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 .
Amendment Entered
In response to the amendment filed on May 21st, 2026, amended claims 1, 3, 8-10, 12, and 15, and new claim 20 are entered. Claims 7 and 11 are canceled, and claims 16-19 remain withdrawn from consideration. Claims 1-6, 8-10, 12-15, and 20 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-6, 8-10, 12-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Kim et al (Kim, Min Ku, et al. "Flexible submental sensor patch with remote monitoring controls for management of oropharyngeal swallowing disorders." Science advances 5.12 (2019): eaay3210.; cited by Applicant; previously cited) in view of Strong et al (U.S. Publication No. 2006/0129058 A1).
Regarding Claim 1, NPL Kim discloses a wearable surface electromyography (sEMG) sensor unit comprising:
a flexible non-stretchable substrate comprising a first layer defining a first side of the substrate (The fabrication of the sensor patch begins with a thin (13 mm), flexible sheet of polyimide (PI); Page 3) and a second layer defining a second side of the substrate (coated with a Cu film (9 mm); Page 3), wherein the substrate has a main body having a multi-sided shape (Fig. 1B);
a plurality of sensor electrodes disposed on the first side, the plurality of sensor electrodes including at least a first pair of active electrodes (The measurement of sub-mental sEMG signals occurs by exploiting double-differential recording using two pairs of recording electrodes (Fig. 1B); Page 2); and
a ground electrode (a reference (ground) electrode placed on the mastoid process; Page 4);
a plurality of traces disposed on the second side (The UV-exposed Cu film was chemically etched in a solution of ferric chloride (FeCl3) to form the two channels of differential sEMG electrodes and the interconnector traces on the surface; Page 6); and
vias connecting the traces to the sensor electrodes (A subsequent photolithographic patterning, followed by wet etching with a Cu etchant (CE-100, Transene), defines the recording electrodes and interconnectors for two pairs of sEMG channels and a strain gauge on each side of the PI sheet; Page 3; The UV-exposed Cu film was chemically etched in a solution of ferric chloride (FeCl3) to form the two channels of differential sEMG electrodes and the interconnector traces on the surface; Page 6).
NPL Kim fails to specifically teach wherein the substrate has a main body having a triangular shape; wherein the ground electrode is disposed on the same side along with the other electrodes; and wherein the ground electrode is disposed adjacent a corner of the main body that defines an apex of the triangular shape of the main body.
In a similar technical field, Strong teaches a system for receiving at least one electromyogram signal representing physiological activity (Abstract), wherein the substrate has a main body having a triangular shape (Examiner’s Note: Enclosure 302 has a triangular shape as shown in Figure 3B); wherein the ground electrode is disposed on the same side along with the other electrodes (Examiner’s Note: Signal electrodes 204 and 206 and reference electrode 208 are shown on the same side in Figure 3B); and wherein the ground electrode is disposed adjacent a corner of the main body that defines an apex of the triangular shape of the main body (Examiner’s Note: Reference electrode 208 is depicted as being disposed adjacent a corner of the main body that defines an apex of the triangular shape of the main body in Figure 3B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the electrode configuration teachings of Strong into those of NPL Kim, since placing the reference electrode in the apex of the triangular shape to help evenly sense electrical potential, balance the electric field, and measure a stable average value.
Regarding Claim 2, NPL Kim discloses wherein the first layer comprises a non-stretchable polymeric sheet (The fabrication of the sensor patch begins with a thin (13 mm), flexible sheet of polyimide (PI); Page 3).
Regarding Claim 3, NPL Kim discloses wherein the non-stretchable polymeric sheet is a polyimide material (The fabrication of the sensor patch begins with a thin (13 mm), flexible sheet of polyimide (PI); Page 3).
Regarding Claim 4, NPL Kim discloses wherein the second layer is a metallic layer (The fabrication of the sensor patch begins with a thin (13 mm), flexible sheet of polyimide (PI) coated with a Cu film (9 mm); Page 3).
Regarding Claim 5, NPL Kim discloses wherein the metallic layer is copper (The fabrication of the sensor patch begins with a thin (13 mm), flexible sheet of polyimide (PI) coated with a Cu film (9 mm); Page 3).
Regarding Claim 6, NPL Kim discloses wherein the plurality of sensor electrodes further comprises a second pair of active electrodes on the first side, the first and second electrode pairs being symmetrically arranged on opposite sides of a medial axis of the substrate (The measurement of sub-mental sEMG signals occurs by exploiting double-differential recording using two pairs of recording electrodes (Fig. 1B) with relatively small diameter (5 mm) and interelectrode distance (12 mm) to reduce detection volume and consequently minimize the effect of cross-talk (22); Page 2; Examiner’s Note: Figure 1B shows the symmetrical arrangement of the first and second electrode pairs).
Regarding Claim 8, NPL Kim discloses wherein the substrate comprises a tab extending from an edge of the main body opposite the apex of the main body (In addition, the sensor patch incorporates a strain gauge (Fig. 1C) to provide piezoresistive responses against relative laryngeal movement during swallowing; Page 2; Figures 1A and 1C; Examiner’s Note: The strain gauge is equivalent to the tab, as it extends from the edge of the body opposite the apex).
Regarding Claim 9, NPL Kim fails to disclose wherein the first pair of active electrodes is disposed between the ground electrode and the edge of the main body.
In a similar technical field, Strong teaches a system for receiving at least one electromyogram signal representing physiological activity (Abstract), wherein the first pair of active electrodes (signal electrodes 204 and 206) is disposed between the ground electrode and the edge of the main body (Signal electrodes 204 and 206 are disposed between the reference electrode 208 and the edge of the main body shown in Figure 3B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the electrode configuration teachings of Strong into those of NPL Kim in order to help evenly sense electrical potential, balance the electric field, and measure a stable average value.
Regarding Claim 10, NPL Kim discloses comprising a reinforcing layer disposed on the substrate, the reinforcing layer being located at interior corners of the substrate on opposite sides of the tab where the edge of the main body intersects the tab (coated with a Cu film; Page 3; Examiner’s Note: The Cu film coats the entire polyimide sheet, which would qualify as at least being located at interior corners of the substrate on opposite sides of the tab where the edge of the main body intersects the tab).
Regarding Claim 12, NPL Kim discloses wherein the sEMG sensor unit is configured for application to orofacial musculature of a patient (the sensor patch is mounted to the submental area so that the embedded sEMG electrodes remain in contact with the skin aligned parallel to underlying muscular fibers; Page 2; Figure 1A) and is configured to optimize management of swallowing disorders (The results reported here represent preliminary testing and validation of a user-friendly “bandage-like” skin sensor patch platform that is specifically designed for the submental area, and assess both muscle activity and laryngeal/thyroid notch movement during swallowing and swallowing maneuvers; Page 6).
Regarding Claim 13, NPL Kim discloses wherein the wearable sEMG sensor unit does not include an integrated adhesive for adhering to a patient's skin (the sensor patch was contacted to the skin with a clinically accepted adhesive material (~10 μmthick, E = ~5 kPa; Silbione HC2 2022, Bluestar Chemical); Page 8; Examiner’s Note: Because the sensor patch needs an external “clinically accepted adhesive material” to adhere it to the skin, the sensor unit does not inherently include an integrated adhesive).
Regarding Claim 14, NPL Kim discloses wherein the first pair of active electrodes comprises differential electrodes (The measurement of sub-mental sEMG signals occurs by exploiting double-differential recording using two pairs of recording electrodes (Fig. 1B); Page 2).
Regarding Claim 15, NPL Kim discloses wherein each of the first pair of active electrodes is proportional in size to a muscle of orofacial musculature of a patient (the sensor patch is mounted to the submental area so that the embedded sEMG electrodes remain in contact with the skin aligned parallel to underlying muscular fibers. The measurement of sub-mental sEMG signals occurs by exploiting double-differential recording using two pairs of recording electrodes (Fig. 1B) with relatively small diameter (5 mm) and interelectrode distance (12 mm) to reduce detection volume and consequently minimize the effect of cross-talk (22); Page 2; Figure 1A).
Regarding the Claim 20, NPL Kim discloses wherein the first pair of active electrodes are arranged to enable sensing of muscle activity from bilateral muscle pairs of orofacial musculature of a patient (The sEMG signals were then collected from the left and right submental muscles; Page 4; Figure 1A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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