DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/09/2026 has been entered.
Claim status
This action is in response to applicant filed on 04/0/2026.
Claim 1 has been amended.
Claims 1-19 are pending for examination.
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.
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.
Claim 1-3, 14-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US 6,471,087) in view of Ganton et al. (US 2016/0149292) and further in view of Agdeppa et al. (US 2016/03388991).
Regarding claim 1: Shusterman disclose a system to monitor a user's health comprising:
a monitor element (Fig. 2A and Fig. 6, items 216 and 218) securable to the user's body (Col. 10, Lines 54-65: Once garment 216 is sized to fit a given patient, and is fitted appropriately with sensor 218, the patient can wear garment 216 and simultaneously locate sensor 218 properly), the monitor element including at least one sensor providing information associated with health of the user, the sensor providing information associated with one or more of:
user heart rate;
user respiration rate;
user blood pressure;
user oxygen level (Fig. 5, Col. 10, Lines 18-26);
a central station in communication with the gateway element (Fig. 2B, item 202), wherein the information associated with health of the user is received by the central station (Col. 11, Lines 29-31), wherein the central station analyzes the information and determines whether intervention is appropriate, based at least on:
at least one heartrate threshold;
at least one respiration rate threshold;
at least one blood pressure threshold; and
at least one oxygen level threshold (Col. 6, Lines 15-22: PC 202 (central station) provide redundant monitoring which is the same as the monitoring unit item 214 (Col. 6, Lines 9-13)).
Shusterman does not explicitly disclose the monitor element being in direct contact and with the user's body at any desired position on an exterior of the user's body.
In analogous art regarding monitoring user’s health, Ganton disclose a monitor element being in direct contact with the user's body at any desired position on an exterior of the user's body (Fig. 8, ¶0028).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of the monitor element being in contact with the user's body at any desired position on an exterior of the user's body as disclose by Ganton, to the monitor element of Shusterman. The motivation is to provide more flexibility of placement of the sensor hence making the system more versatile and efficient.
The combination of Shusterman and Ganton does not explicitly disclose at least one light sensor facing the user, wherein the at least one light sensor provides light sensing information based on light reflected from the at least one light emitting diode off the user's skin; and a bed sensor configured to provide position information associated with a position of the user in a bed.
In analogous art regarding patient monitoring, Agdeppa disclose wherein the at least one light sensor provides light sensing information based on light reflected from the at least one light emitting diode off the user's skin (¶0012).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the at least one light sensor provides light sensing information based on light reflected from the at least one light emitting diode off the user's skin, as disclose by Agdeppa, to the system of the combination of Shusterman and Ganton. The motivation is to provide more accurate and complete information about the user hence making the system more effective.
Regarding claim 2: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, wherein the information associated with the health of the user is stored in a memory (database) associated with the central station (Shusterman: Col. 20, 31-33).
Regarding claim 3: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, wherein the information associated with the health of the user further comprises information associated with:
user weight;
user activity; and
user sleep quality (Shusterman: sensor item 218 include fail sensor 508 and GPS monitor 510 which monitor user activity (Fig. 5, Col. 10, Lines 35-40)).
Regarding claim 14: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1 further comprising an alert device (Shusterman: Fig. 2B, item 238) in wireless communication with the central station (Shusterman: Col. 7, Lines 4-10).
Regarding claim 15: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 14, wherein the alert device comprises an alert button (Shusterman: Fig. 2B, item 238), wherein the alert device transmits an alert signal to the central station when the alert button is actuated (Shusterman: Col. 7, Lines 4-10).
Regarding claim 16: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 15, wherein the central station transmits the alert signal to emergency personnel. (Shusterman: Col. 7, Lines 4-10).
Regarding claim 17: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 15, wherein the alert device provides two way communication with the central station. (Shusterman: Fig. 2A. Notice communication link between item 214 and 208 that have a two arrows line, which indicate two way communication).
Regarding claim 19: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, wherein the alert device provides two way communication with the central station. (Shusterman: Fig. 2A. Notice communication link between item 214 and 208 that have a two arrows line, which indicate two way communication).
Claim 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US 6,471,087) in view of Ganton et al. (US 2016/0149292) in view of Agdeppa et al. (US 2016/03388991) and further in view of Cumming et al. (US 2017/0246041).
Regarding claim 4: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, but does not explicitly disclose wherein the monitor element comprises an adhesive element positioned on an inner surface thereof for contact with the user’s skin to position the monitor element on the user’s body.
In analogous art regarding monitoring user’s health, Cumming disclose a monitor element comprises an adhesive element positioned on an inner surface thereof for contact with the user’s skin to position the monitor element on the user’s body (¶0062: A gentle release adhesive can be used to hold the sensor in position and/or to provide constant intimate contact with the patient's skin).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include an adhesive element positioned on an inner surface thereof for contact with the user’s skin to position the monitor element on the user’s body, as disclose by Cumming, to the monitoring element of The combination of Shusterman, Ganton and Agdeppa. The motivation is to ensure the monitoring element staying in its proper place ensuring a proper reading, therefore making the system more reliable.
Regarding claim 5: The combination of Shusterman, Ganton, Agdeppa and Cumming disclose the system of claim 4, wherein the adhesive element includes an alignment element positions to aid in the positioning of the monitor element on the user’s (Cumming: ¶0062: The sensor can be embedded or attached to the interior surface of the bandage cap in an advantageous position, likely the forehead area).
Claims 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US 6,471,087) in view of Ganton et al. (US 2016/0149292) in view of Agdeppa et al. (US 2016/03388991) and further in view of Kumar et al. (US 2017/0056682).
Regarding claim 6: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, but does not explicitly disclose wherein the monitor element comprises a plurality of electrodes.
In analogous art regarding monitoring user’s health, Kumar disclose wherein the monitor element comprises a plurality of electrodes (Fig. 3, item 502 and 504, ¶0092).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include a plurality of electrodes, as disclose by Kumar, to the monitor element of the combination of Shusterman, Ganton and Agdeppa, since having a limited universe of potential options (type of sensors), the selection of any particular option (electrode sensors) would have been obvious to one of ordinary skill in the art. In re Jones, 412 F.2d 241, 162 USPQ 224 (CCPA 1969). Since either option would provide the same predictable result of sense data, either option would have been obvious to one of ordinary skill.
Regarding claim 7: The combination of Shusterman, Ganton, Agdeppa and Kumar disclose the system of claim 6, wherein a pair of electrodes are provided on a first end of the monitor element (upper patch) and a third electrode is provided on a second end of the monitor element, opposite the first end (lower patch) (Kumar: Fig. 3, ¶0092).
Regarding claim 8: The combination of Shusterman, Ganton, Agdeppa and Kumar disclose the system of claim 7, but does not explicitly disclose wherein the pair of electrodes are provided side by side. However, it does disclose a pair of electrodes (Kumar: ¶0092). Therefore, Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include arrange the pair of electrodes provided in a side by side manner since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9: The combination of Shusterman, Ganton, Agdeppa and Kumar disclose the system of claim 8, wherein the third electrode is spaced a predetermined distance from the pair of electrodes (Kumar: Fig. 3, ¶0092).
Regarding claim 10: The combination of Shusterman, Ganton, Agdeppa and Kumar disclose the system of claim 9, wherein the pair of electrodes and third electrode are positioned to provide ECG information (Kumar: Abstract).
Regarding claim 11: The combination of Shusterman, Ganton, Agdeppa and Kumar disclose the system of claim 7, wherein the first end of the monitor element (item 502) is connected to the second end of the monitor element (Kumar: Fig. 3, item 506) via a flexible bridge element (Kumar: Fig. 3, item 512) such that the first end of the monitor element and second end of the monitor element are movable with the user’s skin relative to each other (Kumar:¶0020: The wearable defibrillator can further include a flexible bridge connecting the first and second patient engagement substrates. The flexible bridge can include an electrical conductor configured to provide electrical communication between the second defibrillator pad electrode and the second plurality of ECG sensing electrodes to one or more of the controller and the one or more capacitors).
Claims 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US 6,471,087) in view of Ganton et al. (US 2016/0149292) in view of Agdeppa et al. (US 2016/03388991) and further in view of Banet et al. (US 2011/0066043).
Regarding claim 12: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, but does not explicitly disclose wherein the light sensing information and ECG information are used by the monitor to determine the user blood pressure.
In analogous art regarding patient monitoring, Banet disclose wherein the light sensing information and ECG information are used by the monitor to determine the user blood pressure (¶0041).
Regarding claim 13: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, but does not explicitly disclose wherein the light sensing information and ECG information are transmitted from the monitor element to the central station and the user blood pressure is determined at the central station.
In analogous art regarding patient monitoring, Banet disclose wherein the light sensing information and ECG information are transmitted from the monitor element to the central station and the user blood pressure is determined at the central station. (¶0041, ¶0071-0072).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the light sensing information and ECG information are transmitted from the monitor element to the central station and the user blood pressure is determined at the central station, as disclose by Banet, to the system of the combination of Shusterman, Ganton and Agdeppa. The motivation is to add redundancy to the measurement hence making it more reliable.
Claims 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US 6,471,087) in view of Ganton et al. (US 2016/0149292) in view of Agdeppa et al. (US 2016/03388991) and further in view of Hayter et al. (US 2009/0005665).
Regarding claim 18: The combination of Shusterman, Ganton and Agdeppa disclose the system of claim 1, but does not explicitly disclose wherein the monitor element checks the information associated with health of the user for errors prior to sending the information associated with health of the user to central station and does not send the information associated with health of the user to the central station when errors are detected..
In analogous art regarding data transmission, Hayter disclose wherein the monitor element checks the information associated with health of the user for errors prior to sending the information associated with health of the user to central station and does not send the information associated with health of the user to the central station when errors are detected. (¶0135).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the monitor element checks the information associated with health of the user for errors prior to sending the information associated with health of the user to central station and does not send the information associated with health of the user to the central station when errors are detected., as disclose by Hayter, to the system of Shusterman, Ganton and Agdeppa. The motivation is to save power and data space by not sending corrupted information.
Response to Arguments
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive.
Applicant argue that it would not be obvious to combine Shusterman with Ganton because Ganton teaches removal of users clothing prior to the application of the sticker and Shusterman uses a garment that is necessary or not only positioning of the sensor but for also connecting the monitoring unit.
Examiner respectfully disagrees: None of the reference explicitly disclose that Shusterman would not operate with a sticker sensor nor Ganton disclose that it would not further operate with a garment to further ensure proper placement of the sensor. The fact that Ganton suggest the removal of clothing is merely an suggestion for the user to the sensor can be sticked to the user skin. By no mean this means that the system of Ganton cannot operate with the garment of Shusterman. A person of ordinary skill in the art would have find it obvious to combine such reference at the very least to add redundancy to the placement and securing of the sensor. Furthermore, alternatively, it will also be obvious to extent the connectors and conduits of the garment of Shusterman and connect it to the sticker sensor of Ganton and still arrive at the invention.
Conclusion
The prior art made of record cited in the PTO-892 and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR CASILLASHERNANDEZ whose telephone number is (571)270-5432. The examiner can normally be reached Monday-Friday, 8:30AM-4:30PM.
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/OMAR CASILLASHERNANDEZ/Primary Examiner, Art Unit 2689
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