DETAILED ACTION
This action is pursuant to the claims filed on July 1, 2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 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 . 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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 7, 9-10, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan et al. (hereinafter ‘Quinlan’, U.S. PGPub. No. 2016/0242654), and further in view of Matsumoto et al. (hereinafter ‘Matsumoto’, U.S. Pat. No. 9,619,055).
In regards to independent claim 1 and 10 and claims 2-3, 9, 11, 12, 20, Quinlan discloses a wearable electronic device (health-monitor patch 100 in Fig. 1A-1C; internal configuration shown in Fig. 6) comprising:
a housing (flexible strip assembly 105, [0030]);
a first electrode and a second electrode (electrodes 660a, 670 and 660b);
an interface (replaceable electrode strip 150 as shown in Fig. 6 and details of the strip 150 is illustrated in Fig. 7A-7B) for electrically coupling a biosensor (the biosensor is not necessarily required as part of the interface; therefore, the replaceable electrode strip 150 is capable of being positioned in a conductive plate; alternatively, the biosensor reads on the two or more electrodes 160a and 160b configured to contact a skin) to electrodes of a wearable electronic device ([0081]: electrodes 660a,660b and 670 are infused on a silicone casing of a flexible strip assembly 105 as shown in Fig. 6), the interface comprising:
a first portion that includes a first material configured to provide a conductive path between the biosensor and the wearable electronic device ([0076]: replaceable electrode strip may include two or more electrodes 160a, 160b and one or more noise electrodes 170 as shown in Fig. 6 and 7A-7B and its respective conductive components (not shown) to electrically connect to the electrodes 660a, 660b and 670 (shown in Fig. 6); note that the two or more electrodes 160a and 160b that is configured to contact a wearer reads on the biosensor since the electrodes 160a and 160b is for biopotential sensing, thus meeting claims 9 and 12);
a second portion that is different than the first portion ([0035], [0065] & [0085]: upper surface of the electrode strip 150 which is shown as a patch adhesion layer 720 comprising non-conductive adhesive surfaces 722 and 726; note that the adhesive surfaces are formed from adhesive models 96042 or 9474LE available from 3M corporation, thus meeting claims 2-3 and 20), the second portion including a second material that is different than the first material ([0065]: the electrodes 160a, 160b and 170 is formed from a conductive material which is different from the surface of the adhesive material), the second material configured to removeably couple the interface to the wearable electronic device (the adhesive layer 720 allows for the strip 150 to be removably coupled to the bottom surface of the assembly 105 as shown in Fig. 6);
a third portion covering one or more surfaces of the first portion and one or more surfaces of the second portion ([0088]: the strip 150 comprising a skin adhesion layer 750 (shown in Fig. 7A and 7B) and is an electrically insulating material including a Tegaderm adhesive or a hydrocolloid adhesive; note that the strip 150 covers lateral surfaces of the electrodes 160a, 160b and 170 and the lower surface of the adhesive layer 720), the third portion including a third material that is different than the first material and the second material (note that the material of the layer 750 is different from the adhesion layer of 720 and the conductive material of 160a,b and 170), and a surface of the third portion contacts an exterior surface of the wearable electronic device (
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wherein when the interface is removably coupled to the wearable electronic device ([0032]: the replaceable electrode strip 150 is capable of being re-adhered to the health-monitor patch and to the skin via an adhesive surface 252), the first portion of the interface contacts the electrodes of the wearable electronic device to provide the conductive path between the biosensor and the electrodes ([0076]: Fig. 6 shows that the electrodes 160a,160b and 170 of the strip 150 contacts the electrodes 660a, 660b and 670, respectively).
Although Quilan teaches that the second portion is disposed above the upper surface of the third portion so that the interface is removably coupled to the wearable device, it fails to disclose that the third portion contacts an exterior surface of the wearable electronic device.
Matsumoto teaches the concept of providing a corner of a detachable substrate without an adhesive material to make is easily accessible to start from the corner to detach the substrate from another layer (col. 10, ln. 45-col. 11, ln. 6: the adhesive material 2202 is disposed on a PET film 220 and the corners 222 of the PET film 220 do not have adhesive material as shown in exemplary Fig. 18). Given that Quilan’s interface is configured to be detachable from the wearable electronic device, it would have been obvious to modify the second portion (e.g. adhesive layer 720) so that the second portion does not extend to the entire surface of the third portion (e.g. skin adhesion layer 750) and the corner or edge of the third portion does not provide the second portion as taught by Matsumoto, as doing so allows the interface to be easily detachable from the device (col. 11, ln. 1-6: This configuration makes it possible to start from the area 222 of one of the four corner areas, from which the PET film 220 is most easily detached from the touch panel 100). The examiner notes that providing corners of the third portion without the second portion allows for the third portion can be configured to contact the external surface of the wearable device.
In regards to claim 7, Quinlan further discloses wherein a first surface of the first portion that contacts a first electrode of the electrodes is flush with a surface of the third portion that contacts the wearable electronic device when the interface is removably coupled to the wearable electronic device; and a second surface of the first portion that contacts a second electrode of the electrodes is flush with the surface of the third portion (the electrodes 160a and 160b and 170 are flushed with the surface of the strip 150 and although not shown in Fig. 6, each of the electrodes are exposed on the opposite side of the strip to directly contact the electrodes of the assembly 105).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4, 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan and Matsumoto as applied to claim 1 or 10 above and further in view of Wahlgren et al. (hereinafter ‘Wahlgren’, U.S. PGPub. No. 2008/0147146).
In regards to claim 4, Quinlan/Matsumoto combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Quinlan/Matsumoto combination does not disclose wherein the second material includes a magnetic material and the second portion is embedded within the third portion.
Wahlgren teaches providing an electrode patch to a skin of a patient through an adhesive means or magnets ([0004]-[0006] & [0017]: see skin tattoo 20 disposed on a skin and magnet metal disc 30 disposed on a bottom surface of the patch in Fig. 8). Therefore, replacing an adhesive layer like that of Quinlan with a plurality of magnets for the same purpose attachment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the second portion comprising an adhesive material of Quinlan with a magnetic material as taught by Wahgren, as doing so are equivalent for coupling electrode patches to the skin and it further allows for precise and repeatable placement of skin electrodes ([0006]).
In addition, the embedding the magnet into the substrate/third portion involves routine skill in the art.
Claims 8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan as applied to claim 1 above.
In regards to claims 8 and 17, Quinlan discloses the invention substantially as claimed in claim 1 and discussed above.
Quinlan does not disclose wherein the first surface of the first portion is raised relative to the surface of the third portion and the second surface of the second portion is raised relative to the surface of the third portion. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to modify the thickness of the first surface and the second surface of the first portion so that it is raised relative to the surface of the third portion, since doing so is an obvious modification to allow the conductive electrodes/components to better contact the first and second electrodes.
In regards to claim 18, Quinlan discloses the invention substantially as claimed in claim 17/16/11 and discussed above except a surface of the first electrode and a surface of the second electrode are each raised relative to the surface of the housing. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to modify the thickness of electrodes, since doing so is an obvious modification to allow the electrodes to be further exposed to better contact the interface and its corresponding conductive portions.
Claims 13-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan as applied to claim 10 above and further in view of Golda et al. (hereinafter ‘Golda’, U.S. PGPub. No. 2020/0237309).
In regards to claims 13-15, Quinlan discloses the invention substantially as claimed in claim 10 and discussed above.
However, Quinlan does not disclose wherein the housing includes a transparent portion; and the third portion of the interface includes a transparent region that is positioned over the transparent portion of the housing when the interface is removably coupled to the surface of the housing.
Golda teaches an electrode patch (patch 100 in Fig. 1D) comprising a housing (upper component side 101 of the device 100 formed from silicone) similar to the housing of Quinlan and further comprising a transparent portion ([0058]: windows or other communication channels or openings 111, 112 (FIG. 1C) may be provided for a pulse oximeter, for example, for LEDs and a sensor. Such openings 111, 112 (e.g., FIG. 1C) would typically be disposed for optimum light communication to and from the patient skin) and a removable patch (113) comprising a corresponding transparent region which includes an aperture ([0086]: a corresponding one or more light apertures 111b/112b are shown in the adhesive of 113 of the example of FIG. 1D to communicate light therethrough in cooperation with the light conduit(s) 111a/112a in/through layer 105 for communication of light data typically involved in pulse oximetry) that is positioned over the transparent portion of the housing. In addition, the removable patch comprises a release liner which is commonly formed from a transparent plastic film layer which would inherently cover the aperture prior to use ([0054], [0056]: use of release liner prior to attaching to a patient). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the housing and the interface of Quinlan to thereby provide transparent portion, transparent region, respectively and release liner along with necessary light emitter diode and light receiver as taught by Golda to configure the electrode patch for other physiological sensing including pulse oximetry ([0022]).
In regards to claim 19, the examiner notes that given that the wearable electronic device of Quinlan is a patch-type device formed from flexible material ([0030]: a health-monitor patch may comprise a flexible strip assembly 105), it is capable of contouring, even forming a ring shape as claimed, to accommodate a finger of a user.
Response to Arguments
Applicant’s arguments, see Remarks, filed August 20, 2026, with respect to the rejection(s) of claim(s) 1-2, 5-7, 9-12, and 19-20 under 35 U.S.C. 102 as being anticipated by Quinlan et al. (U.S. PGPub. No. 2016/0242654) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Matsumoto et al (U.S. Pat. No. 9,619,055).
Matsumoto teaches the concept of providing a corner of a detachable substrate without an adhesive material to make is easily accessible to start from the corner to detach the substrate from another layer (col. 10, ln. 45-col. 11, ln. 6: the adhesive material 2202 is disposed on a PET film 220 and the corners 222 of the PET film 220 do not have adhesive material as shown in exemplary Fig. 18). Given that Quilan’s interface is configured to be detachable from the wearable electronic device, it would have been obvious to modify the second portion (e.g. adhesive layer 720) so that the second portion does not extend to the entire surface of the third portion (e.g. skin adhesion layer 750) and the corner or edge of the third portion does not provide the second portion as taught by Matsumoto, as doing so allows the interface to be easily detachable from the device (col. 11, ln. 1-6: This configuration makes it possible to start from the area 222 of one of the four corner areas, from which the PET film 220 is most easily detached from the touch panel 100). The examiner notes that providing corners of the third portion without the second portion allows for the third portion can be configured to contact the external surface of the wearable device, thus meeting the newly added limitation of independent claims 1 and 10.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 9/23/2026
