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 statements (IDS) submitted on 04/18/2024 and 07/14/2025 are being considered by the examiner.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-3, 6-9, 11, 13, 15, 17, and 21) in the reply filed on 04/14/2026 is acknowledged.
Amended Claims
Claims 1-3, 6-9, 11, 13, 15, 17, 21, 23-24, 26, 28-30, and 32-33 are currently pending. Claims 4-5, 10, 12, 14, 16, 18-20, 22, 25, 27, and 31 are canceled. Claims 23-24, 26, 28-30, and 32-33 are withdrawn as being directed to non-elected inventions. Claims 1-3, 6-9, 11, 13, 15, 17, and 21 are under examination.
Priority
The instant application (filed on 04/18/2024) is a national stage of PCT/CA2022/051541 (filed on 10/19/2022), filed under 35 USC 371. Acknowledgment is made of applicant's claim for domestic priority based on provisional application 63/257,944 (filed on 10/20/2021). Instant claims 1-3, 6-9, 11, 13, 15, 17, and 21 are adequately supported in the provisional application to receive an effective filing date of 10/20/2021.
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.
Claim 21 is 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.
Claim 21: The limitation “wherein the generator is configured to generate an electrical waveform over a wide range of signals” renders claim 21 indefinite with the use of the term “wide.” A range of signals suggests the ability of the device to generate at least two signals, but the bounds of “wide” are unclear as this is based on the perception of the user (i.e. wide could mean vastly different numbers based on the user making the determination).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-9, 11, 15, and 21 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Dar (US PG Pub 2018/0021565 A1, see 04/18/2024 IDS).
Regarding Claim 1, Dar discloses an electrical stimulation system ([0002]), comprising:
• a stimulator ([0102] – external stimulator) including a generator ([0098] – generator contained in the external stimulator) and a controller ([0099] – external device used to control the stimulator via circuitry), the generator is configured to generate an electrical current ([0098] – produces an electric current) and the controller is configured to receive a user input for activating the generator ([0099] – the external stimulator can be wirelessly controlled, such as powering on/off, using a remote control);
• an electrode (Fig. 13, [0118-0119]) including a flexible body ([0070] – the substrate is composed to be flexible and conform to the contours of the human body to which it is attached; [0119] – electrode assembly and substrate coupled) and one or more electrode pads positioned along the flexible body ([0080-0081] – the electrode assembly portion is in contact with the body typically via adhesive gel electrodes); and
• a connector configured to extend through the flexible body ([0064-0065] – connector embedded in the substrate configured for wireless power transmission) and electrically couple with the stimulator by inductive coupling (Fig. 13, [0112-0120] – wireless induction used to wirelessly transmit power), wherein the connector is configured to electrically couple the generator to the one or more electrode pads in response to the stimulator being positioned within a predefined distance to the connector ([0116-0118] – a magnet in the stimulator portion closes a switch to establish an electrical connection when placed a certain distance from the substrate), such that the controller is configured to wirelessly transmit the electrical current from the generator to the one or more electrode pads via the connector ([0115] – coils 614, 616 are wirelessly electrically coupled to the external stimulator to transmit current to the electrode assembly 640”) in response to the user input ([0099] – external device used to control the stimulator).
Therefore, Claim 1 is anticipated by Dar.
Regarding Claim 6, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses wherein the connector has a housing that is configured to receive at least a portion of the flexible body, thereby coupling the electrode to the connector ([0064-0065] – connector embedded in the substrate configured for wireless power transmission to the electrodes, [0114] – connection assembly 630 containing connectors 632 and 634 are embedded in the substrate).
Therefore, Claim 6 is anticipated by Dar.
Regarding Claim 7, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses wherein the controller is configured to determine a speed, a duration, an intensity, or a frequency of the electrical current generated by the generator ([0099] – the simulator can be programmed by the operator, such as switching to different channels, where [0092] shows an instance where the current amount can be controlled).
Therefore, Claim 7 is anticipated by Dar.
Regarding Claim 8, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses wherein the flexible body includes a main portion and one or more legs extending outwardly from the main portion (Fig. 6, [0071] – the stimulator is attached over one electrode lobe, interpreted as equivalent to the main portion, while connected to a second electrode lobe, interpreted as equivalent to the leg), wherein the connector is configured to extend through the flexible body at the main portion ([0064-0065] – connector embedded in the substrate configured for wireless power transmission to the electrodes, [0114] – connection assembly 630 containing connectors 632 and 634 are embedded in the substrate), and each of the one or more legs (Figs. 2-6 – the two electrodes are depicted as inhabiting one of two separate lobes) includes at least one of the one or more electrode pads ([0080-0081] – the electrode assembly portion is in contact with the body typically via adhesive gel electrodes).
Therefore, Claim 8 is anticipated by Dar.
Regarding Claim 9, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses:
• wherein the one or more electrode pads are selectively coupled to the flexible body, and configured to attach the electrode to a body of a user ([0068]); and
• wherein the one or more electrode pads define an adhesive interface of the flexible body that is configured to couple the electrode to the body of the user ([0061], [0081] – the electrode assembly portion is in contact with the body typically via adhesive gel electrodes).
Therefore, Claim 9 is anticipated by Dar.
Regarding Claim 11, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses:
• wherein the electrode includes one or more wires enclosed or embedded within the flexible body, the one or more wires are configured to electrically couple the one or more electrode pads with the connector ([0079], [0116-0118] - electrical circuitry, which includes a conductive mechanism which would be comparable to wires, is used to transmit the stimulation signal from the stimulator to the connector and finally to the electrode assembly).
•wherein the flexible body includes a connection interface defining one or more openings, the connection interface is configured to receive at least a portion of the connector through the one or more openings ([0064-0065], [0114] – connector embedded (via an opening) in the substrate).
Therefore, Claim 11 is anticipated by Dar.
Regarding Claim 15, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses:
• wherein the connector includes one or more sensors configured to detect one or more operating characteristics of the stimulator or the electrode ([0115-0116] – a magnetic switch detects proximity of the stimulator to the connector at a distance where wireless power transfer can occur); and
• wherein the controller is configured to activate the generator in response to the one or more sensors detecting an electrical connection between the stimulator and the electrode (Fig. 13, [0117-0118] – the electrical current from the power source is transmitted to the external stimulator via a first connector/coil when the magnetic switch is closed (when the stimulator is in range of the connector), where the external stimulator produces a particular stimulation pattern and transmits the pattern to the electrodes via the second connector/coil).
Therefore, Claim 15 is anticipated by Dar.
Regarding Claim 21, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses wherein the generator is configured to generate an electrical waveform over a wide range of signals (a wide range of signals is indefinite - see 112(b) rejections, [0099] – stimulation waveform programmable via controller), and to convert the electrical waveform to one or more pulses of the electrical current ([0099] – waveform is programmable to produce a specified stimulation current and the operator being able to control the stimulator suggests multiple settings/waveforms are possible).
Therefore, Claim 21 is anticipated by Dar.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim 2 is rejected under U.S.C 103 as being unpatentable over Dar (US PG Pub 2018/0021565 A1, see 04/18/2024 IDS) in view of Lee (US 2013/0063082 A1, see “Notice of References Cited”).
Regarding Claim 2, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar discloses coils using magnetic induction to wirelessly transfer power between the stimulator (coils C1 and C2) and connector (coils 614 and 616) portions (Fig. 13, [0112-0120] – wireless induction used to wirelessly transmit power). The connector is configured to electrically couple the power source and stimulator and the stimulator to the one or more electrode pads in response to the stimulator being positioned within a predefined distance to the connector ([0116-0118] – a magnet in the stimulator portion closes a switch in the substrate to establish an electrical connection with the external stimulator when placed a predefined distance from the substrate). However, Dar does not disclose wherein the predefined distance includes about 1 centimeter to about 30 centimeters.
Lee, in the same field of endeavor of wireless power transfer ([0014-0015]) using magnetic induction ([0011]), teaches wireless power transfer can be accomplished by electromagnetic inductive coupling using coils, resonance coupling, and radiofrequency/microwave radiation ([0009]), with electromagnetic induction being the most common type ([0010]). Lee further teaches inductive coupling requires a shorter distance of up to 10 cm between transmitter and receiver ([0042] – “When the wireless power transmitter 100 employs the electromagnetic inductive coupling method, the distance between the wireless power transmitter 100 and the plurality of wireless power receivers 110-1, 110-2, ... , 110-n is preferably less than or equal to 10 cm”) than radiofrequency/microwave radiation ([0010]) and resonance coupling ([0042]). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed predefined distance range interpretations of 1-30 cm.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dar’s wireless power transfer feature by incorporating the distance allowing effective wireless power transfer between transmitter and receiver in Lee. This would have been obvious because both Dar and Lee discuss wireless power transfer using inductive coupling and Lee provides a solution/improvement by limiting distances to less than 10 cm to ensure effective coupling. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Dar by incorporating the distance allowing effective wireless power transfer between transmitter and receiver in Lee to set the distance of the magnetic switch in Dar.
Therefore, Claim 2 is obvious over Dar in view of Lee.
Claim 3 is rejected under U.S.C 103 as being unpatentable over Dar (US PG Pub 2018/0021565 A1, see 04/18/2024 IDS) in view of Chen (US PG Pub 2019/0388683, see 04/18/2024 IDS).
Regarding Claim 3, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses:
• wherein the inductive coupling between the connector and the stimulator includes an electromagnetic connection (Fig. 13, [0112-0120] – wireless induction used to wirelessly transmit power via electromagnetic coils);
• wherein the connector is configured to wirelessly transmit the electrical current from the generator to the connector (Fig. 13, [0112-0120] – wireless induction used to wirelessly transmit power), and the connector is configured to distribute the electrical current to the one or more electrode pads ([0119] - electrical current transferred to electrodes; [0080-0081] – the electrode assembly portion is in contact with the body typically via adhesive gel electrodes), and
• wherein the stimulator includes one or more magnets ([0116] – a magnet in the stimulator portion closes a switch to establish an electrical connection when placed a certain distance from the substrate).
Dar discloses “for example, in some embodiments, the connector 132 is configured to provide both a mechanical and an electrical connection between the apparatus 100 and the external stimulator. Said another way, when the external stimulator is mechanically coupled to the apparatus 100 via the connector 132, the external stimulator is also placed in electrical communication with the power source 120. The connector 132 can be any suitable connector, including but not limited to, a snap-fit connector” ([0064]). Dar does not disclose the connector includes one or more corresponding magnets that are configured to mate with the one or more magnets of the stimulator, thereby magnetically coupling the stimulator to the connector.
Chen, in the same field of endeavor of connecting a stimulator to an electrode pad ([0066]), teaches “the electrode pads 107 preferably have a pair of male metal snaps 114 for attaching to a pair of female metal snaps 115 on the electrical stimulation units” ([0066]). However, Chen also teaches “the metal snaps can alternatively be some other type or design of fastener for releasably engaging and electrically connecting the cable 250 to the electrical stimulation unit 204 and/or the electrodes 207a, 207b. Some other fastening force may also be used, such as with magnets, vacuum (like suction cups), or even friction” ([0096]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the snap-fit connector in Dar with the magnetic fastening mechanism in Chen. Dar suggests any suitable connector can be used and is not conceptually limited to the snap-fit connector and Chen provides a number of alternative mechanisms for attachment, including magnetic connections, which would be obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully implementing the magnetic connection in Chen within the apparatus of Dar.
Therefore, Claim 3 is obvious over Dar in view of Chen.
Claim 13 is rejected under U.S.C 103 as being unpatentable over Dar (US PG Pub 2018/0021565 A1, see 04/18/2024 IDS) in view of Wei (US PG Pub 2011/0224754 A1, see “Notice of References Cited”).
Regarding Claim 13, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar discloses the connection assembly is embedded in the substrate ([0114]) and flexible electrode assembly is coupled to a bottom surface of the substrate and electrically connected to receive current from the wireless power transmission arrangement ([0119]), but does not provide details of this connection. Therefore, Dar does not disclose:
• wherein the connector includes a housing defined by a first wall and a second wall;
• wherein at least a portion of the electrode is received within the connector with the flexible body positioned between the first wall and the second wall, thereby coupling the connector to the electrode, and
• wherein one or more of the first wall and the second wall includes a fastening mechanism that is configured to extend through the flexible body when the electrode is received between the first wall and the second wall.
Wei, in the same field of endeavor of a stimulator patch applied on the body surface ([0002]), teaches a coupling arrangement between a central housing component which passes through the conductive pad portion (Fig. 2, [0026-0029]). More specifically, the conductive flexible film 37 and cover 31 have an opening 371 (Fig. 2, [0029]). The base component 34 and the supporting enclosure 32 are joined together while passing through opening 371 so the conductive flexible film 37 is sandwiched between the components 32 and 34 to form a fastening mechanism (Fig. 2, [0028-0029]). The instant specification presents the first wall 174 and second wall 176 as housing components which connect through holes in flexible body 72 to create a wedge fastening (Fig. 8, [0060]). Therefore, the components 32 and 34 in Wei would be considered equivalent to the first and second walls in the claim language. Wei proposes this design as eliminating the use of metallic fasteners and providing greater device durability by forming a single integrated structure ([0009]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dar’s wireless power transfer apparatus by incorporating the wedged coupling of the flexible electrode between two housing components in Wei. This would have been obvious because both Dar and Wei discuss attaching an electrode patch to a substrate and Wei provides a solution/improvement with a specific mechanism (whereas Dar only generally states coupling occurs) where the housing substrate contains components which fasten though the electrode patch in order to fix the electrode in place and facilitate contact with the conductive layer as a single durable piece. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Dar by incorporating the wedge coupling of the flexible electrode between two housing components in Wei.
Therefore, Claim 13 is obvious over Dar in view of Wei.
Claim 17 is rejected under U.S.C 103 as being unpatentable over Dar (US PG Pub 2018/0021565 A1, see 04/18/2024 IDS) in view of Mueller (US PG Pub 2010/0042180 A1, see “Notice of References Cited”).
Regarding Claim 17, Dar anticipates the electrical stimulation system according to Claim 1, as indicated hereinabove. Dar further discloses wherein the stimulator includes a housing formed of a biocompatible material, a water-resistant material, a shatter-resistant material, or a shock-resistant material ([0082] – apparatus can be partially enclosed by a material for comfort and to protect device components (e.g. “waterproof material,” “an insulative material”, “a non-conductive material”)),
• wherein the stimulator includes an indicator that is configured to generate a user feedback indicative of an operation status of the stimulator or the electrode ([0229] – feature to indicate battery depletion using visual indicator which must be visible to the user); and
• at least one rechargeable battery that is configured to supply electrical power to one or more of the generator and the controller ([0063] - power source can include a battery; [0165] – types of batteries are listed: “a Lithium ion rechargeable battery”); and
• wherein the stimulator is communicatively coupled to at least one external electronic device, and the controller is configured to receive the user input for operating the generator from the at least one external electronic device ([0099] – external device used to control the stimulator).
However, Dar does not disclose an indicator positioned along an exterior surface of the housing.
Mueller, in the same field of endeavor of a stimulator with an electrode pad ([0012-0013]), teaches control module 40 uses a status indicator 46 placed on the exterior surface of the housing substrate (Figs. 4-5, [0062-0063]). The potential information communicated by the exterior status indictor 46 includes a power state of device, intensity setting, or stimulation frequency ([0062]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dar’s wireless power transfer apparatus with an indicator light by incorporating the indicator light on the surface of a casing substrate in Mueller. This would have been obvious because both Dar and Mueller discuss a status indicator light and Mueller provides a solution/improvement by both positioning the indicator on the outer surface of the housing (where the location is not specified in Dar) and providing additional functions (i.e. providing more information to the user) which can be implemented in the indicator light beyond the battery status in Dar. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Dar by incorporating the indicator light on the surface of a casing substrate in Mueller.
Therefore, Claim 17 is obvious over Dar in view of Mueller.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights