity of the delivering of the HIFEM energy and the RF energy based on the patient’s comfort (¶[0073] stopping treatment adjusts the intensity to zero), using the control panel to treat the patient’s sleep apnea (¶[0200]).
Regarding claims 11, Schwarz as modified teaches the method of claim 10.
Schwarz further teaches wherein the delivering of the HIFEM energy is pulsed at between 1Hz to 500 Hz (¶[0138]) with the delivering of a continuous application of RF energy in the range of 1 MHz to 3 MHz (¶[0066]) for 30 minutes (¶[0384]).
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(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al. (U.S. Patent Application Publication No. 2023/0191111) hereinafter referred to as Schwarz.
Regarding claim 2, Schwarz as modified teaches the device of claim 1.
Schwarz teaches a portion of the chin and neck support configured to support the patient’s neck and a portion of the chin and neck support configured to support the patient’s jaw during treatment (¶[0176]).
Schwarz therefore teaches all of the claimed invention except for the chin and neck support comprising a “stem” and “seat” portion.
However, Schwarz teaches that the sizes and shapes of all the support should be configured for individual patient comfort in ¶[0176] and contemplates a “T shape” in ¶[0181], replicating shapes of underlying anatomy ¶[0205].
Applicant does not disclose any criticality to the stem and seat configuration of the chin and neck support in the Specification filed 7/16/2024.
Therefore, the examiner considers that it would have been obvious to one of ordinary skill in the art at the time of filing to modify the chin and neck support of Schwarz to comprise a stem and seat portion, because courts have held that changes in shape, size, or proportion are generally considered obvious unless they produce a new and unexpected result or solve a specific problem in a non-obvious way. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al. (U.S. Patent Application Publication No. 2023/0191111) hereinafter referred to as Schwarz; in view of Kayyali et al. (U.S. Patent No. 8,545,416) hereinafter referred to as Kayyali.
Regarding claim 13, Schwarz as modified teaches the method of claim 10.
Schwarz does not teach further comprising: treating the patient’s sleep apnea using a Continuous Positive Airway Pressure device.
Attention is brought to the Kayyali reference, which teaches multi-modal sleep apnea treatment including both of functional electrical stimulation and a CPAP (col. 34, lines 30-51).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Schwarz to include an additional treatment modality, such as a CPAP taught by Kayyali, because Kayyali teaches that multiple modalities improve treatment of a sleeping disorder (Kayyali col. 3, lines 5-19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2021/0298817 to Schwarz et al. teaches RF and HIFEM energy in combination using a handheld applicator.
WIPO International Publication No. WO 2025/076581 to Jafarzadeh teaches HIFEM stimulation to the palate regions within the mouth to treat snoring and sleep apnea.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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