DETAILED ACTION
This action is pursuant to RCE filed on 5/12/2026. Claims 1-8, 11-13, and 15-16 are pending. Claims 9-10 and 14 have been cancelled by the applicant. A non-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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/12/2026 has been entered.
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) 1-8, 11-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Marriott et al. (hereinafter ‘Marriott’, US 11903700 B2) in view of Kasielke et al. (hereinafter ‘Kasielke’, US 20080275326 A1).
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) 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 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) and a first major surface on a side in the first direction (top surface of layer 105);
a third layer that (electronics layer corresponding to electronics 103 in Fig. 1D) and includes an electronic component ([Col 7, lines 26-37]: 103 are electronic components) electrically connected to the conductor ([Col 7, line 63-Col 8, line 26]: the leads 107 connect to the electronic components).
Marriott further discloses that the circuit can be a circuit board embedded on a flat elastic substrate ([Col 3, lines 33-67]). Marriott also contemplates the use of a relatively rigid PCB operably connected to a flexible layer ([Col 8, lines 45-56]).
However, Marriott does not explicitly state that the embodiment of Fig. 1D has a second layer stacked on the first layer in the first direction, that is harder than the first layer, and includes a second major surface on a side in a direction opposite to the first direction and in contact with the first major surface, wherein the second major surface has a first region that is in contact with the first major surface of the first layer and overlaps in a projection along the first direction, a second region in which the electronic component is disposed.
Kasielke teaches a sensor having a substrate with a sensing portion, similar to the layer 105 of Marriott, and a circuit mounting portion electrically connected to the sensor ([Abstract]). As seen in Fig. 3, the electrical circuit can be mounted directly to the portion 16 of substrate 12, which is similar to the embodiment shown in Fig. 1D of Marriott in which the electronics are mounted directly on the top of the flexible layer. The first substrate 16 of Kasielke may also be flexible ([0003]). Kasielke also discloses an alternate embodiment in which an intermediate substrate 80 is disposed between the substrate and the electronics as seen in Fig. 7 and intermediate substrate 80 is adhered to the substrate with adhesive 84 ([0060]). The intermediate substrate 80 can be a rigid conventional printed circuit board on which the electronics are mounted ([0060]). Since Marriott contemplates incorporating a rigid PCB in conjunction with the flexible circuit layer, it would be of routine skill in the art to incorporate a rigid PCB layer between the electronic components and the flexible layer as taught by Kasielke. This rigid PCB would form the second layer, and be harder than the flexible first layer, and the bottom surface would form the second major surface which would contact the first major surface of layer 105. Furthermore, the rigid PCB would be disposed directly under the electronics 103 of Marriott and thus the electronics would be disposed longitudinally and overlap in the contact region between the first and second major surfaces. Given that Marriot contemplates arranging a rigid PCB on the flexible layer, it would have been obvious to one of ordinary skill in the art to adhere the rigid PCB layer (e.g. 80) to the flexible layer (e.g. area 16 of layer 12) as taught by Kasielke to arrive at the contemplated arrangement of Marriott as doing so involves routine skill in the art and a predictable result of providing a degree of structural rigidity to the stacked arrangement of the electronics, rigid PCB, and the flexible, first layer would ensue.
Incorporating the rigid PCB underneath the electronics 103 would mean the area of the second major surface is between 15% and 45% of the area of the first major surface as seen in Fig. 1D.
However, while the Fig. 1D shows this proportion, it is not explicitly stated.
It would have been an obvious matter of design choice to make the area of the second major surface is between 15% and 45% of the area of the first major surface, 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 and is obvious to ensure the rigid layer is sufficiently small. In re Rose, 105 USPQ 237 (CCPA 1955). Additionally, the instant application does not provide criticality to this claimed range. While Table 1 of the instant application shows that testing was done within the claimed range, there is no indication that the range must be met in order for the device to perform properly. Based on Table 1, no testing was performed on ranges outside of the claimed range to show a significant improvement between the claimed range and any other possible range.
Regarding claim 2, the Marriott/Kasielke combination 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, the Marriott/Kasielke combination 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 the second 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, the Marriott/Kasielke combination 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, the Marriott/Kasielke combination 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, the Marriott/Kasielke combination 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 7, the Marriott/Kasielke combination 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. Additionally, the instant application does not provide criticality to this thickness. It simply states that having a certain thickness or larger aids in isolating the layer (page 28 of the instant application specification), which is the same as Marriott.
Regarding claim 8, the Marriott/Kasielke combination 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 Additionally, the instant application does not provide criticality to this thickness. It simply states that having a certain thickness or larger aids in isolating the layer (page 28 of the instant application specification), which is the same as Marriott.
Regarding claims 11 and 12, the Marriott/Kasielke combination discloses the wearable device according to claim 1 and claim 2, respectively.
However, the embodiment shown in Fig. 1D does not show the second layer disposed at an end part of the first layer corresponding to the electrode of the first layer.
Marriott discloses alternate embodiment in which the circuit layer is moved to an end of the device over at least one of the electrodes as seen in Figs. 1G-1N7. Modifying the embodiment of Fig. 1D such that the circuit board that forms the second layer is moved to an end of layer 105 over the electrodes would simply be a rearrangement of parts already contemplated by Marriott. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to place the second layer of the Marriott/Kasielke combination on the end of layer 105 over the electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 13, the Marriott/Kasielke combination 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, and E).
Regarding claim 15, the Marriott/Kasielke combination 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, the Marriott/Kasielke combination 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).
Response to Arguments
Applicant’s arguments, filed 4/15/2026, regarding the 112a and 112b rejections of claims 1-16 have been fully considered and are persuasive in light of the amendments. The 112a and 112b rejections of claims 1-16 have been withdrawn.
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
Applicant initially argues that Marriott does not disclose the second layer having a second major surface that contacts the first layer and overlaps in a region in which the electronic components are disposed. However, this argument is moot. The rejection of record no longer relies on the embodiment shown in Figs. 1E-1G. Instead, the rejection now relies on Fig. 1D in combination with Kasielke to teach a rigid PCB between the electronics and the flexible layer 105. This combination results in a second layer having a second major surface that contacts the first layer and overlaps in a region in which the electronic components are disposed as explained above.
Applicant’s arguments that Marriott does not disclose an area of the second major surface is 15% to 45% of an area of the first major surface because the hinge component has been fully considered but are moot because the rejection of record no longer relies on the embodiment argued. Instead, the rejection of record utilizes Fig. 1D of Marriott in combination with Kasielke. Placing a rigid PCB directly under the electronics 103 would result in the areas falling within the claimed range, as explained above. Additionally, it would be a routine change in size to modify the size of the second layer to fall within the claimed range. While Table 1 of the instant application shows that testing was done within the claimed range, there is no indication that the range must be met in order for the device to perform properly. Based on Table 1, no testing was performed on ranges outside of the claimed range to show a significant improvement between the claimed range and any other possible range.
Therefore, claim 1 remains rejected.
Claims 2-8, 11-13, and 15-16 remain rejected because claim 1 remains rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/W.M./ Examiner, Art Unit 3794 /JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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