DETAILED ACTION
This action is pursuant to the claims filed on 07/11/2024 Claims 1-11 are pending. A first action on the merits of claims 1-11 is as follows.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/11/2024, 11/18/2025, 02/11/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is/are objected to because of the following informalities:
Claim 1 line 10; “(procedure)” should be deleted.
Appropriate correction is required.
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.
Claim(s) 1-5, 7, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lai (U.S. PGPub No. 2017/0027473) in view of Salam (Salam, Abd-El, “Effect of Conductive Fillers on the Cyclic Stress-Strain and Nano-Scale Free Volume Properties of Silicone Rubber”, Chinese Journal of Polymer Science, Oct, 2013).
Regarding claim 1, Lai teaches A flexible sheet electrode comprising: a flexible base material (Figs 1-2, fabric substrate 10); and an elastomer electrode layer provided over the flexible base material (Figs 1-2, conductive coating layer 16; [0041] disclosing 16 as a elastomer), wherein the elastomer electrode layer is formed over an outside of the flexible base material and includes a lamination layer including a conductive elastomer layer (Figs 1-2, layer 16 on outside of substrate 10 and defines lamination layer of conductive elastomer), and in a case where a tensile test is performed on the flexible sheet electrode according to the following procedure, a 100% tensile test force is greater than or equal to 5.0 N and less than or equal to 10.0 N, (procedure) a sample test piece having a rectangular shape is prepared from the flexible sheet electrode, in a case where the elastomer electrode layer of the sample test piece is held by chucks of a tensile testing machine such that a center of the elastomer electrode layer is positioned at a center between the chucks, and a distance between the chucks is elongated from 0% to 250% under a condition of a tensile rate of 250 mm/min, a tension (N) is measured during extension of the distance by X%, and a value of the tension is defined as the X% tensile test force (examiner notes preceding limitations recite intrinsic material properties of the flexible sheet and any flexible sheet of the prior art is capable of undergoing the procedure; the procedure is directed towards known tensile testing (i.e., stress-strain curve) where stress (force/area) is plotted as a function of strain (elongation); it is further noted the claims do not recite a specific value for the area of “the sample test piece having a rectangular shape prepared from the flexible sheet electrode”; thus any material that has the capability of 100% elongation has a corresponding stress (force/area) corresponding to 100% elongation and a range of areas that would yield a force of between 5-10 N at the stress of 100% elongation as claimed based on the fact that Stress = Force/Area, and, in this case, the Stress and Force are known variables).
Lai fails to explicitly teach wherein the 100% tensile test force is greater than or equal to 5.0 N and less than or equal to 10.0 N based on the procedure.
In related prior art, Salam teaches the use of a similar conductive elastomer in tensile testing (Pg 560 and Fig 5) wherein the 100% tensile test force is greater than or equal to 5.0 N and less than or equal to 10.0 N (Fig 4, C10 exhibits a stress of ~0.7 MPa at 100% strain; using stress = F/A with forces of 5 N and 10 N and solving for A, yields an area of 7.14 mm2 through 14.29 mm2 of the C10 conductive elastomer that would provide a 100% tensile test force between 5-10 N, thus the areas required to provide a 100% tensile test force at 5-10 N are on the millimeter scale which is known to be much smaller than the flexible sheet electrode of Lai). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material selection of Lai in view of Salam to incorporate a flexible base material and elastomer electrode layer that yield a 100% tensile test force between 5-10 N based on the procedure as claimed to arrive at the device of claim 1. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that conductive elastomers and flexible base materials are stretchable to 100% elongation with tensile testing (see Salam Fig 5) such that providing the material selections to yield the 100% tensile test force as claimed would yield the predictable result providing a stretchable and flexible wearable bioelectrode.
Regarding claim 2, in view of the combination of claim 1 above, as stated above Salam teaches the use of a similar conductive elastomer in tensile testing (Pg 560 and Fig 5) wherein the 20% tensile test force is greater than or equal to 1.5 N and less than or equal to 5.5 N (Fig 4, C10 exhibits a stress of ~0.18 MPa at 20% strain; using stress = F/A with forces of 1.5 N and 5.5 N and solving for A, yields an area of 8.33 mm2 through 30.55 mm2 of the C10 conductive elastomer that would provide a 20% tensile test force between 1.5-5.5 N, thus the areas required to provide a 20% tensile test force at 1.5-5.5 N are on the millimeter scale which is clearly much smaller than the flexible sheet electrode of Lai). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material selection of Lai in view of Salam to incorporate a flexible base material and elastomer electrode layer that yield a 20% tensile test force between 1.5-5.5 N based on the procedure as claimed to arrive at the device of claim 2. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that conductive elastomers and flexible base materials are stretchable to 20% elongation with tensile testing (see Salam Fig 5) such that providing the material selections to yield the 20% tensile test force as claimed would yield the predictable result providing a stretchable and flexible wearable bioelectrode.
Regarding claim 3, in view of the combination of claim 1 above, Lai further teaches an impregnation layer formed over an inside of the flexible base material (Fig 1, portion of conductive elastomer 16 is embedded within base substrate 10), wherein the impregnation layer includes the conductive elastomer layer and/or an insulating elastomer layer (Fig 1, impregnation layer at h2 includes conductive elastomer layer 16).
Regarding claim 4, in view of the combination of claim 1 above, Lai further teaches wherein the conductive elastomer layer contains a conductive filler ([0041] conductive particles of layer 16) and a non- conductive filler ([0041] hydrophobic adhesive).
Regarding claim 5, in view of the combination of claim 4 above, Lai further teaches wherein the conductive filler contains scale-like silver powder ([0041] conductive particles include silver).
Regarding claim 7, in view of the combination of claim 4 above, Lai further teaches wherein a content of the conductive filler in the conductive elastomer layer is greater than or equal to 50% by mass and less than or equal to 90% by mass ([0042]).
Regarding claim 9, in view of the combination of claim 1 above, Lai further teaches wherein the flexible base material is woven fabric or knitted fabric ([0035] fabric 10 is a weaving fabric).
Regarding claim 10, Lai/Salam teach A wearable bioelectrode (Lai, see Fig 3) comprising: the flexible sheet electrode according to Claim 1 (see combination of claim 1 above).
Regarding claim 11, Lai/Salam teach A biosensor (Fig 3, [0009]) comprising: the wearable bioelectrode according to Claim 10 (see combination of claim 10 above).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lai in view of Salam in view of Ono (U.S. PGPub No. 2024/0225510).
Regarding claim 6, in view of the combination of claim 4 above,
Lai fails to teach wherein the non-conductive filler contains silica particles.
In related prior art, Ono teaches a similar device wherein the non-conductive filler of an elastomer contains silica particles ([0189]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lai in view of Salam and Ono to incorporate the silica particles as non-conductive filler to arrive at claim 6. Doing so would advantageously improve the hardness and mechanical strength of the elastomer ([0189]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lai in view of Salam in view of Lindberg (U.S. PGPub No. 2007/0285868).
Regarding claim 8, in view of the combination of claim 1 above, Lai teaches wherein the conductive elastomer layer contains silicone resin ([0041]).
Lai fails to explicitly teach wherein the silicone resin is a silicone rubber.
In related prior art, Lindberg teaches a similar device wherein a similar conductive elastomer is a rubber ([0032]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive elastomer of Lai in view of Lindberg to incorporate teh silicone rubber as the conductive elastomer to arrive at claim 8. Doing so would be a simple substitution of one well-known conductive elastomer (silicone resin of Lai [0041]) for another well-known conductive elastomer (rubber of Lindberg [0032]) to yield the predictable result of a conductive material for conducting signals.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-13 of copending Application No. 18/728,098 in view of Salam.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, the reference claim 1 recites all of the limitations of instant claim 1 except for:
“in a case where a tensile test is performed on the flexible sheet electrode according to the following procedure, a 100% tensile test force is greater than or equal to 5.0 N and less than or equal to 10.0 N” as claimed.
However, in related prior art, Salam teaches the use of a similar conductive elastomer in tensile testing (Pg 560 and Fig 5) wherein the 100% tensile test force is greater than or equal to 5.0 N and less than or equal to 10.0 N (Fig 4, C10 exhibits a stress of ~0.7 MPa at 100% strain; using stress = F/A with forces of 5 N and 10 N and solving for A, yields an area of 7.14 mm2 through 14.29 mm2 of the C10 conductive elastomer that would provide a 100% tensile test force between 5-10 N, thus the areas required to provide a 100% tensile test force at 5-10 N are on the millimeter scale which is known to be much smaller than the flexible sheet electrode of Lai). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material selection of Lai in view of Salam to incorporate a flexible base material and elastomer electrode layer that yield a 100% tensile test force between 5-10 N based on the procedure as claimed to arrive at the device of claim 1. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that conductive elastomers and flexible base materials are stretchable to 100% elongation with tensile testing (see Salam Fig 5) such that providing the material selections to yield the 100% tensile test force as claimed would yield the predictable result providing a stretchable and flexible wearable bioelectrode.
Regarding claim 2, the reference claim 1 recites all of the limitations of instant claim 2 except for:
“according to wherein in a case where the tensile test is performed on the flexible sheet electrode according to the procedure, a 20% tensile test force is greater than or equal to 1.5 N and less than or equal to 5.5 N” as claimed.
However, in view of the combination of claim 1 above, as stated above Salam teaches the use of a similar conductive elastomer in tensile testing (Pg 560 and Fig 5) wherein the 20% tensile test force is greater than or equal to 1.5 N and less than or equal to 5.5 N (Fig 4, C10 exhibits a stress of ~0.18 MPa at 20% strain; using stress = F/A with forces of 1.5 N and 5.5 N and solving for A, yields an area of 8.33 mm2 through 30.55 mm2 of the C10 conductive elastomer that would provide a 20% tensile test force between 1.5-5.5 N, thus the areas required to provide a 20% tensile test force at 1.5-5.5 N are on the millimeter scale which is clearly much smaller than the flexible sheet electrode of Lai). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material selection of Lai in view of Salam to incorporate a flexible base material and elastomer electrode layer that yield a 20% tensile test force between 1.5-5.5 N based on the procedure as claimed to arrive at the device of claim 2. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that conductive elastomers and flexible base materials are stretchable to 20% elongation with tensile testing (see Salam Fig 5) such that providing the material selections to yield the 20% tensile test force as claimed would yield the predictable result providing a stretchable and flexible wearable bioelectrode.
Regarding claims 3-11, the instant limitations of these claims respectively correspond to reference claims 5, 6, 7, 8, 9, 10, 11, 12, and 13.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794