DETAILED ACTION
This office action is in response to the amendment filed 12/12/2025. As directed by the amendment, claims 1, 3, and 7 have been amended, claims 19-24 have been cancelled, and no claims have been newly added. Thus, claims 1-18 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim(s) 3 is/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 pre-AIA the applicant regards as the invention.
Regarding claim 3, line 2 recites “an intelligent control operative to therapeutic data”. It is unclear how to determine the metes and bounds of an “intelligent” control, whether the presence of a microcontroller or process or is enough to provide an intelligent control, or whether an artificial intelligence control algorithm is required to be implemented in the device. For purposes of examination, the limitation “intelligent control” is interpreted to read on the device having a microcontroller or processor present.
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.
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.
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(s) 1-6, 10-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero Martin (11,327,443) in view of Donaldson (2017/0281086) and Toth et al (2015/0335288).
Regarding claim 1, Trapero Martin in fig 12 discloses a system comprising: a disposable patch (1200) (patch assembly can be disposable) (col 18, ln 3-8) and a reusable patch (100) (electronic device) (col 17, ln 19-26), the disposable patch (1200) having a first side (1210) and an opposite second side (not shown) (col 17, ln 17-230), the disposable patch (1200) having a body formed from a flexible material (patch is thin, flexible, and elastic) (col 18, ln 3-8); a plurality of sensors (1202) (one or more electrodes can be ECG electrodes) positioned on the disposable patch (1200) (col 17, ln 26-35); an electrically conductive pattern (1225) (connecting members) on the disposable patch (1200) wherein segments of the electrically conductive pattern (1225) are electrically connected to the plurality of sensors (1202) (col 17, ln 33-38); the reusable patch (100) (electronic device) for positioning on the disposable patch (1200) (col 17, ln 19-26), the reusable patch (100) shown in figs 2-6 shown to have a plurality of conductive connection points (225) (col 17, ln 8-13); the conductive pattern (1225) of the disposable patch (1200) and the conductive connection points (225) of the reusable patch (100) configured such that in an operative position the conductive connection points (225) of the reusable patch (100) are electrically connected to the conductive pattern (1225) such that one or more electrical components of the reusable patch (100) are electrically connected to the plurality of sensors (1202) of the disposable patch (1200) through the conductive pattern (1225) to receive sensor (1202) data (col 17, ln 33-40).
Trapero Martin does not disclose the disposable patch and reusable patch formed based on a particular user’s data to accommodate the individual, wherein the location of one or more of the plurality of sensors is based on the individual’s data.
However, Donaldson teaches a physiological sensor system including a plurality of sensors, wherein the sensor array is formed based on a particular user’s data to accommodate the individual (using a 3-D scanner to scan a body part and generated on a 2D surface), wherein the location of one or more of the plurality of sensors is based on the individual’s data (array of sensors is customized to fit unique dimensions of a user) (para [0268].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin so that disposable patch and reusable formed based on a particular user’s data to accommodate the individual by using a 3-D scanner to scan a body part and generating the patch based on the 3-D scan, wherein the location of one or more of the plurality of sensors is based on the individual’s data as taught by Donaldson in order to allow the sensors on the patch to be customized to fit unique dimensions of a user and to return to a same position on a user (Donaldson, para [0268]).
The now-modified Trapero Martin’s device does not disclose the device is configured to provide therapeutic treatment in response to sensor data, wherein the flexible material is configured as a therapeutic aid
However, Toth in fig 2a-c teaches a physiological monitoring system including a disposable patch (210) (patch) (para [0444]) and a reusable module (235) (module includes interconnects (240a, b) to removably mate with patch (para [0446]), and wherein the system includes an electrical stimulation component (para [0455]), wherein the module can include the electrical stimulation component (para [0304]), and wherein the electrical stimulation component comprises electrodes controlled by an output signal (2121), wherein the device is configured to receive sensor data (data from sensors (2117)) (para [0532]), and to provide therapeutic treatment (electrical stimulator can be used to stimulate one or more neural structures, nerves, and/or receptors such as near to or within a carotid sinus, a carotid body, a vagus nerve plexus, a baroreceptor, a chemoreceptor, a cutaneously innervated region of tissue, or the like located in the neck of the subject (para [0540] or to stimulate one or more neural structures in the abdominal region of the subject (para [0546])) in response to sensor data (2117) (2111 may be programmed with a control algorithm to control the output (2121) based upon sensor inputs (2117)) (para [0537]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the reusable patch with at least one electrode for contact with skin of a patient wherein the device is configured to receive sensor data, and to provide electrotherapy in response to the sensor data as taught by Toth in order to allow the device to stimulate one or more structures, such as in a neck or torso, in a user (Toth, para [0540]). The now-modified Trapero Martin’s device is considered to be configured so that the flexible material is configured as a therapeutic aid, as Trapero Martin discloses the flexible material aids in providing a stable and high-quality electrical connection to the user for the sensor electrodes (1202) (Trapero Martin, col 18, ln 8-12), and Toth discloses that the sensor data (2117) is used to provide outputs (2121) to provide electrotherapy (para [0537]), and therefore, the modified Trapero Martin’s flexible material is configured so that the flexible material is configured as a therapeutic aid to provide a stable and high quality electrical connection to the sensors, which is used to control outputs to provide therapy to a patient.
Regarding claim 2, Trapero Martin discloses at least one additional disposable patch for use with the reusable patch (100) (reusable patch (1200) is disposable and can come with different adhesive level options, and therefore includes at least one additional disposable patch with a different adhesive level option) (col 18, ln 18-29).
Regarding claim 3, Trapero Martin discloses the reusable patch (100) includes an intelligent control (206) (reusable patch includes a first PCB (206) includes a processor, CPU, etc. for performing calculations and controlling data) (col 7, ln 17-25).
Regarding claim 4, Trapero Martin discloses the reusable patch further includes a communications linkage (first PCB (206) in reusable patch (100) can include a near-field communication (NFC) module, a Bluetooth low energy (BLE) interface, and additional wireless communication interfaces/antenna modules) (col 7, ln 52-55).
Regarding claim 5, modified Trapero Martin discloses a reusable patch.
Modified Trapero Martin does not disclose the reusable patch further comprises at least one actuator.
However, Toth in fig 2a-c teaches a physiological monitoring system including a disposable patch (210) (patch) (para [0444]) and a reusable module (235) (module includes interconnects (240a, b) to removably mate with patch (para [0446]), and wherein the system includes an actuator (stimulatory component) such as a vibratory component (para [0455]), and wherein the actuator can be a piezoelectric material or a motor with an unbalanced shaft (para [0488]), and wherein the actuator is disposed in the module (paras [0304], [0488]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the reusable patch with an actuator comprising a piezo for vibration or a motor as taught by Toth in order to allow the device to communicate to the user as a form of alert, to determine a physiologic and/or physical parameter, and provide sensation to the subject (Toth, para [0304])
Regarding claim 6, Trapero Martin discloses the reusable patch (100) further comprises at least one sensor (reusable patch (100) includes a second PCB (208) can include one or more sensors) (col 7, ln 7-10), and bottom of reusable patch (100) can include a housing window whose shape can be determined by the disposition of sensors in the device (100)) (col 8, ln 65-col 9, ln 7).
Regarding claim 10, Trapero Martin disclose the disposable patch (1200) further comprises a sticky portion for securing to a surface (adhesive so that a second surface of the substrate can be affixed to the skin of the user) (col 17, ln 66-col 18, ln 1).
Regarding claim 11, Trapero Martin discloses the surface is human skin (col 17, ln 66-col 18, ln 1).
Regarding claim 12, modified Trapero Martin discloses a reusable patch.
Modified Trapero Martin does not disclose the reusable patch further comprises at least one actuator.
However, Toth in fig 2a-c teaches a physiological monitoring system including a disposable patch (210) (patch) (para [0444]) and a reusable module (235) (module includes interconnects (240a, b) to removably mate with patch (para [0446]), and wherein the system includes an actuator (stimulatory component) such as a vibratory component (para [0455]), and wherein the actuator can be a piezoelectric material or a motor with an unbalanced shaft (para [0488]), and wherein the actuator is disposed in the module (paras [0304], [0488]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the reusable patch with an actuator comprising a piezo for vibration or a motor as taught by Toth in order to allow the device to communicate to the user as a form of alert, to determine a physiologic and/or physical parameter, and provide sensation to the subject (Toth, para [0304])
Regarding claim 13, the modified Trapero Martin’s reference discloses the actuator is selected from a set consisting of a piezo for vibration and a motor (Toth, para [0488]).
Regarding claim 14, the modified Trapero Martin’s reference disclose at least one electrode (2121 of Toth) for contact with skin of a patient to provide electrotherapy (Toth, para [0540]).
Regarding claim 16, Trapero Martin discloses a software application executing on a computing device and configured for communicating with the reusable patch (100) using a wireless transceiver of the computing device (reusable patch (100) can include an NFC module for communicating with a software application (one or more applications) executing on a computing device (another device (e.g., a smartphone, tablet, or another computing device with supported NFC capabilities) (col 8, ln 3-14).
Regarding claim 17, Trapero Martin discloses the software application translates raw data from the reusable patch into quantifiable results for interpretation and display to a user (raw sensor data can be sent to other computing device (col 14, ln 65-66), and where data can be displayed or managed, and later on, the information might be sent to the cloud for storage and/or analysis (col 25, ln 5-8)).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero Martin, Donaldson, and Toth et al as applied to claim 1 above, and further in view of Cross et al (2008/0288026).
Regarding claim 7, modified Trapero Martin discloses a reusable patch that is removably connected to a disposable patch.
Modified Trapero Martin does not disclose the reusable patch further comprises an adhesive or sticky portion for connecting to the disposable patch.
However, Cross in fig 1 teaches a device including a reusable potion (10) (monitoring device) and a disposable patch (22), and wherein the reusable portion (10) is attached to the disposable patch (22) via a pressure sensitive adhesive (PSA) layer, wherein the reusable portion (10) includes a less aggressive easier to peel PSA layer to come cleanly off the reusable portion (10) so that it can be quickly cleaned and prepared for use for use with a new patch (para [0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the reusable patch with an adhesive or sticky portion comprising an easier to peel PSA layer for connecting to the disposable patch as taught by Cross in order to provide a means of securing the reusable patch to the disposable patch while allowing the reusable patch to be quickly cleaned and prepared for use with a new patch (Cross, para [0078]).
Claim(s) 8-9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero Martin, Donaldson, and Toth et al as applied to claims 1 and 16 above, and further in view of Silver et al (12,178,579).
Regarding claim 8, modified Trapero Martin discloses the disposable patch can be made of a skin-friendly material with biocompatible substrates to achieve a thin, flexible, and elastic patch to be attached to the user (col 18, ln 3-5) with adhesive options for a high-performance athlete (col 18, ln 18-21).
Modified Trapero Martin does not disclose the disposable patch comprises kinesiology tape.
However, Silver teaches a system including a sensor module (102) and a patch (104) (sensor base), wherein the patch (104) comprises kinesiology tape (col 9, ln 40-46).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the disposable patch to comprise kinesiology tape as taught by Silver in order to allow the disposable patch to have an elasticity along the lengthwise direction with no elasticity in the widthwise direction (Silver, col 9, ln 40-47).
Regarding claim 9, modified Trapero Martin discloses a disposable patch.
Modified Trapero Martin does not disclose a second disposable patch, the second disposable patch having a body different in size or shape from the disposable patch, and wherein the reusable patch is configured for use with the disposable patch and use with the second disposable patch.
However, Silver in figs 27-41 teaches a sensor device including a plurality of disposable patches (204, 304, 404, 504, 604, 704, 804) (sensor bases), wherein each of the disposable patches (204, 304, 404, 504, 604, 704, 804) have a body different in size or shape from the other disposable patches (disposable patches have a different shape or footprint to attach to different body parts, such as an elbow, knee, shoulder, or arm) (col 11, ln 13-col 12, ln 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing a second disposable patch, the second disposable patch having a body different in size or shape from the disposable patch, and wherein the reusable patch is configured for use with the disposable patch and use with the second disposable patch as taught by Silver in order to allow the reusable patch to be used with disposable patches with different footprints to conform to different body parts, such as an arm or shoulder of a user (Silver, col 9, ln 61-63, col 12, ln 5-13).
Regarding claim 18, modified Trapero Martin discloses a software application in communication with the reusable patch.
Modified Trapero Martin does not disclose the software application is configured to send data and commands to the reusable patch.
However, Silver teaches a system including a sensor module (102) and a patch (104) (sensor base) (col 9, ln 40-46), wherein the sensor module (102) includes a wireless transceiver (transceiver for wireless communications (not shown)) (col 10, ln 16-34), and wherein the sensor module (102) is configured to connect to a software application (app) executed on a computing device (smartphone), and wherein the software application is configured to send data and commands to the reusable patch (app provides for customization of the settings of the sensor, including sensitivity, and customization of alert attributes, such as intensity and duration) (col 14, ln 20-44).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Trapero Martin by configuring the software application to send data and commands to the reusable patch as taught by Silver in order to allow the software application to allow customization of the settings of the device, including sensor sensitivity, and customization of alert attributes, such as intensity and duration) (Silver, col 14, ln 36-39).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trapero Martin, Donaldson, and Toth et al as applied to claim 1 above, and further in view of Pai et al (2020/0101312).
Regarding claim 15, modified Trapero Martin discloses a reusable patch,
Modified Trapero Martin does not disclose the reusable patch further comprises a light source for providing light therapy.
However, Pai teaches a phototherapy device including a reusable portion (700) (phototherapeutic host) and a disposable patch (800) (patch module) (para [0043]), wherein the reusable portion (700) includes a light source (160) (lighting unit) for providing light therapy (para [0046]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Trapero Martin by providing the reusable patch with a light source for providing light therapy as taught by Pai in order to allow the reusable patch to perform phototherapy on a target acupuncture point of a user (Pai, para [0001]).
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues on page 8, second and third full paragraphs of applicant’s remarks, that claim 3 has been amended for further clarity and that the rejection should be withdrawn. However, the term “intelligent control” is known in the art to incorporate artificial intelligence, such as machine learning or neural networks, and therefore, it is unclear whether the limitation “intelligent control” is intended to incorporate artificial intelligence or not (it is noted that the originally filed disclosure does not appear to disclose an artificial intelligence, as the specification discloses that the intelligent control (36) can be a microprocessor or processor but does not disclose the processor is configured for artificial intelligence or machine learning). If the limitation “intelligent control” is not intended to require an artificial intelligence or machine learning algorithm, it is suggested to amend the claim by deleting the term “intelligent”. Therefore, the rejection is maintained.
Applicant argues on page 8, fourth full paragraph-page 9, first full paragraph of applicant’s remarks, that Trapero Martin does not disclose that the system has a disposable patch and a reusable patch formed based on a particular individual's data to accommodate the individual; and that the flexible material used to form the disposable patch is configured as a therapeutic aid; and that the reusable patch receives sensor data, and to provide therapeutic treatment in response to sensor data, wherein the physical location of one or more of the plurality of sensors is based on the individual's data. However, as discussed above, the feature of a disposable patch and a reusable patch formed based on a particular individual's data to accommodate the individual wherein the physical location of one or more of the plurality of sensors is based on the individual's data is taught by Donaldson, and the feature of a flexible material used to form the disposable patch is configured as a therapeutic aid; and that the reusable patch receives sensor data, and to provide therapeutic treatment in response to sensor data, wherein the physical location of one or more of the plurality of sensors is based on the individual's data is taught by Toth et al. Therefore, it would have been obvious to the skilled artisan, upon seeing the disclosures of Donaldson and Toth, to modify the device of Trapero Martin so that disposable patch and reusable formed based on a particular user’s data to accommodate the individual by using a 3-D scanner to scan a body part and generating the patch based on the 3-D scan, wherein the location of one or more of the plurality of sensors is based on the individual’s data as taught by Donaldson in order to allow the sensors on the patch to be customized to fit unique dimensions of a user and to return to a same position on a user (Donaldson, para [0268]); and to modify the device of modified Trapero Martin by providing the reusable patch with at least one electrode for contact with skin of a patient wherein the device is configured to receive sensor data, and to provide electrotherapy in response to the sensor data as taught by Toth in order to allow the device to stimulate one or more structures, such as in a neck or torso, in a user (Toth, para [0540]). Therefore, the rejection is maintained.
Applicant argues on page 9, third full paragraph-page 10, fourth full paragraph of applicant’s remarks, that because the prior art does not disclose the limitations of claim 1, the dependent claims are allowable for being depending on an allowable claim base. However, as discussed above, because modified Trapero Martin discloses the limitations of claim 1, the rejection of the dependent claims are maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785