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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/29/25 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 10/29/25, amended claim(s) 1 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0259015 to Caspers in view of U.S. Patent No. 5,711,607 to Bernstein, U.S. Patent Application Publication No. 2008/0294358 to Richardson, and U.S. Patent Application Publication No. 2021/0401358 to Quintanar et al. (hereinafter “Quintanar”).
For claim 1, Caspers discloses a method of measuring temperature from a patient (para [0046]) with a temperature sensor assembly (Examiner’s Note: made up of the elements that it includes), wherein the temperature sensor assembly includes a temperature sensor (one of 24a, 24b, 24c, 24d, 24e, or 24f) (Figs. 1-3) (para [0046]) (also see para [0016]) on a substrate (unlabeled, but as can be seen in Figs. 1 and 3) and configured to (Examiner’s Note: functional language, i.e., capable of) detect the temperature from a patient’s skin (para [0046]) and at least two contact probes on the substrate (two of 24a, 24b, 24c, 24d, 24d, or 24f not relied upon above for the claimed “temperature sensor”) (Figs. 1-3) (para [0046]) (also see para [0016]) and positioned on opposing sides of the temperature sensor (para [0047]), wherein the at least two contact probes are positioned such that they are in galvanic contact with the patient’s skin when the substrate is fully contacting the patient’s skin (para [0046]), the method comprising:
detecting, with the temperature sensor, a temperature measurement of the patient (para [0046]);
measuring, at a controller, impedance between the at least two contact probes (para [0043] and [0046]);
determining, at the controller, whether the substrate has lifted from the patient’s skin based on the impedance (para [0029] and [0065]); and
if the substrate has lifted from the patient’s skin, generating a sensor off alert (para [0029] and [0065]).
Caspers does not expressly disclose along an impedance path extending between the at least two contact probes across the temperature sensor.
However, Bernstein teaches measuring impedance (see claims 1 and 5-8) between at least two contact probes (37a, 37b) (Fig. 2) along an impedance path extending between the at least two contact probes (as can be seen in Fig. 2, the impedance path being between 37a and 37b and transversing 32) across the temperature sensor (Examiner’s Note: the temperature sensor being a circuit and the surface that is part of that circuit that is being measured is reference numeral 32, shown in Fig. 2) (also see col. 4, lines 10-20).
It would have been obvious to a skilled artisan to modify Caspers to include measuring impedance along an impedance path extending between the at least two contact probes across the temperature sensor, in view of the teachings of Bernstein, for the obvious advantage of being able to detect whether the temperature measurement being indicated is reliable or not, thereby improving accuracy of the system (see col. 4, lines 40-44 of Bernstein).
Caspers and Bernstein do not expressly disclose wherein determining whether the substrate has lifted from the patient’s skin based on the impedance includes: comparing the impedance between the at least two contact probes and a second impedance between one of the at least two contact probes and another contact probe.
However, Richardson teaches comparing the impedance (para [0066]-[0069] and [0081] teaches comparing; para [0080] teaches switching between pairs; and para [0073]-[0077] teach making models off of multiple lines/points and their measurements and then averaging (which is also a type of comparing) and making a determination between impedances being within a range (which is also a comparison)) between at least two contact probes (two of the probes at points P1 through P6 in Fig. 1) (see para [0026]-[0027]) and a second impedance between one of the at least two contact probes (one of the probes at points P1 through P6 previously relied upon) and another contact probe (another one of the probes at points P1 through P6 in Fig. 1 not previously relied upon) (see Fig. 5) (see para [0026]-[0027]).
Caspers, Biel, and Richardson do not expressly disclose if the substrate has not lifted from the patient’s skin, transmitting the temperature measurement; and if the substrate has lifted from the patient’s skin, generating the sensor off alert without transmitting the temperature measurement to the controller.
However, Quintanar teaches transmitting a temperature measurement (650) (Fig. 6) (para [0100]) (also see para [0101] and [0103]) (also refer to para [0005], which references “patient data” as data collected by the “sensor,” and the sensor can be at least one “temperature sensor”) if the substrate is positioned the patient’s skin (“YES” at 610 in Fig. 6) (para [0087]) (also see para [0091], which uses impedance, which is different from temperature); and not transmitting the temperature measurement to a controller if the substrate is not positioned on the patient’s skin (“NO” at 610 in Fig. 6) (para [0087]) (also see para [0091], which uses impedance, which is different from temperature).
It would have been obvious to a skilled artisan to modify Caspers to include if the substrate has not lifted from the patient’s skin, transmitting the temperature measurement; and if the substrate has lifted from the patient’s skin, generating the sensor off alert without transmitting the temperature measurement to the controller, in view of the teachings of Quintanar, for the obvious advantage of monitoring the patient’s temperature to help manage a condition of the patient such as diabetes. Caspers recognizes that temperature can be used for lift detection, but adding another functionality to the temperature measurement would make Caspers’ device more commercially viable since it will be able to help monitor diabetes (as diabetes affect body temperature) in addition to detecting if a medicament dispenser has lifted from the patient’s skin.
For claim 2, Caspers further discloses comparing the impedance to a threshold impedance and determining that the substrate has lifted from the patient’s skin the impedance exceeds the threshold impedance (para [0010] and [0065]).
For claim 3, Caspers further discloses wherein the sensor includes at least three contact probes (three of 24a, 24b, 24c, 24d, 24d, or 24f) (Fig. 2), and further comprising measuring at least three impedances between at least three pairs of contact probes formed by at least three contact probes (para [0043], [0046], and [0052]), and determining whether the substrate has lifted from the patient’s skin based on the at least three impedances (para [0058] and [0065]).
For claim 4, Caspers further discloses determining a difference between the at least three impedances (para [0046] and [0052]), and determining that the substrate has lifted from the patient’s skin if the difference between any of the at least three impedances exceeds a threshold difference (para [0010], [0058], and [0065]).
For claim 5, Caspers further discloses wherein the sensor includes at least four contact probes (four of 24a, 24b, 24c, 24d, 24d, or 24f) (Fig. 2), and further comprising measuring at least three impedances between at least three pairs of contact probes formed by at least three contact probes (para [0043], [0046], and [0052]) and determining whether the substrate has lifted from the patient’s skin based on the at least three impedances (para [0058] and [0065]).
For claim 6, Caspers further discloses wherein the sensor includes at least four contact probes (four of 24a, 24b, 24c, 24d, 24d, or 24f) (Fig. 2), further comprising measuring at least two impedances between at least two pairs of contact probes formed by the at least four contact probes (para [0043], [0046], and [0052]).
For claim 8, Caspers further discloses measuring at least three impendences from pairs of probes (para [0043], [0046], and [0052]) forming a perimeter around the temperature sensor (Fig. 3, which shows the probes around a perimeter) (para [0047], which states “[a]dditional sensors may also be provided closer to the centre of the device near to the aperture 22”).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caspers in view of Bernstein, Richardson, and Quintanar, and further in view of U.S. Patent Application Publication No. 2018/0084667 to Saeidi et al. (hereinafter “Saeidi”).
For claim 7, Caspers, Bernstein, Richardson, and Quintanar do not expressly disclose wherein the at least two impedances are measured between contact probes on opposite sides of the temperature sensor such that the at least two impedances are measured across the temperature sensor.
However, Saeidi teaches wherein the at least two impedances are measured between contact probes on opposite sides of the temperature sensor such that the at least two impedances are measured across the temperature sensor (para [0011]).
It would have been obvious to a skilled artisan to modify Caspers wherein the at least two impedances are measured between contact probes on opposite sides of the temperature sensor such that the at least two impedances are measured across the temperature sensing element, in view of the teachings of Saeidi, for the obvious advantage of determining voltage drop across the sensor (as opposed to voltage drop between adjacent probes), which will give relative contact strength across the surface.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 10/29/25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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