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 Restriction
As mentioned in Applicant’s response to the restriction requirement (“Applicant Argument/Remarks Made in an Amendment”, filed on 12/16/2025), claim 11 was amended to depend from claim 2. In the response applicant respectfully submitted that the requirement for unit of invention is moot. Examiner respectfully disagrees. During a telephone conversation with Corey Beaubien on 1/08/2026 a provisional election was made without traverse to prosecute the invention of group II, claims 2-10 and 17-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following feature must be shown or canceled from the claims.
In re claim 2, “electronic component”.
In re claim 10, “multi-piece protective cover”.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-10 and 17-19 are objected to because of the following informalities:
In re claim 2, the limitation “System for monitoring a vital sign” should read “A system for monitoring a vital sign”.
In re claim 3, see above (In re claim 2).
In re claim 4, see above (In re claim 2).
In re claim 5, see above (In re claim 2).
In re claim 6,
See above (In re claim 2).
The limitation “-wherein at least two batteries are connected to the positive voltage pin, and/or wherein at least two batteries are connected to the negative voltage pin.” , should read “-wherein the at least two batteries are connected to the positive voltage pin, and/or wherein the at least two batteries are connected to the negative voltage pin.”
The limitation “- wherein the patch device comprises a positive voltage pin and a negative voltage pin, wherein the voltage pins are configured to connect to the electronic component, and/or” should read “- wherein the patch device comprises a positive voltage pin and a negative voltage pin, and/or wherein the voltage pins are configured to connect to the electronic component, and/or”, and will be interpreted as such during examination.
In re claim 7, see above (In re claim 2).
In re claim 8, see above (In re claim 2).
In re claim 9, see above (In re claim 2).
In re claim 10, see above (In re claim 2).
In re claim 17, see above (In re claim 2).
In re claim 18, see above (In re claim 2).
In re claim 19, see above (In re claim 2).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7, 8, 9, 10, 17 and 18 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.
In re claim 7, the limitation “wherein the patch device comprises a network of electrode connection lines for connecting the electrode contact areas to the electronic component”, specifically the limitation “the electrode contact areas”, raises a clarity concern. As written, it is unclear if “the electrode contact areas” are in reference to the “at least one electrode contact area(s)” on the main body or the “at least one electrode contact area(s)” on the arm portion (see claim 4). For examination purposes, as best understood the limitation “wherein the patch device comprises a network of electrode connection lines for connecting the electrode contact areas to the electronic component” will be interpreted as requiring the network of electrical connection lines to connect the at least one electrical contact area on the main body and/or the at least one electrical contact area on the arm portion. Examiner notes that dependent claims 8, 17 and 18 inherit the same deficiencies.
In re claim 9,
The limitation “wherein the battery connection lines comprise at least approximately 100% silver” raises a clarity concern. Specifically, the phrase “at least” implies that the battery connection line must be at a minimum 100% silver, which implies that battery connection lines made up of more than 100% silver would read on the claim. Examiner notes however, that it is physically impossible for battery connection lines to be made up of more than 100% silver. Therefore, for examination purposes the limitation “wherein the battery connection lines comprise at least approximately 100% silver” will be interpreted as “wherein the battery connection lines comprise approximately 100% silver”.
The limitation “wherein the patch device comprises a network of battery connection lines for connecting the positive voltage pin and the negative voltage pin” when viewed in combination with claim 6 raises a clarity concern. As currently structured claim 6 requires the patch device to comprise at least two batteries and include at least one of the following limitations:
- wherein the batteries are arranged symmetrically around a center of the patch device, and/or
- wherein the batteries are located at two opposite ends of the patch device, and/or
- wherein the batteries are connected in parallel, and/or
- wherein the patch device comprises a positive voltage pin and a negative voltage pin,
wherein the voltage pins are configured to connect to the electronic component, and/or
- wherein at least two batteries are connected to the positive voltage pin and/or
wherein at least two batteries are connected to the negative voltage pin.
Examiner notes that the limitation “- wherein the patch device comprises a positive voltage pin and a negative voltage pin” is not required by the claim if any of the previous limitations are met. The limitation “wherein the patch device comprises a network of battery connection lines for connecting the positive voltage pin and the negative voltage pin” raises a question as to what is/or is not required by claim 6. For examination purposes, because the “positive voltage pin” and “negative voltage pin” are not required by claim 6, claim 9 will be interpreted as follows:
Claim 9. System according to claim 6,
wherein the patch device comprises a network of battery connection lines,
wherein the battery connection lines comprise at least approximately 100% silver, and/or
wherein the battery connection lines have a larger cross section surface than the electrode connection lines.
In re claim 10, the limitation “wherein the patch device comprises a multi-piece protective cover on an adhesive surface on its backside(s)” is unclear when read in conjunction with paragraph [0020] of Applicant’s specification. Specifically, it is unclear how the patch device could have more than one “backside” given that only one side of the patch device faces (i.e., attaches to) the living organism (see Instant specification [0020] for Applicants definition of “backside”). For the purposes of examination, the limitation “wherein the patch device comprises a multi-piece protective cover on an adhesive surface on its backside(s)” will be interpreted as “wherein the patch device comprises a multi-piece protective cover on an adhesive surface on its backside”.
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.
Claims 2-4, 7 and 19 are being rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russell (US 2015/0094559).
In re claim 2, Russell discloses system (FIG. 1: 100) for monitoring a vital sign of a living organism ([0023]: “…physiological parameter monitoring system”)
-wherein the system comprises a patch device (110, FIG. 7: 110e) configured to be placed on the living organism (105)
wherein the patch device is configured to be adapted to multiple use scenarios [0036, 0081].
In re claim 3, Russell discloses
wherein the patch device comprises a sensor ([0024]: “sensor unit may include multiple sensors such as…accelerometers”) configured to provide sensor data [0024],
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 ([0024]:“accelerometer…may be operable to determine whether the user is standing, sitting, laying down…”),
wherein the patch device comprises a disposable patch component (705; [0058]: “result of the patch being disposable”) and an electronic component (210-d),
wherein the electronic component comprises the sensor (FIG. 9: 810a; [0063, 0066]: “sensing module may include at least one sensor”; [0075]: Additionally see incorporated reference Russell et al. (App. No. 13/087540) which also shows the sensor (Figure 3a: “accelerometer”) being a part of the electronic component (Figure 3a: middle piece with power sign)), and/or
wherein the electronic component is configured to determine said spatial orientation of the patch device ([0024]:“accelerometer…may be operable to determine whether the user is standing, sitting, laying down…”).
In re claim 4, Russell discloses
wherein the patch device comprises a main body (end region 730-a-1 which includes 210-d, 710-a-1, 715-a-1, 710-a-2, and 710-a-3) and an arm portion (725 to 730-a-2; [0057]),
wherein the main body comprises a housing for an electronic component ([0005]: “the electronics package may include a housing”), and/or
wherein the arm portion has an at least partially rounded form (FIG. 7), and/or
wherein the main body comprises at least one electrode contact area(s) ([0057]: “end regions 730 may also host the electrodes”), and/or
wherein the arm portion comprises at least one electrode contact area(s) ([0057]: “end regions 730 may also host the electrodes”), and/or
wherein the patch device is configured in such a way that the system can acquire an electrocardiogram of the living organism via the electrode area(s).
In re claim 6, Russell discloses wherein the patch device comprises at least two batteries (735 and [0066]: “internal power supply”),
- wherein the batteries are arranged symmetrically around a center of the patch device, and/or
- wherein the batteries are located at *two opposite ends of the patch device (FIG. 7), and/or
- wherein the batteries are connected in parallel, and/or
- wherein the patch device comprises a positive voltage pin and a negative voltage pin,
wherein the voltage pins are configured to connect to the electronic component, and/or
wherein at least two batteries are connected to the positive voltage pin and/or
wherein at least two batteries are connected to the negative voltage pin.
*Examiner notes that the first battery indicated by marker 735 is located at the right side of the patch device, while the second battery (i.e., [0066]: “internal power supply”) is included in the electronics package (210-d) which is located on the left side of the patch device.
In re claim 7, Russell discloses
wherein the patch device comprises a network of electrode connection lines (715-a-1, 715-a-2) for connecting the electrode contact areas to the electronic component ([0056]; Regarding the limitation “the electrode contact areas” see above section Claim Rejections 112 (In re claim 7)), and/or
wherein the electrode connection lines are arranged in a snake coil form on the arm portion.
In re claim 19, see above (In re claim 3).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 2015/0094559), in view of Tarler (US 7,206,630).
In re claim 5, Russell 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 Russell, 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 Russell 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 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 2015/0094559), in view of Hung et al. (US 2020/0054226).
In re claim 8, Russell discloses
wherein the electrode connection lines comprise a conductive material ([0057]: “conductive tracks 715-a-1, 715-a-2”).
Russell 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 Russell, 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 2015/0094559).
In re claim 9, Russell discloses
wherein the patch device comprises a network of battery connection lines (740, battery connections for [0066]: “internal power supply”) *for connecting the batteries to the positive voltage pin and the negative voltage pin,
Russell does not disclose
wherein the battery connection lines comprise at least approximately 100% silver, and/or
wherein the battery connection lines have a larger cross section surface than the electrode connection lines.
Regarding the limitation “wherein the battery connection lines comprise at least approximately 100% silver”, it would have been obvious to one of ordinary skill in the art before the effective filing date at the time the invention was made to make the battery connection lines out of silver since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use or purpose. MPEP 2144.07. Moreover, one of ordinary skill in the art would be motivated to have the battery connection lines be comprised of silver because it is known to be highly conductive and corrosion resistant.
*Regarding the limitation “for connecting the batteries to the positive voltage pin and the negative voltage pin” see above section Claim Rejections 112 (In re claim 9).
Claim 10 is rejected under 35 U.S.C 103 as being unpatentable over Russell (US 2015/0094559), in view of Park et al. (WO 2016/070128 A1).
In re claim 10, Russell discloses wherein the patch comprises an adhesive surface on its backside ([0056]: “bottom side…may be at least partially covered by an adhesive”).
Russell does not disclose wherein the patch device comprises a multi-piece protective cover on an adhesive surface on its backside(s).
Park discloses an analogous system for monitoring a vital sign (abstract: “cardiac monitoring system”) that like Russell 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 Russell 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
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dhillon et al. (US 2020/0352510) discloses a patch device capable of measuring blood pressure, pulse oximetry, and other vital signs (abstract).
Marek et al. (US 2016/0113535) discloses a patch device with retractable electrode wires (abstract).
Spencer et al. (US 2019/0320929) discloses a patch device (FIG. 3A) that monitors a patient’s vital signs [0020]. Spencer further discloses the patch device including multiple electrodes (14, 16, 18) a protective cover [0028].
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