DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Currently, claims 1-20 are pending with claims 11-20 withdrawn, and claims 1-6, 9-14, 16 and 18 amended. Applicant’s amendments to the claims have obviated the previously-filed rejections of claims 1-10 under 35 U.S.C. 112(b). The following is a complete response to the June 17, 2026 communication.
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
Applicant’s amendments to claim 16 is acknowledged. With respect to the restriction requirement set forth in the February 3, 2025, Applicant’s amendment to claim 16 has rendering the holding between Groups I and III in the February 3, 2025 restriction requirement as no longer applicable because the relationship between I and III no longer holds as subcombination and combination. Accordingly, claims 16-20 will be held as no longer withdrawn and will be examined on the merits herein.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sotzing (US Pat. Pub. 2015/0017421 A1) further in view of Sotzing et al. (US Pat. Pub. 2007/0089845 A1) hereinafter “Sotzing ‘845”.
Regarding claim 1, Sotzing provides for a wearable bio-potential monitoring device for measuring bio-potentials comprising:
an electrode comprising a first fabric comprising an assembly of polymeric fibers and nucleophile derivatized nanoparticles dispersed therewith such that the electrode is free of metal (see [0015] with the fabric formed of the electrically conductive fibrous substrate; see further the desiccant materials throughout as in [0015] and [0029]), and
a first electrically conductive polymer disposed on the first fabric and at least in partial contact with the nucleophile derivatized nanoparticles (electrically conductive polymer disposed on the polymeric fiber as in [0015]), and
While Sotzing further contemplates the general use of the disclosed fabric as a wiring element (see [0048] contemplating “electrically conductive synthetic leather as a conductive wire”) with such synthetic leather comprising an assembly of polymeric fibers and nucleophile derivatized nanoparticles dispersed therewith such that the electrode is free of metal (see [0015] with the fabric formed of the electrically conductive fibrous substrate; see further the desiccant materials throughout as in [0015] and [0029]), and an electrically conductive polymer disposed on the fabric and at least in partial contact with the nucleophile derivatized nanoparticles (electrically conductive polymer disposed on the polymeric fiber as in [0015]), Sotzing fails to specifically provide that a non-metallic wiring element is used to provide for a wire for medical devices including a bio-potential monitoring device.
Sotzing ‘845 provides for a similar device as that of Sotzing and specifically discloses the use of a wire for a circuit including non-metallic conductive polymer fiber-based structures (see at least [0127]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a polymer-based wiring element that is free of metal as in Sotzing ‘845 as the wiring element of Sotzing. Further the Examiner is of the position that it would have been obvious to have utilized the materials of Sotzing (in view of the direction in [0048] providing the Sotzing’s materials are suitable to be used for wires) for the wiring element of the combination given the direction in Sotzing ‘845 provides that the use of such non-metal polymer-based materials as in Sotzing in the form of the conductive polymer that is free of metal are readily capable of being used as non-metal medical leads/wire. Such provides an advantage of ensuring that both the electrode and the wiring element are formed of a similar or a same material that is free of metal, but still readily capable of transferring electrical signals/energy to and from the body.
Regarding claim 2, in view of the combination in the rejection of claim 1 above, the combined monitoring device would include each of the electrode and the wiring element to individually comprise at least one of nylon 6, nylon 66, nylon 610, nylon 12, co-polymerized nylon, polyethylene terephthalate, polytrimethylene terephthalate, spandex (polyurethane-polyurea copolymer), polybutylene terephthalate, polypropylene terephthalate, polyurethane, polypropylene, polyethylene, polyester-based polyurethane, a copolymer thereof, or a combination thereof (see the polymeric fiber materials as in [0028] of Sotzing).
Regarding claim 3, in view of the combination in the rejection of claim 1 above, the combined monitoring device would include nucleophile derivatized particles for each of the electrode and the wiring element to comprise silica, titania, alumina, calcium oxide, amine functionalized nanoparticles, or a combination thereof (see [0029] of Sotzing listing the relied upon desiccant materials).
Regarding claim 4, in view of the combination in the rejection of claim 1 above, the materials per the teaching of Stozing would provide that the first electrically conductive polymer and the second electrically conductive polymer comprises at least one a poly(3,4-ethylenedioxythiophene), a poly(3,4-ethylenedioxy thiophene):poly(styrenesulfonate) aqueous dispersion, a substituted poly(3,4- ethylenedioxy thiophene), a poly(thiophene), a substituted poly(thiophene), a poly(pyrrole), a substituted poly(pyrrole), a poly(aniline), a substituted poly(aniline), a poly(acetylene), a poly(p- phenylenevinylene), a poly(indole), a substituted poly(indole), a poly(carbazole), a substituted poly(carbazole), a poly(azepine), a (poly)thieno[3,4-b]thiophene, a substituted poly( thieno[3,4- b]thiophene), a poly(dithieno[3,4-b:3',4'-d]thiophene), a poly(thieno[3,4-b]furan), a substituted poly(thieno[3,4-b]furan), or a derivative thereof (see the electrically conductive polymer materials as in [0024]). Regarding claim 5, in view of the combination in the rejection of claim 1 above, the materials per the teaching of Sotzing would provide that the first electrically conductive polymer and the second electrically conductive polymer to comprise various ones of the claimed materials set forth in claim 5 as in [0024] of Sotzing. Regarding claim 6, in view of the combination in the rejection of claim 1 above, the materials per the teaching of Sotzing would provide that the first fabric and the second fabric are each fabric that is stretchable and electrically insulating (in view of Sotzing, see at least [0020], [0024], [0027], and [0028] that provide for the polymeric substrate forming at least a portion of the claimed fabric to be formed of the same materials as in Applicant’s own disclosure at [0072] that is disclosed as an insulating and stretchable material).
Regarding claim 7, in view of the combination in the rejections in claims 1 and 6 above, the materials per Sotzing provide that the stretchable fabric comprises at least one of a polyurethane, a polyester-polyurethane copolymer, a blend of polyurethane or polyester- polyurethane and an additional synthetic organic polymer selected from the group consisting of a polyacrylic, a polyamide, a polycarbonate, a polyether, a polyester, a polyethylene, a polyimide, a polyurea, a polythiourea, a polysiloxane, a polyisoprene, a polybutadiene, a polyethylene oxide, a polylactic acid, and copolymers thereof (via the polymeric fibers as in [0028] of Sotzing).
Regarding claim 8, the Examiner is of the position that the electrode of Sotzing is capable of being washed as claimed. Such is a functional recitation of the intended use of the electrode which, at this time, fails to structurally distinguish the claimed electrode from the prior art electrode of Sotzing.
Regarding claim 9, in view of the combination in the rejection of claim 1 above, the materials per the teaching of Sotzing would provide that the first fabric and the second fabric individually comprise interlaced fibers, filaments, yarns, laces, meshes, nets, knitted fibers or woven fibers or wherein the fabric comprises a non-woven fabric selected from felt, twisted fibers or braided fibers (see [0017] providing for woven and non-woven arrangements in Sotzing), and wherein the fabric has a (1) substantial surface planar area in relation to its thickness (via the fabric being formed into a sheet as in [0083] of Sotzing), and (2) adequate mechanical strength to give it a cohesive structure (via the fabric able to form multiple structures throughout Sotzing including the sheet as in [0083] of Sotzing).
Regarding claim 10, Sotzing provides that the electrically conductive polymer is a film (see at least [0026] providing that such is a film).
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sotzing (US Pat. Pub. 2015/0017421 A1) in view of Sotzing et al. (US Pat. Pub. 2007/0089845 A1) hereinafter “Sotzing ‘845” as applied to claim 1 above, and further in view of Pani et al (“Fully Textile, PEDOT:PSS based electrodes for wearable ECG monitoring systems”).
Regarding claims 16 and 18, while the combination of Sotzing and Sotzing ‘845 provide for the device/electrode as in the rejection of claim 1 above, the combination fails to provide for a monitoring system coupled to the electrode by the wiring element (claim 16), and that the monitoring system is at least one of an electrocardiogram system, an electroencephalogram system, an electromyography system, a heart rate system, a respiratory rate system, a bioelectrical impedance analysis system and an electrodermal activity system (claim 18).
Pani, however, provides for an electrode comprising a monitoring system in conjunction with a conductive polymeric fabric (textile electrode based on woven fabric treated with PEDOT:PSS as in the Abstract in combination with and ECG system at throughout; EEG contemplate in page 548 in Conclusion section). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the electrode in combination with a monitoring system as taught by Pani to provide for an exemplary device that combines low cost, simple-to-fabricate electrodes in a known monitoring system.
Regarding claim 17, Sotzing provides for the inclusion of at least one of a belt, garment, footwear, headwear, wrist band, or chest strap (see paragraph [0023] providing for the system being usable in apparel or footwear).
Regarding claim 20, the combination as set forth in the rejection of claim 17 above would provide for an ECG system that is capable of measuring ECG in the heart range of 40 to 180bpm while in a wet condition (as per the teaching through Pani of the monitoring of ECG from the heart in wet conditions).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sotzing (US Pat. Pub. 2015/0017421 A1) in view of Sotzing et al. (US Pat. Pub. 2007/0089845 A1) hereinafter and Pani et al (“Fully Textile, PEDOT:PSS based electrodes for wearable ECG monitoring systems”) as applied to claim 18 above, and further in view of Chen et al.(“Soft, conformable polymer dry electrodes for high quality ECG and EEG recording”).
Regarding claim 19, the combination of Sotzing, Sotzing ‘845 and Pani, in the rejections of claims 17 and 18 above, provide for the functionality as an electrocardiogram system that is capable of measuring signals from the heart. The combination of references fails to provide, however, that the monitoring system is operable with a signal to noise ratio range of between 3dB to 30 dB (per claim 19). Chen discloses a similar device/system as the cited prior art references and specifically teaches a polymer electrode for recording ECG (see the Abstract) having a single to noise ratio range of 3 to 30dB (signal processing as discussed in section 3.3.1, with the resultant SNR to be above 3dB; see figure 12c). Therefore, it is the Examiner’s position that it would have been obvios to one of ordinary skill in the art at the time of filing to have utilized the signal processing techniques of Chen to the combined monitoring system to provide for teachniques that would improve ECG signals to noise ratio such that the resultant measured signal is not negatively impacted by noise artifacts when monitored.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of claims 1-10 under 35 U.S.C. 103 as unpatentable over the combination of Sotzing in view of Sotzing ‘845 on pages 2-4 of the Remarks. Applicant first provides an overview of Sotzing and Sotzing ‘845 references, the subject matter of amended claim 1, and relevant information with respect to obviousness under 35 U.S.C. 103 on pages 2-3. Applicant then alleges on pages 3-4 that the combination of Sotzing and Sotzing ‘845 fails to provide for each and every limitation set forth in claim 1 given, in part, that Sotzing fails to provide for the wiring element as claimed.
Applicant further contends that disclosure in Sotzing ‘845 provides for “intrinsically conductive polymers whereas the claimed wiring element comprises a fabric comprising an assembly of polymeric fibers and nucleophile derivatized nanoparticles dispersed therewith, and an electrically conductive polymer disposed on the fabric and at least in partial contact with the nucleophile derivatized nanoparticles”. To this end, Applicant argues that the “materials in Sotzing ‘845 are different from the materials in Sotzing” and concludes that “any wires taught in Sotzing ‘845 would not have motivated one of ordinary skill in the art to the electrically conductive synthetic fiber and fibrous substrate of Sotzing as a wiring system”. Applicant also concludes that there would be no “expectation of success for the use of the material in Sotzing for both a wiring system and electrode free of metal in a bio-potential monitoring device” such that any combination of Sotzing and Sotzing ‘845 would be based on impermissible hindsight.
This is not persuasive. While Applicant may argue that the examiner's conclusion of obviousness in the rejection of claim 1 in relying on the combination of Sotzing and Sotzing ‘845 is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, the Examiner finds that the combination is based on the disclosure in each of Sotzing and Sotzing ‘845, and not from knowledge taken only from Applicant’s disclosure. Sotzing readily contemplates that its disclosure materials can be utilized in conductive wires per the disclosure in [0048].
Specifically, the disclosure of Sotzing ‘845 is relied upon to teach that it is known in the art to utilize a conductive, polymer-based, non-metal, fiber structur as a wire and/or lead for circuitry as well as in medical devices (as disclosed in [0127]). The combination in the rejection of claim 1 above has specifically relied upon the use of the materials of construction (fabric including polymeric fibers and nanoparticles having an electrically conductive polymer disposed thereon) in Sotzing as the material of construction of the wiring element of the combination. The materials of Sotzing itself are specifically disclosed as being suitable for wiring elements as in paragraph [0048] with Sotzing ‘845 being relied upon, again, to teach similar non-metal polymer-based materials in electrical circuits and medical devices. Thus, the resultant structure of the combination in the rejection of claim 1 above of Sotzing and Sotzing ‘845 readily addresses the use of a second assembly of fibers and nanoparticles as claimed.
Thus, it is for at least the reasoning set forth in the rejections and remarks above that the Examiner maintains that the rejection of claims 1-10 under 35 U.S.C. 103 as being unpatentable over Sotzing (US Pat. Pub. 2015/0017421 A1) further in view of Sotzing et al. (US Pat. Pub. 2007/0089845 A1) hereinafter “Sotzing ‘845” remains tenable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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