DETAILED ACTION
This action is pursuant to claims filed on 7/7/2026. Claims 1-11 are pending, claims 12-20 have been withdrawn by applicant without traverse. A final 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 .
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 1-11 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.
Claim 1 is rejected because it is indefinite whether “a part of a conductor region” in line 8 is the same “part of the conductor region” in line 6. Based on Figs. 1A-1C of the instant application and the corresponding portions of the specification, they are the same part. Additionally, as the claim is written, only a single conductor region has been introduced, so it is unclear if this “part of a conductor region” in line 8 is part of the “conductor region” introduced in line 4, or part of a different conductor region. For the purposes of compact prosecution, “a part of a conductor region” in line 8 will be treated as the same part as “part of the conductor region” in line 6.
Claims 2-11 are rejected due to their dependance on claim 1.
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) in further view of Seghir et al. (hereinafter ‘Seghir’, “Extended PDMS stiffness range for flexible systems”).
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 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), wherein the part of the conductor region is accessible for external electrical connections through the opening in the first layer of polysiloxane (this limitation is tied to the opening to at least part of the conductor region of the first conductor; the claim is written as an “or” statement, the opening is to the part of the conductor region of first conductor or to a further conductive layer; the external connection can only be present in the first scenario as the claim is written; thus, because Liu discloses the alternative option, the claim limitation is met);
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.
The PDMS layer of the Liu/Ghaffari combination is an elastic solid because it is a physical substrate that is flexible and stretchable. Furthermore, PDMS is known in the art to be cured to form a solid layer.
However the Liu/Ghaffari combination does not explicitly state that the PDMS layer is cured to form the elastic solid.
Seghir teaches that PDMS is a very versatile and useful soft polymeric material and discusses various ways to tune the stiffness of the layer to optimize its performance in specific applications, such as in flexible sensors ([Abstract]). Seghir further discusses 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]). Modifying the curing temperature and the curing times are two of the main parameters used to tune the stiffness of the PDMS layer ([Introduction]). 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 teachings of Seghir with the Liu/Ghaffari combination such that the PDMS is cured at a specific temperature and specific time in order to impart the desired flexibility.
Regarding claim 2, the Liu/Ghaffari/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir/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/Seghir/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/Seghir/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/Seghir/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/Seghir combination as applied to claim 7/1 and described above, in view of Ronay et al. (hereinafter ‘Ronay’, US 20220377885 A1).
Regarding claim 8, the Liu/Ghaffari/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir 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/Seghir combination in order to provide a sacrificial support layer that allows for ease of transport and storage.
Regarding claim 10, the Liu/Ghaffari/Seghir/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/Seghir/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).
Response to Arguments
Applicant’s arguments regarding claim 1 have been fully considered but are not persuasive.
Applicant’s initial arguments that Liu does not teach the polysiloxane layer are not persuasive since Ghaffari is used to teach that limitation since it is merely a selection between known materials in the art.
The applicant additionally argues that the neither Liu nor Ghaffari disclose, teach, or suggest curing polysiloxane to function as an elastic solid. This argument is 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. Namely, Seghir is used to teach curing the PDMS to function as an elastic solid.
Applicant also argues that Liu does not disclose “a part of a conductor region is accessible for external connections through the opening in the first layer of polysiloxane. While it is true that Liu does not disclose that, the added limitation is only present when the opening is to a part of the conductor region of the first conductor, since those two parts are interpreted as the same part as outlined in the 112b rejection above. As the claim is written, there are two scenarios, one in which the opening is to a part of the conductor region of the first conductor wherein that part is accessible for external electrical connections, or that the opening is to a further conductive layer. Liu discloses the second scenario as discussed above. Since Liu has an opening to a further conductor that is electrically connected to the conductor region of the first conductor by one or more vias, the claim limitation is met.
The examiner recommends amending to further clarify whether the opening is only exposing a part of the first conductor region for external electrical connection, or whether the second “part of a conductor region” is a different part than the first part introduced.
In order to advance prosecution, the examiner also recommends incorporating into the independent claim the additional conductors and the offset configuration created by the layer 656 between the sensing regions as shown in Figs. 6B and 6C. Such an amendment would require further search and consideration but would aid in advancing prosecution.
Therefore, claim 1 remains rejected.
Claims 2-11 remain rejected because claim 1 remains rejected.
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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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
