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 .
Claims Accounting
Applicant's arguments, filed 09/02/2025, have been fully considered. The following rejections are reiterated. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/02/2025, however the rejections made in the instant office action have been reiterated.
Claims 4, 5, 8, 14, and 19 are withdrawn due to the election of species requirements.
Claims 1-3, 6-7, 9-13, 15-18, and 20-22 are the current claims hereby under examination.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2014/0012157 by Gilhuly (hereinafter "Gilhuly" – previously cited) in view of US Patent 5,697,391 by Rantala et al. (hereinafter "Rantala" – previously cited) in view of US Patent Publication 2021/0038145 by Simonetti et al. (hereinafter "Simonetti" – previously cited), evidenced by US Patent Publication 2018/0154140 by Bouton et al. (hereinafter “Bouton” – previously cited).
Regarding claim 1, Figs. 12-13 of Gilhuly teaches a kinemyography sensor comprising:
a flexible substrate (Body 200 can be flexible [0174]), a printed stimulation circuit printed on the substrate ([0174]; “the conductive leads connecting to the stimulating electrodes 208 printed to it”) and comprising a pair of stimulation electrodes (stimulating electrodes 208) configured to adhere to a patient’s skin ([0190] “electrode body 210 can be made to adhere to the patient”) to deliver a kinemyography stimulus (stimulating electrodes creates muscle motion [0173]); and a sensor (motion sensor 201 [0173]).
However, Gilhuly is silent regarding:
a support frame configured to attach to a patient’s thumb and forefinger and having a bendable middle section configured to bend in response to movement of the patient’s thumb;
wherein at least a portion of the flexible substrate is attached to the support frame;
a bend sensor printed on the substrate and located on the bendable middle section of the support frame, wherein the bend sensor is configured to sense the bending of the support frame.
Rantala teaches: a support frame (Fig. 1, elongated connecting part 2) configured to attach to a patient’s thumb and forefinger (Fig. 1, Col 4, lines 32-45) and having a bendable middle section (Fig 1, articulation 9) and a mechano-sensor (e.g. bend sensor) positioned in the bendable middle portion, configured to bend in response to movement of the patient’s thumb (Col 4, lines 46-53, “allowed to at least slightly move on the plane of angle 5 … by the response of muscular activity to the stimulation.”). The bendable support frame and the mechano-sensor in the middle allows for the measurement of thumb motion while minimizing the effects of the other movements of the hand and changes in environmental factors (Rantala, Col 3, lines 45-48).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the flexible substrate of Gilhuly with the support frame of Rantala and to have substituted the accelerometer of Gilhuly with the mechano-sensor of Rantala to maintain the sensing capabilities of the thumb, while minimizing the effects of the other movements of the hand and changes in environmental factors, as taught by Rantala (Col 3, lines 45-48). In this combination, the accelerometer of Gilhuly at the end of the thumb is substituted with the bend sensor of Rantala in between the thumb and the forefinger. Bouton teaches that while accelerometers can be used to obtain information such as joint angles (the movement of the thumb relative to the forefinger), other categories of sensors such as micro-electro-mechanical sensors and bend sensors may also be used to measure this data (Bouton, [0118]). Therefore the substitution of the bend sensor taught by Rantala for the accelerometer taught by Gilhuly is substituting known prior art elements to obtain predictable results (See MPEP 2143.I.A).
A combination of the flexible substrate taught by Gilhuly and the support frame taught by Rantala would place the mechano-sensor 380 on the sensing mechanism of Gilhuly and attached to the support frame of Rantala (located at articulation 9) to maintain the sensing ability of the thumb. Therefore, this combination also teaches: a flexible substrate, wherein at least a portion of the flexible substrate is attached to the support frame. Furthermore, this combination also teaches the bend sensor being located on the bendable middle section of the support frame and the bend sensor being configured to sense the bending of the support frame.
The combination of Gilhuly and Rantala is silent regarding a printed bend sensor printed on the substrate.
Simonetti teaches a printed bend sensor (Fig 78, [0485-0487]) printed on the substrate (may be printed with resistive ink 786, dielectric ink layer 782, and conductive ink 783 and 785 on a flexible substrate such as substrate 784). Using a printed bend sensor can increase the cost-effectiveness of the integrated sensor ([0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the mechano-sensor taught by the combination of Gilhuly and Rantala to be a printed bend sensor to increase the cost-effectiveness of the integrated sensor, as taught by Simonetti ([0128]).
Regarding claim 2, the combination of Gilhuly, Rantala, and Simonetti teaches the kinemyography sensor of claim 1, wherein the printed bend sensor comprises a printed resistive sensor configured to change resistance when the bendable middle section bends so as to sense the movement of the patient’s thumb. The printed bend sensor (Fig 78, [0485-0487]) as taught by Simonetti uses a resistive ink (786), making it a printed resistive sensor. The combination of Gilhuly, Rantala, and Simonetti as applied in claim 1 teach the printed bend sensor is located on the bendable middle section of the support frame, therefore, as the support frame bends due to the movement of the patient’s thumb, the printed bend sensor changes resistance.
Regarding claim 3, the combination of Gilhuly, Rantala, and Simonetti teaches the kinemyography sensor of claim 2, wherein the printed resistive sensor includes a conductive ink layer printed on the substrate, a dielectric ink layer printed on the conductive ink layer. The printed bend sensor taught by Fig. 78 Simonetti comprises conductive ink 783 and 785 printed on the substrate, a dielectric ink layer (dielectric ink layer 782) printed on the conductive ink layer (the dielectric layer is the top layer [0485]).
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Annotated Fig. 12
Claims 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilhuly, in view of Rantala view of Simonetti as applied in claim 1 and further in view of US Patent Publication 2016/0081580 by Bergelin et al. (hereinafter "Bergelin" - previously cited), as evidenced by Technologies for Printing Sensors… (2015) by Khan et al. (hereinafter, "Khan" – previously cited).
Regarding claim 6 the combination of Gilhuly, Rantala, and Simonetti teaches the kinemyography sensor of claim 1, wherein the flexible substrate includes an elongated body with a first end and a second end (see annotated Fig. 12 of Gilhuly), wherein the elongated body includes: a connection section at the first end (see annotated Fig. 12 of Gilhuly) having a plurality of contact pads (Gilhuly, [0181]; electrical contacts at monitor insertion end 205) and configured to mate with a sensor connector of a neuromuscular transmission monitoring device (Gilhuly, [0181], the connector 203 provides an interface to the monitoring equipment); a sensor section having the printed bend sensor is printed thereon, wherein the sensor section is attached to the bendable middle section of the support frame (the combination of Gilhuly, Rantala and Simonetti as applied to claim 1 teaches that the acceleration sensor is substituted with a printed bend sensor attaching to the bendable middle section of the support frame, therefore the sensor section would attach to the bendable middle section of the support frame).
However the combination of Gilhuly, Rantala, and Simonetti is silent regarding: the connection section having a plurality of contact pads printed thereon and the stimulation section having the pair of stimulation electrodes printed thereon.
Fig. 3 of Bergelin teaches stimulation electrodes (element 3) printed on a substrate and a connector comprised of printed electrical contacts (element 16). Gilhuly and Bergelin both feature flexible substrates with printed leads, as printing leads on flexible circuitry is common and can be cost effective (Khan, Introduction, lines 1-8)). It would therefore be beneficial to print other elements onto the flexible circuit board to reduce insulated wiring and reduce the cost of manufacturing by printing electrical connections (Khan, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the stimulating electrodes and plurality of contact pads taught by the combination of Gilhuly, Rantala, and Simonetti to be printed, as taught by Bergelin to the cost of manufacturing by printing electrical connections and components (Khan, Introduction).
Regarding claim 7, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 6, wherein the sensor section is at the second end of the flexible substrate (See annotated Fig. 12).
Regarding claim 9, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 6, wherein the elongated body further includes: a first lead section between the connection section and the stimulation section (see Annotated Fig. 12), the first lead section having at least two stimulation leadwires (Gilhuly, Fig 13; stimulator leads 215 connect stimulation section to the connection section) and at least two sensor leadwires printed thereon (Gilhuly, Fig 12; signal traces 204 (plural indicates at least 2) connect sensing section to the connection section); and a second lead section between the stimulation section and the sensor section, the second lead section having the two sensing leads printed thereon (Gilhuly, Fig 12; signal traces 204 (plural indicates at least 2) connect sensing mechanism to the connection section).
Regarding claim 10, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 6, wherein the plurality of contact pads printed on the connection section (as applied in claim 6) includes at least two stimulation contact pads, wherein the two stimulation contact pads are each connected to a stimulation electrode by a printed leadwire.
The combination of Gilhuly, Rantala, Simonetti, and Bergelin does not teach wherein the plurality of contact pads printed on the connection section includes at least two sensing contact pads, wherein the two sensing contact pads are each connected to a sensing element by a printed leadwire.
Fig. 3 of Bergelin shows each electrode having one printed leadwire connected to a printed contact pad. This is consistent with Fig. 13 of Gilhuly showing depicting two stimulator leads 215 printed, one for each electrode (Gilhuly, [0178]). Fig. 12 of Gilhuly describes signal traces 204 (plural meaning at least two) connecting the sensor and the connection section to carry power, ground, and communication signals. It would be obvious that each of the signal traces would have at least one contact pad, to facilitate electrical connections with the monitoring device.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the contact pads of Gilhuly, Rantala, Simonetti, and Bergelin to include at least two sensing contact pads and two stimulation contact pads, wherein the two sensing contact pads are each connected to a sensing element by a printed leadwire, to facilitate electrical connections to the monitoring device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gilhuly, in view of Rantala in view of Simonetti and further in view of US Patent 4,776,325 by Etingher et al. (hereinafter “Etingher” – previously cited).
Regarding claim 11, the combination of Gilhuly, Rantala, and Simonetti teaches the kinemyography sensor of claim 1, wherein the support frame has a first leg (Rantala, Fig. 1; first branch 4a) configured to attach to the patient’s thumb and a second leg (Rantala, Fig. 1; branch 4b) configured to attach to the patient’s forefinger.
The combination of Gilhuly, Rantala, and Simonetti is silent regarding the support frame being a molded polymer having curved shape.
Rantala further teaches that the support frame comprises a V-shape or an L-shape (Col 4, lines 32-33). Regarding the shape of the support frame, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. See MPEP § 2144.04-IV-B. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the support frame to be curved to match the curvature of a patient’s hand to improve comfort.
However the combination of Gilhuly, Rantala, and Simonetti is silent regarding the support frame being a molded polymer.
Rantala further teaches that the support frame is preferably made of a stiff material (Col 4, lines 55-59). While Rantala does not teach the support frame being made of a polymer, Etingher teaches a stiff material may be a polymer (Etingher, Col. 8, lines 6-9).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the material to be a polymer, as using polymers can provide stiffness while allowing flexibility and comfort (Etingher, Col. 8, lines 6-9).
Furthermore, regarding claim 11, the term “molded” of the claimed phrase “molded polymer” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, even though Rantala is silent as to the process used to create the support frame, the combination of Gilhuly, Rantala, Simonetti, and Etingher would be the same or similar as that claimed, especially since both applicant’s product and the combination of prior art product is made of a polymer material.
Claims 12-13, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gilhuly in view of Simonetti in view of Bergelin as evidenced by Khan and Bouton.
Regarding claim 12, Figs. 12-13 of Gilhuly teach a kinemyography sensor comprising:
a flexible substrate (Body 200 can be flexible [0174]) including: a stimulation section ([0174] stimulation mechanism, also see Annotated Fig. 12) having a pair of stimulation electrodes (stimulating electrodes 208) and configured to adhere to a patient’s skin ([0190] “electrode body 210 can be made to adhere to the patient”) to deliver a kinemyography stimulus (stimulating electrodes creates muscle motion [0173]);
a sensor section ([0174] sensing mechanism, also see Annotated Fig. 12) having a sensor (motion sensor 201 [0173]) to sense movement of the patient’s thumb ([0174] muscle motion of the thumb is quantized by the accelerometer 201) and
a connection section at the first end of the substrate (see Annotated Fig. 12), the connection section having a plurality of contact pads (electrical contacts 205) configured to mate with a sensor connector of a neuromuscular transmission monitoring device ([0181] connector 203 allows connection to monitoring equipment).
Gilhuly is silent regarding the sensor being bend sensor being positioned between a patient’s thumb and forefinger to sense movement of the patient’s thumb.
Rantala teaches: a support frame (Fig. 1, elongated connecting part 2) configured to attach to a patient’s thumb and forefinger (Fig. 1, Col 4, lines 32-45) and having a bendable middle section (Fig 1, articulation 9) and a mechano-sensor (e.g. bend sensor) positioned in the bendable middle portion, configured to bend in response to movement of the patient’s thumb (Col 4, lines 46-53, “allowed to at least slightly move on the plane of angle 5 … by the response of muscular activity to the stimulation.”). The bendable support frame and the mechano-sensor in the middle allows for the measurement of thumb motion while minimizing the effects of the other movements of the hand and changes in environmental factors (Rantala, Col 3, lines 45-48).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the flexible substrate of Gilhuly with the support frame of Rantala an to have substituted the accelerometer of Gilhuly with the mechano-sensor of Rantala to maintain the sensing capabilities of the thumb, while minimizing the effects of the other movements of the hand and changes in environmental factors, as taught by Rantala (Col 3, lines 45-48). In this combination, the accelerometer of Gilhuly at the end of the thumb is substituted with the bend sensor of Rantala in between the thumb and the forefinger. Bouton teaches that while accelerometers can be used to obtain information such as joint angles (the movement of the thumb relative to the forefinger), other categories of sensors such as micro-electro-mechanical sensors and bend sensors may also be used to measure this data (Bouton, [0118]). Therefore the substitution of the bend sensor taught by Rantala for the accelerometer taught by Gilhuly is substituting known prior art elements to obtain predictable results (See MPEP 2143.I.A).
A combination of the flexible substrate taught by Gilhuly and the support frame taught by Rantala would place the mechano-sensor 380 on the sensing mechanism of Gilhuly and attached to the support frame of Rantala (located at articulation 9) to maintain the sensing ability of the thumb. Therefore, this combination also teaches: a flexible substrate, wherein at least a portion of the flexible substrate is attached to the support frame. Furthermore, this combination also teaches the bend sensor being located on the bendable middle section of the support frame and the bend sensor being configured to sense the bending of the support frame.
The combination of Gilhuly and Rantala do not teach the bend sensor being a printed bend sensor.
Simonetti teaches a printed bend sensor (Fig 78, [0485-0487]) printed on the substrate (may be printed with resistive ink 786, dielectric ink layer 782, and conductive ink 783 and 785 on a flexible substrate such as substrate 784). Using a printed bend sensor can increase the cost-effectiveness of the integrated sensor ([0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the mechano-sensor taught by the combination of Gilhuly and Rantala to be a printed bend sensor to increase the cost-effectiveness of the integrated sensor, as taught by Simonetti ([128]).
The combination of Gilhuly, Rantala, and Simonetti do not teach the pair of stimulation electrodes being printed on the flexible substrate and the plurality of contact pads being printed.
Fig. 3 of Bergelin teaches stimulation electrodes (element 3) printed on a substrate and a connector comprised of printed electrical contacts (element 16). Gilhuly and Bergelin both feature flexible substrates with printed leads, as printing leads on flexible circuitry is common and can be cost effective (Khan, Introduction, lines 1-8)). It would therefore be beneficial to print other elements onto the flexible circuit board reduce the cost of manufacturing by printing electrical connections (Khan, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the stimulating electrodes and plurality of contact pads taught by the combination of Gilhuly, Rantala, and Simonetti to be printed, as taught by Bergelin to reduce the cost of manufacturing by printing electrical connections and components (Khan, Introduction).
Regarding claim 13, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 12, wherein the printed bend sensor comprises a resistive sensor configured to change resistance when bent. The printed bend sensor (Fig 78, [0485-0487]) as taught by Simonetti uses a resistive ink (786). The combination of Gilhuly, Rantala, Simonetti, and Bergelin teach the printed bend sensor is located on the bendable middle section of the support frame, therefore, as the support frame bends due to the movement of the patient’s thumb, the printed bend sensor changes resistance.
Regarding claim 15, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 12, wherein the flexible substrate further includes: two printed stimulation leadwires, one extending from each of the pair of stimulation electrodes to a respective stimulation contact pad on the connection section (Gilhuly, Fig 13; stimulator leads 215 connect stimulation section to the connection section, with one leadwire going to each respective electrode); and two printed sensor leadwires, one extending from each end of the printed bend sensor to a respective sensing contact pad on the connection section (Gilhuly, Fig 12; signal traces 204 (plural indicates at least 2) connect the sensing mechanism to the connection section, Fig. 3 of Bergelin shows the printed leads corresponding each to one printed contact pad). The combination of Gilhuly, Rantala, Simonetti, and Bergelin does not teach the printed leads extending from each end of the printed bend sensor.
The side of the sensor that the leads connect to is a matter of design choice unless the connection point of the printed leads produces a new, or unexpected result. The printed leads may be rearranged so that the leads extend from each end of the printed bend sensor. The courts have held that the particular placement of an element was held to be an obvious matter of design choice. See MPEP 2144.04.VI.C.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the lead placements so that the printed leads taught by the combination of Gilhuly, Rantala, Simonetti, and Bergelin extend from either end of the printed bend sensor.
Regarding claim 16, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 15, wherein the flexible substrate further includes: a first lead section between the connection section and the stimulation section (see Annotated Fig. 12), the first lead section having at least two stimulation leadwires (Gilhuly, Fig 13; stimulator leads 215 connect stimulation section to the connection section) and at least two sensor leadwires printed thereon (Gilhuly, Fig 12; signal traces 204 (plural indicates at least 2) connect sensing section to the connection section); and a second lead section between the stimulation section and the sensor section, the second lead section having the two sensing leads printed thereon (Gilhuly, Fig 12; signal traces 204 (plural indicates at least 2) connect sensing mechanism to the connection section).
Regarding claim 17, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 15, wherein the connection section includes the sensing contact pads (contact pads corresponding to the sensing section, as applied in claim 15) and stimulation contact pads printed thereon (contact pads corresponding to the stimulation section, as applied in claim 15).
Regarding claim 18, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 15, wherein the sensor section is at the second end of the flexible substrate (See annotated Fig. 12).
Regarding claim 20, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the kinemyography sensor of claim 12, further comprising a support frame (support frame of Rantala as applied to claim 12) configured to attach to a patient’s thumb and forefinger and having a bendable middle section configured to bend in response to movement of the patient’s thumb (as applied to claim 12), wherein the sensor section is attached to the bendable middle section (as applied to claim 12).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gilhuly in view of Rantala in view of Simonetti in view of Bergelin, as evidenced by Khan.
Regarding claim 21, Gilhuly teaches a neuromuscular transmission monitoring system comprising:
a kinemyography sensor ([0173], monobody electrode sensor strip);
a neuromuscular transmission monitoring device ([0181] monitoring equipment (not shown in figures)) including a sensor connector configured to removably mate with a first end of the kinemyography sensor ([0181] electrical contacts are exposed at monitor insertion for conductive access) so as to receive sensing signals therefrom ([0178] conductive leads 204 connect to the connector and can carry quantized measurement signals);
wherein the kinemyography sensor comprises a flexible substrate (Body 200 can be flexible [0174] including: a stimulation section ([0174] stimulation mechanism) having a pair of stimulation electrodes (stimulating electrodes 208) and configured to adhere to a patient’s skin ([0190] “electrode body 210 can be made to adhere to the patient”) to deliver a kinemyography stimulus (stimulating electrodes creates muscle motion [0173]);
a sensor section ([0174] sensing mechanism) having a sensor (motion sensor 201 [0173]) to sense movement of the patient’s thumb ([0174] muscle motion of the thumb is quantized by the accelerometer 201) and
a connection section at the first end of the substrate (section containing the connector 203), configured to mate with a sensor connector of a neuromuscular transmission monitoring device ([0181] connector 203 allows connection to monitoring equipment).
Gilhuly, is silent regarding:
Having a bend sensor being printed on the substrate, wherein the bend sensor is configured to be positioned between a patient’s thumb and forefinger
Rantala teaches: a support frame (Fig. 1, elongated connecting part 2) configured to attach to a patient’s thumb and forefinger (Fig. 1, Col 4, lines 32-45) and having a bendable middle section (Fig 1, articulation 9) and a mechano-sensor (e.g. bend sensor) positioned in the bendable middle portion, configured to bend in response to movement of the patient’s thumb (Col 4, lines 46-53, “allowed to at least slightly move on the plane of angle 5 … by the response of muscular activity to the stimulation.”). The bendable support frame and the mechano-sensor in the middle allows for the measurement of thumb motion while minimizing the effects of the other movements of the hand and changes in environmental factors (Rantala, Col 3, lines 45-48).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the flexible substrate of Gilhuly with the support frame of Rantala an to have substituted the accelerometer of Gilhuly with the mechano-sensor of Rantala to maintain the sensing capabilities of the thumb, while minimizing the effects of the other movements of the hand and changes in environmental factors, as taught by Rantala (Col 3, lines 45-48). In this combination, the accelerometer of Gilhuly at the end of the thumb is substituted with the bend sensor of Rantala in between the thumb and the forefinger. Bouton teaches that while accelerometers can be used to obtain information such as joint angles (the movement of the thumb relative to the forefinger), other categories of sensors such as micro-electro-mechanical sensors and bend sensors may also be used to measure this data (Bouton, [0118]). Therefore the substitution of the bend sensor taught by Rantala for the accelerometer taught by Gilhuly is substituting known prior art elements to obtain predictable results (See MPEP 2143.I.A).
A combination of the flexible substrate taught by Gilhuly and the support frame taught by Rantala would place the mechano-sensor 380 on the sensing mechanism of Gilhuly and attached to the support frame of Rantala (located at articulation 9) to maintain the sensing ability of the thumb. Therefore, this combination also teaches: a flexible substrate, wherein at least a portion of the flexible substrate is attached to the support frame. Furthermore, this combination also teaches the bend sensor being located on the bendable middle section of the support frame and the bend sensor being configured to sense the bending of the support frame.
The combination of Gilhuly and Rantala do not teach the bend sensor being a printed bend sensor printed on the substrate.
Simonetti teaches a printed bend sensor (Fig 78, [0485-0487]) printed on the substrate (may be printed with resistive ink 786, dielectric ink layer 782, and conductive ink 783 and 785 on a flexible substrate such as substrate 784). Using a printed bend sensor can increase the cost-effectiveness of the integrated sensor ([0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the mechano-sensor taught by the combination of Gilhuly and Rantala to be a printed bend sensor to increase the cost-effectiveness of the integrated sensor, as taught by Simonetti ([128]).
The combination of Gilhuly, Rantala, and Simonetti do not teach the pair of stimulation electrodes being printed on the flexible substrate.
Fig. 3 of Bergelin teaches stimulation electrodes (element 3) printed on a substrate. Gilhuly and Bergelin both feature flexible substrates with printed leads, as printing leads on flexible circuitry is common and can be cost effective (Khan, Introduction, lines 1-8)). It would therefore be beneficial to print other elements onto the flexible circuit board to reduce insulated wiring and reduce the cost of manufacturing by printing electrical components (Khan, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the stimulating electrodes taught by the combination of Gilhuly, Rantala, and Simonetti to be printed, as taught by Bergelin to reduce insulated wiring and reduce the cost of manufacturing by printing electrical connections and components (Khan, Introduction).
Regarding claim 22, the combination of Gilhuly, Rantala, Simonetti, and Bergelin teaches the system of claim 21, wherein the kinemyography sensor further comprises a support frame (support frame of Rantala as applied to claim 21) configured to attach to the patient’s thumb and forefinger and having a bendable middle section configured to bend in response to movement of the patient’s thumb (as applied to claim 21), wherein the sensor section of the flexible substrate is attached to the bendable middle section (as applied to claim 21).
Response to Arguments
Applicant’s arguments filed 09/02/2025 have been fully considered.
The amendment to claim 6 overcomes the previous objection of record.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103 have been considered, but are not found persuasive. Applicant’s arguments that the sensor of Simonetti cannot be applied to the system of Gilhuly without significant adjustment and engineering, and that the cited references do not teach a means for such adaptation nor provide a motivation for doing so are not found persuasive. The sensors of Gilhuly and Rantala are both sensors that are used to sense motion of the thumb. Bouton teaches that accelerometers (i.e., motion sensors) and electro-mechanical sensors (i.e. bend sensors) may both be used to measure data and obtain information such as joint angles. Therefore, the substitution of the bend sensor for the motion sensor merely comprises substituting known prior art elements to obtain predictable results. See MPEP 2143.I.A. The printed bend sensor of Simonetti is also an electro-mechanical sensor, capable of measuring data and obtaining information such as joint angles, and is therefore operational for sensing hand motion between a thumb and forefinger. At the time of the effective filing date, one of ordinary skill in the art would have found it obvious to substitute the transducer of Rantala with the printed bend sensor of Simonetti because using a printed bend sensor can increase the cost-effectiveness of the integrated sensor (Simonetti; [0128]). With regards to the argument that the sensor taught by Simonetti is not operational for attachment to a support frame, one of ordinary skill in the art at the time of the effective filing date would be capable of substituting the electro-mechanical sensor of Rantala with the electro-mechanical sensor (i.e., printed bend sensor) of Simonetti. This combination would result in the sensor of Simonetti attached to the support frame.
Regarding the argument that none of the cited references teach a one-piece device where the substrate also attaches to a support frame, this argument is directed against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Gilhuly, Rantala, and Simonetti is relied upon to teach a one-piece device (taught by Gilhuly) where the substrate also attaches to a support frame (taught by Rantala). It would have been prima facie obvious to one of ordinary skill in the art to have attached the one-piece substrate to a support frame to minimize the effects of the other movements of the hand, as taught by Rantala (Col 3, lines 45-48).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2016/0023206 by Lenigk et al. teaches a flexible substrate attached to a support frame.
US Patent Publication 2019/0008453 by Spoof teaches a kinemyography sensor featuring a mechano-sensing section that is attached to a support frame between the thumb and forefinger.
THIS ACTION IS MADE FINAL. 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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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791