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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/22/2026 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 4/22/2026. Claim 1 has been amended. No claims were canceled or newly added.
Response to Arguments
Applicant’s response with respect to the art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities: there are grammatical mistakes within the claim. In line 29, it appears “of the energy” should read “of the energy source”.
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 1, 15, 21, 30, 32-34, 43-44, 52, 54, 59 and 61-62 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.
Claim 1, lines 27-28 recite the term “the conductive reference electrode”. It is unclear whether the term “the conductive reference electrode” is referring to “a conductive reference node” in lines 14-15 or a different conductive reference electrode altogether. For the purposes of examination, it will be interpreted as being the same conductive reference node.
8. Claims 15, 21, 30, 32-34, 43-44, 52, 54, 59 and 61-62 are rejected at least because they depend from a claim(s) which is indefinite.
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.
Claims 1, 15, 30, 32-34, 43-44, 52, 54, 59, and 61-62 are rejected under 35 U.S.C 103 as being unpatentable over Prakash et al. (International Publication No.: WO 2018/075893 A1 – Previously Cited) and further in view of Bergelin et al. (US Pub.: 2016/0081580 A1) and further in view of Alexander et al. (NPL reference, “Research Techniques Made Simple: Transepidermal Water Loss Measurement…”, published November, 2018 – Previously Cited).
Regarding claim 1, Prakash teaches an electroceutical dressing (e.g. Figs.
2A, 2B, 2F – antimicrobial dressing 100) comprising:
a substrate having two sides (e.g. Figs. 2A, 2B, 2F – substrate 104; paragraph 0046),
wherein one of the sides is a wound-facing side and a second side opposite the wound-facing side (e.g. paragraph 0046);
a first electrode (e.g. Figs. 2B, 2F – cathode 108) positioned on the wound-facing side of the substrate (104), wherein the first electrode (108) is configured to be in at least partial contact with a wound when the electroceutical dressing (100) is placed on the wound (e.g. paragraphs 0045-0046; 0055);
a second electrode (e.g. Figs. 2B, 2F – anode 106) positioned on the wound-facing side of the substrate (104), wherein the second electrode (106) is configured to be in at least partial contact with the wound when the electroceutical dressing is placed on the wound (e.g. paragraphs 0045-0046; 0055);
a third electrode (e.g. Fig. 2F – electrode 214; paragraph 0056) positioned on the wound-facing side of the substrate (104), wherein the third electrode (214) is configured to be in at least partial contact with the wound when the electroceutical dressing is placed on the wound (e.g. paragraphs 0045-0046; 0056);
wherein the first electrode (108) comprises a conductive cathode (e.g. paragraph 0045),
the second electrode (106) comprises a conductive anode (e.g. paragraph 0045),
and an energy source having a positive terminal and a negative terminal (e.g. Figs. 2B, 2F – energy source 110),
wherein the positive terminal is configured to connect to one of the conductive anode and/or the conductive cathode, and the negative terminal is configured to connect to an other of the conductive cathode and/or the conductive anode when the electroceutical dressing is placed on the wound (e.g. paragraphs 0045-0046), wherein when connected to the conductive anode and the conductive cathode the energy source induces an electrical current to flow from the conductive cathode, through the wound, and to the conductive anode (e.g. paragraphs 0045-0046; 0056); and the third electrode (214) is not electrically connected to either the positive terminal or the negative terminal of the energy (e.g. paragraph 0056).
However, Prakash does not explicitly teach that the third electrode comprises a conductive reference node; and the conductive reference electrode is not electrically connected to either the positive terminal or the negative terminal of the energy; and a plurality of sensors integrated into the electroceutical dressing, wherein the plurality of sensors comprise a transepidermal water loss probe, an electrical impedance sensor, and an eddy current sensor, wherein a change in sensed electrical characteristics of the electrical impedance sensor and the eddy current sensor are used to estimate healing of the wound, wherein measurements obtained from the transepidermal water loss probe verify a restoration of a skin barrier function and also serve as a measure of validation of measurements obtained from the electrical impedance sensor and the eddy current sensor.
Bergelin, in a same field of endeavor of wound healing systems, discloses a conductive reference node (e.g. Fig. 1 – impedance reference electrode 1; Fig. 2 – perforation 13; paragraph 0051); and the conductive reference electrode is not electrically connected to either the positive terminal or the negative terminal of the energy (e.g. paragraph 0051).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electroceutical dressing of Prakash to incorporate a conductive reference node as well as the conductive reference electrode is not electrically connected to either the positive terminal or the negative terminal of the energy, as taught and suggested by Bergelin, in order to provide the predictable results of having a reference signal for impedance measurements which is also used to provide a mapping of the wound (Bergelin, paragraph 0054).
However, Prakash in view of Bergelin does not explicitly teach a plurality of sensors integrated into the electroceutical dressing, wherein the plurality of sensors comprise a transepidermal water loss probe, an electrical impedance sensor, and an eddy current sensor, wherein a change in sensed electrical characteristics of the electrical impedance sensor and the eddy current sensor are used to estimate healing of the wound, wherein measurements obtained from the transepidermal water loss probe verify a restoration of a skin barrier function and also serve as a measure of validation of measurements obtained from the electrical impedance sensor and the eddy current sensor.
Prakash in another embodiment further teaches a plurality of sensors integrated into the electroceutical dressing, wherein the plurality of sensors comprise an electrical impedance sensor, and an eddy current sensor, wherein a change in sensed electrical characteristics of the electrical impedance sensor and the eddy current sensor are used to estimate healing of the wound (e.g. paragraph 0061, – electrical impedance sensor, eddy current sensor).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash and Bergelin to incorporate an eddy current sensor and electrical impedance sensor, as taught and suggested by another embodiment of Prakash, for the purpose of having quantified measurements to detect/measure wound healing (Prakash, paragraph 0061).
However, Prakash in view of Bergelin does not explicitly teach a transepidermal water loss probe, wherein measurements obtained from the transepidermal water loss probe verify a restoration of a skin barrier function and also serve as a measure of validation of measurements obtained from the electrical impedance sensor and the eddy current sensor.
Alexander, in a same field of sensors/devices for assessing skin health, discloses a transepidermal water loss probe (e.g. pg. 1).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash and Bergelin to incorporate a transepidermal water loss probe, as taught and suggested by Alexander, because transepidermal water loss is a widely used objective measurement for assessing the barrier function of the skin and thus providing indication of skin health (Alexander, pg. 1).
With regards to the limitations of “wherein measurements obtained from the transepidermal water loss probe verify a restoration of a skin barrier function and also serve as a measure of validation of measurements obtained from the electrical impedance sensor and the eddy current sensor”, the Examiner notes that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus (see MPEP 2114 – Section II). The combination of Prakash, Bergelin, and Alexander teach a transepidermal water loss probe, eddy current sensor, and electrical impedance sensor which all give measurements. Thus, the references would be capable of being employed in this manner if desired.
Regarding claim 15, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein a change in electrical characteristics of the energy source and/or the three or more electrodes over time is used to estimate healing (e.g. paragraph 0061, – additionally, this limitation contains functional language (see MPEP 2114) and is intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation), wherein a change in electrical characteristics of the energy source and/or the three or more electrodes includes a change in resistance and/or impedance between any two of the electrodes, and/or a change in current and/or voltage of the energy source (e.g. paragraph 0061).
Regarding claim 30, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein the conductive anode is larger than the conductive cathode (e.g. paragraphs 0011, 0051).
Regarding claim 32, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 30 as discussed above, and Prakash further teaches wherein the conductive anode is conformed to a shape such that it substantially covers the wound (e.g. paragraphs 0011, 0051).
Regarding claim 33, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein a size and shape of the electroceutical dressing is determined by at least one of wound size, wound shape, and location of the wound (e.g. paragraphs 0026, 0051).
Regarding claim 34, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein a size and shape of at least one of the conductive anode and the conductive cathode is determined by at least one of wound size, wound shape, and location of the wound (e.g. paragraphs 0011, 0051).
Regarding claim 43, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein the energy source comprises at least two electrodes in a spaced pattern on an insulating substrate (e.g. paragraph 0024, 0030) and the at least two electrodes are comprised of a biocompatible reduction/oxidation reaction materials such that a voltage differential is created between the at least two electrodes (e.g. paragraphs 0024, 0030 – additionally, this limitation contains functional language (see MPEP 2114) and is intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 44, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 43 as discussed above, and Prakash further teaches wherein the energy source comprises a plurality of electrodes in a spaced pattern on the insulating substrate wherein a first subset of the plurality of electrodes are connected in electrical series and a second set of the plurality of electrodes are connected in a separate electrical series (e.g. paragraphs 0014, 0030) and the plurality of electrodes are comprised of a biocompatible reduction/oxidation reaction material (e.g. paragraphs 0014, 0030) such that a voltage differential is created between the first subset of the plurality of electrodes connected in electrical series and the second subset of the plurality of electrodes connected in electrical series (e.g. paragraphs 0014, 0030 – additionally, this limitation contains functional language (see MPEP 2114) and is intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 52, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash in another embodiment further teaches further comprising a barrier that substantially covers the second side of the substrate (e.g. paragraphs 0017, 0057), said barrier configured to maintain a desired moisture level of the wound (e.g. paragraphs 0017, 0057).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash, Bergelin, and Alexander to include a barrier that substantially covers the second side of the substrate, as taught and suggested by another embodiment of Prakash, for the purpose of limiting the evaporation of moisture from the substrate and/or the wound surface and to prevent outside moisture from entering the wound (Prakash, paragraph 0057).
Regarding claim 54, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash in another embodiment further teaches further comprising a current-limiting element (e.g. paragraphs 0018, 0032), wherein the current limiting element limits the electrical current flowing through the wound to a desired range (e.g. paragraphs 0018, 0032).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash, Bergelin, and Alexander to include a current-limiting element, as taught and suggested by another embodiment of Prakash, for the purpose of better controlling the level of current in order to avoid unacceptable levels of heating caused by the electrical current flow (Prakash, paragraph 0018).
Regarding claim 59, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash in another embodiment further teaches further comprising a voltage indicator (e.g. paragraphs 0019, 0061), wherein the voltage indicator indicates voltage being provided by the energy source (e.g. paragraphs 0019, 0061), and/or a current indicator (e.g. paragraphs 0019, 0061), wherein the current indicator indicates a presence and/or a magnitude of the electrical current flowing through the wound (e.g. paragraphs 0019, 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash, Bergelin, and Alexander to include a voltage indicator and/or a current indicator, as taught and suggested by another embodiment of Prakash, in order to provide the predictable results of a user/clinician being able to determine/confirm the presence/amount of voltage/current during treatment (Prakash, paragraph 0061).
Regarding claim 61, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches wherein at least one of the three or more electrodes are comprised of a biocompatible reduction/oxidation reaction material (e.g. paragraphs 0014, 0030).
Regarding claim 62, Prakash in view of Bergelin in view of Alexander teaches the electroceutical dressing of claim 61 as discussed above, and Prakash further teaches wherein the electrical current flowing through the wound inhibits formation of a biofilm within the wound (e.g. paragraphs 0021, 0023), at least partially disrupts a biofilm growing within the wound, at least partially destroys sessile bacteria within the wound, and/or at least partially destroys planktonic bacteria within the wound (e.g. paragraphs 0021, 0023).
Claim 21 is rejected under 35 U.S.C 103 as being unpatentable over Prakash and further in view of Bergelin and further in view of Alexander and further in view of Smola et al. (European Publication No.: EP 3040086 A1 – Previously Cited).
Regarding claim 21, Prakash in view of Bergelin in view of Alexander teaches
the electroceutical dressing of claim 1 as discussed above, and Prakash further teaches further comprising an insulating material (e.g. paragraph 0024), wherein the energy source is substantially insulated from at least one of the conductive anode and the conductive cathode using the insulating material (e.g. paragraph 0024).
However, Prakash in view of Bergelin in view of Alexander does not explicitly teach wherein the insulating material is substantially an electrical insulator when in its solid form but when moistened forms an electrically-conductive solution, wherein the insulating material comprises NaCl, KCl, sugar, glucose, or any other material that presents electrically isolating properties in the solid phase and upon exposure to a solvent dissolves entirely or in-part to generate an electrically conducting solution.
Smola, in a same field of endeavor of wound healing systems, discloses the use of NaCl (sodium chloride) in a layer of the wound healing system (e.g. paragraph 0066, – additionally this limitation contains functional language (see MPEP 2114) and is intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Prakash, Bergelin, and Alexander to incorporate a layer of NaCl, as taught and suggested by Smola, in order to provide the predictable results of improved wound healing (Smola, paragraph 0066).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights