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 (IDSs) submitted on September 9, 2024, and July 3, 2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 3-6 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.
Claims 3-6 recite the limitations "the at least one pair of surface electromyography electrodes” in lines 1-2 (Claim 3) and “one in the pair of surface electromyography electrodes” in line 4 (Claim 3). There is insufficient antecedent basis for these limitations in these claims. For purposes of examination, “the at least one pair of surface electromyography electrodes” in Claim 3 will be read as “at least one pair of surface electromyography electrodes”, and “one in the pair of surface electromyography electrodes” in Claim 3 will be read as “one electrode in the at least one pair of surface electromyography electrodes”.
Claims 4-6 also recite the limitation “the surface electromyography electrodes” in line 1 (Claim 4). Claim 5 recites the limitation “the pair of surface electromyography electrodes” in line 3. There is insufficient antecedent basis for these limitations in these claims. For purposes of examination, both “the surface electromyography electrodes” from Claim 4 and “the pair of surface electromyography electrodes” from Claim 5 will be read as “the at least one pair of surface electromyography electrodes”.
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.
Claim(s) 1, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230389875 A1 (Xu et al.) in view of US 20140371562 A1 (Lee et al.).
Regarding Claim 1, Xu teaches A body-attached electromyogram sensor including a surface electromyography electrode (see para. 0019; see also Fig. 5), comprising:
the surface electromyography electrode (see para. 0019; see also Fig. 5);
and a substrate (see para. 0009),
wherein the surface electromyography electrode includes a first electrode layer of a film disposed on its bottom surface (see para. 0044, “An encapsulation layer of polyimide (PI) . . . was spin-coated and cured on top of [sacrificial] PMMA”),
a metal layer deposited on an upper surface of the first electrode layer (see para. 0044, “a bilayer of chromium (Cr, 5 nm) and gold (Au, 50 nm) was sputtered (Denton Desktop Pro) on the PI layer”),
and a second electrode layer deposited on an upper surface of the metal layer, (see para. 0044, “Another PI encapsulation layer was applied on top of the sensor components”).
and the substrate is disposed on a lower surface of the surface electromyography electrode and includes at least a porous layer (see para. 0035, “polymer nanofibers . . . can be electrospun on top of stamp-supported devices, which serves as a porous substrate with desired flexibility and mass permeability”).
Although Xu teaches that various polymers that are suitable for electrospinning may be used as the porous substrate (see para. 0035), Xu does not disclose that the porous layer can be specifically a porous silicon layer.
Lee teaches a substrate for an electrode that includes a porous silicone layer (see para. 0042, “the porous polymer support layer serves to provide flexibility to the flexible electrode. Accordingly, any polymer material capable of ensuring superior flexibility may be used in the porous polymer support layer. For example, most silicone rubber such as polydimethylsiloxane (PDMS) may be used.”).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Xu in view of Lee to provide that the porous substrate includes specifically a porous silicon layer (e.g., porous PDMS). Doing so would amount to a substitution of one known material for another to achieve similar predictable results.
Regarding Claim 7, the combination of Xu and Lee as discussed in Claim 1 includes a porous silicon layer that includes polydimethylsiloxane (PDMS) (see para. 0042 of Lee).
Regarding Claim 8, the combination of Xu and Lee as discussed in Claim 1 includes a metal layer that includes a first metal layer that is an adhesion layer film (chromium) deposited on the upper surface of the first electrode layer, and a second metal layer that is a conduction layer (gold) deposited on an upper surface of the first metal layer (see para. 0044 of Xu).
Regarding Claim 9, the combination of Xu and Lee as discussed in Claim 1 includes a first electrode layer and a second electrode layer that each include polyimide (see para. 0044 of Xu).
Regarding Claims 10 and 12, Xu teaches the surface electromyography electrode is serpentine (see para. 0036, “enlarged image (FIG. 1(c) left) shows serpentine electronics integrated on the BCEM”).
Regarding Claim 11, Xu does not explicitly teach that the body-attached electromyogram sensor has a thickness of 70 to 370 μm that includes a thickness of the surface electromyography electrode and a thickness of the substrate. However, Xu teaches that 100-μm-thick substrates are common in the industry (see para. 0039). As such, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to have the surface electromyography electrode and substrate together form a thickness of 70 to 370 μm, which would be around the typical thickness range expected given the thickness of the substrate.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230389875 A1 (Xu et al.) in view of US 20140371562 A1 (Lee et al.) and further in view of US 20240293064 A1 (Hatakeyama et al.).
Regarding Claim 2, Xu teaches the substrate has an area larger than that of the surface electromyography electrode (see Fig. 5). However, Xu and Lee fail to teach that the substrate includes a silicone adhesive layer coated on a lower surface of the first electrode layer and that the porous silicon layer is coated on a lower surface of the silicone adhesive layer.
Hatakeyama teaches using adhesive layers for bio-electrodes and further teaches that silicone adhesives are “the most preferable in terms of high water repellency, low occurrence of a rash on the skin, and allowing the skin to breathe” (see para. 0115). It would have been obvious before the effective filing date of the claimed invention to combine the teachings of Xu, Lee, and Hatakeyama to further provide for a silicone adhesive layer coated between the first electrode layer and the porous silicon layer. Doing so could ensure the first electrode layer and porous silicon layers are adhered to each other while maintaining biocompatibility and breathability, as recognized by Hatakeyama.
Regarding Claim 3, Xu teaches at least one pair of surface electromyography electrodes are disposed within the substrate while being spaced apart from each other by a predetermined distance (see para. 0041; see also Fig. 5), and one in the pair of surface electromyography electrodes is a negative electrode and the other is a positive electrode (see para. 0036, “Embodiments can incorporate microfabricated bipolar electrodes”; see also para 0041 and Fig. 5).
Claim(s) 4, 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230389875 A1 (Xu et al.) in view of US 20140371562 A1 (Lee et al.), US 20240293064 A1 (Hatakeyama et al.), and further in view of US 20200121210 A1 (Herr et al.) and US 20160120435 A1 (Young).
Regarding Claims 4 and 6, the combination of Xu, Lee, and Hatakeyama does not explicitly disclose the surface electromyography electrodes include a connector connecting the pair of surface electromyography electrodes to each other or that an electrical lead for each surface electromyography electrode is connected to the connector. However, Herr teaches surface electromyography electrodes including a connector [208] connecting a pair of surface electromyography electrodes and their respective electrical leads to each other (see para. 0035). It would have been obvious for a person having ordinary skill in the art to combine the teachings of Xu, Lee, Hatakeyama, and Herr to further provide a connector connecting a pair of surface electrodes and respective electrical leads to each other. Doing so would serve to create a connection between the electrodes and other devices or parts of the device, such as for signal processing, as recognized by Herr (see para. 0040).
Claim(s) 5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230389875 A1 (Xu et al.) in view of US 20140371562 A1 (Lee et al.), US 20240293064 A1 (Hatakeyama et al.), and further in view of US 20200121210 A1 (Herr et al.) and US 20160120435 A1 (Young).
Regarding Claim 5, Xu teaches the pair of surface electromyography electrodes are spaced apart from each other in an X-axis direction (see Fig. 5) but is not explicitly about the distance. Xu also fails to disclose that the surface electromyography electrode has its length in a Y-axis longer than its length in an X-axis.
While Herr also does not explicitly disclose that the centers of the surface electromyography electrodes are within 18 to 20 mm, Herr does teach distances between centers that overlap with the claimed range (e.g., 15 mm to 20 mm) (see para. 0038). As such, in the combination of Xu, Lee, Hatakayama, and Herr, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the center to center distance of Herr from between 15 and 20 mm to between 18 and 20 mm as applicant appears to have placed no criticality on the claimed range (see para. 0014 indicating the distance “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to the length of the electrode being longer in a y-axis than an x-axis, Young teaches EMG electrodes of varying shapes, including oval-shaped electrodes (see para. 0035). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of Xu into a more oval-shape in view of the teachings of Young. Doing such a modification would yield a length along a y-axis that is longer than along an x-axis which could be preferable depending on the desired contact area. Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47).
Conclusion
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
