DETAILED ACTION
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 .
Response to Arguments
§ 102 Rejections and § 103 Rejections
Applicant’s arguments filed on 07/29/2026 have been fully considered but are moot in view of a new grounds of rejection.
Claim Objections
Claim 7 is objected to because of the following informalities. Appropriate correction is required.
In re claim 7, the limitation “and/or the at least two electrode second contact areas of the arm portion” should read “and/or the at least two second electrode contact areas of the arm portion”.
Claim Rejections - 35 USC § 102
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.
Claims 2, 4, 7, 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shennib et al. (US 2006/0224072).
In re claim 2, Shennib discloses, a system (FIG. 7) for monitoring a vital sign [0018] of a living organism (5)
-wherein the system comprises a patch device (12; [0038]) configured to be placed on the living organism (FIG. 7)
wherein the patch device is configured to be adapted to multiple use scenarios ([0018]: apparent as the “patch device” is “designed for continuous long-term wear”), and
wherein
the patch device comprises
a main body (42) and
an arm portion (portion of 12 spanning from 44 to 24)
the main body comprises
a housing (outer structure of 42) for an electronic component (33) and
at least two first electrode contact areas (21, 22, 45, 46, 47, 48, 49; [0038])
the arm portion
has an least partially rounded form (see FIGS. 6-7 which show 44 and 43 shaped like a “C”) and
comprises at least two second electrode contact areas (23, 24; [0038]).
In re claim 4, Shennib discloses, wherein the patch device is configured in such a way that the system can acquire an electrocardiogram of the living organism via the at least two first electrode areas and/or the at least two second electrode contact areas [0038].
In re claim 7, Shennib discloses,
wherein the patch device comprises a network of electrode connection lines ([0035]: “with trace extensions”) for connecting the at least two first electrode contact areas of the main body (FIG. 6) and/or the at least two electrode second contact areas of the arm portion to the electronic component (FIG. 6), and/or
wherein the electrode connection lines are arranged in a snake coil form on the arm portion.
In re claim 20, Shennib discloses, wherein the arm portion is attached to one side of the main body (side of 12 closest to reference marker 48) and extends at least partially below the main body (FIG. 6, FIG. 7).
In re claim 21, Shennib discloses, wherein the arm portion corresponds approximately to a quarter of a circle (see FIGS. 6-7 and mapping of “an arm portion” above In re claim 2).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over by Shennib et al. (US 2006/0224072), in view of Russell (US 2015/0094559).
In re claim 3, Shennib discloses,
wherein the patch device comprises a disposable patch component [0022] and an electronic component (31, 32, 33, 34, 35, 36, and 37).
Shennib does not disclose
wherein the patch device comprises a sensor configured to provide sensor data
wherein the system is configured to determine a spatial orientation of the patch device via the sensor data when the patch device is placed on the living organism,
wherein the electronic component comprises the sensor, and/or
wherein the electronic component is configured to determine said spatial orientation of the patch device.
Russell, like Shennib, discloses a patch device (FIG. 1: 110, shown in greater detail in FIG. 7: 110e) for monitoring a vital sign of a living organism [0023]. As disclosed by Russell, the patch device includes an electronic component (810d, [0061]) that houses a variety of sensors including an accelerometer [0063]. The accelerometer is capable of detecting a person’s posture and/or activity level, which allows the electronic component to determine whether or not the person is sitting standing, laying down, or engaged in physical activity [0063].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the following modifications to the system of Shennib
modify the patch device to comprise a sensor configured to provide sensor data,
modify the electronic component to comprise the sensor,
modify the electronic component to be configured to determine said spatial orientation of the device
as taught by Russell. One would have been motivated to make this modification to have the ability to collect information about a user’s posture and activity level (Russell, [0024]). Accordingly, such a modification, would yield “wherein the system is configured to determine a spatial orientation of the patch device via the sensor data when the patch device is placed on the living organism”, given that the electronic component, i.e., a part of the system, is capable of determining spatial orientation.
In re claim 19, see above (In re claim 3).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shennib et al. (US 2006/0224072), in view of Tarler (US 7,206,630).
In re claim 5, Shennib does not disclose
wherein the arm portion is configured to be detached from the main body,
wherein the patch device comprises a perforation arranged between the arm portion and the main body for detaching the arm portion from the main body.
Tarler discloses an analogous system for monitoring a vital sign (abstract: “ECG monitoring”) that like Shennib, includes a patch (FIG. 3) configured to be attached to a patient. Tarler discloses the patch having a main body (12), an arm portion (portion to the right of 22), electrodes (14) and conducting wires (20) that connect the electrodes to an electronic component (34). Tarler further discloses the patch containing a perforation (22) that allows the arm portion of the patch to detach from the main body (col. 15, lines 43-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patch device of Shennib to include wherein the arm portion is configured to be detached from the body, wherein the patch device comprises a perforation arranged between the arm portion and the main body for detaching the arm portion from the main body, as taught by Tarler. One would have been motivated to make this modification to have an easy way to remove an electrode from the system (Tarler, col. 15, lines 43-46).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shennib et al. (US 2006/0224072), in view of Baker et al. (US 2008/0139953).
In re claim 6, Shennib does not disclose,
wherein the patch device comprises at least two batteries,
- wherein the at least two batteries are arranged symmetrically around a center of the patch device, and/or
- wherein the at least two batteries are located at two opposite ends of the patch device, and/or
- wherein the at least two batteries are connected in parallel, and/or
- wherein
the patch device comprises a positive voltage pin and a negative voltage pin,
the voltage pins are configured to connect to the electronic component, and/or
the at least two batteries are connected to the positive voltage pin, and/or
the at least two batteries are connected to the negative voltage pin
Baker, like Shennib, discloses a patch device (FIG. 2) for monitoring a vital sign of a living organism (abstract). As shown in FIG. 2, the patch device includes two batteries (204 left, 204 right) located at opposite ends of the patch device (FIG. 2). As disclosed by Baker, the two batteries can be connected in series or in parallel depending on voltage requirements of the patch device [0054]. As shown in FIG. 4A, the two batteries are each supplied with a battery connection point (402, 401) that connect to a positive voltage pin (407; [0054]: “one polarity”) and a negative voltage pin (410; [0054]: “second polarity”) via a network of battery connection lines (412).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patch device of Shennib to have the main body of the patch device of Baker. One would have been motivated to make this modification given that the two main bodies are functionally equivalent. Moreover, one of ordinary skill would have the ability to select the main body (i.e., that of Shennib or Baker) that would best meet their needs. Accordingly, such a modification would yield “wherein the patch device comprises at least two batteries, - wherein the at least two batteries are arranged symmetrically around a center of the patch device, and wherein the at least two batteries are located at two opposite ends of the patch device, and - wherein the at least two batteries are connected in parallel, and - wherein the patch device comprises a positive voltage pin and a negative voltage pin, the voltage pins are configured to connect to the electronic component”.
In re claim 9, the proposed combination yields (all mapping directed to Baker unless indicated otherwise)
wherein the patch device comprises the positive voltage pin and the negative voltage pin (see proposed modification above In re claim 6; [0054]: “one polarity…at connection pad 407”, “pad 410 providing a second polarity”), and
wherein the patch device comprises a network of battery connection lines (412) for connecting the at least two batteries to the positive voltage pin and the negative voltage pin [0054], and/or
wherein the battery connection lines have a larger cross section surface than the electrode connection lines.
The proposed combination does not yield,
wherein the battery connection lines comprise approximately 100% silver.
Baker further discloses the network of battery connection lines optionally being comprised of silver [0059].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the network of battery connection lines of the proposed combination to comprise approximately 100% silver, as taught by Baker. One would have been motivated to make this modification because silver is a known resistive material used in such applications, as evidenced by Baker. Moreover, one of ordinary skill in the art would have the ability to select a material that would best meet their patch device’s unique resistance needs (see Baker, [0059]).
Claims 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shennib et al. (US 2006/0224072), in view of Hung et al. (US 2020/0054226).
In re claim 8, Shennib does not disclose
wherein the electrode connection lines comprise a mixture of silver and silver chloride,
wherein the mixture comprises approximately 50% of silver and approximately 50% of silver chloride
Hung discloses an analogous patch (FIG. 1) for monitoring a vital sign (abstract: “heart rhythm monitoring”). Hung further discloses the patch having a main portion covered by a housing (10), a battery (40), an electronic circuit (50), and two electrodes (31) with connection lines (30) for transferring data to the electronic circuit [0041]. Hung further discloses the electrode connection lines being made out of silver chloride (AgCl) or silver-silver chloride (Ag/AgCl).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode connection lines of Shennib, to comprise a mixture of silver and silver chloride, as disclosed by Hung. One would have been motivated to make this modification because silver chloride is a known conductive material often used in electrode applications. Moreover, one of ordinary skill in the art would have the ability to choose a material that would best meet their needs.
Regarding the limitation “wherein the mixture comprises approximately 50% of silver and approximately 50% of silver chloride”, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the mixture comprise approximately 50% of silver and approximately 50% of silver chloride, 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 re claim 17, the proposed combination yields,
wherein the electrode connection lines comprise a mixture of silver and silver chloride (see above In re claim 8),
Regarding the limitation “wherein the mixture comprises approximately 80% of silver and approximately 20% of silver chloride”, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the mixture comprise approximately 80% of silver and approximately 20% of silver chloride, 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 re claim 18, the proposed combination yields,
wherein the electrode connection lines comprise a mixture of silver and silver chloride (see above In re claim 8),
Regarding the limitation “wherein the mixture comprises approximately 95% of silver and approximately 5% of silver chloride”, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the mixture comprise approximately 95% of silver and approximately 5% of silver chloride, 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.
Claim 10 is rejected under 35 U.S.C 103 as being unpatentable over Shennib et al. (US 2006/0224072), in view of Park et al. (WO 2016/070128 A1).
In re claim 10, Shennib discloses wherein the patch comprises an adhesive surface (39; [0036]) on its backside (FIG. 3).
Shennib does not disclose, wherein the patch device comprises a multi-piece protective cover on an adhesive surface on its backside
Park discloses an analogous system for monitoring a vital sign (abstract: “cardiac monitoring system”) that like Shennib includes a patch (FIG. 7: 100) configured to be worn on a patient (FIGS. 9A-9F). The patch disclosed by Park also includes a multi-piece cover (FIG. 9A: 600 on right, 600 on left) that covers an adhesive layer located on a bottom side of the patch [0125].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patch taught by Shennib l to comprise a multi-piece protective cover, as taught by Park. One would have been motivated to make this modification to prevent debris or other material from accumulating on the adhesive surface of the patch prior to application.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
