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 .
Priority
This action is a national stage entry under 35 USC 371 of PCT/EP2022/050690 filed 13 January 2022, which claims the benefit of domestic priority from US Provisional Application no. 63/199,618 filed 13 January 2021.
Election/Restrictions
Applicant's election with traverse of Group I, pertaining to claims 1-6 and 19 in the reply filed on 16 January 2026 is acknowledged. The traversal is on the ground(s) that the process and product made are not materially distinct. The requirement has been reconsidered in light of the preliminary amended filed 16 January 2026 linking the Groups II-V to Group I.
The requirement is therefore WITHDRAWN.
Claims 1-11, 13-16, 18, and 19 are pending.
Claim Objections
Claim 8 is objected to because of the following informalities: lines 4 recites “applying an communication”, wherein it is recommended to change “an” to “a”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant).
In regard to claim 1, Hogg et al. discloses a device 195 (an electrodermal patch) for providing electrical stimulation to a user (relying on specific embodiment of figures 1F described at para 812), comprising:
a conductive medium 183 configured to apply electrical stimulation to a user (para 812, electrode 183 supplies electrical stimulation pulses from pulse generator 187);
a receiver 182, configured to receive a directed wireless signal (para 812, transceiver 182 receives signal 197 and is considered to be capable of receiving a wireless telemetry signal directed to it by device 198); and
a processor 193, configured to: interpret the received signal 197; and initiate electrical stimulation via the conductive medium 183 based on the interpreted signal (para 812, a microcontroller 193 of device 195 interprets a signal 197 from external device 198 to generate a plurality of electrical stimulation pulses to be output by the pulse generator 187).
In regard to claim 2, Hogg et al. teaches that the conductive medium 183 (i.e., the electrodermal patch 195) is embedded within a garment, optionally wherein the garment comprises a strap, sleeve, wrap, or item of clothing (para 822, electro-dermal patch device 195 is incorporated into a form fitting garment such as a tight undershirt (for example, a Body Glove, Lycra or Spandex undershirt) which when worn by the user)).
In regard to claim 3, Hogg et al. teaches that the conductive medium 183 comprises an electrode, optionally a carbon electrode or a hydrogel electrode (para 812, the conductive medium is the electrode 183 which is in physical connection with a hydrogel pad).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Schwarz et al. (US Publication no. 2018/0093095 – disclosed by Applicant).
In regard to claim 4, Hogg et al. substantially discloses the invention as claimed, however does not teach that the conductive medium is configured to apply an electrical stimulation causing a haptic sensation in the user and/or wherein the interpreted signal is configured to instruct an electrical stimulation causing a haptic sensation in the user. Schwarz et al. is directed to a transcutaneous electrical stimulation system comprising structure and functions similar to Hogg et al. Schwarz et al. is configured to provide an electrical stimulation pulse that is perceptible by the user (para 6). It is considered to have been obvious to one of ordinary skill in the art to modify the electrical stimulation pulses to provide a haptic sensation to the user in order to provide a sensory experience with the stimulation.
Claim(s) 5-7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402).
In regard to claim 5, Hogg et al. is considered to substantially disclose the invention as claimed, however does not teach that the receiver is configured to receive signals from certain directions and not from others. In Hogg et al., the transceiver 114/182 is configured to receive signals directed to it from external device 105/198, wherein the transmission may be IR based (para 793, transceiver 114 wirelessly communicates with external device 105 and is considered to be capable of receiving a wireless telemetry signal directed to it by device 105; para 794, communication between device 105 and transceiver 114 may communicate using infrared and is therefore considered suggestive that any data transmissions type may be suitably employed to transmit information between the companion devices and transceivers), though does not teach limiting the direction from which the signal is received. Hogg et al. does teach that use of specific encoding or antenna configurations can be used to avoid undesired signals from being received by the receiver caused unintended stimulation, but does not teach directionality as recited by the claims (para 1741). Baker et al. is directed to infrared data transmission and communication. Baker et al. teach that it is known that use of IR carries signal on a beam of light having a frequency in the infrared portion of the frequency spectrum and operates on a line of sight between two devices communicating via IR (col 12 lines 13-32). This requires that the two devices communicating over an IR signal be generally aligned in the same direction as each other. This is construed to mean that IR signal communication necessarily requires directed signals that only permit receipt of signals from certain directions and not from others. Additionally, IR signal communication provides an advantage of providing for low power consumption for signal transmission. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify IR communication between the transceiver 114 and external device 105 of Hogg et al. to receive signals from certain directions and not from other directions since Baker et al. teaches that this feature is well-known in IR signal communications and provides the benefit of preventing receipt of communication from unauthorized or unwanted sources that may inadvertently energize device 110, and also permits transmission of data signal with low power. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 6, Hogg et al. as modified in view of Baker et al. would configured the receiver to receive the directed wireless signal only when the receiver has direct line-of-sight of a transmitter of the directed wireless signal (Baker et al. col 12 lines 13-32 explicitly teaches that IR beams require line of sight alignment and directionality between communication devices).
In regard to claim 7, Hogg et al. disclose a system comprising:
a first device 195 for providing electrical stimulation to a user according to claim 1 (device 195, described above with respect to claim 1);
a second device 198 (para 812, figure 1F) for transmitting an electrical stimulation program to the first device 195 (para 812, external device 198 wirelessly directs a signal 197 to transceiver 182 of device 195, and in turn, to the microcontroller 193 and pulse generator 187 which generates a plurality of electrical pulses),
the second device 198 comprising:
a processor, configured to encode an electrical stimulation program into a wireless signal (device 198 is considered similar to device 105 described in para 792 contains a computer readable medium and processor; in a similar device 192 of para 811, the external device 192 comprises the power source and controller adapted to generate an electrical signal, power signal, or data signal 196 that is wirelessly transmitted to transceiver 182 and, in turn, to the pulse generator 187 and used by the pulse generator 187 to generate a plurality of electrical pulses; in this manner, the external devices 192/198 are considered capable of encoding the electrical stimulation signal into a wireless signal).
However, Hogg et al. does not teach a directional transmitter, configured to transmit the signal in one or more specific directions and not in other directions. In Hogg et al., the transceiver 114/182 is configured to receive signals directed to it from external device 105/198, wherein the transmission may be IR based (para 793, transceiver 114 wirelessly communicates with external device 105 and is considered to be capable of receiving a wireless telemetry signal directed to it by device 105; para 794, communication between device 105 and transceiver 114 may communicate using infrared and is therefore considered suggestive that any data transmissions type may be suitably employed to transmit information between the companion devices and transceivers), though does not teach limiting the direction from which the signal is received. Hogg et al. does teach that use of specific encoding or antenna configurations can be used to avoid undesired signals from being received by the receiver caused unintended stimulation, but does not teach directionality as recited by the claims (para 1741). Baker et al. is directed to infrared data transmission and communication. Baker et al. teach that it is known that use of IR carries signal on a beam of light having a frequency in the infrared portion of the frequency spectrum and operates on a line of sight between two devices communicating via IR (col 12 lines 13-32). This requires that the two devices communicating over an IR signal be generally aligned in the same direction as each other. This is construed to mean that IR signal communication necessarily requires directed signals that only permit receipt of signals from certain directions and not from others. Additionally, IR signal communication provides an advantage of providing for low power consumption for signal transmission. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify IR communication between the transceiver 182 and external device 198 of Hogg et al. to receive signals from certain directions and not from other directions since Baker et al. teaches that this feature is well-known in IR signal communications and provides the benefit of preventing receipt of communication from unauthorized or unwanted sources that may inadvertently energize device 195, and also permits transmission of data signal with low power. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 16, Hogg et al. in view Baker et al. are considered to teach a method for providing electrical stimulation to a user, comprising:
transmitting an electrical stimulation program from the second device 198 according to the system of claim 7 (para 812 of Hogg et al. an external device 198 comprises a power source and transceiver adapted to generate the power signal 197 that is wirelessly transmitted to the transceiver 182, See rejection of claim 7 for additional features of the system);
receiving the electrical stimulation program at the first device according to the system of claim 7 (para 812, in turn, to the microcontroller 193 and pulse generator 187 which generates a plurality of electrical pulses); and
providing electrical stimulation to the user according to the received electrical stimulation program (para 812, The electrical pulses are communicated to the electrode 183 and, thereafter, to the patient's epidermal layer through an optional hydrogel pad).
Baker et al. supplies the limitations for the directional transmission. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify IR communication between the transceiver 182 and external device 198 of Hogg et al. to receive signals from certain directions and not from other directions since Baker et al. teaches that this feature is well-known in IR signal communications and provides the benefit of preventing receipt of communication from unauthorized or unwanted sources that may inadvertently energize device 195, and also permits transmission of data signal with low power. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402), further in view of Sit et al. (US Publication no. 2020/0139138).
In regard to claim 8, Hogg et al. in view of Baker et al. is considered to substantially suggest the invention as claimed, however does not teach that encoding the electrical stimulation program into the signal comprises: receiving the electrical stimulation program; applying a communication protocol to the electrical stimulation program using pulse width modulation. Sit et al. teach that external devices configured to wirelessly communicate data (e.g., stimulation program configuration data) to or more other devices (in the case of Sit et al., the other device is implantable, but still considered applicable for exchange of information between devices), a transmitter is configured to perform data modulation comprising amplitude shift keying with pulse width modulation (para 87). It is therefore considered to have been obvious to one of ordinary skill in the art to encode the data transmitted between devices 198 and 195 of Hogg et al. using pulse width modulation since Sit et al. demonstrate that it was a known method for wireless transfer of information. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402), and Sit et al. (US Publication no. 2020/0139138), further in view of Klosterman et al. (US Publication no. 2005/0021108).
In regard to claim 9, Hogg et al. in view of Baker et al. and Sit et al. substantially suggest the invention as claimed, however do not teach applying a communication protocol to the electrical stimulation program using pulse width modulation comprises: selecting a carrier frequency known to both the device for transmitting the electrical stimulation program and to the device configured to provide electrical stimulation to a user; selecting a start pulse width and an end pulse width known to both the device for transmitting the electrical stimulation program and to the device configured to provide electrical stimulation to a user, wherein the start and end pulse widths are not equal; selecting a first pulse width to define a bit value of one and a second pulse width to define a bit value of zero, wherein the first and second pulse widths are not equal to one another or to the start and end pulse widths; converting the bits of the electrical stimulation program into pulses; concatenating the start and end pulses to the beginning and end, respectively, of the converted electrical stimulation program; and applying the carrier frequency to the concatenated pulses.
Klosterman et al. describe a technique for bidirectional communication between a stimulator and external device using pulse width modulation technique that includes selecting a carrier frequency (e.g., an RF link, an inductive link, or an infrared energy, para 15), setting frequencies of pulse widths with binary bits of one and zero and transmits pulses in a stream over the carrier to the target device (para 94-95, figure 23 describes techniques for a stream (i.e., concatenation) of pulse PW1 and PW2 comprising different widths and set to different bit levels in order to transmit the information over the carrier wave). In view of this, modification of Hogg et al. to incorporate pulse width modulation for encoding the signal transmitted from device 198 to device 195 is considered to have been obvious to one of ordinary skill in the art since Klosterman et al. teaches that pulse width modulation is a well-known technique for transmitting data containing signals in a simple and low power consuming manner. The modification would comprise the application of a known technique to a known device to yield predictable results.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402), further in view of Grosskopf et al. (EP 3311882).
In regard to claim 10, Hogg et al. in view of Baker et al. is considered to substantially suggest the invention as claimed, however neither reference teaches the electrical stimulation program comprises at least one of: an identifier for the device for providing electrical stimulation to a user, an identifier for transmitting an electrical stimulation program, a length of an electrical stimulation, an intensity of electrical stimulation, a type of electrical stimulation, and a delay after reception of the signal before electrical stimulation begins. Grosskopf et al. is directed to an electrical stimulation system that transmits control stimulation signals to a stimulation device over a wireless communication link, wherein the control signals may be transmitted from a remote control or other handheld device. Grosskopf et al. teaches wireless transmission of control signals to a stimulation device involves transmitting an identifier for transmitting the electrical stimulation program and set of stimulation parameters associated with the stimulation program (para 15-17 and 19). It is considered to have been obvious to one of ordinary skill in the art to modify the wireless transmission of Hogg et al. to include transmission of an identifier to identify the stimulation program in order to ensure only authorized stimulation programs are recognized and received by the stimulation device during wireless transmission in order to prevent undesired stimulation causing harm or discomfort to a user.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402) and Grosskopf et al. (EP 3311882), further in view of Schwarz et al. (US Publication no. 2018/0093095 – disclosed by Applicant).
In regard to claim 11, Hogg et al. substantially discloses the invention as claimed, however does not teach that the conductive medium is configured to apply an electrical stimulation causing a haptic sensation in the user and/or wherein the interpreted signal is configured to instruct an electrical stimulation causing a haptic sensation in the user. Schwarz et al. is directed to a transcutaneous electrical stimulation system comprising structure and functions similar to Hogg et al. Schwarz et al. is configured to provide an electrical stimulation pulse that is perceptible by the user (para 6). It is considered to have been obvious to one of ordinary skill in the art to modify the electrical stimulation pulses to provide a haptic sensation to the user in order to provide a sensory experience with the stimulation.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Brink et al. (US Publication no. 2018/0154144).
In regard to claim 13, Hogg et al. substantially describe the invention as claimed, however do not teach the system further comprising: a third device, in communication with the first and second devices via a wireless communications protocol, the third device comprising a processor configured to: receive, from the first device, data relating to the electrical stimulation applied by the conductive medium; and receive, from the second device, data relating to the transmitted signal. Hogg et al. applied above includes a first device 195 in wireless communication with a device 198 (para 812). Device 198 is similar to companion device 105 of figure 1A, wherein the companion device is configured to monitor, record, learn, and modify stimulation parameters delivered by the stimulation device 110 (para 889). These functions are considered applicable to devices 198 and 195 of figure 1F. In this manner, Hoog et al. describes a second device data relating to the electrical stimulation applied by the conductive medium. Hogg et al. also teaches that device 105/198 is configured to communicate with a third party device (including a third party application software on an external device), with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data (para 891). However, it is not clear that this third device is configured to from the first device, data relating to the electrical stimulation applied by the conductive medium; and receive, from the second device, data relating to the transmitted signal. At most, it appears that Hogg et al. permits the third device to receive data from the second device. Brink et al. is directed to a system for providing stimulation pulses to tissue. Brink et al. describe a first device 102 for providing stimulation to a user, a patient programmer 104B serving as a second device, and a clinician programmer 104A serving as a third device. Figure 1 shows that second device 104B is capable of sending and receiving data to/from first device 102, that third device 104A is capable of sending and receiving data to/from first device 102, and second device 104B is capable of sending and receiving data to/from third device 104B (para 38). Brink et al. teach that the first device is configured for receiving data relating to the electrical stimulation applied by the conductive medium/stimulation device (para 39, programmer 104A may retrieve information from IMD 102 regarding the performance device 102). Moreover, the communication channels between devices 104A, 104B, and 102 are considered capable of transmitting data containing information of any intended use. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the third party device Hogg et al. to communicate with both the external second device and directly with the stimulation device since Brink et al. explicitly discloses the configuration wherein the capability for communication in this manner would permit not only a user to control output of stimulation but to also permit a third party such as clinician oversite over the stimulation therapy. The modification would comprise the application of a known technique to a known device to yield predictable results.
In regard to claim 14, Hogg et al. in view of Brink et al. substantially suggest the invention as claimed. Brink et al. teach that the third device 104A comprises a display and is configured to record and display the data relating to the transmitted signal and/or the data relating to the electrical stimulation applied by the conductive medium (para 38). Therefore the modification to include a display on a third party device is considered obvious to one of ordinary skill in the art in view of the express teaching in Brink et al. Moreover, the third party device of Hogg et al. also has this feature (para 889, companion device 105 may be a smartphone 605 as in figure 6A).
In regard to claim 15, Hogg et al. in view of Brink et al. substantially suggest the invention as claimed. Brink et al. teaches that the wireless communications protocol is Bluetooth Low Energy utilized between devices 104A, 104B, and 102 (para 92). Therefore the modification to implement a Bluetooth communication protocol between devices is considered obvious to one of ordinary skill in the art in view of the express teaching in Brink et al. Moreover, Hogg et al. suggests that the devices utilized therein may implement Bluetooth as well (para 991 and 992).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant) in view of Baker et al. (US Patent no. 6,944,402), further in view of Klosterman et al. (US Publication no. 2005/0021108).
In regard to claim 18, Hogg et al. in view of Baker et al. substantially suggest the invention as claimed, however do not teach transmitting the electrical stimulation program comprises encoding the electrical stimulation program into an encoded wireless signal, comprising: selecting a carrier frequency; selecting a start pulse width and an end pulse width, wherein the start and end pulse widths are not equal; selecting a first pulse width to define a bit value of one and a second pulse width to define a bit value of zero, wherein the first and second pulse widths are not equal to one another or to the start and end pulse widths; converting the bits of the electrical stimulation program into pulses; concatenating the start and end pulses to the beginning and end, respectively, of the converted electrical stimulation program; and applying the carrier frequency to the concatenated pulses.
Klosterman et al. describe a technique for bidirectional communication between a stimulator and external device using pulse width modulation technique that includes selecting a carrier frequency (e.g., an RF link, an inductive link, or an infrared energy, para 15), setting frequencies of pulse widths with binary bits of one and zero and transmits pulses in a stream over the carrier to the target device (para 94-95, figure 23 describes techniques for a stream (i.e., concatenation) of pulse PW1 and PW2 comprising different widths and set to different bit levels in order to transmit the information over the carrier wave). In view of this, modification of Hogg et al. to incorporate pulse width modulation for encoding the signal transmitted from device 198 to device 195 is considered to have been obvious to one of ordinary skill in the art since Klosterman et al. teaches that pulse width modulation is a well-known technique for transmitting data containing signals in a simple and low power consuming manner. The modification would comprise the application of a known technique to a known device to yield predictable results.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hogg et al. (US Publication no. 2020/0164209 – disclosed by Applicant).
In regard to claim 19, Hogg et al. substantially discloses the invention as claimed, however does not explicitly make clear that the embodiment of figure 1F uses a directed infrared signal as the directed wireless signal. Hogg et al. does teach that communication between external device 105 and device 110 of figure 1A may be achieved by infrared radiation (para 794). In view of this, it is considered to have been obvious to one of ordinary skill in the to modify embodiment of Figure 1F to communicate via infrared radiation since it is suggested by Hogg et al. to be a suitable alternative technique for such purposes.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 23 April 2026
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