DETAILED ACTION
This action is pursuant to Response to Restriction filed on 3/17/2026. Claims 1-11 are pending, claims 12-20 have been withdrawn by applicant without traverse. A first action on the merits of claims 1-11 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 .
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/17/2026.
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) 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (hereinafter ‘Liu’, US 20220369927 A1) in view of Ghaffari et al. (hereinafter ‘Ghaffari’, US 20160232807 A1).
Regarding independent claim 1, Liu discloses an adhesive skin patch (adhesive skin patch in Fig. 1) including a first substrate (substrate 110 in Fig. 1), a first conductor (first conductor comprising electrode 125 and bottom interconnect 130 in Fig. 1; Fig. 3 shows that this is a single layer printed on the substrate) and an adhesive layer (adhesive in Fig. 1 on substrate 110a; [0038]: 110a is made of PDMS and an adhesive such as MG7-9850); wherein
the first conductor comprises a conductor region (bottom interconnect 130 in Fig. 1) and a sensing region (electrode 125 in Fig. 1) that is in electrical connection with the conductor region (sensing region and conductor region in electrical connection based on the ECG signal traveling through both as seen in Fig. 2);
the first substrate includes an opening (opening 120 in Fig. 1) to at least part of the conductor region of the first conductor (opens to the bottom interconnect as seen in Fig. 1) or to a further conductive layer electrically connected to the conductor region of the first conductor by one or more vias (opens to top interconnect that is connected to the first conductor by a via in Fig. 1);
the adhesive layer includes an opening to at least part of the sensing region of the first conductor (there is an opening in the adhesive layer through which electrode 125 is exposed in Fig. 1).
Liu further states that the first substrate may be formed using a stretchable polymer, for example Proflex SEBS, polyurethane, or PMMA ([0038]).
However, Liu is silent to the first substrate being made of polysiloxane
Ghaffari teaches a device for sensing and analysis using conformal sensors which can be used to measure electrical activity such as EKG, similar to Liu ([Abstract], [0232]). Ghaffari further teaches that the conformal sensor device includes one or more electronic components, including the at least one sensor component, for obtaining measurement data are disposed on a flexible and/or stretchable substrate ([0013], [0121], Figs. 2A-2C). The stretchable substrate can include a variety of polymers such as polyimides, polyesters, a silicone or siloxane (e.g., polydimethylsiloxane (PDMS)), a photo-patternable silicone, a SU8 or other epoxy-based polymer, a polydioxanone (PDS), a polystyrene, a parylene, a parylene-N, an ultrahigh molecular weight polyethylene, a polyether ketone, a polyurethane, a polyactic acid, a polyglycolic acid, a polytetrafluoroethylene, a polyamic acid, a polymethyl acrylate, or any other flexible materials ([0121]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the material the substrate of Liu for PDMS, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331. Furthermore, Ghaffari teaches that PDMS is a known alternative to polyurethane and polymethyl acrylate for a flexible/stretchable substrate in an EKG sensor, and would thus maintain operability when substituting PDMS for polyurethane or PMMA.
Regarding claim 2, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 1, wherein the first conductor is a conductor layer formed into a pattern that comprises the conductor region and the sensing region (the formation of the electrode region 125 and interconnect 130 forms the pattern – the claim does not specify what this pattern is, only that it is formed by the conductor and sensing regions; furthermore, [0043]: the conductive ink is screen printed to form the electrode and bottom interconnect as seen in Fig. 3 – this inherently forms a pattern).
Regarding claim 3, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 1, wherein the polysiloxane includes polydimethylsiloxane (Ghaffari [0121]: the polysiloxane is PDMS).
Regarding claim 4, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 1, wherein the part of the conductor region of the first conductor is formed to provide a contact for electrical connection with the sensing region (forms a contact with the via as seen in Fig. 2 such that the ECG signal can be transferred from the sensing region through the conductive region and through the via; [0035]: traces can extend through the aperture to electrically connect the bottom interconnect to the top interconnect).
Regarding claim 7, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 1, wherein the adhesive skin patch includes one or more further conductors (top interconnect 140 in Fig. 1), wherein each conductor is separated from another conductor by one or more intermediate layers of polysiloxane (top interconnect is separated from bottom interconnect by layer 110 which is PDMS in the combination as described above); the conductors of the adhesive skin patch are electrically connected by vias that extend through one or more intermediate layers of polysiloxane (via highlighted in Fig. 1 connecting bottom and top interconnects; [0034]: one or more apertures may be used to accommodate multiple conduction paths – throughout the disclosure the via is directly associated with each aperture – see Fig. 1 and [0025]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the Liu/Ghaffari combination as applied to claim 1 and described above, in view of Wu et al. (hereinafter ‘Wu’, US 20210177319 A1).
Regarding claim 5, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 1, wherein the adhesive skin patch includes a second layer of polysiloxane ([0038]: layer 110a, which coats the first conductive layer as seen in Fig. 1, can contain PDMS); and the adhesive layer and the second layer of polysiloxane include a common opening to at least part of the sensing region (layer 110a and the adhesive both have an opening through which the electrode 125, which forms the sensing region, is exposed as seen in Fig. 1).
Liu further discloses that the adhesive MG7-9850 and PDMS are mixed ([0038]).
However, because the adhesive and PDMS are mixed in the second layer, Liu does not disclose the second layer of PDMS is between the adhesive layer and the first conductive layer.
Wu teaches a skin attached blood oxygen saturation detection system and preparation method thereof that has a flexible packaging material coated in an adhesive functional layer ([Abstract]). While not particularly directed towards ECG measurement, the art is analogous to both the instant application and the Liu/Ghaffari combination because it is solving the same problem of the best method to attach sensors to the skin. Wu further teaches that the substrate can be PDMS on which an adhesive layer of MG7-9850 is added ([0033]). This provides a peeling energy 10 times higher than that of ordinary PDMS so that the prepared system may be well attached to the part of the body to be tested and has strong anti-interference ([0033]). The adhesive are flexible, exhibit good biocompatibility, and do not react with the PDMS ([0033]). Adding the adhesive functional layer is done by coating the upper surface of the PDMS with the functional adhesive layer, which provides a thin layer of adhesive above the PDMS which exhibits good adhesion and may be closely attached to the skin to achieve the wearability of the device. Wu teaches utilizing both the same adhesive and polysiloxane layer as Liu, namely PDMS and MG7-9850. The only difference is Liu mixes the two while Wu coats the adhesive onto the PDMS. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of coating the PDMS layer with the adhesive as taught by Wu to the layer 110a of Liu because it would yield predictable results and result in an improved device, namely, a device that maintains flexibility and biocompatibility and has a higher adhesive strength. Thus, the result is the claimed invention where the second PDMS layer is between the first conductor and the adhesive layer.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Liu/Ghaffari/Wu combination as applied to claim 5/1 and described above, in view of Rogers et al. (hereinafter ‘Rogers’, US 20180165566 A1).
Regarding claim 6, the Liu/Ghaffari/Wu combination discloses an adhesive skin patch according to claim 5.
However, the combination is silent to the first and second polysiloxane layers enclosing the first conductor in a water-tight manner in regions beyond the opening.
Rogers teaches a sensor device for mounting on the tissue surfaces of a patient ([Abstract]). The device can provide for various biosensing modalities such as ECG, similar to the combination presented above ([0180]). As seen in Fig. 1B, the device is constructed in layers that contain insulating layers of polyimide and in some embodiments a thin silicone elastomer to encapsulate the system ([0118]). Encapsulating the system with a layer of PDMS provides for a waterproof system ([0017]). Utilizing a waterproof system allows for the device to remain operational for several days or months ([0182]). People inherently get wet over the course of several days to weeks, so if the device were not waterproof, the water would harm the electronics. The device of the Liu/Ghaffari/Wu combination already provides layers of PDMS which encapsulate the conductor around the opening. This is the same structure as the claimed device. The claim does not provide any specific structure for the water-tightness. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure the PDMS layers of the Liu/Ghaffari/Wu combination encapsulate the conductor sufficiently to ensure waterproofness, as taught by Rogers, to facilitate long-term wear of the device by protecting the conductive structures.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Liu/Ghaffari combination as applied to claim 7/1 and described above, in view of Ronay et al. (hereinafter ‘Ronay’, US 20220377885 A1) and in further view of Seghir et al. (hereinafter ‘Seghir’, “Extended PDMS stiffness range for flexible systems”).
Regarding claim 8, the Liu/Ghaffari combination discloses an adhesive skin patch according to claim 7 as described above. The via shown in Fig. 1 connects the top and bottom interconnects through a single layer of PDMS in the combination.
Liu further states that each substrate portion may be one or more layers of the overall-material integrated with the substrate ([0034]).
However, the Liu/Ghaffari combination is silent to at least one of the vias interconnects two conductors through two or more intermediate layers of polysiloxane.
Ronay teaches a sensor structure comprising a first substrate with a conductive contact disposed thereon and a second substrate with an electronic component disposed thereon and a via which connects the contact layer and the electronic component ([0005]). As seen in Fig. 10, a via 41 penetrates through two layers, 32 and 34 to connect the trace 36 to the conductive material 30 ([0062]). Ronay states that the materials may contain one or more dissimilar characteristics which helps to reduce problems associated with material fatigue, creep, etc. ([0062]). Ronay goes on to give the example of using both a rigid and flexible TPU for the two substrates ([0055]).
Seghir teaches the ability to tune PDMS and control PDMS film stiffness ([Abstract]). Seghir states that PDMS is very versatile and by varying the hardening agent to PDMS ration, and varying the curing process, the stiffness of PDMS can be accurately controlled ([Abstract], [Results and Discussion]).
Therefore, because Liu contemplates the ability for the substrate layers to be formed of multiple layers ([0034]) and Seghir teaches that the properties of PDMS can be modified based on the curing time and hardening agents, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine an additional PDMS layer that is stiffer than the original, as taught by Ronay, to reduce problems with material fatigue and creep. Adding an additional PDMS layer stacked with the original would mean the via would penetrate through two layers of PDMS to contact the two conductors.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over the Liu/Ghaffari combination as applied to claim 1 and described above, in view of Mihara et al. (hereinafter ‘Mihara’, US 20220378375 A1).
Regarding claim 9, the Liu/Ghaffari combination discloses the invention of claim 1 substantially as described above.
However, the combination is silent to the device including a releasable part.
Mihara teaches a bioelectrode with a deformable electrode layer and an elastomeric layer on which the electrode is layered onto, similar to the device of Liu ([Abstract]). As seen in Fig. 1B, the elastomeric layer 16 has an electrode layer 14 on the bottom surface and a through hole 21, through which conductor 22 resides for connection to an external measurement device ([0049]). This is extremely similar to the device of Liu. Mihara further teaches that the bioelectrode comprises a releasable part which includes a water-permeable layer 10 and a water-soluble layer 20 ([0043]). The water-permeable layer serves as a support so the device can be easily transported and stored, then once the electrode is attached to the user the water-permeable layer can be removed by dissolving the water-soluble layer so the electrode can be attached to the measurement device ([0025], [0050]). Including a sacrificial support layer in the device of the Liu/Ghaffari combination is of routine skill in the art and would not affect the functionality of the device. The water-permeable and water-soluble layers could be easily laminated on top of the substrate 110 and top interconnect of Liu. 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 water-permeable and water-soluble layers of Mihara with the device of the Liu/Ghaffari combination in order to provide a sacrificial support layer that allows for ease of transport and storage.
Regarding claim 10, the Liu/Ghaffari/Mihara combination discloses an adhesive skin patch according to claim 9, wherein the releasable part includes a layer of liquid-soluble polymer ([0043]: water-soluble sacrificial layer 20; [0013]: the water-soluble layer is dissolved with water).
Regarding claim 11, the Liu/Ghaffari/Mihara combination discloses an adhesive skin patch according to claim 10, wherein the liquid-soluble polymer is soluble with water ([0013]: the water-soluble layer is dissolved with water).
Conclusion
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