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 .
Status of Claims
Applicant's arguments, filed 04/01/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/01/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1 and 3.
Applicants have left claims 2 and 4 as originally filed/previously presented.
Claims 5-7 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/12/2025.
Claims 1-4 are the current claims hereby under examination.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 4 of Remarks, filed 04/01/2026, with respect to claims 1 and 3 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objection of claims 1 and 3 have been withdrawn.
Claim Rejections - 35 USC § 103 - Maintained
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 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.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al. (US 20200100711 A1) (previously cited), hereinafter referred to as Choudhury, in view of Aizenberg et al. (US 20150209198 A1) (previously cited), hereinafter referred to as Aizenbeg, in view of Wang et al. (US 20170325724 A1) (previously cited), hereinafter referred to as Wang, in view of Ochoa et al. (“Flexible Sensors for Chronic Wound Management”) (cited in the IDS filed 10/10/2024) (previously cited), hereinafter referred to as Ochoa.
The claims are generally directed towards a device comprising: a bandage comprising a first surface with an adhesive layer configured to face healthy skin or wounded tissue and a second surface on an opposite side of the first surface, wherein the adhesive layer has openings; a sensor comprising a porous, omniphobic pad on which are printed two or more electrodes between which is dropcasted a PANi-EB/Ag comprising a polyaniline-emeraldine base and silver microflake composite film, wherein the sensor is placed on the adhesive layer of the bandage and measures a pH of a wound exudate using an impedance; an absorbent pad, which has been placed on the sensor; and a detachable potentiostat comprising an electrochemical sensing application chip and an impedance analyzer chip to perform electrochemical measurements and impedance spectroscopy, respectively, a microcontroller, a battery, and a communication module, wherein the detachable potentiostat is interfaced through the openings of the adhesive layer with the sensor for detecting and monitoring a wound condition.
Regarding claim 1, Choudhury discloses a device (Abstract, “sensor system …”, Fig. 2A-2B, Fig. 3A-3B, para. [0016]) comprising:
a bandage comprising a first surface with an adhesive layer configured to face healthy skin or wounded tissue and a second surface on an opposite side of the first surface, wherein the adhesive layer has openings (Fig. 2A-2B, “front side”, “back side”, Fig. 3A, para. [0094], “wound care platform … adhesive vinyl sheet, bandage …”, para. [0107], “patch applied on the skin …”);
a sensor comprising printed two or more electrodes (Fig. 2A-2B, Fig. 3A-3B, Fig. 31, para. [0075], “working electrode, a reference electrode and a counter electrode”, para. [0102-0104], para. [0143-0144], “flexible sensors were prepared by screen printing the electrodes …”), between which is dropcasted a polyaniline and silver microflake composite film (para. [0082], “PANI”, para. [0084-0085], “metal nano-materials … metal catalysts … silver …”, para. [0121], “polymer (polyaniline) … based matrix …”), wherein the sensor is placed on the adhesive layer of the bandage (Fig. 2A-2B, para. [0102-0107], “integrated on a fabric-based material … integrated on dressing materials … on a bandage …”) and measures a pH of a wound exudate (para. [0019], “measures both a biomarker as well as pH …”, para. [0095], para. [0210]);
an absorbent pad, which has been placed on the sensor (Fig. 2A-2B, para. [0102-0107], “integrated on dressing materials … flexible fabric-based material such as gauze, bandages, or dressing materials …”); and
a detachable potentiostat comprising an electrochemical sensing application chip and an impedance analyzer chip to perform electrochemical measurements and impedance spectroscopy, respectively, a microcontroller, a battery, and a communication module (Fig. 31, para. [0097], “reusable …”, para. [0211], “wearable platform … miniaturized potentiostat and a microcontroller, integrated with a low power Bluetooth for wireless data transmission … battery …”), wherein the detachable potentiostat is interfaced through the openings of the adhesive layer with the sensor for detecting and monitoring a wound condition (Fig. 2A-2B, Fig. 31, para. [0211], “all three electrodes have been connected to corresponding pins of the AFE, linked to the microcontroller …”).
However, Choudhury does not explicitly disclose the sensor comprises a porous, omniphobic pad on which the electrodes are printed on.
Aizenberg teaches an analogous device for wound dressings (para. [0009]). Aizenberg further teaches the use of a porous, omniphobic pad for wound dressings (para. [0100], para. [0171]). 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 sensor disclosed by Choudhury to additionally include a porous, omniphobic pad on which the electrodes are printed on, as taught by Aizenberg. This is because Aizenberg teaches omniphobic surfaces allow for bacteria to be repelled (para. [0100]) and allows for drainage of exudate fluid (para. [0118]), which one of ordinary skill in the art would recognize as being beneficial for wound monitoring to prevent the harboring of bacteria within the dressing.
However, modified Choudhury does not explicitly disclose PANi-EB comprising a polyaniline-emeraldine base composite film.
Wang teaches of an analogous bandage device for measuring a pH of a wound exudate (Abstract, Fig. 1A-1B, para. [0004]). Wang further teaches utilizing PANi-EB comprising a polyaniline-emeraldine base composite film for monitoring pH (para. [0281-0282]). 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 PANi/Ag composite film taught by modified Choudhury to explicitly be a PANi-EB comprising polyaniline-emeraldine base composite film, as taught by Wang. This is because Wang teaches PANi-EB is a known and suitable polymer for monitoring pH, and is beneficial due to the reversable emeraldine salt(ES0-emeraldine base (EB) transition (para. [0282]).
However, modified Choudhury does not explicitly disclose the sensor measures the pH using an impedance.
Ochoa teaches an analogous device comprising a bandage for monitoring a wound condition (Abstract). Ochoa further teaches measuring the pH using an impedance (pg. 79, “Flexible pH sensors”, right col., para. 3”). 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 sensors disclosed by modified Choudhury to measure the pH using an impedance, as taught by Ochoa. This is because Ochoa teaches pH sensing using impedance can easily be incorporated into wound dressings, as compared to traditional pH meters (pg. 79, “Flexible pH sensors”).
Regarding claim 2, modified Choudhury discloses the device of claim 1, wherein the wound condition to be monitored comprises a bacterial infection (para. [0119], “wound status and infection …”, para. [0188], “bacterial toxicity”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al. (US 20200100711 A1) (previously cited), hereinafter referred to as Choudhury, in view of Aizenberg et al. (US 20150209198 A1) (previously cited), hereinafter referred to as Aizenbeg, in view of Wang et al. (US 20170325724 A1) (previously cited), hereinafter referred to as Wang, in view of Ochoa et al. (“Flexible Sensors for Chronic Wound Management”) (cited in the IDS filed 10/10/2024) (previously cited), hereinafter referred to as Ochoa as applied to claim 1 above, and further in view of Glavan et al. (“Rapid fabrication of pressure-driven open-channel microfluidic devices in omniphobic RF paper”) (cited in the IDS filed 10/10/2024) (previously cited), hereinafter referred to as Glavan.
Regarding claim 3, modified Choudhury discloses the device of claim 1.
However, modified Choudhury does not explicitly disclose wherein the porous, omniphobic pad is chemically modified pad by treating the porous pad with RSiCl3 fluorinated alkyltrichlorosilane.
Glavan teaches of an analogous porous, omniphobic pad (Abstract, pg. 2922-2923, “Introduction”). Glavan further teaches the omniphobic pad is treated with fluorinated alkyltrichlorosilane (Abstract, pg. 2923, “Choices of materials”, left col., para. 2). 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 porous, omniphobic pad taught by modified Choudhury to explicitly be chemically modified by treating the porous pad with RSiCl3 fluorinated alkyltrichlorosilane, as taught by Glavan. This is because Glavan teaches treating the pad with fluorinated alkyltrichlorosilane is known and easy method, due to no specialized equipment, for providing the hydrophobic properties of omniphobic pads (pg. 2923, “Choices of materials”, left col., para. 2), while also preserving the mechanical properties of the paper (Abstract).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al. (US 20200100711 A1) (previously cited), hereinafter referred to as Choudhury, in view of Aizenberg et al. (US 20150209198 A1) (previously cited), hereinafter referred to as Aizenbeg, in view of Wang et al. (US 20170325724 A1) (previously cited), hereinafter referred to as Wang, in view of Ochoa et al. (“Flexible Sensors for Chronic Wound Management”) (cited in the IDS filed 10/10/2024) (previously cited), hereinafter referred to as Ochoa as applied to claim 1 above, and further in view of Futashima et al. (US 20200305746 A1) (previously cited), hereinafter referred to as Futashima.
Regarding claim 4, modified Choudhury discloses the device of claim 1.
However, modified Choudhury does not explicitly disclose wherein the silver in the PANi-EB/Ag composite film has a particle size of 2-5 µm.
Futashima teaches an analogous device including a sensor with two or more electrodes (Abstract, para. [0048]). Futashima teaches the electrodes include a silver coating layer to achieve electrical conduction (para. [0059]). Futashima further teaches the silver coating includes silver microflakes with a particle size of 2-5 µm (para. [0080]). 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 silver microflakes taught by modified Chowdhury to explicitly have a particle size of 2-5 µm, as taught by Futashima. This is because Futashima teaches a particle size of 2-5 µm is a suitable size for allowing uniform distribution, while also providing conductivity of the electrode (para. [0101]).
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not persuasive.
Applicants have argued on page 5 of Remarks, filed 04/01/2026, and within the Declaration under 37 C.F.R. 1.130(b) (hereinafter referred to as “Declaration”), filed 04/01/2026, attempting to disqualify the relied-upon subject matter of Choudhury as prior art under 35 USC 102(a)(2).
The Examiner respectfully disagrees. #4 of the Declaration attempts to show the Inventor-originated disclosure (“Pal”) discloses the same subject matter as Choudhury. However, MPEP 2154.02(b) recites “The subject matter in the prior disclosure being relied upon under AIA 35 U.S.C. 102(a) must be the same "subject matter" as the subject matter previously publicly disclosed by the inventor for the exceptions in AIA 35 U.S.C. 102(b)(1)(B) and 102(b)(2)(B) to apply. The exceptions in AIA 35 U.S.C. 102(b)(1)(B) and 102(b)(2)(B) do not apply even if the only differences between the subject matter in the prior art disclosure that is relied upon under AIA 35 U.S.C. 102(a) and the subject matter previously publicly disclosed by the inventor are mere insubstantial changes, or only trivial or obvious variations.” (emphasis added).
The subject matter of Pal and the subject matter of Choudhury are clearly different (i.e., they are not identical). While Pal and Choudhury utilize similar things, such as using a bandage, electrodes, absorbent pads, and circuitry, the “subject matter” is not the same, or identical. The 102(b)(2)(B) exception does not apply even in view of mere insubstantial changes or trivial variations. Choudhury is therefore not disqualified as prior art. The rejection is maintained as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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