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 December 18, 2025 in response to the Office Action of September 24, 2025 has been acknowledged and entered. Applicant’s amendments have overcome the 112(b) rejections.
Claim Objections
Claims 1, 16, and 19 are objected to because of the following informalities:
Claim 1, line 19: “electronic amplifier of the signal” should read –an electronic amplifier that amplifies the signal”
Claim 16, line 3: “said at least one electrode modules” should read --said at least one electrode module--
Claim 19, lines 1-5 : “wherein said computer programs configured to receive in input by said control module information about a gain and offset to be used in the analog/digital conversion step, a notch frequency to be used in the signal processing and a passband of a frequency filter to be applied and to carry out the following operations” should read -- wherein said computer programs are configured to receive in input, by said control module, information about a gain and offset to be used in the analog/digital conversion step, a notch frequency to be used in the signal processing and a passband of a frequency filter to be applied and to carry out the following operations--
Claim 19, line 15: “the processing” should read --processing--
Claim 19, line 16: “said at least one control module” should read --said control module--
Appropriate correction is required.
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, 6-7, 10, and 13-17 rejected under 35 U.S.C. 103 as being unpatentable over Banerji (WO 2012161657) (previously cited) in view of Hsueh (WO 2013029196).
Regarding claim 1, Banerji teaches an integrated system for detecting and processing electromyographic signals and for controlling an actuator comprising at least a mechanical actuator and configured to carry out at least a kind of movement as a function of at least an input signal, (Figs. 7A, 8A; Page 4, line 12- Page 5, line 2; Page 21, lines 25-29; Page 72, line 13; Page 78, line 21; Page 79, line 23 orthosis system, i.e., comprising actuators and motors activated as a function of the measured EMG signals), said system comprising:
a controller (30) or control module (Fig. 8B; Page 81, line 18-Page 82, line 5) at least an electrode module (200) configured to acquire, amplify, convert and process electromyographic signals (Fig. 8B, Page 21, lines 24-29; Page 81, lines 18-25);
a supplying module (70) configured to provide an electric supply with predetermined voltage and current to said controller (30) and to said at least one electrode module (200) (Fig. 8B, Page 81, lines 26-27), said controller (30), said at least one electrode module (200) and said supplying module (70) being connected in parallel on the same bus, (Fig. 8B, Page 82, lines 2-5) wherein said electrode module (200) comprises: at least an electromyography sensor (surface EMG electrodes 210) having at least two conductive surfaces positioned on an outer side of an envelope (sleeve 220) of at least one electrode module (200), so they are in contact with skin, (See Fig. 2A; Page 51, lines 26-33, EMG sensors have, by nature, conductive surfaces in contact with the skin), configured to detect a signal on the skin deriving from muscle contraction, (Page 50, lines 12-25), and memory unit (i.e., data storage elements) on which computer programs or electrode firmware are loaded, configured to process the signal acquired by said at least one sensor (electrode). (Page 21, lines 6-13; Page 23, lines 25-32; Page 24, lines 4-7).
However, Banerji does not specifically teach an “an electronic amplifier [that amplifies] the signal detected by at least one sensor, analog/digital converter, installed on a printed circuit board contained inside the envelope of said at least one electrode module and in electric contact with an inner portion of said at least two conductive surfaces configured to convert the signals into digital signals, amplified by said electronic amplifier” and “wherein a position of the analog/digital converter is coincident with an acquisition position and in that between said at least one sensor and said analog/digital converter, filtration steps or other processing steps are not interposed, except for an amplification step of the signal”.
Hsueh, in a related field of endeavor, teaches a wearable upper limb electrical stimulation device comprising an electronic amplifier (355) (See Fig. 6A; Page 9, lines 20-22) that amplifies the signal detected by at least one sensor (myoelectric signal sensing element 20), an analog/digital converter (37), installed on a printed circuit board (See Fig. 1, block diagram of circuit) contained inside the envelope of said at least one electrode module (Fig. 1, fixing kit 60 with plurality of sensing elements) and in electric contact with an inner portion of said at least two conductive surfaces (See Fig. 4, plurality of sensing elements 20 in electric contact with an inner portion of said at least two conductive surfaces of limb 70) configured to convert the signals into digital signals, (Page 9, lines 27-29), amplified by said electronic amplifier (355). (See Fig. 6A; Page 9, lines 20-22), wherein a position of the analog/digital converter is coincident with an acquisition position (Fig. 1, analog/digital converter 37 is coincident with electromyographic signal acquisition unit 35), and in that between said at least one sensor (20) and said analog/digital converter (37), filtration steps or other processing steps are not interposed, except for an amplification step of the signal. (Fig. 1, no filtration steps or other processing steps interposed between sensor 20 and analog/digital converter 37 except for an amplification step of the signal; Page 9, lines 19-21, the EMG signal is first amplified by the instrumentation amplifier 353 and then amplified by amplifier circuit 355).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified the electrode module of Banerji to teach “an electronic amplifier [that amplifies] the signal detected by at least one sensor, an analog/digital converter, installed on a printed circuit board contained inside the envelope of said at least one electrode module and in electric contact with an inner portion of said at least two conductive surfaces configured to convert the signals into digital signals, amplified by said electronic amplifier” and “wherein a position of the analog/digital converter is coincident with an acquisition position and in that between said at least one sensor and said analog/digital converter, filtration steps or other processing steps are not interposed, except for an amplification step of the signal,” as taught by Hsueh. Doing so eliminates noise frequencies and boosts the EMG signal. (Page 9, lines 22-29).
Regarding claim 6, Banerji teaches wherein said electrode firmware is also configured to receive in input by said control module (10) and by means of a communication module, information about a sampling frequency of the signal by said at least one sensor (21) and a sending frequency of the signal.
Regarding claim 7, Banerji teaches wherein said electrode firmware is configured to compare a shape of said at least one frequency spectrum of the signal detected by said at least one sensor with a shape of at least a reference frequency spectrum. (Page 28, line 24 – Page 29, line 6).
Regarding claim 10, Banerji teaches wherein said system comprises a plurality of electrode modules, which can be arranged in different positions to each other, with no mutual positioning constraints. (See Fig. 2C; Page 50, plurality of electrode modules 210).
Regarding claim 13, Banerji teaches wherein said control module comprises: control of memory unit on which the computer programs are loaded; digital communication interface to communicate with other electrodes, and at least an output of analog or digital kind for the control of the actuator; communication module to communicate with an external processor means where respective computer programs are loaded configured to allow a user to communicate with said control module by means of a suitable user interface. (Page 28, lines 9-21).
Regarding claim 14, Banerji teaches wherein said control module (Fig. 8B; Page 81, line 18-Page 82, line 5) controls directly said actuator (Figs. 7A, 8A; Page 4, line 12- Page 5, line 2; Page 21, lines 25-29; Page 72, line 13; Page 78, line 21; Page 79, line 23 orthosis system, i.e., comprising actuators and motors activated as a function of the measured EMG signals), providing the same with both a control signal and the power needed for supplying the mechanical actuator included in said actuator (Page 72, lines 23-28 by way of one or more flexible drive shafts 512 that are configured to transfer or deliver mechanical power), and in that said control module is configured for electronic control of at least a power actuator and respective computer programs (Fig 7A, motor mechanism 510).
Regarding claim 15, Banerji teaches wherein said system comprises also an outer controller (Page 73, lines 15-16 mechanical power interface module 530) configured to receive input analog and/or digital signals, and to provide the actuator with control signals and the power needed to said mechanical actuator and wherein said control module is configured to control said outer controller. (Page 73, lines 16-26).
Regarding claim 16, Banerji teaches wherein said computer programs loaded on said control module are configured for: recording basal signals acquired by said at least one electrode module during a muscle rest condition of a user, adapting acquisition parameters of the analog/digital converter on the printed circuit board of said at least one electrode module and digital filtering parameters, so that the signal-to-noise ratio is improved for said at least one electrode module as a function of the recorded basal signals. (Page 29, lines 8-26).
Regarding claim 17, Banerji teaches wherein said at least one sensor comprises an electromyography sensor, comprising at least two electrodes (210) configured to detect a difference of potential between two distinct skin regions. (See Fig. 2C).
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Lu (CN 106491128) (previously cited).
Regarding claim 3, Banerji as modified does not teach “wherein said at least one electrode module comprises also temperature sensors and/or humidity sensors, configured to detect temperature and humidity relating to the skin region where at least one electrode module is positioned, and in that said memory unit are also configured to acquire and process the signals detected by said temperature sensors and/or humidity sensors.”
Lu, in a related field of endeavor, teaches wherein said at least one electrode module (Fig. 1) comprises also temperature sensors (2) and/or humidity sensors (4), (Abstract), configured to detect temperature and humidity relating to the skin region where said at least one electrode module is positioned, (Page 5, lines 23-27), and in that said memory unit are also configured to acquire and process the signals detected by said temperature sensors and/or humidity sensors (via circuit board 8). (Fig. 5; Page 7, lines 1-7).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein said electrode module comprises also temperature sensors and/or humidity sensors, configured to detect temperature and humidity relating to the skin region where the electrode is positioned, and in that said electronic means are also configured to acquire and process the signals detected by said temperature sensors and/or humidity sensors” as taught by Lu. Doing so ensures a steady and precise electromyography signal. (Abstract).
Regarding claim 11, Banerji as modified does not teach “wherein all the components of said at least one electrode module are enclosed inside the envelope with waterproof and powder resistance features and apt to guarantee its functioning without damage even in presence of natural humidity, splashes or sweating.”
Lu teaches wherein all the components of said at least one electrode module (Fig. 5, circuit board 8) are enclosed inside an envelope with waterproof and powder resistance features (Fig. 5, shell 1) and apt to guarantee its functioning without damage even in presence of natural humidity, splashes or sweating. (Page 4, lines 14-26).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein all the components of said at least one electrode module are enclosed inside an envelope with waterproof and powder resistance features and apt to guarantee its functioning without damage even in presence of natural humidity, splashes or sweating” as taught by Lu. Doing so ensures measurement of a stable and accurate electromyographic signal. (Page 4, lines 16, 22).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Harshbarger (WO 2012141714) (previously cited).
Regarding claim 8, Banerji as modified does not teach “wherein said firmware is also configured to detect a presence of peaks under 10 Hz of frequency indicating the presence of electrode-skin movements and to send a respective warning signal to said control module.”
Harshbarger, in a related field of endeavor, teaches wherein said electrode firmware is also configured to detect a presence of peaks under 10 Hz of frequency (Fig. 34) indicating a presence of electrode-skin movements and to send a respective warning signal to said control module. (Fig. 34 is magnitude plot 3400 of four band pass filters usable to separate each channel into different frequency bands before average power of each band is calculated, such as in feature extraction. In FIG. 34, pass bands are between 1-4 Hz, 6-15 Hz).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein said electrode firmware is also configured to detect a presence of peaks under 10 Hz of frequency indicating a presence of electrode-skin movements and to send a respective warning signal to said control module” of Harshbarger. Doing so ensures a steady and precise electromyography signal. (Abstract).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Herrala (WO 2016207471) (previously cited).
Regarding claim 9, Banerji as modified does not teach “wherein said electrode firmware is configured to detect periodically a central frequency of said at least one frequency spectrum, and to send a warning signal to said control module in case said central frequency decreases over time.”
Herrala, in a related field of endeavor, teaches a system for measuring muscle signals, (Abstract), wherein said electrode firmware is configured to detect periodically a central frequency of said at least one frequency spectrum, (Page 12, lines 5-31 spectral analysis, detection of central frequency), and to send a warning signal to said control module in case said central frequency decreases over time. (Page 14, lines 11-20).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein said electrode firmware is configured to detect periodically a central frequency of said at least one frequency spectrum, and to send a warning signal to said control module in case said central frequency decreases over time” of Herrala. Doing so provides feedback that may be used to optimize training and exercise to match one's target. (Page 11, lines 12-14).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Brockway (WO 2005104779).
Regarding claim 12, Banerji as modified teaches wherein said supplying module (70) comprises at least a rechargeable electric battery, provided with a suitable connector for a recharge by means of connection to an electric network (Page 81, lines 26-27), but does not specifically teach “by means of a common outer voltage transformer with respect to the supplying module.”
Brockway, in a related field of endeavor, teaches an implantable medical device for measuring EMG signals, (Paragraph [0075]), comprising a rechargeable battery, provided with a suitable connector for a recharge by means of a common outer voltage transformer with respect to the supplying module. (Paragraph [0083]; Fig. 20A, 20B, show the recharging of an implantable medical device 800 by transformer coupling energy from a recharging device 820 located outside the body to a coil located inside the implantable medical device 800).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein said supplying module comprises at least a rechargeable electric battery, provided with a suitable connector for a recharge by means of connection to an electric network by means of a common outer voltage transformer with respect to the supplying module” as taught by Brockway. Doing so provides drive circuitry that would create a charging current for the rechargeable battery. (Paragraph [0083]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Yang (CN 108670244) (previously cited).
Regarding claim 18, Banerji as modified does not teach “wherein said at least one sensor comprises a force myography sensor, comprising a capacitive pressure sensor configured to measure a pressure exerted on said at least one electrode module by muscle under a skin region where said at least one electrode module is installed.”
Yang, in a related field of endeavor, teaches a physiological monitoring device wherein said at least one sensor comprises a force myography sensor, comprising a capacitive pressure sensor configured to measure a pressure exerted on said at least one electrode module by muscle under a skin region where said at least one electrode module is installed. (Page 14, lines 39-41 of Machine Translation).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “wherein said at least one sensor comprises a force myography sensor, comprising a capacitive pressure sensor configured to measure a pressure exerted on said at least one electrode module by muscle under a skin region where said at least one electrode module is installed” of Yang. Doing so provides a mechanism for additional processing of the electromyography signals.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Banerji in view of Hsueh, further in view of Jiang (CN 110141239) (previously cited).
Regarding claim 19, Banerji as modified does not teach “wherein said computer programs configured to receive in input by said control module information about a gain and offset to be used in the analog/digital conversion step, a notch frequency to be used in the signal processing and a passband of a frequency filter to be applied and to carry out the following operations: acquiring the signals detected by said at least one sensor and converting the signals into digital signals by said analog/digital converter; obtaining at least a frequency spectrum relative to said signals acquired at point; carrying out notch operations on said signals by eliminating from each signal frequencies relative to possible interferences deriving from the electric supply; carrying out frequency filtering operations on said signals, by applying predetermined amplitude band-pass filters; transmitting the signal obtained through the processing of the previous points to said at least one control module.”
Jiang, in a related field of endeavor, teaches said computer programs being configured to receive in input by said control module information about the gain and offset to be used in the analog/digital conversion step, (Paragraph [0088]), the notch frequency to be used in the signal processing (Paragraphs [0022], [0134]), and the passband of the frequency filter (Paragraph [0088]) to be applied and to carry out the following operations: acquiring the signals detected by said at least one sensor and converted in digital ones by said analog/digital conversion means (Paragraph [0088]); obtaining at least a frequency spectrum relative to said signals acquired at point (Paragraph [0088]); carrying out notch operations on said signals by eliminating from each signal the frequencies relative to possible interferences deriving from the electric supply (Paragraphs [0022], [0134]); carrying out frequency filtering operations on said signals, by applying predetermined amplitude band-pass filters (Paragraph [0088]); transmitting the signal obtained through the processing of the previous points to said at least one control module (Paragraph [0086]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing data to have modified Banerji as modified to provide “said computer programs being configured to receive in input by said control module information about the gain and offset to be used in the analog/digital conversion step, the notch frequency to be used in the signal processing and the passband of the frequency filter to be applied and to carry out the following operations: acquiring the signals detected by said at least one sensor and converted in digital ones by said analog/digital conversion means; obtaining at least a frequency spectrum relative to said signals acquired at point; carrying out notch operations on said signals by eliminating from each signal the frequencies relative to possible interferences deriving from the electric supply; carrying out frequency filtering operations on said signals, by applying predetermined amplitude band-pass filters; transmitting the signal obtained through the processing of the previous points to said at least one control module” as taught by Jiang. Doing so provides a system that can eliminate common-mode interference and amplify the signal. (Paragraph [0088]).
Response to Arguments
Applicant's arguments filed 12/18/25 with respect to the 103 rejection have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Hsueh is relied upon.
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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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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