DETAILED ACTION
This action is pursuant to claims filed on 6/5/2026. Claims 1-5 and 7-10 are pending, claims 9 and 10 are newly added by the applicant. A final action on the merits of claims 1-5 and 7-10 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) 1-2, 4-5, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ueda et al. (hereinafter ‘Ueda’, JP 2015093167A) in view of Goldberg et al. (hereinafter ‘Goldberg’, RU 2668200 C2) and in further view of Kumar et al. (hereinafter ‘Kumar’, US 20190022400 A1).
Regarding independent claim 1, Ueda discloses a biological sensor that is to be affixed to a living body and is for acquiring a biological signal ([Abstract]: biological sensor to collect biological data), the biological sensor comprising:
a cover member (covering body 5 in Fig. 1); and
a sticking layer comprising (adhesive member 2 in Fig. 1):
a porous substrate (adhesive member 2 in Fig. 1) having a porous structure ([Page 4 of Translation]: moisture permeability may be imparted by forming the double-sided pressure-sensitive adhesive body 2 in a porous shape having a plurality of fine pores of several microns; as seen in Fig. 1, the double-sided adhesive layer 2 has a thickness which means there is an interior porous substrate with adhesive on either side),
an adhesive on a side of the living body ([Abstract]: the adhesive body is double sided – thus there is adhesive on the side of the living body), the porous substrate being disposed on the cover member on a side of the living body (layer 2 is on the bottom of the cover; [Page 2]: adhesive body 2 is adhered to a living body),
wherein a moisture permeability is within a range from 65 g/m2-day to 4000 g/m2-day ([Page 4]: the moisture permeability of the biosensor is preferably 1800 g/m2·day).
an electrode affixed to the adhesive layer (electrode 4 in Fig. 1; [Abstract]: the electrode part is arranged on the side of the double-sided adhesive body facing the skin);
a sensor body (detection unit 3 – the claim does not provide any particular structure to the sensing body and based on the instant application, it includes a variety of components as seen in Fig. 2 of the instant application) that acquires biological information ([Page 2 of translation]: the detection unit 3 is a device that acquires a biological signal transmitted through the electrode unit 4 as biological data); and
a wiring that connects the sensor body and the electrode (detection unit 3 is connected to the electrodes 4 by wire 6 as seen in Fig. 1),
wherein the cover member includes a concave portion formed in a recessed shape on a side of the living body (cover includes a space within which the sensor body sits as seen in Fig. 1; the concave portion is the indentation portion where the sensor body 3 resides),
wherein the porous substrate has a first through hole (holes through which wires 6 connect to the electrodes as seen in Fig. 1 – a through hole is inherent because the wires penetrate through the sticking layer and do not go around as seen in Fig. 2), and
wherein the concave portion forms a storage space in which the sensor body (the concave portion houses the detection unit 3).
However, Ueda does not disclose the sticking layer comprises a porous substrate on which a first adhesive layer is laminated nor the specific permeability of the sticking layer within a range from 65 g/m2-day to 4000 g/m2-day.
Goldberg teaches a carrier system for a medical device to be attached to the body ([Abstract]). Goldberg further teaches a layered structure as seen in Fig. 4 in which a first adhesive layer 34 is laminated to a base layer 30 on which a second adhesive layer 38 is disposed for mounting the housing 20 as seen in Fig. 4. Furthermore, Goldberg teaches that the base layer be made of a microporous substrate to impart vapor permeability ([Page 8 of translation]). In order to improve long term wear and stable adhesion to the skin, the adhesive is made from an acrylate with a vapor permeability exceeding 400 g/m^2-day ([Page 4 of translation]). Furthermore, both Ueda and Goldberg discuss the importance of maintaining a skin contacting layer that is flexible and porous (Ueda [Pages 2, 4-5 of translation] and Goldberg [Pages 7-8 of translation]). It would be of routine skill in the art to combine the laminated sticking layer of Goldberg with the adhesive layer of Ueda such that Ueda comprises a sticking layer that is laminated with adhesive layers on the top and bottom because it would maintain functionality and would lead to the expected outcome of creating a laminated layer with a moisture permeability of 400 g/m^2-day. 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 laminated sticking layer of Goldberg with the adhesive member of Ueda such that the adhesive member of Ueda comprises a porous substrate with adhesive laminated on both side to both ensure that the overall sensor achieved the desired permeability and the device could be worn for long periods of time while maintaining stability. This would further result in the electrode being affixed to the first adhesive layer since it is affixed to the underside adhesive as described in Ueda. Furthermore, the claim does not describe how the electrode is affixed to the adhesive layer and the sides of the electrode are connected to the sides of the adhesive layer as seen in Fig. 1 of Ueda since the electrode fills the electrode recess completely, thus touching/affixing to the walls on the skin-contacting portion forming the first adhesive layer.
However, the Ueda/Goldberg combination is silent to the sticking layer as a whole exhibiting a shear stress of 5x10^4 N/m^2 to 65x10^4 N/m^2 when the sticking layer is deformed in a direction perpendicular to a thickness direction of the sticking layer by 5% to 15% of a length of the sticking layer in a longitudinal direction.
As the claim is written, the shear stress is of the sticking layer as a whole. The shear stress of the layer can be interpreted as the shear stress exhibited between layers or the shear stress as a material property of the layer.
Both Ueda and Goldberg disclose that the adhesive layer is formed from a pressure-sensitive acrylic adhesive and the adhesive force can be adjusted based on the utilization time of the biosensor (Ueda [Page 2], Goldberg [Page 6]). Additionally, Ueda states that the stretchability and flexibility should be excellent in order to maintain contact with the body ([Page 2]) and Goldberg states the porous substrate layer requires a balance between elasticity while maintaining a degree of rigidity (Goldberg [Page 8]). The instant application states that the adhesive layer can additionally be formed from an acrylic-based pressure-sensitive adhesive ([0040]) and provides an example of an adhesive that is known in the art in paragraph [0098]. Furthermore, Goldberg teaches that the material of the porous substrate can be foamed polyurethane, polyolefin, acrylic polymer, polyvinyl chloride, or polyester ([Page 8]). These are the same materials of the instant application for the porous substrate ([0035] of instant application). Because the materials of the adhesive layer and the porous substrate of the instant application and those of the Ueda/Goldberg combination are the same, it would be of routine skill in the art to modify the thickness, amount, or surface area to alter the shear stress to the desired range because Ueda and Goldberg disclose modifying the strength of the adhesive layer and porous substrate to modify the flexibility, directly resulting in modifying the shear stress of the sticking layer. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sticking layer of the Ueda/Goldberg combination such that the shear stress was from 5x10^4 N/m^2 to 65x10^4 N/m^2 when the sticking layer is deformed in a direction perpendicular to a thickness direction of the sticking layer by 5% to 15% of a length of the sticking layer in a longitudinal direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, given that the materials disclosed in the instant application and the materials of the prior art are the same, the layer would exhibit a shear stress within this range as it is a material property of the layer.
While the through holes that penetrate the porous substrate face upward, which is toward the concave portion, it is not disposed directly below the concave opening in Ueda.
Ueda discloses a prior art embodiment in Fig. 9 that contains three electrodes 102 with three corresponding through holes as shown by the dashed line through the layer 101. The embodiment shown in Fig. 9 has an electrode and wiring through-hole placed directly under the detection unit 103. Combining a third electrode directly under the detection unit 3 in Fig. 1 of Ueda would require a through-hole directly under the detection unit for a wire connection. This would in turn result in the through hole and concave portion coming together to form to form the storage area for the sensing body. The through hole and concave portion come together to form the storage space and the detection unit 3 is accommodated in the storage space. The claim does not limit how much of the sensor body must be included in the portions that form the storage space. Since the through hole is directly below the concave portion, they together form a storage space which the sensor body is in. It would have been obvious to one having ordinary skill in the art at the time the invention was made to add a third electrode, through hole, and wire under the detection unit as shown in Fig. 9, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
However, the Ueda/Goldberg combination does not disclose a second substrate on which the sensor body is mounted.
Kumar teaches a wearable defibrillator device that includes a plurality of ECG electrodes adapted for long-term wear ([Abstract]). Kumar further teaches a vapor permeable layer 122 with a welded a border layer 120 ([0118]). The housings, which contain the controllers and memory are disposed on top of the vapor permeable layer as seen in Figs. 3A and 3B. The vapor permeable layer allows for vapor transport away from the skin [0078] and the border layer prevents water from entering the patient engagement section of the device ([0118]). Because the layer 122 is disposed above the first adhesive layer 128 and supports the control units, it teaches the claim language of the instant application. Additionally, because the support layer is moisture permeable, functionality of the moisture permeable property is maintained when combined with the Ueda/Goldberg combination. Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the substrate comprising the vapor permeable layer 122 with the welded border 120 between the detection device 3 and the adhesive layer 2 of the Ueda/Goldberg combination in order to provide a barrier around the adhesive/skin interface to improve long-term ware.
Regarding claim 2, the Ueda/Goldberg/Kumar combination discloses the invention of claim 1 substantially as described above. The combination further discloses a second adhesive layer is disposed on a surface on the sticking layer on a side of the cover member (Ueda [Page 4 of Translation]: double-sided pressure-sensitive adhesive body 2; this means that the adhesive layer 2 has adhesive on both sides, creating an adhesive layer on the cover member side of layer 2; Goldberg [Page 6] and Fig. 4 shows adhesive layer 38).
Regarding claim 4, the Ueda/Goldberg/Kumar combination discloses the invention of claim 1 substantially as described above. The combination further teaches a moisture permeability of the porous substrate is within a range from 100 g/m^2-day to 5000 g/m^2-day (Goldberg [Page 4 of translation]: the vapor permeability of the base and/or adhesive layer preferably exceeds 400 g/m^2-day).
Regarding claim 5, the Ueda/Goldberg/Kumar combination discloses the invention substantially in claim 1 and described above. Ueda further discloses that the adhesive layer is formed from an acrylic adhesive ([Page 2]) and the adhesive layer and cover have flexibility ([Page 2 and Page 3]).
However, Ueda is silent to the biological sensor exhibits a shear stress between the biological sensor and the living body of from 5x10^4 N/m^2 to 25x10^4 N/m^2 when 25% to 35% of an entire length of the biological sensor in the longitudinal direction is deformed parallel to a contact surface with the living body.
Ueda does disclose that the adhesive layer is formed from a pressure-sensitive acrylic adhesive and the adhesive force can be adjusted based on the utilization time of the biosensor ([Page 2]). Additionally, Ueda states that the stretchability and flexibility should be excellent in order to maintain contact with the body ([Page 2-3]). The instant application states that the adhesive layer can additionally be formed from an acrylic-based pressure-sensitive adhesive ([0040]) and provides an example of an adhesive that is known in the art in paragraph [0098]. Because the material of the adhesive layer and that of Ueda are the same and the shear stress is interpreted as the shear stress between the device and the skin which is reliant upon the adhesive strength of the adhesive, it would be of routine skill in the art to modify the thickness, amount, or surface area of the adhesive to alter the shear stress to the desired range because Ueda discloses modifying the strength of the adhesive layer to increase or decrease utilization time which is effectively modifying the shear stress of the layer to increase or decrease adherence. Therefore, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the adhesive layer of Ueda such that the biological sensor exhibits a shear stress of from 5x10^4 N/m^2 to 25x10^4 N/m^2 when 25% to 35% of an entire length of the biological sensor in the longitudinal direction is deformed parallel to a contact surface with the living body, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 7, the Ueda/Goldberg/Kumar combination discloses the invention substantially in claim 1 as described above. The combination further teaches the device comprising: a third adhesive layer provided on the second substrate on a side of the living body (Kumar [0118]: the border layer 120 can also include an adhesive), wherein the third adhesive layer and the first adhesive layer form a sticking surface to be affixed to the living body (Kumar [0118]: the border layer 120 can adhere the patient engagement substrate to the skin of the patient).
Regarding claim 9, the Ueda/Goldberg/Kumar combination discloses the invention substantially in claim 1, wherein the cover member comprises a planar portion and a projection portion extending away from the planar portion in a height direction of the biological sensor, and the concave portion is formed inside of the projection portion (highlighted below in Ueda Fig. 1).
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Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the Ueda/Goldberg/Kumar combination as applied to claim 1 and described above in further view of Elolampi et al. (hereinafter ‘Elolampi’, US 20170223846 A1).
Regarding claim 3, the Ueda/Goldberg/Kumar combination discloses the invention substantially in claim 1 and described above. Ueda further discloses that the cover member 5 can be made of a variety of materials such as polyurethane resin, polyethylene resin, polypropylene resin, polyvinyl chloride resin, polyamide resin, ethylene / vinyl acetate copolymer resin, polyester resin, polyvinyl alcohol resin, and polyacrylate resin that allows for flexibility ([Page 3 of Translation]).
While these materials are known in the art to have a hardness that can fall within the claimed range, Ueda is silent to the hardness of the cover.
Elolampi teaches a flexible encapsulation housing for conformal electronic systems such as sensors configured to measure physiological parameters of a person or animal ([0030]-[0032]). Elolampi further teaches that the housing can be made from a soft, flexible material such as polyimide (PI), a polyethylene terephthalate (PET), a silicone, or a polyurethane, plastics (including a thermoplastic, a thermoset plastic, or a biodegradable plastic), elastomers (including a thermoplastic elastomer, a thermoset elastomer, or a biodegradable elastomer), and fabrics (including a natural fabric or a synthetic fabric), such as but not limited to acrylates, acetal polymers, cellulosic polymers, fluoropolymers, nylons, polyacrylonitrile polymers, polyamide-imide polymers, polyacrylates, polybenzimidazole, polybutylene, polycarbonate, polyesters, polyetherimide, polyethylene, polyethylene copolymers and modified polyethylenes, polyketones, poly(methyl methacrylate, polymethylpentene, polyphenylene oxides and polyphenylene sulfides, polyphthalamide, polypropylene, polyurethanes, styrenic resins, sulphone based resins, vinyl-based resins, or any combinations of these materials ([0047]). The material of the encapsulation housing facilitates the modulation of stress or strain due to stretching, bending, compression, torsion, or other deformation ([0052]). Elolampi further specifies the Shore A Hardness of the encapsulation layer to be from about 10A to about 60A or higher for favorable mechanical properties ([0053]). Because the claimed range overlaps substantially with the range taught by Elolampi, a prima facie case of obviousness exists as both the Elolampi and the instant application disclose a hardness that allows for flexibility and reduced stress. Therefore, because Elolampi teaches the some of the same housing materials as Ueda, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure that the hardness of the housing of Ueda falls within the claimed range to ensure the desired mechanical properties which would aid in reducing stress on the electronic components.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Ueda/Goldberg/Kumar combination as applied to claim 1 and described above in further view of Sano et al. (hereinafter ‘Sano’, CN 103945759 A).
Regarding claim 8, the Ueda/Goldberg/Kumar combination discloses the invention substantially in claim 1 and described above. Ueda further discloses that the electrode configuration of the embodiment shown is not limiting and that a conductive adhesive can be disposed under the electrode as shown in Fig. 7.
However, the combination does not disclose the electrode comprising a through hole through which the first adhesive layer can be exposed.
Sano teaches a biological electrode sheet for detecting ECG ([Abstract]). Sano further teaches that the electrode 2 may take the form of a mesh which allows for the conductive adhesive 3 to penetrate through ([0049]). This in turn increases the contact area of the adhesive 3 and the electrode when flexibly deformed along the skin surface ([0049]). Because Ueda is not limiting to the electrode shape or disposition, and even contemplates the use of conductive adhesive below the electrode, it would be a simple combination for one skilled in the art to substitute the disk electrode of Ueda for the mesh electrode of Sano as the device would remain operable and the combination would not result in any unexpected 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 mesh electrode of Sano with the device of the Ueda/Goldberg combination such that the disk electrode is substituted for a mesh electrodes which creates a plurality of through holes through which the adhesive can penetrate to the skin, thus increasing contact between the adhesive and the skin when the skin surface is flexibly deformed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Ueda/Goldberg/Kumar combination as applied to claim 9/1 and described above in further view of Mazar et al. (hereinafter ‘Mazar’, US 20110144470 A1).
Regarding claim 10, the Ueda/Goldberg/Kumar combination disclose claim 9 as described above. Ueda also discloses that the detection unit includes various detection pieces as well as storage and transmission units ([Pages 2-3 of the translation]). Ueda further discloses that the thickness of the cover layer 5 is not limited ([Page 4 of translation]).
However, the detection unit 3 of Ueda is shown as a simple rectangle in the diagram and the disclosure of Ueda is silent to the exact structure of the detection unit within the concave portion of the cover layer.
Mazar teaches a device configured to adhere to the skin of a patient and monitor at least one physiological signal of a subject ([0011]). Mazar further teaches a similar device design to that of Ueda, wherein an electronics layer sits above the electrode layer and the device is completely covered by a covering layer as seen in Fig. 2A. The electronic components 209 function in the same manner as the detection unit of Ueda. The components 209 are configured to measure the physiological signal of the subject and communicate those readings for remote monitoring ([0049]). Mazar additionally teaches that an electronics housing or encapsulant 211 can be included that only covers the electronic components 209. This additional layer provides for protection, insulation, and cushioning for the electronic components ([0050]). This layer is provided in addition to the outer cover layer 213 as seen in Fig. 2A. Providing an additional layer between the detection unit of Ueda and the outer cover would be of routine skill in the art and provide for the obvious benefits of additional protection, insulation, and cushioning. Furthermore, including an additional layer over the detection unit would only require a small change in thickness of Ueda, which is already contemplated by Ueda, and would create space between the detection unit and the outer cover layer such that the cover layer is free from directly contacting the detection unit, as the claim requires. 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 electronics encapsulant of Mazar with the Ueda/Goldberg/Kumar combination such that there is an additional layer between the detection unit and the outer cover layer to provide for additional protection, insulation, and cushioning.
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 6/5/2026, regarding claim 1 have been fully considered but are not persuasive.
Applicant initially argues that the because the wiring and the detection unit are now claimed as separate components, Ueda does not disclose the through hole and the concave portion forming a storage area to accommodate the sensor body. This is not persuasive. As the combination above explains, Fig. 9 discloses forming a through hole directly under the sensor body, which is directly under the concave portion. Together, the through hole and the concave portion form a storage space. The detection unit 3 is inside of that storage space. The claim is not specific to the size or shape of the storage space and is not specific to how the sensor body is disposed in the storage space. The claim does not state that the sensor body cannot be completely in the concave portion of the storage space. While the through-hole is a passageway for the wiring, it is still part of the storage space as it forms a continuous opening with the concave portion. Thus, the argument is not persuasive because a storage space is formed with the concave portion and the through-hole in which the sensor body is accommodated.
The applicant’s argument that the covering body 5 in Ueda is a sheet-like member and does not provide for a concave shape to cooperate with the through hole is not persuasive. This argument was specifically addressed in the previous office action dated 3/9/2026. Fig. 1 clearly discloses a concave recess in which the detection unit 3 resides as highlighted below. A concave recess must be formed in the cover 5 in order to house the detection unit, as previously explained. Therefore, the argument is not persuasive.
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Applicant’s arguments regarding the shear stress not being obvious to one of ordinary skill in the art are not persuasive. The applicant argues that the claimed shear stress is a specific parameter that the prior art does not identify as affecting the result. However, this is not persuasive. As explained in the rejection above, the shear stress can be interpreted two distinct ways. One way is as a material property of the layer. Since the materials are the same as the instant application, the resulting shear stress is simply a property of that layer that the combination of record would inherently exhibit. It can additionally be interpreted as the shear stress between the layers of the substrate before delamination. The flexibility and the adhesive strength are the two key factors that directly control the shear stress prior to delamination of the layers. This is standard knowledge. Modifying the flexibility and adhesive strength directly affect the shear stress experienced between layers. Therefore, it would be obvious for one of ordinary skill in the art to modify the flexibility and adhesive strength of the layers to result in the claimed shear stress, as explained in the rejection above.
Should the applicant wish to overcome the prior art of record, specific structural limitations should be claimed such as the materials, surface area, thicknesses, etc. that are different from those disclosed in the prior art and result in the claimed shear stress.
Therefore, the rejection of claim 1 remains.
The rejections of claims 2, 4, 5, and 7 remain because the rejection to claim 1 remains.
Applicant’s arguments regarding claim 3 and 8 have been fully considered but are not persuasive. The applicant does not specifically challenge Elolampi and Sano as applied to claims 3 and 8. Therefore, because the rejection of claim 1 remains, the rejections to claims 3 and 8 remain.
Claims 9 and 10 are rejected are rejected as explained above.
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
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