DETAILED ACTION
This action is pursuant to claims filed on 11/4/2025. Claims 1-16 are pending. A final action on the merits of claims 1-16 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 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 1-16 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.
Claims 1 and 14 recite “the surface being disposed in a second direction opposite the first direction and including a range corresponding to at least a disposed range of the electronic component.” Based on the specification of the instant application, it appears that the applicant intends the “ranges” to be the surface areas of the respective surfaces and electronic components. However, the applicant does not have support in the original disclosure that the surface includes “a range corresponding to at least a disposed range of the electronic component.” Based on Figs. 1, 4, and 5, the surface area/width of layer 121 is exactly the same size as electronics 120. Thus, the instant application lacks support for the range being at least a range of the electronic component. Therefore, claims 1 and 14 fail to comply with the written description requirement. The claims contain subject matter which was not described in the disclosure as originally filed and thus introduces new matter.
Claims 2-13 and 15-16 are rejected due to their dependance on claims 1 and 14, respectively.
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 1-16 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.
Claims 1 and 14 “the surface being disposed in a second direction opposite the first direction and including a range corresponding to at least a disposed range of the electronic component.” The “range” and “disposed range” are undefined in the claim. It is unclear to what range is being referred. This could be the surface area, width, length, height, volume, location, etc. It is indefinite what the claim is attempting to limit. Therefore, because it is indefinite what the ranges being claimed are, claims 1 and 14 are rejected.
Claims 2-13 and 15-16 are rejected due to their dependance on claims 1 and 14, respectively.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 9, and 11-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Marriott et al. (hereinafter ‘Marriott’, US 11903700 B2).
Regarding independent claim 1, Marriott discloses a wearable device, comprising:
a detector configured to detect living body information of a subject (detectors 108, 109, and 110 in Fig. 1D; [Col 7, line 63-Col 8, line 26]: the conductive pads 108, 109, and 110 are for ECG);
a first layer (layer 105 in Fig. 1D and corresponding layer 503 in Fig. 1E, including lower part of connector 517 in Fig. 1G) that is flexible and disposed in a first direction relative to the detector and includes a conductor electrically connected to the detector ([Col 7, line 63-Col 8, line 26]: the layer 105 is a flexible circuit layer that is disposed above the electrodes as seen in Fig. 1D and may include traces 107 that connect to the electrodes as shown in Fig. 1D and are for electrical communication; [Col 7, line 63-Col 9 line 16]: the electronic implementation shown in Figs. 1A-D can be implemented in a way shown in Figs. 1E-1N7 in which layer 503 is the flexible layer);
a second layer that is disposed in the first direction relative to the first layer (layer 505 shown in Fig. 1E disposed above the layer 503, including upper part of connector 517 in Fig. 1G) and is harder than the first layer ([Col 8, line 45-Col 9 line 16]: layer 505 is a rigid circuit board); and
a third layer that is disposed in the first direction relative to the second layer (electronics layer corresponding to electronics 103 in Fig. 1D and 519 in Fig. 1E) and includes an electronic component ([Col 7, line 63-Col 9 line 16]: 103 and 519 are electronic components) electrically connected to the conductor ([Col 7, line 63-Col 8, line 26]: the leads 107 connect to the electronic components),
wherein the second layer has a surface (bottom of connector 517, which is part of the second layer, in Fig. 1G) in contact with the first layer (bottom surface of the portion of the connector 517 corresponding to the second layer contacts the upper portion of the connector 517 corresponding to the first layer – the claim does not define how much of the layers contact each other), the surface being disposed in a second direction opposite the first direction (surface is disposed in a downward direction which is opposite the first direction) and including a range (bottom surface of connector 517 has a width) corresponding to (“corresponding to” is a broad term that simply defines a relationship, in this case it will be interpreted as less than) at least a disposed range of the electronic component (the width of the bottom surface of connector 517 is less than the width of the electronic components 519 in Fig. 1G).
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Regarding claim 2, Marriott discloses the wearable device according to claim 1, wherein the detector includes an electrode part (contacts 108, 109, and 110 correspond to electrode parts) that includes an electrode electrically connected to the conductor ([Col 7, line 63-Col 8, line 26]: the leads 107 connect the electrode contacts to the electronic components), and a conductive gel part that is capable of contacting skin of the subject and is electrically connected to the electrode ([Col 18, lines 56-60]: the electrodes have a conductive gel applied between them and the patient skin), and the detector is configured to detect an electrocardiogram as the living body information ([Col 7, line 63-Col 8, line 26]: the conductive pads 108, 109, and 110 are for ECG).
Regarding claim 3, Marriott discloses the wearable device according to claim 2, further comprising: a fourth layer (layer 113i/layer 3 in Fig. 1O2) that has a waterproof property ([Col 36, lines 8-67]: the layer is made of 3M 1504XL High Tack Adhesive Transfer Medical Tape; this layer is fluid resistant which is a waterproof property as evidenced by 3M Medical Transfer Adhesive 1504XL https://www.3m.com/3M/en_LB/p/d/v100986326/) and is disposed in a second direction opposite the first direction relative to the detector (disposed toward the skin side relative to the detector as it is closer to the skin than the hydrogels as seen in Fig. 1O2); and a fifth layer (layer 113h/layer 2 in Fig. 1O2) that has a water-absorbing property ([Col 36, lines 8-67]: the layer is made of 3M Medical Tape 4076, Polyester Spunlace Nonwoven Extended Wear; per page 17 of the specification of the instant application, the water-absorbing layer can be made of a non-woven polyester and because Marriott discloses the same material, the polyester layer disclosed by Marriott inherently has a water-absorbing property as it is the same as the instant application) and is disposed in the second direction relative to the fourth layer (the layer 113h is disposed closer to the patient relative to layer 113i as seen in Fig. 1O2).
Regarding claim 4, Marriott discloses the wearable device according to claim 3, wherein the fourth layer and the fifth layer each have an opening part through which the conductive gel part contacts skin of the subject (opening parts 113g in both layers as seen in Fig. 1O2 corresponding to the hydrogels 113k).
Regarding claim 5, Marriott discloses the wearable device according to claim 4, wherein the opening part of the fifth layer is larger than the opening part of the fourth layer (the openings in the layer 113h are larger than the openings in layer 113i as seen in Fig. 1O2; this can additionally be seen in Fig. 1R1 where the openings in layer 113h are larger than those in 113i).
Regarding claim 6, Marriott discloses the wearable device according to claim 3, wherein the fifth layer includes non-woven fabric ([Col 36, lines 8-67]: the layer is made of 3M Medical Tape 4076, Polyester Spunlace Nonwoven Extended Wear; this material is a non-woven polyester fabric tape).
Regarding claim 9, Marriott discloses the wearable device according to claim 1, wherein an area of the second layer is 5 to 50% of an area of the first layer (the second layer covers 50% of the area of the first layer as seen in Fig. 1F as it covers half of the first layer).
Regarding claim 11, Marriott discloses the wearable device according to claim 1, wherein the second layer is disposed at an end part of the first layer (the second layer is disposed on the end as seen in Fig. 1E).
Regarding claim 12, Marriott discloses the wearable device according to claim 2, wherein the second layer is disposed at a position corresponding to the electrode of the first layer (the second layer is disposed above the ECG electrode 509 as seen in Fig. 1G and the holes corresponding to the electrodes are disposed on the ends as seen in Fig. 1O2).
Regarding claim 13, Marriott discloses the wearable device according to claim 1, wherein the first direction corresponds to a direction departing from the skin when the wearable device is bonded to skin of the subject (the first direction is the direction away from the skin as seen in Fig. 1D, E, and F).
Regarding independent claim 14, Marriott discloses a wearable device configured to acquire living body information of a subject, the wearable device comprising:
a first layer (layer 113h/layer 2 in Fig. 1O2) that has a water-absorbing property ([Col 36, lines 8-67]: the layer is made of 3M Medical Tape 4076, Polyester Spunlace Nonwoven Extended Wear; per page 17 of the specification of the instant application, the water-absorbing layer can be made of a non-woven polyester and because Marriott discloses the same material, the polyester layer disclosed by Marriott inherently has a water-absorbing property as it is the same as the instant application);
a second layer (layer 113i/layer 3 in Fig. 1O2) that has a waterproof property ([Col 36, lines 8-67]: the layer is made of 3M 1504XL High Tack Adhesive Transfer Medical Tape; this layer is fluid resistant which is a waterproof property as evidenced by 3M Medical Transfer Adhesive 1504XL https://www.3m.com/3M/en_LB/p/d/v100986326/) and is disposed in a first direction relative to the first layer (disposed above the first layer as seen in Fig. 1O2);
a conductive gel part (hydrogel 113k in Fig. 1O2) that is disposed in the first direction relative to the second layer (disposed above the second layer as seen in Fig. 1O2) and is capable of contacting skin of the subject (contacts the skin through openings 113g);
an electrode part (contacts 108, 109, and 110 correspond to electrode parts) that is disposed in the first direction relative to the conductive gel part (the conductive contacts are disposed above the hydrogel) and includes an electrode electrically connected to the conductive gel part ([Col 18, lines 56-60]: the electrodes have a conductive gel applied between them and the patient skin – the gel being conductive forms an electrical connection between the electrode and gel);
a third layer (layer 105 in Fig. 1D and corresponding layer 503 in Fig. 1E, including lower part of connector 517 in Fig. 1G) that is flexible and disposed in the first direction relative to the electrode part and includes a conductor electrically connected to the electrode part ([Col 7, line 63-Col 8, line 26]: the layer 105 is a flexible circuit layer that is disposed above the electrodes as seen in Fig. 1D and may include traces 107 that connect to the electrodes as shown in Fig. 1D and are for electrical communication; [Col 7, line 63-Col 9 line 16]: the electronic implementation shown in Figs. 1A-D can be implemented in a way shown in Figs. 1E-1N7 in which layer 503 is the flexible layer); and
a fourth layer that is disposed in the first direction relative to the third layer (layer 505 shown in Fig. 1E disposed above the layer 503, including upper part of connector 517 in Fig. 1G) and includes an electronic component electrically connected through the conductor ([Col 7, line 63-Col 9 line 16]: 103 and 519 are electronic components and are disposed on the rigid circuit board; [Col 7, line 63-Col 8, line 26]: the leads 107 connect to the electronic components).
wherein the fourth layer has a surface (bottom of connector 517, which is part of the fourth layer, in Fig. 1G) in contact with the third layer (bottom surface of the portion of the connector 517 corresponding to the fourth layer contacts the upper portion of the connector 517 corresponding to the third layer – the claim does not define how much of the layers contact each other), the surface being disposed in a second direction opposite the first direction (surface is disposed in a downward direction which is opposite the first direction) and including a range (bottom surface of connector 517 has a width) corresponding to (“corresponding to” is a broad term that simply defines a relationship, in this case it will be interpreted as less than) at least a disposed range of the electronic component (the width of the bottom surface of connector 517 is less than the width of the electronic components 519 in Fig. 1G).
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Regarding claim 15, Marriott discloses a detection method, comprising: detecting an anomaly of the subject based on the living body information acquired by using the wearable device according to claim 1 ([Col 4, lines 37-43]: the device may be a continuous monitor of a number of vital signs; [Col 4, line 55-Col 5, line 3]: the device may detect and analyze arrhythmic events).
Regarding claim 16, Marriott discloses the detection method according to claim 15, wherein the detection method detects an anomaly of the subject based on the living body information for a detection duration of 72 hours or longer ([Col 59, lines 11-67]: the device can monitor ECG for several days, which can be up to 10 days or two weeks).
Claim Rejections - 35 USC § 103
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) 7, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Marriott.
Regarding claim 7, Marriott discloses the invention substantially in claim 3/2/1 as described above. Marriott further discloses that the layer 113i isolates the hydrogel from the absorbent layer, similar to the instant application ([Col 37, lines 20-52]).
However, Marriott is silent to the thickness of the fourth layer.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the thickness of the fourth layer between 30 µm to 150 µm, 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. In this case, the goal of the prior art is to create a layer that isolates the absorbent layer from the hydrogel. This is the same goal as the instant application and is thus an obvious modification.
Regarding claim 8, Marriott discloses the invention of claim 7/3/2/1 as described above.
However, Marriott is silent to the thickness of the fourth layer.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the thickness of the fourth layer between 30 µm to 150 µm, 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. In this case, the goal of the prior art is to create a layer that isolates the absorbent layer from the hydrogel. This is the same goal as the instant application and is thus an obvious modification.
Regarding claim 10, Marriott discloses the invention of claim 9/1 as described above. Marriott further shows that the electronics can cover less than half of the area of the first layer as shown in Fig. 1D.
However, Marriott is silent to the second layer covering 15 to 45% of the area of the first layer.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the second layer cover 15 to 45% of the first layer, 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. In this case, the goal of the prior art is to create a rigid layer supports and protects the electronics, similar to the instant application. Furthermore, it would be an obvious design choice to further shrink the size of the rigid circuit board to allow for increased comfort and a more ergonomic fit.
Response to Arguments
Applicant's arguments filed 11/4/2025 have been fully considered but they are not persuasive.
The applicant argues that Marriott is silent to the arrangement to layers 103 and 105 and attaching circuitry directly to layer 105 is less preferred. This is not persuasive. The layers are further described in Figs. 1E and 1G. These figures show two distinct layers, 503 and 505. Layer 503 corresponds to layer 105 in Fig. 1D. Layer 505 is disposed over layer 503 and connects to the layer 503 at connector 517. As explained in the rejection above, each part of the connector is part of the corresponding layer. These two portions contact each other, thus the two layers contact each other. The claim is broadly written and does not distinctly claim what constitutes each layer and which portion of the layers contact each other.
Applicant further argues that Marriott teaches away and fails to disclose or suggest that the supporting layer has a surface in contact with the flexible layer over a range corresponding to the electronic component. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the supporting layer has a surface in contact with the flexible layer over a range corresponding to the electronic component) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The claims require that the second layer has a surface which contacts the first layer and the surface includes a range corresponding to at least a disposed range of the electronic component. As described above, “a range” and “disposed range” are undefined. The claim does not state what ranges are being referred to. This could be the surface area, width, length, location, etc. Additionally, as described above, the two layers contact each other at the connector 517. Therefore, claims 1 and 14 remain rejected because Marriott discloses the corresponding layers contact each other at a surface and the “ranges” upon which the applicant relies are undefined.
Claims 2-13 and 15-16 are remain rejected because claims 1 and 14 remain 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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794