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 .
Election/Restrictions
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20th, 2025.
Applicant’s election without traverse of Group I (Claims 1-15) in the reply filed on November 20th, 2025 is acknowledged.
Claim Objections
Claims 8 and 11 are objected to because of the following informalities:
Claim 8 recites “the body” in line 2, but should read “the main body”.
Regarding Claim 11, Examiner notes that there are currently two claims indicated as “Claim 11”. For examination purposes, the claims will be referred to as “Claim 11A” which recites “The wearable sEMG sensor unit of claim 10, wherein the reinforcing layer is disposed at an interior corner defined by a tab of the substrate and a main body of the substrate” and “Claim 11B” which recites “The wearable sEMG sensor unit of claim 1, wherein the first pair of active electrodes are arranged to enable sensing of muscle activity from bilateral muscle pairs of the orofacial musculature”.
Appropriate correction is required.
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.
Claims 3, 7-12, and 15 are 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 3 recites the limitation "the non-stretchable polymeric sheet" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It appears that Claim 3 was intended to be dependent on Claim 2, instead of Claim 1.
The term “generally” in claim 7 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “high” in claim 10 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites “to reduce tearing” in line 3. The term “reduce” implies that there will be at least some amount of tearing, which does not necessarily seem to be the case. In order to address this, Examiner suggests that the Applicant amend to have the claim recite “to reduce a likelihood of tearing of the substrate”, or something of the like. 7
Claim 11B recites the limitation "the orofacial musculature" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the orofacial musculature" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the orofacial musculature" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-15 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) in view of Lee et al (U.S. Publication No. 2018/0271393 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);
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).
Although NPL Kim teaches a ground electrode, NPL Kim fails to teach wherein the ground electrode is disposed on the first side of the flexible non-stretchable substrate along with the other plurality of sensor electrodes.
In a similar technical field, Lee teaches skin-mountable electronic devices and methods suitable for fabricating and using the devices (Abstract), comprising a plurality of sensor electrodes disposed on the first side, the plurality of sensor electrodes including at least a first pair of active electrodes and a ground electrode (The device includes a nanocomposite elastomer structure 10 comprising a thin film of Cu nanowire mesh layer (1.0 g/m2) on a D-PI film (300 nm thick) patterned to form three separate units 24, each comprising a pattern 20 of filamentary serpentine traces 22. Each unit 24 serves as a reference, ground, or measurement electrode (from the left) that can be directly coupled to the skin, as represented in FIG. 9; [0043]; Figures 9-10).
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 ground electrode teachings of Lee into those of NPL Kim in order to allow for high quality recordings of electrocardiograms (ECG) and electromyograms (EMG) by applying the device, comprising both ground and active electrodes, directly onto the user (Lee [0043]).
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 7, NPL Kim discloses wherein the substrate comprises a main body having a generally triangular shape (Examiner’s Note: Figure 1B depicts that the patch has a generally triangular shape with a wider bottom portion and a smaller top portion).
Regarding Claim 8, NPL Kim discloses wherein the substrate comprises a tab extending from an edge of the body opposite an 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 ground electrode is disposed adjacent the apex, and 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, Lee teaches skin-mountable electronic devices and methods suitable for fabricating and using the devices (Abstract), wherein the ground electrode is disposed adjacent the apex, and wherein the first pair of active electrodes is disposed between the ground electrode and the edge of the main body (The device includes a nanocomposite elastomer structure 10 comprising a thin film of Cu nanowire mesh layer (1.0 g/m2) on a D-PI film (300 nm thick) patterned to form three separate units 24, each comprising a pattern 20 of filamentary serpentine traces 22. Each unit 24 serves as a reference, ground, or measurement electrode (from the left) that can be directly coupled to the skin, as represented in FIG. 9; [0043]; Figures 9-10; Examiner’s Note: The apex of the body is equivalent to the top portion of the structure 10, and the ground electrode 24 is disposed adjacent to the top portion of the structure 10. Furthermore, the ground electrode is disposed in the middle of the structure, which puts the active electrodes in between the ground electrode and the edge of the structure 10).
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 ground electrode teachings of Lee into those of NPL Kim in order to allow for high quality recordings of electrocardiograms (ECG) and electromyograms (EMG) by applying the device, comprising both ground and active electrodes, directly onto the user (Lee [0043]).
Regarding Claim 10, NPL Kim discloses comprising a reinforcing layer disposed on the substrate, the reinforcing layer being located at a high stress area of the substrate to reduce tearing of the substrate (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-1C; 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. A piezoresistive strip (Velostat, 3M) is then printed with a conductive adhesive epoxy (#8331, MG Chemicals) to serve as the strain sensing element; Page 3; Examiner’s Note: The strain gauge can be equivalent to the reinforcing layer, since it is disposed on the substrate in the form of a piezoresistive strip, which is located at an area where laryngeal movement occurs during swallowing, which may be considered a “high stress area”, as best understood).
Regarding the Claim 11A, NPL Kim discloses wherein the reinforcing layer is disposed at an interior corner defined by a tab of the substrate and a main body of the substrate (A piezoresistive strip (Velostat, 3M) is then printed with a conductive adhesive epoxy (#8331, MG Chemicals) to serve as the strain sensing element; Page 3; Figures 1A-1C; Examiner’s Note: The piezoresistive strip can be seen in Figures 1A-1C, and there are multiple corners surrounding the strip that can be defined by a tab and main body of the substrate. For example, the bottom end of the piezoresistive strip (equivalent to the gray/black line in Figures 1A and 1C) can be interpreted as being disposed at an interior corner defined by a tab of the substrate (equivalent to the yellow layer that encompasses the piezoresistive strip in Figures 1A and 1C) and the main body of the substrate (equivalent to the yellow patch area that encompasses the electrodes)).
Regarding the Claim 11B, NPL Kim discloses wherein the first pair of active electrodes are arranged to enable sensing of muscle activity from bilateral muscle pairs of the orofacial musculature (The sEMG signals were then collected from the left and right submental muscles; Page 4; Figure 1A).
Regarding Claim 12, NPL Kim discloses wherein the sEMG sensor unit is configured for application to the 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 the orofacial musculature (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).
Conclusion
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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/CHANEL J YOON/Examiner, Art Unit 3791