DETAILED ACTION
This action is pursuant to the claims filed on March 15, 2024. Claims 1-4 are pending. A first action on the merits of claims 1-5 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al. (hereinafter ‘Chae’, KR-1023608614, cited in IDS) and further in view of Felix et al. (hereinafter ‘Felix’, U.S. PGPub. No. 2015/0087951).
In regards to claim 1, Chae discloses a device for monitoring a biosignal (wearable device 10 in Fig. 1, [0037]: the wearable device 10 may be a device that is attached to the user’s skin and measures a biosignal such as an electrocardiogram (ECG)), comprising:
a support (electrode pattern layer 220 in Figs. 3-5) where an electrode is formed ([0063]: electrode pattern layer 220 comprising electrodes 221);
an attachment part (any of the layers 330 or 340 in Fig. 3) formed on a lower surface of the support (any of the layers 330 or 340 which is configured to be disposed below the support layer 220) and provided with a first hole formed in a position corresponding to the electrode (holes 301 and 302 along layers 330 and 340, respectively in Fig. 3);
a first cover layer (first attachment layer 320 in Fig. 3, [0082]: the first attachment layer 320 is a member in direct contact with the user's skin and may be an adhesive member for fixing the patch unit 300 to the user's skin. For example, the first attachment layer 320 is a tape including a biocompatible material and may be a silicon tape) configured to cover a lower surface of the attachment part (the layer 320 is formed below the layer 330 and 340), and provided with a second hole formed in a position corresponding to the first hole (holes 301 along layer 320);
an attachment pad (hydrogel 310) electrically connected to the electrode (221) via the first hole and the second hole (the hydrogel 310 is disposed within a cavity formed by the holes 302 and 301 of the layers 320, 330 and 340 in Fig. 3).
However, Chae does not disclose a second cover layer configured to cover a part of the first cover layer where the attachment pad is exposed.
Felix teaches a device (wearable monitor 12 in Fig. 1) similar to that of Chae in which the device is configured to be attached to a patient for physiological monitoring. Specifically, Felix teaches providing a layer or a liner (liner layer 40 in Fig. 8) to cover the entire lower surface of the device which would include gels or the claimed attachment pad (gels 41 in Fig. 8) and an adhesive layer or the claimed second cover layer (adhesive layer 43 in Fig. 8, [0052]). 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 device of Chae and incorporate a second cover layer or the liner layer as taught by Felix as doing so involves routine skill in the art and a predictable result of protecting the lower surface of the device and the gel prior to use would ensue ([0052]).
In regards to claim 2, Chae/Felix combination further discloses a waterproof layer (fixing unit 400 as shown in Fig. 7; [0095]: the fixing unit 400 may include a waterproof material… to prevent external moisture from flowing into the inside of the wearable device 10A (waterproofness)) formed to cover an upper surface of the support with a perimeter greater than a perimeter of the support ([0094]: fixing unit 400 may have an area greater than those of the electrode unit 200 and/or the patch unit 300), and provided with a third hold (accommodation groove 410 in Fig. 7) formed at one side thereof, wherein the third hole allows a first connection member (terminal 221a which is arranged on the top side of the layer 220) electrically connected to the electrode to be exposed on the upper surface of the support (the lower surface of the main body unit 100 is in electrical connection with the electrodes 221 via 221a (terminal which is arranged on both sides of the layer 220; note that the accommodation groove 410 allows for the terminals 221a disposed on the upper side of the layer 220 to be exposed when the main body unit 100 is not attached to the electrode unit 200).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Chae and Felix as applied to claim 2/1 above, and further in view of Boleyn et al. (hereinafter ‘Boleyn’, U.S. PGPub. No. 2019/0090769).
In regard to claims 3 and 5, Chae/Felix combination discloses the invention substantially as claimed in claim 2/1 and discussed above.
However, Chae/Felix combination does not disclose a receiving part coupled to the support via the third hole formed in a position corresponding to the first connection member, and a body housing fixing member formed at one side thereof.
Boleyn teaches a patch for biosignal monitoring (wearable monitor 12 in Figs. 1-3). Boleyn further teaches a flexible backing comprising a plurality of electrodes (electrodes 38 and 39 disposed on patch 20 as best shown in Figs. 4 & 8) which is analogous to the support (220) of Chae. Boleyn specifically discloses providing a receiving part (receptacle 25 in Fig. 6) along the upper surface of the flexible backing (20) for receiving a body housing (monitor recorder 14 in Fig. 4-5) so that the body housing (monitor recorder 14) is removeably coupled to the receiving part via a body housing fixing member formed at one side thereof ([0072]: the monitor recorder 14 removably and reusably snaps into an electrically non-conductive receptacle 25 during use; catch (26) disposed along one lateral side of the receptacle 25 and a tension clip 27 disposed along an opposite lateral side of the receptacle 25 in Fig. 4 is configured to catch the recorder 14). Furthermore, the receiving part comprises a second connection member (electrical pad 34 formed on a bottom surface of the receptacle 25), wherein the second connection member is electrically connected to the first electrical member ([0076]: the electrical pad 34 is configured to electrically connect the ECG electrode and its circuit trace (not shown) to a body housing monitor recorder 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify an upper surface of the support along the third hole (e.g. the accommodation groove 410 in Fig. 1) of Chae and incorporate a receiving part along the support and a fourth hole (e.g. the electrical pad equivalent to 34 of Boleyn) for electrically connecting the first connection member or the conductive trace/terminal of the electrodes with the body housing and releasably connecting the receiving part with the body housing via the body housing fixing member as taught by Boleyn. Doing so allows the body housing to be detachably coupled to the receiving part so that the body housing which comprises all the electronic components for signal gathering and transmission is reusable while the support and the additional layers are configured to be disposed after a period of use ([0019], [0043], [0045], [0072]).
In regards to claim 4, Chae/Felix/Boleyn combination discloses substantially all the limitations of the claim(s) except for a third cover layer configured to cover the waterproof layer, and provided with a fifth hole formed in a shape corresponding to a perimeter of the receiving part. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Chae/Boleyn combination and incorporate an additional waterproof layer, 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 and as doing so provides an additional measure of protection against moisture permeating through the device.
Conclusion
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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/EUN HWA KIM/Primary Examiner, Art Unit 3794 1/16/2026