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
The amendment filed on 07/27/2026 has been acknowledged. Claims 1-2, 4-6, and 8-19 remain pending in the application and are under examination.
Response to Arguments
Applicant’s arguments filed 07/27/2026 have been fully considered but are not persuasive or are moot.
Applicant’s traversal of 35 U.S.C. 112(b) rejection, In re claim 12 is moot as the claim has been amended to overcome the previous rejection.
Applicant argues, regarding 35 U.S.C. 103 Rejection, In re claim 1, that the references are structurally incompatible and lack direct parallel channel topology. Applicant argues that neither DiUbaldi nor Rami Murillo suggests connecting two independent generators in parallel to a single transmission/reception channel as recited in amended claim 1.
Examiner respectfully disagrees. As described in the Non-Final Rejection submitted on 04/28/2026, DiUbaldi discloses wherein the first connection terminal and second connection terminal are connected to said transmission terminal, as well as a reception channel and Rami Murillo discloses wherein the second and fourth connection terminals are connected to said reception channel, the references yield the limitation “in that the first connection terminal and the third connection terminal are connected to said transmission channel and in that the second connection terminal and the fourth connection terminal are connected to said reception channel”. In response to Applicant's argument the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As described in 35 U.S.C. 103 Rejection, In re claim 1, for safely removing the voltage from the tissue. Further, the claims do not preclude an upstream analog amplitude modulator mixing the signals prior to (an) electrode(s). See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). 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., independent generators connected to a single transmission/reception channel) are not recited in the rejected claim(s). 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).
Applicant argues that the low-frequency signal of DiUbaldi would act as an electrical short circuit across the output of the high-frequency generator if applied to the parallel transformer coupled circuit as described in claim 1.
Examiner respectfully disagrees. 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., parallel transformer coupled circuit) are not recited in the rejected claim(s). 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).
Applicant argues that the references teach away from the combination due to the incompatibility of the clinical and electrical methodologies of the references. Applicant argues that Rami Murillo’s therapeutic purpose is to perform targeted, moderate diathermy on very small localized spots and does not supply the claimed fusion of two different therapeutic energies into a single active-electrode circuity while DiUbaldi aims for a non-thermal deep transdermal neurostimulation using time-multiplexed signal packages and that the combination of the two would completely disrupt Rami Murillo’s control unit, making it impossible to measure and balance the localized currents which would defeat the clinical purpose of Rami Murillo and electrically short-circuit DiUbaldi’s high frequency carrier.
Examiner respectfully disagrees. In response to Applicant's argument that combining Rami Murillo and DiUbaldi would defeat the purpose of Rami Murillo and short-circuit DiUbaldi’s high frequency carrier, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). For the purposes of the rejection, Examiner has relied on Rami Murillo to provide “wherein a return electrode receives a signal from active electrodes and is connected to first and second voltage generators, via terminals analogous to the recited second and fourth connection terminals” (Non-Final Rejection 04/28/2026), and does not rely on Rami Murillo for the specific details of dynamically shifting the phases of its generators nor for the for the focus on diathermy. Examiner notes that Rami Murillo is being used to modify DiUbaldi, therefore this combination does not rely on the clinical purpose of Rami Murillo, and it would not affect the clinical purpose of the proposed system. Regarding the assertion that such a modification would short-circuit DiUbaldi’s high frequency, as these modifications are not incorporating features of Rami Murillo that would contribute to a short-circuit event, Examiner asserts the high frequency of proposed combination would not short-circuit.
Claim Interpretation
While not necessarily unclear, it is conceivable that the following terms could be interpreted in ways other than the manner in which they are interpreted herein. Accordingly, Examiner seeks correction or confirmation of the following claim interpretations.
In reclaim 10, the limitation "of the pulse type" will be interpreted as requiring a frequency like that illustrated in FIG. 3B, i.e., one that exhibits a pulse wave type pattern.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1, the limitations “a first frequency” on line 17 and “a second frequency” on line 20 are unclear as they appear to refer back to the first frequency and the second frequency, respectively, which were previously recited in the claim on lines 2 and 4. It is unclear if these limitations are attempting refer to the previous recitations or if they are presenting a new instance of a first frequency and a second frequency. For purposes of examination, the claims will be interpreted as best understood in light of the specification as referring to the previous frequencies such that they read “the first frequency” and “the second frequency”.
In re claim 19, the limitations “a first frequency” on line 13 and “a second frequency” on line 14 are unclear, see above 35 U.S.C. 112(b) Rejection, In re claim 1, substantially the same reasoning applied.
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 1–12, 19 are rejected under U.S.C. 103 as being unpatentable over DiUbaldi (US 8165695) in view of Rami Murillo (US 20170001004) and Jia (CN 209301693).
In re claim 1, DiUbaldi discloses an electrotherapy device (Fig. 1a: 100) comprising:
a first voltage-generating module (104, 106, 108a, 206)
configured to generate a first voltage having a first frequency (Col. 3, ln. 29-31: “second waveform generator adapted to generate a carrier waveform having a second frequency”; voltage is inherent due to the waveform, frequency, overall electrotherapy device) and
comprising
a first connection terminal (206) and
a second voltage-generating module (107, 109, 108b, 216)
configured to generate a second voltage having a second frequency strictly higher than the first frequency (Col. 8, ln. 57-59: “fourth waveform generator 109 may also be included that generates a fourth carrier waveform 214 having a frequency different from the second carrier waveform”; note: if the frequency of the fourth and second carrier waveforms are different, one frequency must be higher than the other, for the purposes of examination the fourth frequency is considered higher than the second), and
comprising
a third connection terminal (216) and wherein the device comprises:
a transmission channel (108c and output of 108c),
a reception channel (Col. 3, ln. 49: “a return electrode for receiving the signal package”, i.e. voltage; it is inherent that there is a reception channel in the return electrode), and
in that the first connection terminal and the third connection terminal are connected to said transmission channel (Fig. 1a: 206 and 216 connect to 108c) and
a control unit (Col. 10, ln. 27-59; Fig. 3: 312) configured to simultaneously:
control the first voltage-generating module to generate the first voltage at a first frequency (Col. 3, ln. 29-31; col. 10, ln. 27-59;),
control the second voltage-generating module to generate the second voltage at a second frequency (Col. 8, ln. 57-59; col. 10, ln. 27-59;),
the control unit being configured to generate in the transmission channel a signal (output of modulation in 108c; col. 8, ln. 57-67 and col. 9, ln. 1-8) associating
a sinusoidal voltage at the first frequency modulated by a third frequency (Col. 3, ln. 62-64; Fig. 2b: 216; col. 8, ln. 65-67 and col. 9, ln. 1-2; modulator Fig. 1a: 108a) and
a sinusoidal voltage at the second frequency modulated by a fourth frequency (sinusoidal curve in Fig. 2b: 216; col. 9, ln. 2-5; modulator Fig 1a: 108b),
the signal being the sum of the voltage of the first generating module and of the voltage of the second generating module (Col. 9, ln. 5-8; output of modulation in 108c).
DiUbaldi lacks:
a second connection terminal,
a fourth connection terminal,
in that the second connection terminal and the fourth connection terminal are connected to said reception channel,
wherein the first frequency is comprised in a first frequency interval between 1 kHz and 10 kHz, wherein the second frequency is comprised in a second frequency interval between 100 kHz and 10 MHz
Rami Murillo discloses an analogous electrotherapy device (abstract) wherein a return electrode (Fig. 2: 20) receives a signal from active electrodes (Fig. 2: 26 and 25 pass through human tissue onto 20) and is connected to first and second voltage generators, via terminals analogous to the recited second and fourth connection terminals (Fig. 2: 20 is connected to voltage generators 251 and 261).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device disclosed by DiUbaldi by providing wherein the return electrode is connected to the two voltage generators as taught by Rami Murillo as it would complete the circuit (Rami Murillo [0052]), allowing the voltage to return to both the generators, and safely remove the current from the tissue of the patient preventing damage. Such a modification would yield “a second connection terminal, a fourth connection terminal, and in that the second connection terminal and the fourth connection terminal are connected to said reception channel”.
Jia discloses a neuromuscular electrical stimulator (abstract) that, like the electrotherapy device disclosed by DiUbaldi, discloses a frequency signal modulated by another frequency signal wherein the modulated signal is output (Pg. 1, ln. 49-56) which then provides stimulation to muscles of a patient (Pg. 4, ln. 19-23) and discloses a control module for the modulation of the signals (Pg. 1, ln. 49-53). In addition, Jia discloses wherein a high frequency signal (Pg. 4, ln. 35-36: between 500 kHz-2MHz) is modulated with medium/intermediate (Pg. 4, ln. 38-39: between 1-10KHz) and low (Pg. 4, ln. 36-38: between 1-120 Hz or 300-700 Hz) frequency modulated signals.
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device disclosed by the DiUbaldi by providing wherein a high frequency signal (between 500KHz – 2MHz) is modulated by medium (between 1-10KHz) and low (between 1-120 Hz or 300-700 Hz) frequency signals as taught by Jia because it allows the device to have the functions of both low to medium frequency neuromuscular stimulation and high frequency electric temperature and thermal effect (Pg. 1, ln. 43-46) wherein the high frequency signals enter deep into the human body, such as muscles and blood vessels, and can reduce inflammation and analgesia with a warming effect, and can also be applied to beauty, body sculpting, and muscle (Pg. 4, ln. 19-23) and the low and medium/intermediate frequencies mainly act on superficial tissues such as skin and subcutaneous fat (Pg. 4, ln. 21-22).
The proposed combination of DiUbaldi, Rami Murillo, and Jia would yield an electrotherapy device comprising: a first voltage-generating module configured to generate a first voltage having a first frequency and comprising a first connection terminal and a second connection terminal, a second voltage-generating module configured to generate a second voltage having a second frequency strictly higher than the first frequency and comprising a third connection terminal and a fourth connection terminal, wherein the first frequency is comprised in a first frequency interval between 1 kHz and 10 kHz, wherein the second frequency is comprised in a second frequency interval between 100 kHz and 10 MHz, wherein the device comprises: a transmission channel, a reception channel, and in that the first connection terminal and the third connection terminal are connected to said transmission channel and in that the second connection terminal and the fourth connection terminal are connected to said reception channel, and a control unit configured to simultaneously: a. control the first voltage-generating module to generate the first voltage at a first frequency, and b. control the second voltage-generating module to generate the second voltage at a second frequency, the control unit being configured to generate in the transmission channel a signal associating a sinusoidal voltage at the first frequency modulated by a third frequency and a sinusoidal voltage at the second frequency modulated by a fourth frequency, the signal being the sum of the voltage of the first generating module and of the voltage of the second generating module.
In re claim 2, DiUbaldi discloses wherein the first voltage-generating module is configured to generate a sinusoidal voltage (Fig. 2b: 214; col. 3, ln. 63-64).
In re claim 4, DiUbaldi wherein the first voltage-generating module is configured to generate a sinusoidal voltage (Fig. 2b: 216) of the first frequency modulated by the third frequency (Fig. 1a: 108a; col. 8, ln. 65-67 and col. 9, ln. 1-2).
In re claim 5, DiUbaldi discloses wherein the third frequency is approximately 20 Hz (Col. 3, ln. 58-59).
DiUbaldi lacks wherein the third frequency is comprised in a third frequency interval between 1 Hz and 150 Hz.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the third frequency is comprised in a third frequency interval between 1 Hz and 150 Hz, 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 re claim 6, DiUbaldi wherein the second voltage-generating module is configured to generate a sinusoidal voltage (Fig. 2b: 214; col. 9, ln. 2-5).
In re claim 8, DiUbaldi discloses wherein the second voltage-generating module is configured to generate a sinusoidal voltage of the second frequency modulated by the fourth frequency (Fig. 2b: 216; Col. 9, ln. 2-5).
In re claim 9, DiUbaldi discloses wherein the fourth frequency is approximately 10 Hz (Col. 3, ln. 59-60).
DiUbaldi lacks wherein the fourth frequency is comprised in a fourth frequency interval between 1 Hz and 150 Hz.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the fourth frequency is comprised in a fourth frequency interval between 1 Hz and 150 Hz, 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 re claim 10, DiUbaldi discloses wherein the fourth frequency is of the pulse type (See Claim Interpretation – In re claim 10; col. 3, ln. 62-63; Fig. 2b: top waveform).
In re claim 11, DiUbaldi discloses wherein the second voltage-generating module comprises an activation command configured to generate a pulse sinusoidal voltage at the fourth frequency (Col. 10, ln. 27-59; col. 9, ln. 2-5; Fig. 2: 210; it is inherent that an activation command must be driving voltage generation).
In re claim 12, DiUbaldi discloses the device according to claim 1, wherein the first voltage-generating module comprises a transmission command configured to transmit the voltage of the first generating module at the third frequency (Col. 10, ln. 27-59; col. 8, ln. 65-67 and col. 9, ln. 1-2; it is inherent that a transmission command is behind the transmission of the first voltage, where the first frequency is modulated by the third frequency).
In re claim 19, see above (In re claim 1).
Claims 13-14, 16-18 are rejected under U.S.C. 103 as being unpatentable over DiUbaldi (US 8165695) in view of Rami Murillo (US 20170001004) and Jia (CN 209301693) in view of Bluvshtein (US 20180256242).
In re claim 13, DiUbaldi lacks wherein
the first generating module comprises a first transformer having a first inductance and
the second generating module comprises a second transformer having a second inductance.
Bluvshtein discloses a medical device for controlling a therapeutic voltage applied to a patient [0016] wherein generator comprises a transformer to amplify the signal (e.g. voltage) ([0039]; it is inherent that the transformer would have its own inductance).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device of the proposed combination by providing a transformer having an inductance to each of the generating modules as this would allow for both the first and second frequency to be input into the transformer, amplifying any weak signals. The inductances at each transformer would differ as each transformer would be corresponding to voltages with different frequencies. Such a modification would yield “the first generating module comprises a first transformer having a first inductance and the second generating module comprises a second transformer having a second inductance”.
In re claim 14, DiUbaldi lacks wherein the second generating module comprises
an output filter comprising
an LC circuit comprising
a coil and
a capacitor.
Bluvshtein discloses a medical device for controlling a therapeutic voltage applied to a patient [0016] wherein the circuitry comprises a filter (Fig. 5: 524) to filter a signal (e.g. voltage), wherein the filter comprises a LC circuit comprising an inductor (i.e. coil) and a capacitor [0039].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device of the proposed combination by providing wherein the second generating module comprises and output filter comprising an LC circuit of a coil and a capacitor as the filter can receive a square wave signal (i.e. pulse) and output a sinusoidal waveform to the patient (Bluvshtein [0022]).
In re claim 16, DiUbaldi lacks wherein the control unit is configured to vary the impedance in the transmission channel responsive to the control unit controlling the first voltage-generating module to generate the first voltage at a first frequency.
Bluvshtein discloses a medical device for controlling a therapeutic voltage applied to a patient [0016] wherein the controller monitors the impedance and alters the voltage as a part of an impedance feedback loop [0043, 0065].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device of the proposed combination by providing wherein the control unit is configured to vary the impedance in the transmission channel responsive to the first voltage-generating module generating the first voltage at a first frequency as it would allow for the controller to determine the voltage and power to deliver to the tissue at a particular impedance in response to current conditions (Bluvshtein [0017]).
In re claim 17, DiUbaldi lacks wherein the ratio of the first inductance and second inductance is greater than 500.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the ratio of the first inductance and second inductance is greater than 500, 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 re claim 18, DiUbaldi lacks wherein the ratio of the first inductance and second inductance is greater than 1000.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the ratio of the first inductance and second inductance is greater than 1000, 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.
Claim 15 is rejected under U.S.C. 103 as being unpatentable over DiUbaldi (US 8165695) in view of Rami Murillo (US 20170001004) and Jia (CN 209301693) in view of Bluvshtein (US 20180256242) in view of Von Novak (US 20170207824).
In re claim 15, DiUbaldi lacks wherein the output filter comprises a resonant capacitor for resonating at the second frequency of the second generating module.
Von Novak discloses an apparatus for receiving wireless power on a user worn medical device [0003] wherein a circuitry comprises resonant capacitors to tune to a specific frequency which can be combined with tuned circuits (i.e. LC circuits) [0051].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the electrotherapy device of the proposed combination by providing wherein the output filter comprises a resonant capacitor resonating and the second frequency of the second generating module as it would allow the filter to specifically target a higher frequency and filter out other frequencies while working to maintain a fixed voltage (Von Novak [0051]).
Potential Allowable Subject Matter
To ensure compact prosecution, Examiner notes that addition of structural features described in the argument “connecting two independent generators of different frequency ranges directly in parallel to a single transmission/reception channel” to emphasize that the connectional terminals (first, second, third, and fourth connection terminals) are each connected to an output of the independent generators (first voltage-generating module and second voltage-generating module) may place the claims in condition for allowance, subject to additional search and consideration.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
