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 .
Response to Amendment
This Action is in response to the Amendment filed February 19, 2026.
Claims 2-3, 9, 16, and 20 are amended.
Claims 2-4, 9-13, and 15-36 are pending.
Response to Arguments
Applicant’s arguments, see the middle of page 14 of the Amendment, filed 02/19/2026, with respect to the rejection of claim 16 have been fully considered and are persuasive. The rejections of claims 16-24 have been withdrawn.
Applicant's arguments filed 02/19/2026 regarding the rejections of claims 2-4, 9-11, and 33-36 have been fully considered but they are not persuasive.
Applicant argues that the new limitations: “a socket coupled with the radiofrequency generator and the electric current” and “a flexible connector configured to be connected to the socket” are not known in the prior art. The Examiner disagrees.
While the instant specification describes a flexible connector in paragraph [0257] and the main unit as having sockets where each socket is configured to connect one specific pad and/or applicator for a specific treatment area in paragraph [0259], the claimed socket embodiment “coupled with a radiofrequency generator and the electric current generator” is not supported in the instant application, nor is the embodiment illustrated as required. Moreover, the use of a flexible cable/connector and sockets were well-known to those skilled in the art before the effective filing date of the claimed invention as shown in Fig. 1 of US Patent No. 9,008,793 to Cosman, Sr. to provide energy to multiple electrodes (e.g., column 7, lines 12-33 of Cosman). Thus, one of ordinary skill in the art would have recognized the benefits of using sockets to couple a radiofrequency generator and electric current in view of the teachings of Cosman. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza so that it has a socket coupled to a radiofrequency generator and a socket coupled to the electric current generator, in view of the teachings of Cosman that sockets and flexible cables are well-known engineering expedients (electrical connectors) in the medical art.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., removably connected, plug-in connector, latch configured for repeated use) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner further notes the removability/repeated use feature is not supported by the originally filed specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the socket coupled to the RF generator and electric current generator and the flexible connector connected to the socket must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-4, 9-13, 15, and 33-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the instant specification describes a flexible connector in paragraph [0257] and the main unit as having sockets where each socket is configured to connect to one specific pad and/or applicator for a specific treatment area in paragraph [0259], the claimed socket embodiment “coupled with a radiofrequency generator and the electric current generator” is not supported in the instant application, nor is the embodiment illustrated so it is unclear the inventor or a joint inventor had possession of the claimed invention at the time the application was filed.
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.
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 2-4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2012/0271206 to Shalev et al. (hereinafter referred to as “Shalev”) in view of US Patent Application Publication No. 2019/0134414 to Prouza et al. (hereinafter referred to as “Prouza”), US Patent No. 9,008,793 to Cosman, Sr. et al. (hereinafter referred to as “Cosman”) and legal precedent.
Regarding claim 2, Shalev discloses a device for a non-invasive treatment of a patient (e.g., title of the invention: non-invasive fat removal), comprising: a radiofrequency (RF) generator having an output power (e.g., Fig. 5, RF Generator 510) and configured to generate radiofrequency energy having a frequency in a range of 100 kHz to 550 MHz (e.g., paragraph [0033]: the AC signal output by the RF generator is a low current signal with a frequency between 0.5 MHz-1MHz, which is within the claimed range); an electric current generator configured to generate pulsed electric current (e.g., Figs. 4-5, Electric Pulse generator 520) comprising pulses having a duration in a range of 0.1 µs to 10 s (e.g., paragraphs [0033], [0040]: electric pulse 610 of 100 microseconds is provided after a RF signal 620 is applied where the sequence is applied receptively); a coupling/connector coupling the radiofrequency generator and the electric current generator (e.g., paragraph [0033] and Fig. 5, a coupling/connection occurs at either/both of RF Generator 510 and EP Generator 520); an applicator (e.g., Fig. 5, applicator 540) configured to be coupled to the radiofrequency generator and the electric current generator (see Fig. 5), and configured to be attached to a body part of a patient, the applicator comprising: a coupling/connector configured to be connected to the coupling/connector coupled with the RF generator and the EP generator (e.g., paragraphs [0033]-[0035]: applicator 540 applies the actions described above that include providing an AC current in the form of a RF electrical pulse for heating the user’s skin, providing low current DC pulse signals to cause the muscles to expand and contract – thus, the applicator 540 is connected to the coupling/connector of the RF generator and the EP generator via control board 530); an electrode configured to apply the pulsed electric current to the body part (e.g., paragraphs [0032]-[0037]: applicator 110 includes one or more heads/electrodes 115 that serve as massage contacts that contact a patient’s skin as shown in Fig. 4) to cause a muscle contraction of a muscle within the body part (e.g., paragraph [0007]: method includes electrical muscle stimulation (EMS) to contract the muscles below the heated area (e.g., paragraphs [0012] and [0031]: RF energy heats the user’s skin at the adipose layer and EMS flow contracts the muscles below the heated adipose layer), wherein the applicator is further configured to apply the radiofrequency energy to the body part to heat the body part (e.g., paragraphs [0007], [0012], and [0033]); and a control unit configured to control the radiofrequency generator and the electric current generator according to the one or more treatment protocols (e.g., paragraph [0033]: paragraph [0033]: control board 530 determines the actions of the device, such as the duration, intensity, frequency and other parameters of the electrical pulses for stimulating muscles and controlling the RF energy 130 of Fig. 4 to heat the adipose layer; Fig. 5, control board 530).
Shalev differs from the claimed invention in that 1) it does not expressly disclose that a user interface configured to allow an operator of the device to select one or more treatment protocols for treatment of the patient, nor does Shalev expressly disclose 2) a flexible connector coupled to the coupling/connector/socket.
However, with respect to 1, Prouza, in the non-invasive treatment of a patient art (e.g., abstract and paragraph [0002]: noninvasive, aesthetic automated radio-frequency treatment device and method for treating soft tissue), teaches an applicator with two energy sources (e.g., paragraph [0012]: treatment results may be enhances with a combination of treatment RF energy with another type of treatment energy, such as electric current) and a user interface adapted to allow an operator of the device to select one or more treatment protocols for treatment of the patient (e.g., paragraphs [0083] and [0085]: user interface 101 may be used for selection of a treatment protocol where control unit 103 may be able to change parameters of delivered treatment energy to the patient body based on treatment protocol incorporated in the user interface). Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized the benefits of a user interface to allow the operator to select treatment protocols for treatment of the patient in view of the teachings of Prouza. Consequently, one of ordinary skill in the art would have modified the dual energy source applicator of Shalev so that its control unit has a user interface that allows an operator to select one or more treatment protocols for treatment of the patient in view of the teachings of Prouza that such were well-known engineering expedients in the non-invasive aesthetic treatment art, and because the combination would have yielded predictable results.
With respect to 2), the use of a flexible cable/connector and sockets were well-known to those skilled in the art before the effective filing date of the claimed invention as shown in Fig. 1 of Cosman to provide energy to multiple electrodes (e.g., column 7, lines 12-33 and Fig. 1 of Cosman where Fig.1 shows bendable/flexible cables 24, 27, 31, 34 that are received in sockets/jacks). Thus, one of ordinary skill in the art would have recognized the benefits of using sockets to couple a radiofrequency generator and electric current in view of the teachings of Cosman. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza so that it has a socket coupled to a radiofrequency generator and a socket coupled to the electric current generator, in view of the teachings of Cosman that sockets and a flexible cable connecting the applicator to the control board/electrical connector/socket are well-known engineering expedients (electrical connectors) in the medical art.
Shalev in view of Prouza differs from the claimed invention in that the combination does not expressly teach the range of power output by the radiofrequency generator. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Shalev so that its radiofrequency generator has an output power in a range of 0.1 W to 400 W, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] (In addition, see MPEP 2144.05).
With respect to claim 3, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 2, wherein the applicator further comprises: a conductive lead connecting the electrode with the flexible connector (e.g., Fig. 5 of Shalev: electrode 570 is connected to the EP generator 520; paragraph [0130] of Prouza: electrodes may be formed by conductive wire or system of wires, by a conductive plate). Accordingly, one or ordinary skill in the art before the effective fling date of the claimed invention would have recognized the benefits of a connector coupling generators to the applicator as taught by Shalev and Prouza. Consequently, one of ordinary skill in the art would have modified the device for non-invasive treatment of Shalev in view of Prouza, Cosman, and legal precedent to have a connector coupling the generators to the applicator and a conductive connector providing electrical communication of the applicator to the treatment device/electrode of the combination as taught by Shalev, Prouza, and Cosman to be well-known engineering expedients in this art, and because the combination would have yielded predictable results.
As to claim 4, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 2, wherein the electrode is further configured to apply the radiofrequency energy to the body part to heat the body part (e.g., paragraph [0007] of Shalev: area of the adipose layer of the skin is heated by the RF energy), wherein the radiofrequency energy is applied in pulses having a duration in a range of 0.5 ms to 5 s (e.g., paragraph [0040] of Shalev: RF energy signal may be shorter than the duration of the electric pulse and thus is a pulse of 100 microseconds), and wherein the radiofrequency energy and the pulsed electric current are applied sequentially (e.g., paragraph [0040] of Shalev: the sequency is applied repetitively - electric pulse 610 for 100 microseconds (0.1 ms) and then RF pulse for RF signal for a duration of 9ms).
Referring to claim 9, Shalev discloses a device for a non-invasive treatment of a patient, comprising: a radiofrequency generator having an output power (e.g., Fig. 5, RF Generator 510) and configured to generate radiofrequency energy having a frequency in a range of 400 kHz to 80 MHz (e.g., paragraph [0033]: the AC signal output by the RF generator is a low current signal with a frequency between 0.5 MHz-1MHz, which is within the claimed range); an electric current generator (e.g., Figs. 4-5, Electric Pulse generator 520) configured to generate pulsed electric current comprising pulses having a duration in a range of 0.1 µs to 10 s (e.g., paragraphs [0033], [0040]: electric pulse 610 of 100 microseconds is provided after a RF signal 620 is applied where the sequence is applied receptively); a coupling/connector coupling the radiofrequency generator and the electric current generator (e.g., paragraph [0033] and Fig. 5, a coupling/connection occurs at either/both of RF Generator 510 and EP Generator 520);an applicator (e.g., Fig. 5, applicator 540) configured to be coupled to the radiofrequency generator and the electric current generator (see Fig. 5), and configured to be attached to a body part of a patient during a treatment (e.g., paragraphs [0032]-[0037]: applicator 110 includes one or more heads/electrodes 115 that serve as massage contacts that contact a patient’s skin as shown in Fig. 4), the applicator comprising: a coupling/connector configured to be connected to the coupling/connector coupled with the RF generator and the EP generator (e.g., paragraphs [0033]-[0035]: applicator 540 applies the actions described above that include providing an AC current in the form of a RF electrical pulse for heating the user’s skin, providing low current DC pulse signals to cause the muscles to expand and contract – thus, the applicator 540 is connected to the coupling/connector of the RF generator and the EP generator via control board 530); a radiofrequency electrode configured to apply the radiofrequency energy to the body part to heat the body part (e.g., paragraphs [0008] and [0032]-[0037]: applicator 110 includes one or more heads/electrodes 115 that serve as massage contacts that contact a patient’s skin as shown in Fig. 4); and an electrotherapy electrode configured to apply the pulsed electric current to the body part to cause muscle contraction of a muscle within the body part (e.g., paragraphs [0007]-[0008]: method includes electrical muscle stimulation (EMS) to contract the muscles below the heated area; [0012] and [0031]: RF energy heats the user’s skin at the adipose layer and EMS flow contracts the muscles below the heated adipose layer); and a control unit configured to control the radiofrequency generator and the electric current generator according to the one or more treatment protocols (e.g., paragraph [0033]: control board 530 determines the actions of the device, such as the duration, intensity, frequency and other parameters of the electrical pulses for stimulating muscles and controlling the RF energy 130 of Fig. 4 to heat the adipose layer; Fig. 5, control board 530).
Shalev differs from the claimed invention in that it does not expressly disclose 1) a user interface configured to allow an operator of the device to select one or more treatment protocols for treatment of the patient; and 2) a fastening mechanism configured to attach the applicator to the body part. However, Prouza, in the non-invasive treatment of a patient art (e.g., abstract and paragraph [0002]: noninvasive, aesthetic automated radio-frequency treatment device and method for treating soft tissue), teaches an applicator with two energy sources (e.g., paragraph [0012]: treatment results may be enhances with a combination of treatment RF energy with another type of treatment energy, such as electric current) and a user interface adapted to allow an operator of the device to select one or more treatment protocols for treatment of the patient (e.g., paragraphs [0083] and [0085]: user interface 101 may be used for selection of a treatment protocol where control unit 103 may be able to change parameters of delivered treatment energy to the patient body based on treatment protocol incorporated in the user interface). Prouza also teaches its applicator may be fixed to the patient (e.g., paragraph [0120] of Prouza). Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized the benefits of a user interface to allow the operator to select treatment protocols for treatment of the patient and a fastening mechanism to fix /attach the applicator to the body part in view of the teachings of Prouza. Consequently, one of ordinary skill in the art would have modified the dual energy source applicator of Shalev so that its control unit has a user interface that allows an operator to select one or more treatment protocols for treatment of the patient and a fastening mechanism to fix/attach the applicator to the body part in view of the teachings of Prouza that such were well-known engineering expedients in the non-invasive aesthetic treatment art, and because the combination would have yielded predictable results.
Shalev in view of Prouza differs from the claimed invention in that the combination does not expressly teach a flexible connector coupled to the coupling/connector. However, Cosman, in a related art: multiple electrode radiofrequency generator, teaches that the use of a flexible cable/connector and jacks/sockets was well-known to those skilled in the tissue treating art before the effective filing date of the claimed invention as shown in Fig. 1 of Cosman to provide energy to multiple electrodes (e.g., column 7, lines 12-33 and Fig. 1 of Cosman where Fig.1 shows bendable/flexible cables 24, 27, 31, 34 that are received in sockets/jacks). Thus, one of ordinary skill in the art would have recognized the benefits of using sockets to couple a radiofrequency generator and electric current in view of the teachings of Cosman. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza so that it has a socket coupled to a radiofrequency generator and a socket coupled to the electric current generator, in view of the teachings of Cosman that sockets and a flexible cable connecting the applicator to the control board/electrical connector/socket are well-known engineering expedients (electrical connectors) in the medical art.
Shalev in view of Prouza and Cosman differs from the claimed invention in that the combination does not expressly teach the range of power output by the radiofrequency generator. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Shalev in view of Prouza so that its radiofrequency generator has an output power in a range of 0.1 W to 400 W, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] (In addition, see MPEP 2144.05).
With respect to claim 10, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 9, wherein the electrotherapy electrode has a surface area in a range of 0.5 cm2 to 50 cm2, and wherein a distance between the radiofrequency electrode and the electrotherapy electrode is in a range of 0.7 mm to 30 mm. However, the above combination teaches an electrotherapy electrode, but not the surface area of the electrode; and a RF electrode where both on the applicator, but not the distance between the two types of electrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Shalev in view of Prouza, Cosman, and legal precedent within the specified range of surface area of the electrotherapy electrode and to modify the distance between the two types of electrodes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Claims 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev in view of Prouza, Cosman, and legal precedent as applied to claim 2 above, and further in view of US Patent Application Publication No. 2018/0085580 to Perez et al. (hereinafter referred to as “Perez).
With respect to claim 33, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 2, wherein the applicator further comprises a pad having a surface area in a range of 1 cm2 to 50 cm2, the pad configured to be attached to the body part and wherein the electrode is coupled to the pad and has a surface area in a range of 1 cm2 to 25 cm2 (e.g., Figs. 2A-C and paragraph [0793] of Perez: electrodes extend from housing 213 into pads 220 …the electrode surface area ranges from 0.1 inches2 to 10 inches2). Thus, Perez teaches to one of ordinary skill in the art a pad having a larger surface area than an electrode surface area where the electrode surface area ranges from 0.0254 cm2 to 25.4 cm2. With respect to the specific surface areas of the pad and the electrode, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Shalev in view of Prouza, Cosman, legal precedent, and Perez to have those surface areas within the specified range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Accordingly, one of ordinary skill in the art would have recognized the benefits of an applicator pad having surface area greater than that of the surface area of the electrode coupled to the pad in view of the teachings of Perez, as modified by In re Aller. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza, Cosman, and legal precedent to have the features of claim 33 in view of the teachings of Perez that such and electro-dermal patch was effective in a transcutaneous electrical stimulation device, and because the combination would have yielded predictable results.
With respect to claim 35, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 33, but does not expressly disclose that the applicator has a pad having a thickness in a range of 0.01 mm to 15 mm, and wherein the pad has a stiffness in a range of shore OO10 to shore D80 and comprises a polyimide film, polytetrafluoroethylene, polyethylene terephthalate, epoxy, polyamide, polyethylene foam, silicone, or fabric. However, Perez in the non-invasive stimulation (transcutaneous electrical stimulation) art teaches a flexible electro-dermal patch 500 comprising a housing 530, which is in electrical communication with electrode contacts 535, is within a range of 2 to 4 mm above the skin surface and a polyimide layer/film 540 that is semi-rigid (e.g., paragraphs [0823]-[0825] of Perez) and that the electro-dermal patch 500 has overmold portions 505, 510 that are flexible and have a hardness/stiffness in a range of 30 to 70 on the sub-zero shore scale (e.g., paragraphs [0825] and [0827] of Perez). With respect to the specific thickness of the patch and the specific shore value, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Shalev in view of Prouza, Cosman,, legal precedent and Perez to have a thickness and shore value within the specified range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Accordingly, one of ordinary skill in the art would have recognized the benefits of a pad having a thickness between 0.01 mm to 15 mm and having a shore value between OO10 to shore D80 in view of the teachings of Perez as modified by In re Aller. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza, Cosman, and legal precedent to have the features of claim 7 in view of the teachings of Perez that such and electro-dermal patch was effective in a transcutaneous electrical stimulation device, and because the combination would have yielded predictable results.
As to claim 36, Shalev in view of Prouza, Cosman, legal precedent and Perez teaches the device of claim 35, wherein the pad is banana shaped with at least one curvature but does not expressly teach the dimensions of the curvature in a range of 0.002 mm-1 to 10 mm-1, and wherein a distance between the electrode and an edge of the pad is in a range of 0.1 mm to 10 mm. Prouza further teaches that one or more electrodes may have different sizes and shapes that influence the size of the treated area and that the shapes of the electrodes may be asymmetrical or at least partially symmetrical (e.g., Prouza paragraphs [0130]: electrodes influence the size of the treated area; [0267] and Fig. 14B: the treatment area can be banana shaped). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pad curvature of the device of the above combination to be within the specified range and the location of the electrode of the combination to be within the specified range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233]. In addition, the curvature would depend upon the patient and the area of the patient being treated; and the originally-filed specification does not indicate advantages of the specific dimensions of the curvature or the distance between the electrode and the edge of the pad.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev in view of Prouza, Cosman, and legal precedent as applied to claim 9 above, and further in view of US Patent Application Publication No. 2022/0008244 to Hart et al. (hereinafter referred to as “Hart”).
With respect to claim 11, Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 9, but does not expressly teach that the one or more treatment protocols comprises a protocol for treatment of sleep apnea or snoring, and wherein the muscle comprises at least one of mylohyoid muscle, stylohyoid muscle, geniohyoid muscle, digastric muscle, platysma muscle, or genioglossus muscle. However, Hart teaches, in a related art: improving air intake by stimulating the genioglossus muscle of the tongue, that it was known in the art to electrically stimulate the genioglossus of the tongue to improve muscle strength and to alleviate sleep apnea (e.g., paragraphs [0008], [0060] of Hart). Accordingly, one of ordinary skill in the art would have recognized the benefits of electrically stimulating the genioglossus muscle to treat sleep apnea in view of the teachings of Hart. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza, Cosman, and legal precedent so that one or more treatments includes a protocol for treating sleep apnea by stimulating the genioglossus muscle in view of the teachings of Hart that such was effective in strengthening facial and throat muscles, and because the combination would have yielded predictable results.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev in view of Prouza, Cosman, legal precedent as applied to claim 2 above, and further in view of Hart.
Shalev in view of Prouza, Cosman, and legal precedent teaches the device of claim 2, but does not expressly teach that the one or more treatment protocols comprises a protocol for treatment of sleep apnea or snoring, and wherein the muscle comprises at least one of mylohyoid muscle, stylohyoid muscle, geniohyoid muscle, digastric muscle, platysma muscle, or genioglossus muscle. However, Hart teaches, in a related art: improving air intake by stimulating the genioglossus muscle of the tongue, that it was known in the art to electrically stimulate the genioglossus of the tongue to improve muscle strength and to alleviate sleep apnea (e.g., paragraphs [0008], [0060] of Hart). Accordingly, one of ordinary skill in the art would have recognized the benefits of electrically stimulating the genioglossus muscle to treat sleep apnea in view of the teachings of Hart. Consequently, one of ordinary skill in the art would have modified the device of Shalev in view of Prouza, Cosman, and legal precedent so that one or more treatments includes a protocol for treating sleep apnea by stimulating the genioglossus muscle in view of the teachings of Hart that such was effective in strengthening facial and throat muscles, and because the combination would have yielded predictable results.
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.
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Claims 2-4 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,679,255 in view of Shalev, Prouza, and Cosman.
Instant claims 2 and 9 are encompassed by and conflict with claim 1 of the ‘255 patent, except for the radiofrequency generator and the electric current generator taught by Shalev (power range of RF generator obvious in view of In re Aller), the user interface and specific body part, which are taught by Prouza as discussed in paragraph 12 above, and the socket and flexible connector in view of the teachings of Shalev and Cosman as discussed above in paragraph 12. One of ordinary skill in the art would have modified the device of the ‘255 patent to have those features because they are well-known engineering expedients in the medical art.
The features of claims 3-4 and 10 are rendered obvious by the teachings of Shalev and/or Schwarz as discussed in paragraph 7 with respect to claims 3-4, and 10. Hence, instant claims 3-4 and 10 are encompassed by and conflict with claim 1 of the ‘255 patent as modified by Shalev and Prouza.
Claims 35-36 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,679,255 in view of Shalev, Prouza, Cosman and Perez. The features of claims 35-36 and 33 are rendered obvious by the teachings of Shalev, Prouza and Perez as discussed in paragraph 13 with respect to claims 35-36, and 33. Hence, instant claims 35-36, and 33 are encompassed by and conflict with claim 1 of the ‘255 patent as modified by Shalev, Prouza, and Perez.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,679,255 in view of Shalev, Prouza, and Hart.
The features of claim 11 are rendered obvious by the teachings of Hart as discussed in paragraph 14 with respect to claim 11. Hence, instant claim 11 is encompassed by and conflict with claims 1 of the ‘255 patent as modified by Shalev, Prouza, and Hart.
Claims 25 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 10, 13-14, and 16-22 of U.S. Patent No. 11,679,255 in view of Shalev, Axelgaard, and Prouza.
Instant claim 25 is encompassed by and conflicts with claim 14 of the ‘255 patent, except for the generator configured to generate an electric current taught by Shalev as above, the applicator of Shalev can be a pad with a flexible substrate, electrotherapy electrode coupled to the underside of the flexible substrate and a connector coupled to the pad to provide the pulsed electric current from the generator of Shalev as taught by Axelgaard in paragraph 10 of the Office Action dated 11/20/2025 and the user interface taught by Prouza as discussed in paragraphs 7 and 10 of the Office Action dated 11/20/2025. One of ordinary skill in the art would have modified the device of the ‘255 patent to have those features for the reasons indicated in paragraphs 7 and 10.
Alternatively, instant claim 25 is encompassed by and conflicts with claim 22 of the ‘255 patent, except for the generator configured to generate an electric current taught by Shalev and the connector coupling the pad with the generator taught by Axelgaard in paragraph 10 of the Office Action dated 11/20/2025. One of ordinary skill in the art would have modified the device of the ‘255 patent to have those features for the reasons indicated in paragraph 10.
The features of claim 32 are rendered obvious by the teachings of Shalev as discussed in paragraph 11 of the Office Action dated 11/20/2025 with respect to claim 19. Hence, instant claim 32 is encompassed by and conflicts with claim 22 of the ‘255 patent as modified by Shalev, Axelgaard, and Prouza.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 or 22 of U.S. Patent No. 11,679,255 in view of Shalev, Axelgaard, Prouza, and Perez. As discussed above, claims 14 and 22 of the ‘255 patent encompass and conflict with instant claim 25. Claim 26 adds “wherein a stiffness of the flexible substrate is in a range of shore OO30 to shore A100 (see rationale for modifying device with shore value in paragraph 8 above) and a surface area of the pad is in a range of 1 cm2 to 50 cm2 (e.g., Figs. 2A-C and paragraph [0793] of Perez: electrodes extend from housing 213 into pads 220 …the electrode surface area ranges from 0.1 inches2 to 10 inches2). Thus, Perez teaches to one of ordinary skill in the art a pad having a larger surface area than an electrode surface area where the electrode surface area ranges from 0.0254 cm2 to 25.4 cm2).
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 or 22 of U.S. Patent No. 11,679,255 in view of Shalev, Axelgaard, Prouza, and Charlesworth.
Instant claim 27 is encompassed by and conflicts with claims 14 or 22 of the ‘255 patent, as modified above w/r/t claim 25, except for the features of claim 27.
The features of claim 27 are rendered obvious by the teachings of Shalev and Charlesworth as discussed in paragraph 8 of the Office Action dated 11/20/2025 with respect to claim 17. Hence, instant claim 27 is encompassed by and conflicts with claims 14 or 22 of the ‘255 patent as modified by Shalev, Axelgaard, Prouza, and Charlesworth.
Allowable Subject Matter
Claims 16-24 are allowed.
Claims 28-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The Examiner notes that claims 25-27 and 32 are rejected on the ground of double patenting, and would be allowable upon the filing of a proper terminal disclaimer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792