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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 07/31/2024 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartley et al. (U.S. 2019/0009097), herein Hartley. Regarding claim 1, Hartley discloses a wearable assembly configured to generate electrical pulses for transmission to an implanted tissue stimulator, the wearable assembly comprising: a flexible band 300 configured to be worn by a patient having the implanted tissue stimulator (see Figures 6A, 7A, and 15A-19); a docking connection receptacle integral to the flexible band, wherein the docking connection receptacle is equipped with a docking connector terminal that is integral to the docking connection receptacle (see annotated Figures 18B and 19 below); a transmitting antenna 136 disposed within the flexible band and electrically coupled by wires 500 to the docking connection receptacle so as to receive electrical signals through the docking connection receptacle and transmit one or more electromagnetic signals upon receipt of such electrical signals to the implanted tissue stimulator (“an antenna 136 is positioned along a body covering 300 while the remainder of the external device 130 is tethered thereto by a wire (e.g. cable or interconnect 500)”, paragraph [0143]); and a portable pulse generation device 130/260 configured to be removably secured within the docking connection receptacle of the flexible band, the portable pulse generation device configured to output electrical signals to a device connector terminal of the portable pulse generation device, wherein securing the portable pulse generation device within the docking connection receptacle results in the device connector terminal mating with the docking connector terminal so the electrical signals from the portable pulse generation device pass to the transmitting antenna for transmission to the implanted tissue stimulator (see Figures 6A, 7A, and 15A-19 and “FIG. 18B illustrates a similar embodiment of an external device 130 and body covering 300 worn by a patient such that the body covering 300 is positioned around the waist of the patient, above the patient's pants 465. However, in this embodiment, a portion of the external device 130 is disposed within the body covering 300 and a portion is disposed outside of the body covering 300 but attached thereto. Again, the portions tethered together by a wire 500. FIG. 19 illustrates a similar embodiment, wherein the external device 130 extends throughout the body covering 300 yet is removable from the body covering 300. Here, the antenna 136 of the external device 130 is shown in a pocket 450 within the body covering 300 while the remainder of the external device 130 (e.g. the power supply 250 and controller 260) are disposed in another pocket within the body covering 300, the portions joined together by a wire 500. In this embodiment, the antenna 136 is positioned along the patient's back while the remainder of the external device 130 is positioned along the patient's side. This layout may provide more comfort and convenience for the patient.”, paragraph [0144]).
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Regarding claim 2, Hartley discloses that the transmitting antenna is integral with the flexible band (“one or more antennas 136 integrated into the body covering 300”, paragraph [0130]).
Regarding claim 3, Hartley discloses that the flexible band is configured with opposite edges and wherein mating fastenings are located on the opposite edges of the flexible band so that the flexible band can be wrapped about a body part and the opposite edges fastened together (see annotated figures above).
Regarding claim 4, Hartley discloses that the flexible band is stretchable such that the flexible band expands when wrapped around a body of a user and when removed from the body, the flexible band returns to an original shape (“the body covering 300 may comprise a belt, a bra, a shirt, a jacket, a harness, a vest, a shoulder brace, suspenders, a holster, a back brace, a necklace, a lanyard, underwear, a jock strap, a feminine napkin, pants, a body cavity insert, a garter belt, or an elastic band, to name a few.”, paragraph [0129]).
Regarding claim 5, Hartley discloses one or more electronic components 250 within and integral with the flexible band and electrically connected to the docking connector terminal (“the remainder of the external device 130 (e.g. the power supply 250 and controller 260) are disposed in another pocket within the body covering 300”, paragraph [0144]).
Regarding claim 6, Hartley discloses that the one or more electronic components is a non-volatile memory (“ Here, the external device 130 further comprises a power supply 250, a system controller (which may include user accessible controls) and memory 260 which may be coupled to a Bluetooth or other standard communication protocol 220, a transceiver 270 coupled to the system controller and memory 260, and a signal conditioner and multiplexer 280 coupled to the transceiver 270 and the system controller and memory 260.”, paragraph [0116]).
Regarding claim 7, it is respectfully submitted that the recitation “the non-volatile memory stores data relating to the portable pulse generation device that has been mated to the docking connector terminal” fails to further define the claimed invention over that of the prior art because it is directed to an intended use or function of the memory rather than further defining any further structural aspect of the device itself. Furthermore, Hartley discloses that the non-volatile memory stores data relating to the portable pulse generation device that has been mated to the docking connector terminal (“The external device 130 can collect data from embedded sensors, patient input, and/or one or more implants, and store the data in embedded memory”, paragraph [0122]).
Regarding claim 8, it is respectfully submitted that the recitation “the data stored by the non-volatile memory includes identification data that identifies a unique one of a plurality of portable pulse generation devices” fails to further define the claimed invention over that of the prior art because it further defines data that is intended to be stored rather than further defining any further structural aspect of the device itself.
Regarding claim 9, it is respectfully submitted that the recitation “the data includes information relating to a plurality of unique portable pulse generation devices that have been mated to the docking connector terminal” fails to further define the claimed invention over that of the prior art because it further defines data that is intended to be stored rather than further defining any further structural aspect of the device itself.
Regarding claim 10, Hartley discloses a secondary antenna disposed within and integral with the flexible band and electrically coupled to the docking connection receptacle by one of a plurality of wires within the flexible band (“the external device comprises a first external device, the system further comprises at least a second external device comprising at least one external antenna”, paragraph [0026], “Alternatively, combinations of the above may be envisioned wherein a secondary accessory (e.g. an inductive receiver coil) is worn during sleep”, paragraph [0176], “Alternatively, combinations of the above may be envisioned wherein a secondary accessory (e.g. an inductive receiver coil) is worn during sleep”, paragraph [0176], and “transmitting antenna 1136 and receiving antenna 1110”, paragraph [0197], and wherein the use of the recitation “at least one external antenna” throughout the disclosure anticipates two or more antennae).
Regarding claim 11, Hartley discloses that the secondary antenna is configured to receive signals and provide the received signals to a mated pulse generation device (“The external device 130 can also receive information from the implantable device 110 via several methods depending on the data protocols of the implantable device 110.”, paragraph [0117], “Alternatively, combinations of the above may be envisioned wherein a secondary accessory (e.g. an inductive receiver coil) is worn during sleep”, paragraph [0176], and “transmitting antenna 1136 and receiving antenna 1110”, paragraph [0197]).
Regarding claim 12, Hartley discloses that the portable pulse generation device is configured with a plurality of settings that include at least one of: an amplitude setting, a pulse width setting, a frequency setting, and a preset program setting (“the system is configured to optimize amplitude, phase, and/or other transmission parameters based on the coupling parameters”, paragraph [0022]).
Regarding claim 13, Hartley discloses one or more skin contacting electrodes integral with the flexible band (see “Skin Contacts” in Figure 3 and “Skin contacts 240 may be used to communicate with the implant, or to sense skin contact as an interlock to enable therapy, or to sense stimulation as an operational monitor or diagnostic.”, paragraph [0116]).
Regarding claim 14, Hartley discloses that the one or more skin contacting electrodes are connected to the docking connection receptacle (see Figure 3 and “Skin contacts 240 may be used to communicate with the implant, or to sense skin contact as an interlock to enable therapy, or to sense stimulation as an operational monitor or diagnostic.”, paragraph [0116]).
Regarding claim 15, Hartley discloses that the portable pulse generation device is configured, after connection to the docking connection receptacle, to generate a plurality of pre-programmed pulses in response to the portable pulse generation device receiving a signal indicating that the skin contacting electrodes are contacting skin of a wearer (“Skin contacts 240 may be used to communicate with the implant, or to sense skin contact as an interlock to enable therapy, or to sense stimulation as an operational monitor or diagnostic.”, paragraph [0116]).
Regarding claim 16, Hartley discloses one or more internal electronic devices connected to the skin contacting electrodes and configured to process one or more signals generated by the skin contacting electrodes (see Figure 3).
Regarding claim 17, Hartley discloses that the process carried out by the one or more electronic devices is that of amplification, analog-to-digital conversion, and/or digital signal processing (“the switch matrix is placed before power amplification, and directs signals with the desired magnitudes/phases to the proper RF transmission pathways.”, paragraph [0184]).
Regarding claim 18, Hartley discloses that the internal electronic devices are configured as an electrical nerve stimulation (TENS) pulse generator (“In some embodiments, the system further comprises a feedback element configured to notify the patient that repositioning of the at least one external antenna is desired. The feedback element can comprise an element selected from the group consisting of: a visual feedback element; an LED; an acoustic feedback element; a buzzer; a tactile feedback element; a haptic transducer; modified stimulation; paresthesia-causing stimulation; and combinations thereof”, paragraph [0035], where “paresthesia-causing stimulation” is considered to satisfy the broadest reasonable interpretation for “electrical nerve stimulation”, as something that causes paresthesia would necessarily stimulation a nerve).
Regarding claim 19, Hartley discloses a wearable assembly configured to generate electrical pulses for transmission to an implanted tissue stimulator, the wearable assembly comprising: a flexible band 300 configured to be worn by a patient having the implanted tissue stimulator (see Figures 6A, 7A, and 15A-19); a docking connection receptacle integral to the flexible band, wherein the docking connection receptacle is equipped with a docking connector terminal that is integral to the docking connection receptacle (see annotated Figures 18B and 19 above); a transmitting antenna 136 secured to the flexible band and electrically coupled by wires 500 to the docking connection receptacle so as to receive electrical signals through the docking connection receptacle and transmit one or more electromagnetic signals upon receipt of such electrical signals to the implanted tissue stimulator (“an antenna 136 is positioned along a body covering 300 while the remainder of the external device 130 is tethered thereto by a wire (e.g. cable or interconnect 500)”, paragraph [0143]); and a portable pulse generation device 130/250/260 configured to be removably secured within the docking connection receptacle of the flexible band, the portable pulse generation device configured to exchange electrical signals through the docking connector terminal with the transmitting antenna (see Figures 6A, 7A, and 15A-19 and “FIG. 18B illustrates a similar embodiment of an external device 130 and body covering 300 worn by a patient such that the body covering 300 is positioned around the waist of the patient, above the patient's pants 465. However, in this embodiment, a portion of the external device 130 is disposed within the body covering 300 and a portion is disposed outside of the body covering 300 but attached thereto. Again, the portions tethered together by a wire 500. FIG. 19 illustrates a similar embodiment, wherein the external device 130 extends throughout the body covering 300 yet is removable from the body covering 300. Here, the antenna 136 of the external device 130 is shown in a pocket 450 within the body covering 300 while the remainder of the external device 130 (e.g. the power supply 250 and controller 260) are disposed in another pocket within the body covering 300, the portions joined together by a wire 500. In this embodiment, the antenna 136 is positioned along the patient's back while the remainder of the external device 130 is positioned along the patient's side. This layout may provide more comfort and convenience for the patient.”, paragraph [0144]).
Regarding claim 20, Hartley discloses a wearable assembly configured to generate electrical pulses for transmission to an implanted tissue stimulator, the wearable assembly comprising: a flexible band 300 configured to be worn by a patient having the implanted tissue stimulator (see Figures 6A, 7A, and 15A-19); a docking connection receptacle integral to the flexible band, wherein the docking connection receptacle is equipped with a docking connector terminal that is integral to the docking connection receptacle (see annotated Figures 18B and 19 above); a transmitting antenna 136 disposed within the flexible band and electrically coupled by wires 500 to the docking connection receptacle so as to receive and transmit electrical signals through the docking connection receptacle (“an antenna 136 is positioned along a body covering 300 while the remainder of the external device 130 is tethered thereto by a wire (e.g. cable or interconnect 500)”, paragraph [0143]); and a portable pulse generation device 130/250/260 configured to be removably secured within the docking connection receptacle of the flexible band, the portable pulse generation device configured to automatically output pre-programmed electrical signals to a device connector terminal of the portable pulse generation device when the portable pulse generation device is secured within the flexible band (see Figures 6A, 7A, and 15A-19 and “FIG. 18B illustrates a similar embodiment of an external device 130 and body covering 300 worn by a patient such that the body covering 300 is positioned around the waist of the patient, above the patient's pants 465. However, in this embodiment, a portion of the external device 130 is disposed within the body covering 300 and a portion is disposed outside of the body covering 300 but attached thereto. Again, the portions tethered together by a wire 500. FIG. 19 illustrates a similar embodiment, wherein the external device 130 extends throughout the body covering 300 yet is removable from the body covering 300. Here, the antenna 136 of the external device 130 is shown in a pocket 450 within the body covering 300 while the remainder of the external device 130 (e.g. the power supply 250 and controller 260) are disposed in another pocket within the body covering 300, the portions joined together by a wire 500. In this embodiment, the antenna 136 is positioned along the patient's back while the remainder of the external device 130 is positioned along the patient's side. This layout may provide more comfort and convenience for the patient.”, paragraph [0144]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Speck et al. (U.S. Patent No. 10,874,868).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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