DETAILED ACTION
This action is pursuant to claims filed on 12/26/2025. Claims 1-10 are pending, claim 11 has been cancelled by the applicant. A final action on the merits of claims 1-10 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 .
Information Disclosure Statement
The information disclosure statement filed 10/30/2025 has been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendments to claim 1 introduce new matter not included in the original disclosure. Claim 1 recites “a substrate, on which a sensor is mounted” in line 11. Based on Fig. 3 and paragraph [0013] the specification of the instant application, the sensor body is mounted on the substrate, not a separate sensor. Reciting a sensor body in line 2 and a second sensor in line 11 indicates that there are two separate sensors on the device. This addition of a second sensor is not disclosed in the original filing, thus claim 1 is rejected.
Claim 1 also recites “the electrode has a plurality of through holes […] portions of the first adhesive layer exposed from the plurality of through holes are configured to be attached to pads” in lines 13-15. Based on Fig. 3 of the instant application, each electrode only contacts a single pad, not multiple pads. Therefore, claim 1 is further rejected for stating that the electrode contacts multiple pads which is not disclosed in the original filing.
Claims 2-10 are rejected due to their dependance on claim 1.
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 1-10 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 recites “a substrate, on which a sensor is mounted” in line 11. Based on Fig. 3 and paragraph [0013] the specification of the instant application, the sensor body is mounted on the substrate, not a separate sensor. Reciting a sensor body in line 2 and a second sensor in line 11 is indefinite because it is unclear whether there should be two separate sensor portions, or a single sensor portion as consistent with the specification. Therefore, the claim is rejected due to this ambiguity. For the purposes of compact prosecution, this will be interpreted as a single sensor body as consistent with the specification.
Claim 1 also recites “the electrode has a plurality of through holes […] portions of the first adhesive layer exposed from the plurality of through holes are configured to be attached to pads” in lines 13-15. Based on Fig. 3 of the instant application, each electrode only contacts a single pad, not multiple pads. Therefore, claim 1 is indefinite because it is unclear whether the electrode is intended to contact multiple pads or a single pad as consistent with the specification and drawings.
Claims 2-10 are rejected due to their dependance on claim 1.
Claim 7 is rejected because “the electrodes” lacks antecedent basis. Only a single electrode has been introduced in claims 5 and 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) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hung et al. (hereinafter ‘Hung’, US 2020/0054226 A1) in view of Nishimura et al. (hereinafter ‘Nishimura’, US 20180235502 A1), in view of Reif et al. (hereinafter ‘Reif’, US 20190094088 A1), in view of Elsherbini et al. (hereinafter ‘Elsherbini’, US 20180020982 A1), and in further view of Trapero et al. (hereinafter ‘Trapero’, US 20210228134 A1).
Regarding independent claim 1, Hung discloses a biological sensor comprising:
a sensor body (circuit 50 in Fig. 2) for acquiring biological information ([0010]: the circuit process the electrical signal to acquire information about heart rhythm);
an electrode (electrodes 31 in Fig. 3) connected to the sensor body ([Abstract]: each electrode is connected to the electric circuit);
a first layer member (comprising layers 22 and 10 in Fig. 2 – this is consistent with paragraph [0012] of the instant application which states the first layer member comprises multiple parts) configured to store the sensor body ([Abstract]: the waterproof case helps to form a waterproof space to accommodate the electric circuit), a first adhesive layer (adhesive on layer 22 in Fig. 3; [0040]: layer 22 has an adhesive) being disposed on one surface of the first layer member facing the electrode (disposed under the layer 10, as are the electrodes 30, as seen in Figs. 2 and 3); and
a second layer member (second layer member 24 in Fig. 3) being stuck onto the one surface of the first layer member ([0047]: the lower cover 24 is under the enforcement layer 23 and aligned to the waterproof case 10 for combining each other and implementing waterproofness, further the lower cover 24 is provided with a hook compatible with the slot in layer 10 such that they are tightly attached to each other), and having a shape for covering the sensor body (shape of layer 24 matches layer 10 to form the waterproof case as seen in Figs. 2 and 3) and exposing the electrode (electrode is exposed to the side of layer 24 as seen in Fig. 3), a second adhesive layer (adhesive layer 27 in Fig. 3) being disposed on a surface of the second layer member opposite to the first layer member (disposed on the underside of layer 24 as seen in Fig. 3) and,
a substrate (substrate 23 in Fig. 3), on which the sensor body is mounted (circuit 50 is mounted on the substrate as seen in Figs. 2 and 3 – the circuit is mounted onto the reinforcement layer as it is on the FL layer in Figs. 2 and 3), between the first layer member and the second layer member (the layer 23 is between layers 22/10 and 24 as seen in Figs. 2 and 3),
wherein a material of the second layer member is waterproof ([0047]: the lower cover 24 is combined with the water-proof case 10 to form a water-proof property and is made of a material such as plastic, metal or rubber),
wherein a sticking surface configured to stick to a living body is formed by the first layer member and the second layer member ([0040]: layer 22 is sticky to attach the layer to the skin; [0048]: the sticky attach layer of adhesive layer 27 is attached to the skin; each adhesive layer attaches to the skin to allow for the first and second layers to adhere to the skin).
However, Hung discloses two conflicting properties of a polyurethane layer coated with an acrylic adhesive, which forms the first adhesive layer.
The first property is a polyurethane layer with an acrylic adhesive prevents external water and vapor from entering the space between the layer and the skin ([0040]). The second property is that a PU layer coated with an acrylic glue is water-proof but also vapor permeable ([0048]). Nishimura teaches a multi-layered sensor similar to that of Hung, see Fig. 1. Nishimura further teaches the use of a polyurethane layer coated with an adhesive which is both water-proof and vapor permeable. This water-proof and vapor permeable property allows for sweat to be dissipated, thus preventing rash, while also preventing external water from penetrating the layer, enabling long term wear ([0037]-[0038]). The property taught by Nishimura is similar to the second property taught by Hung. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to choose one of the two adhesive layer properties as disclosed by Hung to protect the entire device from water damage and eliminate sweat buildup because selecting one of the two properties to obtain a water-proof, moisture vapor permeable adhesive layer involves only routine skill in the art and a predictable result of preventing sweat accumulation will occur.
However, the Hung/Nishimura combination is silent to the second layer 24 being a resin.
Reif teaches components and assemblies for the acquisition and analysis of data collected from sites on the body ([Abstract]). The device comprises electronic components such as sensor acquisition systems (SAS) and dedicated electronics devices (DED) which provide the electronic components for signal conditioning, data collection, storage, analysis, feedback, and communication ([Abstract]). Reif further teaches that the SAS receptable and the DED device housings are fabricated from a moisture impermeable material such as plastic, a thermoplastic elastomer (which is known in the art to be a type of resin), a natural or synthetic rubber, or the like ([0064]). Reif defines “substantially impermeable” to mean that the housing or layers prevent the penetration of liquid in order to inhibit or prevent degradation or alteration of sensing or electrical signals resulting from moisture ([0007]). Furthermore, the goals of the housings of Hung and Reif are the same, namely to create waterproof housings in order to protect the internal electronics. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (a thermoplastic elastomer as taught by Reif) for another (rubber, plastic, or metal as disclosed by Hung) since the substitution of a resin such as thermoplastic elastomer for the housing base would have yielded predictable results, namely, maintaining the waterproof, moisture impermeable property and protect the electronics from external moisture.
However, the Hung/Nishimura/Reif combination is silent to the second layer 24 being impervious to vapor.
While Hung is silent to the second layer 24 being impervious to vapor, Hung discloses that it is desirable to prevent vapor from entering the water-proof case ([0029]). The water-proof case houses the battery and electric circuit 50 ([0024]). Keeping the electronics dry is obvious as the goal of the housing is to both be water-proof and impervious to vapor ([0029]). Furthermore, ensuring the housing is impervious to both vapor and moisture inhibits or prevents degradation or alteration of sensing or electrical signals resulting from moisture as taught by Reif ([0007]). Therefore, because Hung discloses the concept of utilizing a housing that is impervious to vapor, it would be obvious to one of ordinary skill in the art to ensure that the thermoplastic elastomer that forms the second cover 24 of the Hung/Nishimura/Reif combination is impervious to vapor. Ensuring the layer 24 is impervious to vapor ensures the electronics are housed inside of a vapor-proof housing in order to protect the electronics from external moisture.
However, the Hung/Nishimura/Reif combination is silent to the electrodes comprising holes through which the adhesive penetrates to contact pads or the skin.
Elsherbini teaches a layered biological monitoring system, similar to that of Hung ([Abstract]). The monitoring patch has electrodes 510 connected to traces 512 ([0054]). The electrodes are provided with voids or perforations which aid in anchoring the electrodes, reduce the cost of manufacturing when using a manufacturing technique such as printing, and increase flexibility while maintaining the electrical performance characteristics ([0053]). The electrodes of Hung are also printed electrodes as described in paragraph [0041] of Hung. It would be an obvious benefit to Hung to utilize these voids since the electrode manufacturing processes are the same between both of the references and thus the same benefits would be seen. 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 perforations taught by Elsherbini with the electrodes of the Hung/Nishimura/Reif combination such that the electrodes are better anchored, the manufacturing cost is decreased, and the flexibility is increased.
Additionally, the traces of Elsherbini are made of conductive ink, which is known to be manufactured through printing ([0054]). Because the electrode is manufactured via printing and Elsherbini teaches utilizing a trace which connects to the electrode rather than one integral to the electrode as seen in Figs. 4 and 5, it would be an obvious design choice to print the traces first and then print the electrodes on top of the terminal ends of the traces since that is merely one of two possible ways to print the electrodes and the traces. The claim does not provide any specific structure or function to the “pads” recited. They are therefore interpreted as the terminal ends of the traces which connect to the underside of the electrodes. Furthermore, providing the electrodes of Hung with perforations disposed on top of the terminal ends of the traces would result in the adhesive of the adhesive layer 22 penetrating through the perforations and contacting the terminal ends of the traces.
However, the patch of the Hung/Nishimura/Reif/Elsherbini combination teaches hydrogels between the electrode and the skin which would block the adhesive from reaching the skin.
Trapero teaches a system for acquiring ECG ([Abstract]). The system has a similar layered structure to that of Hung as seen in Figs. 2-4. Trapero further teaches that the electrodes of the system can be wet electrodes utilizing a hydrogel, dry silver-silver chloride electrodes, or semi-dry electrodes ([0085]). The electrodes of Hung are already silver-silver chloride electrodes as explained in paragraph [0041], they just additionally utilize a hydrogel, making them wet electrodes. Therefore, it would be a well within the level of ordinary skill in the art to utilize a dry silver-silver chloride electrode over a wet silver-silver chloride electrode since Trapero teaches they are known equivalent structures in the art. The substitution of one known element (the dry electrodes of Trapero) for another (the wet electrodes of Hung) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the dry electrode of Trapero would have yielded predictable results, namely, providing a sensing surface to collect bio signals. The resulting combination thus teaches an electrode with perforation that the adhesive can penetrate through to contact the end terminals of the trace as well as the skin of the user, thus arriving at the claimed invention.
Regarding claim 2, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 1 further comprising: a connection portion (extension portion coming off of electrodes 31 in Fig. 3 – this is also the trace of the combination as discussed above) disposed between the first layer member and the second layer member (the extension portions are clearly disposed between the first and second layers in Fig. 3), overlapping with a part of the electrode (as discussed in the combination above, the electrode overlaps with a portion of the trace as well as the terminal end of the trace), and for connecting the electrode to the sensor body (Hung [0027]: electrode part 31 is the sensing end and the legs extend from the sensing end into the waterproof housing to connect to the circuit).
Regarding claim 3, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 2 further comprising: a third adhesive layer ([0042]: adhesive on the upper and lower parts of enforcement layer 23) disposed on the second layer member at least at a position facing a part in which the connection portion overlaps with the electrode ([0042]: the adhesive layer is on the underside of enforcement layer 23, which would place it on the top side of the second layer member 24 which is the part that faces upward where the connection portion overlaps with the electrode in the combination).
While it is the examiner’s opinion that Hung disclosing the adhesive on the underside of layer 23 would place it on the upper side of layer 24, Hung states that the primary objective of this underside adhesive is for sticking to layer 28 ([0042]). It would have been an obvious matter of design choice to increase the size of the adhesive to cover the whole underside of layer 23, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). This would further provide the obvious benefit of increasing the adhesion between layers 23 and 24.
Regarding claim 4, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 2,
wherein the connection portion is disposed between the electrode and the second layer member (the electrode is between the electrode and the second layer member 24 in the horizontal direction as seen in Fig. 3 of Hung), and includes a terminal portion being in contact with the electrode (terminal portion is the portion that connects to the terminal pad which connects to the electrode in the combination – this is provided with no definitive structure in the claim and is interpreted as the portion of the trace right before it ends that overlaps with the electrode), and
wherein the plurality of through holes includes a first through hole, a portion of the first adhesive layer is exposed to the connection portion through the through hole in the state where the electrode is attached to the first adhesive layer (there are multiple through-holes through the electrode as seen in Fig. 5 of Elsherbini, there would be one that is over the end of the trace right before the pad portion that is exposed to the adhesive from the first layer).
Regarding claim 5, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 1, wherein the first layer member includes a cover member (cover member 10 in Fig. 2), including a storage space for storing the sensor body ([Abstract]: the waterproof case helps to form a waterproof space to accommodate the electric circuit); a foamed sheet (foamed sheet FL in Fig. 3) including a second through hole (two holes shown in layer FL in Fig. 3) at a position corresponding to the storage space (the holes correspond to where the ends of the connection portion connect to the circuit inside the housing as shown in Figs. 2 and 3); and a fourth adhesive layer ([0038]: sticky paste layer around the foam layer) for pasting the cover member and the foamed sheet to each other ([0038]: the sticky paste aligns with the perimeter of the foam layer and the layer 10 so they connect to each other and the layer 22), wherein the first adhesive layer is disposed on the second layer member side of the foamed sheet (layer 22 is under the foam layer as shown in Fig. 3).
Regarding claim 6, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 5, wherein the foamed sheet has an open-cell structure ([0038]: the foam layer can be formed from open-cell foam).
Regarding claim 7, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the invention substantially in claim 5/1 and described above. Hung further discloses the cover member and the foamed sheet have elongated shapes (cover member 10 and foam sheet FL have elongated rectangular shapes as shown in Figs. 2 and 3), wherein the sensor body is disposed in a central portion in the longitudinal direction (sensor body circuit is internal to the shape as shown in Fig. 2), and wherein thicknesses of the cover member at the end sides for the cover member and the end sides of the foamed sheet in the longitudinal direction are less than a thickness of the cover member in the central portion in the longitudinal direction (the thickness of the ends in the longitudinal direction are thinner on case 10 due to the chamfers reducing the height of the cover at the edges as seen in Fig. 2).
However, the Hung/Nishimura/Reif/Elsherbini/Trapero combination does not disclose that the electrodes are on the ends of the cover member and foamed sheet in the longitudinal direction.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to orient the housing so the electrodes are at the ends in the longitudinal direction because applicant has not disclosed that placing the electrodes at the long ends of the cover provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected the biosensor of Hung and applicant’s invention to perform equally well with either electrode placement taught by Hung or the claimed placement because both placements would perform the same sensing function. Therefore, it would have been prima facie obvious to modify Hung to obtain the invention as specified in claim 7 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hung.
Regarding claim 8, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 1, wherein the plurality of through holes includes a first through hole, and a portion of the first adhesive layer is exposed through the first through hole in a state where the electrode is attached to the first adhesive layer (the adhesive layer 22 is exposed through all of the through holes of the electrode as described in the combination of claim 1 above)
Regarding claim 9, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 1, wherein a thickness of the first adhesive layer is changed depending on a position on the first layer member ([0038]: there is a sticky paste around the perimeter of the cover layer 10 to combine it with layer 22; the sticky paste increases the thickness of the adhesive layer based on the location of the edge of the cover 10).
Regarding claim 10, the Hung/Nishimura/Reif/Elsherbini/Trapero combination discloses the biological sensor according to claim 1, wherein an adhesive force of the first adhesive layer is stronger than an adhesive force of the second adhesive layer ([0040] the layer 22 is coated with an acrylic adhesive; [0048]: the layer 27 uses an acrylic glue adhesive; with the same acrylic adhesive, layer 22 would have the larger adhesive force due to the larger area it covers).
Response to Arguments
Applicant’s arguments with respect to newly 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. Namely, Elsherbini and Trapero are used to teach the newly added limitation.
The examiner recommends further defining the structure shown in Fig. 3 of the instant application. As it stands, the structure, function, and location of the pads are undefined. “Pad” is a very broad term that can be interpreted in a variety of ways. In the current case, it is simply interpreted as the very end printed portion of the trace. Additionally, it would be beneficial to add the relationship between the substrate, connection portions, and pads as shown in Fig. 3. Incorporating these features would help in distinguishing over the prior art. As it currently stands, Hung requires only small modifications that are taught by the prior art as described above. Ensuring permeability or impermeability is well within the level of ordinary skill in the art and changing the printed shape/order of the electrodes and traces is also an obvious modification to make. Thus, the rejection of claim 1 remains.
The rejections of dependent claims 2-10 remain 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