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 .
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.
Claims 1-2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/066077 A1 to Odaka et al. (hereinafter “Odaka”) in view of US 2015/0335876 A1 to Jeffery et al. (hereinafter “Jeffery”) and US 2007/0060975 A1 to Mannheimer et al. (hereinafter “Mannheimer”).
Regarding claim 1, Odaka teaches:
A stimulating system (see abstract), comprising:
a stimulation electrode unit including a plurality of electrodes adapted to be attached to a living body (See annotated fig. 1A below, fig. 2B, and fig. 4C below, and para [0019]-[0020]);
a stimulation control device configured to form an electric circuitry with the stimulation electrode unit, and to control a stimulation current that is caused to flow into the living body through the electrodes (see annotated fig. 1A and fig. 4C below, and para [0019]-[0022]);
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wherein the stimulation electrode unit includes a connector configured to form a part of the electric circuitry (see fig. 9 – reference number 12, para [0019], para [0028], para [0120]), but does not explicitly teach wherein
the connector includes a substrate on which a plurality of conductive contacts electrically connected to the electrodes,
and does not explicitly disclose an information element retaining identifier information identifying the stimulation electrode element, wherein the stimulation control device is configured to read out the identifier information through the electric circuitry,
and
determine, based on the identifier information, whether the electrical circuit is formed by an adequate stimulation electrode unit;
and wherein the information element is a resistor printed on the substrate.
However, Jeffery, who is in the same field of endeavor, teaches methods and systems for attaching a wearable neurostimulator (see abstract, para [0004], and fig. 6). The system (figs. 1D and fig. 6) teaches wherein,
the connector includes a substrate on which a plurality of conductive contacts electrically connected to the electrodes (See figs. 16A-16B, fig. 18A, para [0069], para [0187], para [0217]), and
an information element (RC circuit) retaining identifier information identifying the stimulation electrode element, wherein the stimulation control device is configured to read out the identifier information through the electric circuitry (see para [0010], para [0127], para [0142], para [0146], and para [0148], first sentence and the last sentence stated here: “Additionally or alternatively, the controller may include an electrical connector and resonating circuit, such as a series of electrical pins, and the electrode assembly may include a resistive element or a capacitive element.”)
and
determine, based on the identifier information, whether the electrical circuit is formed by an adequate stimulation electrode unit (see para [0010], para [0126]-[0127], para [0142]), but does not explicitly disclose wherein the information element is a resistor printed on the substrate.
However, Mannheimer teaches a flexible circuit combination electrode battery assembly used for providing neurostimulation to a patient (see abstract). The system (figs. 1 and 4A) teaches wherein an information element/resistor is printed on the substrate (see abstract, fig. 7 – 56 and 61, para [0059], para [0066], para [0068], para [0071], and para [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Odaka with the teachings of Jeffery and Mannheimer to arrive at the claimed invention. Such modification would improve the system by properly identifying the electrode element characteristics and/or the status regarding the connectivity of the electrodes, ultimately improving the overall treatment efficiency for medical workers when treating each patient.
Regarding claim 2, Odaka as modified teaches:
The stimulating system according to claim 1, wherein the information element (the RC circuit) is disposed in the electric circuitry ( See Jeffrey - para [0142] - [0143], para [0146], para [0126]-[0127], and para [0217]).
Regarding claim 7, Odaka teaches:
A stimulation electrode unit, comprising:
a plurality of electrodes adapted to cause a stimulation current to flow into a living body (See annotated fig. 1A below, fig. 2B, and fig. 4C below, and para [0019]-[0020]),
a connector (see fig. 1A – 12) electrically connected to the electrodes, and adapted to form an electric circuitry with a stimulation control device configured to control the stimulation current (see fig. 1A – 12 and para [0028]), but does not explicitly disclose,
an information element provided in the connector and retaining identifier information identifying the stimulation electrode unit, wherein the identifier information is adapted to be read out by the stimulation control device through the electric circuitry, and to be subjected to determination of whether the electric circuitry is formed by an adequate stimulation electrode unit;
wherein the connector includes a substrate on which a plurality of conductive contacts electrically connected to the electrodes;
and wherein the information element is a resistor printed on the substrate.
However, Jeffery, who is in the same field of endeavor, teaches methods and systems for attaching a wearable neurostimulator (see abstract, para [0004], and fig. 6). The system (figs. 1D and fig. 6) teaches wherein,
the connector includes a substrate on which a plurality of conductive contacts electrically connected to the electrodes (See figs. 16A-16B, fig. 18A, para [0069], para [0187], para [0217]), and wherein the connectors contains an information element (RC circuit) retaining identifier information identifying the stimulation electrode element, wherein the stimulation control device is configured to read out the identifier information through the electric circuitry (see para [0010], para [0127], para [0142], para [0146], and para [0148], first sentence and the last sentence stated here: “Additionally or alternatively, the controller may include an electrical connector and resonating circuit, such as a series of electrical pins, and the electrode assembly may include a resistive element or a capacitive element.”)
and
determine, based on the identifier information, whether the electrical circuit is formed by an adequate stimulation electrode unit (see para [0010], para [0126]-[0127], para [0142]), but does not explicitly disclose wherein the information element is a resistor printed on the substrate.
However, Mannheimer teaches a flexible circuit combination electrode battery assembly used for providing neurostimulation to a patient (see abstract). The system (figs. 1 and 4A) teaches wherein an information element/resistor is printed on the substrate (see abstract, fig. 7 – 56 and 61, para [0059], para [0066], para [0068], para [0071], and para [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Odaka with the teachings of Jeffery and Mannheimer to arrive at the claimed invention. Such modification would improve the system by properly identifying the electrode element characteristics and/or the status regarding the connectivity of the electrodes, ultimately improving the overall treatment efficiency for medical workers when treating each patient.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Odaka in view of hereinafter Jeffery.
Regarding claim 8, Okada teaches:
A relay cable/wiring part configured to form an electric circuitry between a stimulation electrode unit including a plurality of electrodes adapted to be attached to a living body and a stimulation control device/electric stimulator configured to control a stimulation current that is caused to flow into the living body through the electrodes (see fig. 1A – reference number 6 and 7, para [0023]-[0025]),
comprising:
a first connector configured to be detachably connected to the stimulation electrode unit (see fig. 1A – 12 and para [0028]), but does not explicitly disclose wherein,
a second connector configured to be detachably connected to the stimulation control device/stimulator;
a wiring section electrically connecting the first connector and the second connector;
and an information element provided in the wiring section and retaining identifier information identifying the stimulation electrode unit, wherein the identifier information is adapted to be read out by the stimulation control device through the electric circuitry, and to be subjected to determination of whether the electric circuitry is formed by an adequate stimulation electrode unit.
However Jeffery, who is in the same field of endeavor, teaches methods and systems for attaching a wearable neurostimulator (see abstract, para [0004], and fig. 6). The system (figs. 1D and fig. 6) teaches wherein,
A first and second connector configured to be detachably connected to the stimulation control device/stimulator (see para [0016]-[0017], para [0019], and para [0021]);
a wiring section/electrical traces electrically connecting the first connector and the second connector (see fig. 5D, fig. 18A, and fig. 23A, para [0010], para [0069], and para [0127] );
the connector includes a substrate on which a plurality of conductive contacts electrically connected to the electrodes (See figs. 16A-16B, fig. 18A, para [0069], para [0187], para [0217]), and
an information element (RC circuit) retaining identifier information identifying the stimulation electrode element, wherein the stimulation control device is configured to read out the identifier information through the electric circuitry (see para [0010], para [0127], para [0142], para [0146], and para [0148], first sentence and the last sentence stated here: “Additionally or alternatively, the controller may include an electrical connector and resonating circuit, such as a series of electrical pins, and the electrode assembly may include a resistive element or a capacitive element.”)
and
determine, based on the identifier information, whether the electrical circuit is formed by an adequate stimulation electrode unit (see para [0010], para [0126]-[0127], para [0142]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Odaka with the teachings of Jeffery to arrive at the claimed invention. Such modification would improve the system by properly identifying the electrode element characteristics and/or the status regarding the connectivity of the electrodes, ultimately improving the overall treatment efficiency for medical workers when treating each patient.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Odaka in view of Jeffery and Mannheimer, and further in view of US 9,675,810 B2 to McIntyre et al. (hereinafter “McIntyre”).
Regarding claims 10 and 11, Odaka as modified teaches:
The stimulating system according to claim 1 and the stimulation electrode unit according to claim 7, but does not explicitly disclose wherein a resistance value of the resistor is associated with a type of the stimulation electrode unit.
However, McIntyre teaches an electrode identification system for defibrillators (see abstract, line 1). The system (fig. 1) teaches wherein a resistance value of the resistor is associated with a type of the stimulation electrode unit (see col. 4, lines 15-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Odaka with the teachings of McIntyre to arrive at the claimed invention. Such modification would improve the system by properly identifying the electrode element characteristics and/or the status regarding the connectivity of the electrodes, ultimately improving the overall treatment efficiency for medical workers when treating each patient.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Odaka in view of Jeffery, and further in view of McIntyre.
Regarding claim 12, Odaka as modified teaches:
The relay cable according to claim 8, but does not explicitly disclose wherein a resistance value of the resistor is associated with a type of the stimulation electrode unit.
However, McIntyre teaches an electrode identification system for defibrillators (see abstract, line 1). The system (fig. 1) teaches wherein a resistance value of the resistor is associated with a type of the stimulation electrode unit (see col. 4, lines 15-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Odaka with the teachings of McIntyre to arrive at the claimed invention. Such modification would improve the system by properly identifying the electrode element characteristics and/or the status regarding the connectivity of the electrodes, ultimately improving the overall treatment efficiency for medical workers when treating each patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9,415,229 B2 to Lee et al. teaches an electrical stimulation and electrical measurement system of neural cells and muscle cells (see abstract).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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