DETAILED ACTION
This action is pursuant to claims filed on 12/2/2025. Claims 1, 3-8, and 10 are pending, claims 2 and 9 have been cancelled by the applicant. A final action on the merits of claims 1, 3-8, and 10 is as follows.
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 .
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.
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 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the Pandya et al. (hereinafter ‘Pandya’, US 20190072912 A1) in view of Xue (US 20210157278 A1).
Regarding independent claim 1, Pandya discloses a biological monitoring electrode (crown electrode in Fig. 11A) comprising an electrode body (electrode body 1104 in Fig. 11A), wherein an outer surface of the electrode body (top and sides of electrode body 1104 in Fig. 11A) is coated with an insulating anti-interference material layer (insulating layer 1108b in Fig. 11A; [0149]: 1108a may be an insulative coating applied to the surface of the housing; [0156]: as shown in Fig. 11A, the coating 1108 extends across one or more sides of the top and outer surfaces of the crown with a portion of the outer surface not covered in order to define an area of the crown that can electrically couple to the wearer’s finger; [0153]: insulator 1108 may be positioned to prevent moisture from electrically shorting the crown – because the applicant has not claimed the structure of the “insulating anti-interference material layer” an insulating layer that protects from external moisture satisfies the claim requirement) having a first opening on an upper surface of the electrode body (upper opening that exposes the face of electrode body 1104 in Fig. 11A), through which the electrode body is exposed to be in contact with a user’s skin to acquire biological information ([0156]: as shown in Fig. 11A, the coating 1108 extends across one or more sides of the top and outer surfaces of the crown with a portion of the outer surface not covered in order to define an area of the crown that can electrically couple to the wearer’s finger),
wherein the electrode body has a convex portion that at least partially protrudes outwardly beyond the insulating anti-interference material layer at the first opening (convex portion of electrode body 1104 that protrudes beyond the layer 1108b as shown in Fig. 11A), and
wherein the electrode body serves as a button for a wearable device ([0058]: crown 210 may be manipulated by a user to rotate or translate the shaft, as indicated by arrows 220 in Fig. 2B – thus functioning as a button), and the insulating anti-interference material layer has a second opening at a position corresponding to a bottom end of the electrode body (second opening is where the coating 1108b stops on the electrode body in Fig. 11A), the electrode body is exposed by the second opening, actuates a tactile switch of the wearable device, and forms an electrical connection with the ECG circuit ([0150]: the tactile switch 1110 may be actuated as the shaft 1102 translates along an axis of the shaft 1102 to provide a crown input; a spring-biased conductor 1114 may be mechanically and electrically connected to at least one of the shaft 1102 or the shaft retainer 1106, and in FIG. 11 is shown to be connected to the shaft retainer 1106; the spring-biased conductor 1114 may be biased to electrically contact the shaft 1102 and/or shaft retainer 1106 during all phases of rotation and translation of the crown 210, and may electrically connect the shaft 1102 and/or shaft retainer 1106 to a circuit 1116 (e.g., a processor); when the crown is translated by a user, the spring-biased conductor 1114 may deform to maintain electrical contact with the shaft 1102 and/or shaft retainer 1106).
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However, Pandya is silent to the shaft 1102 directly contacting and forming an electrical connection with the tactile switch.
Xue teaches an electronic device that is worn by a user and measures biological data through a key when the key is pressed, which actuates an elastic member, and forms an electrical connection to the circuit board ([Abstract], [0004]). Similar to Pandya, Xue teaches a watch that has an electrode disposed on the rear cover as seen in Fig. 2 and the key which functions as a button and forms a second ECG sensor ([0021], [0023]). The key 140, the elastomeric member 150 (which is functions as a trigger), the ECG sensor, and the detection electrode 130 form a detection circuit with the body of the user to obtain ECG data ([0025]). The ECG sensor is inside of the mounting cavity of the device and can be integrated into the circuit, similar to the processor of Pandya ([0019]). Utilizing a conductive switch 150 between the key 140 and the internal ECG sensor allows for a simpler and highly reliable electrical connection structure ([0025]). Combining the direct electrical coupling of the processor to the tactile switch and directly to the electrode body would be of routine skill in the art and would lead to the expected outcome of a simpler circuitry by simply removing the conductor 1114 and sending the signal directly through the switch. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrode, switch, processor configuration of Xue with the device of Pandya in order to form a simpler and highly reliable connection between the electrode and the processor.
Regarding claim 10, the Pandya/Xue combination discloses a wearable device comprising the biological monitoring electrodes according to claim 1 (wearable device shown in Pandya Fig. 2A).
Claim(s) 3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over the Pandya/Xue combination as applied to claim 1 and described above, in view of Morita et al. (hereinafter ‘Morita’, US 20180055399 A1).
Regarding claim 3, the Pandya/Xue combination discloses the invention according to claim 1 as described above. The combination further discloses the insulating anti-interreference material layer comprises an insulating coating layer ([0149]: 1108a may be an insulative coating applied to the surface of the housing; [0156]: as shown in Fig. 11A, the coating 1108 extends across one or more sides of the top and outer surfaces of the crown). Pandya also discloses that it is a goal of the invention to modify the interfaces of the assembly to increase the SNR and reduce signal attenuation ([0153]).
However, the Pandya/Xue combination is silent to the insulating anti-interference material layer comprising an insulating layer as a top layer and a metal mesh layer and/or metal foil layer disposed between the insulating coating layer and the electrode body.
Morita teaches a biological electrode tool providing an electrode portion which is attached to a human body to acquire biological information ([Abstract]). Morita further teaches that the electrode is covered along the entire circumference of the electrode portion by a shield 40, which is in turn covered by a nonwoven, non-conductive fabric 30b ([0044], [0017]). The shield 40 is formed is formed of an electrically conductive foil and is positioned between the insulating fabric and the electrode ([0044]-[0045]). The shield layer is made of a conductive layer 41 and the insulating adhesive 42(31) which is at least provided in the areas where the conductive layer may contact the electrode ([0045]). The shield layer makes it possible to send the biological signal obtained by the electrode portion to the measurement equipment while minimizing the entry of external noise ([0013]). Thus, an increase in SNR is achieved and covering the shield with an insulative coating prevents the body from having to contact the foil, thus increasing comfort ([0013]). While directed towards a different type of electrode configuration (i.e. it’s not a button on a watch), Morita still focusses on increasing SNR during sensing which would be an obvious benefit to, and is a goal of, the device of the Pandya/Xue combination. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the insulating layer and shield arrangement of Morita with the insulating layer of the Pandya/Xue combination such that the insulating layer 1108b incorporates a metal foil shield between the electrode and the insulating layer to increase the signal to noise ration and minimize the effects of external noise while preventing direct skin contact with the shield.
Regarding claim 6, the Pandya/Xue/Morita combination discloses the in biological monitoring electrode according to claim 3, wherein the insulating coating layer is a plastic layer (Pandya [0159]: the insulative layers and coatings 1108 may be liquid crystal polymer (LCP) – LCP is a type of plastic).
Regarding claim 7, the Pandya/Xue/Morita combination discloses the biological monitoring electrode according to claim 3, further comprising an adhesive layer for bonding and fixing the electrode body to the metal foil layer or the metal mesh layer (Morita [0045]: during the formation of the shield layer 40, the electrically conductive layer 41 is coated on the insulating fabric 30 and then the shield is coated with an insulating adhesive layer 42(31) which is provided in the areas that the electrically conductive layer 41 may contact the electrode – thus the conductive layer 41 of shield 40 is adhered to the electrode via insulating adhesive 42(31)).
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over the Pandya/Xue/Morita combination as applied to claim 3/1 and described above, in view of Tao (CN 208962623 U).
Regarding claim 4, the Pandya/Xue/Morita combination discloses the biological monitoring electrode according to claim 3, wherein the metal foil layer is fixed to a surface of the electrode body ([0045]: the electrically conductive foil layer of the shield is bonded via insulating adhesive layer 42 to the electrode 11). Morita further teaches that the metal foil layer of the shield is made of copper ([0045]).
However, the Pandya/Xue/Morita combination does not disclose a metal mesh layer fixed to a surface of the metal foil layer.
Tao teaches a multilayer copper foil for strong electromagnetic shielding ([Abstract]). The invention of Tao comprises a first copper foil shielding layer and a second mesh shielding layer disposed above the first ([Abstract], Fig. 1). Utilizing a copper foil and a copper mesh layer aids in reducing the electromagnetic radiation effect by increasing the shielding property ([Page 2 of Translation]). While not particularly directed towards ECG electrodes, Tao still discloses the benefits of the copper foil and mesh layers to microelectronic technology ([Page 1 of Translation]). Because the shield of the Pandya/Xue/Morita combination and the device of Tao are both directed towards copper shielding against electromagnetic interference, the art is analogous. Furthermore, combining a copper mesh with the copper foil layer of the Pandya/Xue/Morita combination is within the level of ordinary skill in the art and would simply lead to the expected outcome of increased shielding. Additionally, in paragraph [0034] of the instant application, the applicant states that a foil, mesh, or combination thereof can simply be chosen based on the desired shielding property. Thus, the combination of foil and mesh is not critical and is simply selected based on the desired shielding effects. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the copper foil shield of the Pandya/Xue/Morita combination with the copper mesh layer of Tao such that the mesh layer is adhered to the copper foil layer to increase the shielding property of the device.
Regarding claim 5, the Pandya/Xue/Morita combination discloses the biological monitoring electrode according to claim 3, wherein the metal foil layer is a copper foil layer (Morita [0045]: the shield comprises a metal foil of Cu).
However, the Pandya/Xue/Morita combination does not disclose a copper mesh layer.
Tao teaches a multilayer copper foil for strong electromagnetic shielding ([Abstract]). The invention of Tao comprises a first copper foil shielding layer and a second mesh shielding layer disposed above the first ([Abstract], Fig. 1). Utilizing a copper foil and a copper mesh layer aids in reducing the electromagnetic radiation effect by increasing the shielding property ([Page 2 of Translation]). While not particularly directed towards ECG electrodes, Tao still discloses the benefits of the copper foil layer to microelectronic technology ([Page 1 of Translation]). Because the shield of the Pandya/Xue/Morita combination and the device of Tao are both directed towards shielding against electromagnetic interference, the art is analogous. Furthermore, combining a copper mesh with the foil layer of the Pandya/Xue/Morita combination is within the level of ordinary skill in the art and would simply lead to the expected outcome of increased shielding. Additionally, in paragraph [0034] of the instant application, the applicant states that a foil, mesh, or combination thereof can simply be chosen based on the desired shielding property. Thus, the combination of foil and mesh is not critical and is simply selected based on the desired shielding effects. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the copper foil shield of the Pandya/Xue/Morita combination with the copper mesh layer of Tao such that the copper mesh layer is adhered to the copper foil layer to increase the shielding property of the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morita as applied to claim 7/3/1 and described above.
Regarding claim 8, the Pandya/Xue/Morita combination discloses the biological monitoring electrode according to claim 7, wherein the adhesive layer is a plastic layer (Morita [0045]: adhesive layer 31 is made of polyethylene which is a plastic).
However, the Pandya/Xue/Morita combination is silent to the layer being formed by spray molding.
Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985). In the present case, the claim is unpatentable because the products are not patentably distinct as they are both plastic adhesive layers for bonding the electrode to the shield foil layer.
Response to Arguments
Applicant’s arguments, see page 5, filed 12/2/2025, with respect to the drawing objections have been fully considered and are persuasive in light of the newly submitted Fig. 2. The objections of the drawings have been withdrawn.
Applicant’s arguments with respect to Morita as applied amended claim 1 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. Specifically, Morita is no longer used to teach the electrode body having a convex portion protruding outwardly beyond the insulating anti-interference layer.
Applicant’s arguments with respect to Pandya as applied amended claim 1 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. Specifically, a different embodiment of Pandya is used in the new rejection of record and the examiner no longer relies on 1246 as the insulating material.
Applicant's arguments filed 10/2/2025 regarding Pandya not disclosing an outer surface of the electrode body coated with an anti-interference material layer have been fully considered but they are not persuasive. In the embodiment shown in Fig. 11A of Pandya, the insulating coating covers the sides and a portion of the top of the electrode. The top edge is an outer surface exposed to the environment and the sides are an “outer surface” because they are directed outwardly away from the inside of the electrode.
Furthermore, applicant’s arguments regarding the “insulating anti-interreference material layer” of claim 1 are fully considered but are not persuasive. The layer is claimed as a single insulating layer in claim 1. Neither the structure nor the function of the layer is disclosed in claim 1. An insulating layer that protects from shorting meets the claim limitation because it is a single material layer that insulates and protects from some external interference. Additionally, including a metal shield with an insulating layer is known in the art as taught by Morita. Therefore, the claim limitation is not novel or inventive and is thus rejected.
Additionally, applicant’s arguments regarding Pandya not teaching or suggesting an opening in the insulative layer is not persuasive. As explained in the rejection above, the insulating coating 1108b covers the sides and top edge of the electrode button as seen in Fig. 11A. Since the insulating layer is all around the edge of the button, there is an opening in the center where the electrode is exposed. The size of the opening is not claimed and “opening” is a broad term. The electrode of Pandya is surrounded by the insulative coating 1108b, thus there is inherently an opening in the center because there is an absence of insulative material. Similarly, the second opening is the absence of material on the bottom portion of the electrode. The material surrounds the electrode and the bottom of the electrode penetrates through, thus there is a second opening in the material. This is consistent with the instant application. As shown in Fig. 2 of the instant application, the “openings” are aligned so that the coating surrounds the electrode except for a top portion and a bottom portion. The coating of the instant application forms a ring around the electrode, the hole through the middle is just smaller. This is the same as Pandya, only the openings of Pandya are larger.
Finally, the applicant’s statement that the Office Action acknowledges that claim 9 is novel and inventive in view of Morita is not accurate. The previous rejection of claim 9 simply didn’t rely on Morita for the rejection.
As explained in the new rejection above, the combination of Pandya and Xue discloses the subject matter of the newly amended claim 1. Therefore, the rejection of claim 1 remains. The rejections of the dependent claims remains because the rejection of the independent claim remains.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
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