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 .
Response to Amendment
This office action is responsive to the amendment filed on 03/23/2026. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-21 are presently pending in this application, with claims 18-21 being withdrawn from consideration. Applicant’s amendments to the drawings, specification, and claims have overcome each and every objection and 112(b) rejections set forth in the Non-Final Office Action mailed on 12/23/2025. The 112(a) rejection has been maintained.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 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:
Regarding claim 1, the phrase “a therapeutic agent disposed in of the wound dressing” in lines 7-8 should read “a therapeutic agent disposed in ,
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites “a lower tissue-contacting layer non-detachable from the upper layer” in line 6, and this limitation is new matter. Applicant points to para. 0028 of the spec. for support for the amendment which states that “a direct connection between first and the second entities can be non-detachable, for example, through the use of chemical adhesives or weldment.” This paragraph is provided as general definitions for terms used therein and does not contain any subject matter limiting it to the relationship between the upper layer and lower tissue-contacting layer. Therefore, paragraph 0028 nor any other part of the disclosure provides written description support for the lower tissue-contacting layer being non-detachable from the upper layer.
Regarding claims 2-17, these claims are rejected due to their dependency upon claim 1.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Papay et al. (U.S Patent Pub. No. 20130178785 A1, “Papay”).
Regarding claim 1, Papay discloses (Claim 1) a system (10 in Fig. 1C) for healing a wound (12) of a subject in need thereof (see Fig. 1A-3B and para.0035), the system (10) comprising:
a wound dressing (14) comprising:
an upper layer (28 and 48) comprising a porous material (48) covered by an outer film (28) defining a vacuum port (port of 28, see Fig. 1C and para. 0035, 0038, and 0050 – second end 104 of vacuum line 100 is connected at a port in film 28 to fluidly communicate with porous material 48);
a lower tissue-contacting layer (30) non-detachable from the upper layer (28, 48, see Fig. 1C and para.0035 and 0038 – lower surface 30 is non-detachable from the upper surface 28 and first porous material 48);
a therapeutic agent disposed in of the wound dressing (14, see Fig. 1C and para. 0045 – the therapeutic agent is disposed within channel 60 from therapeutic agent source 76);
and at least one electrode (54) in the wound dressing (14) and in electrical communication with the therapeutic agent (see Fig. 1C and 3A-3B and para. 0041);
a controller (20) in electrical communication with the at least one electrode (54, see para. 0051 – power source 20 is being interpreted as a controller as it provides electrical signals for controlling the activation of the at least one electrodes 54),
a vacuum (98) configured to generate negative pressure within the porous material (48, see Fig. 1C and para. 0050); and
a fluid line (100) having one end (102) connected to the vacuum port (port of 28) and another end (104) connected to the vacuum (98, see Fig. 1C and para. 0050).
Regarding claim 2, Papay discloses (Claim 2) the system (10) of claim 1, wherein the therapeutic agent is in ionic form (see para. 0057).
Regarding claim 3, Papay discloses (Claim 3) the system (10) of claim 1, wherein the lower tissue-contacting layer (30) contains the therapeutic agent in ionic form and wherein the at least one electrode (54) overlies the lower tissue-contacting layer (30, see Fig. 1C and para. 0057 for ionic limitation, see Fig. 2B and para. 0037 – bottom surface 30 forms a portion of flexible body 14 to assist in containing the therapeutic agent within flexible body 14 formed by surfaces 28 and 30, further bottom surface 30 comprises outputs ports 44 for the therapeutic agent to move through and therefore, contains the therapeutic agent when it moves through ports 44).
Regarding claim 4, Papay discloses (Claim 4) the system of claim 1, wherein the wound dressing further comprises an intermediate layer (54) between the upper layer (28 and 48) and the lower tissue-contacting layer (30, see Fig. 1C – electrode 54 is interpreted as the intermediate layer).
Regarding claim 5, Papay discloses (Claim 5) the system (10) of claim 4, wherein the lower tissue-contacting layer (30) contains the therapeutic agent and the intermediate layer (54) comprises the at least one electrode (54, see Fig. 2B and para. 0037 - bottom surface 30 forms a portion of flexible body 14 to assist in containing the therapeutic agent within flexible body 14 formed by surfaces 28 and 30, further bottom surface 30 comprises outputs ports 44 for the therapeutic agent to move through and therefore, contains the therapeutic agent when it moves through ports 44, see Fig. 1C – electrode 54 is interpreted as the intermediate layer).
Regarding claim 10, examiner notes the limitations of claim 10 are directed towards the at least one capacitor of the limitation “the wound dressing comprising at least one electrode or at least one capacitor” which is being interpreted as an optional limitation of claim 1. Therefore, claim 10 is rejected along with the parent claim 1.
Regarding claim 11, Papay discloses (Claim 11) the system (10) of claim 1, wherein the at least one electrode (54) is a plurality of electrodes (see Fig. 3A and para. 0041).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Papay in view of Holladay et al. (U.S Patent No. 6328728 B1, “Holladay”) in view of Johnson et al. (U.S Patent No. 5978701, “Johnson”).
Regarding claim 6, Papay discloses the system of claim 4, as discussed above.
However, Papay fails to disclose (Claim 6) wherein the intermediate layer comprises a porous dielectric barrier layer overlying the lower tissue-contacting layer.
Holladay discloses an electro-transport device for transdermal delivery of drugs to the human body. Holladay teaches the limitations (Claim 6) wherein the intermediate layer (12, 14, and upper portion of 20) comprises a dielectric barrier layer (20) overlying the lower tissue-contacting layer (28, 16, 18, and lower portion of 20, see Fig. 1 and annotated Holladay drawing 1 below and Col.11, lines 54-67 – the device 10 may comprise an insulator 20 that extends between the two electrodes 12 and 14 and longitudinally through the intermediate layer comprising the electrodes 12,14 and through the lower-tissue contacting layer comprising reservoirs 16,18 and adhesives 28 such that the upper portion overlies the tissue contacting layer, insulator 20 may operate as an insulating barrier between the electrodes 12 and 14 and be comprised of
insulating materials such as polyisobutylene or ethylene vinyl acetates both of which are dielectric materials).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intermediate layer taught by Papay to incorporate an insulator between the electrodes as taught by Holladay such that upon incorporating the two oppositely charged electrodes of Holladay, the insulator prevents electrical short circuiting, is formed form a material that is hydrophobic to prevent any transfer of ions or electronics, and capable of strong bonding to the surface below for structural integrity (see Col.11,lines 54-67).
However, modified Papay fails to disclose the limitation of (Claim 6) a porous dielectric barrier layer.
Johnson discloses an iontophoresis device comprising a control unit having a dielectric foam layer for insulating two electrodes. Johnson teaches (Claim 6) a porous dielectric barrier layer (434, see Fig. 9 and Col. 19, lines 19, 1-13 and Col.20, lines 24-33 – device 400 may comprise a drug unit 401 and a controller 414, the controller 414 employing a capacitor which couples to skin contacting electrodes and a reservoir in the drug unit 401, the capacitor is formed from a coupling electrode 440 and grounding electrode 430 which are insulated by a wall 434, the wall 434 may be made of a closed cell dielectric foam with a chosen thickness and area). Examiner notes the teachings of the controller forming a capacitor having a dielectric insulating wall are applicable to the claim limitations of insulating two oppositely charged electrodes using a dielectric layer.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dielectric layer taught by modified Papay to be formed as a closed cell foam as taught by Johnson such that the foam can cover a larger surface area between the two electrodes to provide insulation (see Col.20, lines 24-33).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Papay in view of Flick et al. (U.S Patent Pub. No. 20060264796 A1, “Flick”).
Regarding claim 8, Papay discloses the system of claim 1, as discussed above. However, Papay fails to disclose (Claim 8) wherein the at least one electrode is an electrically conductive polymer foam.
Flick discloses a medical device with a conductive layer and an absorbent layer bathed in a medicament to treat a wound using iontophoresis (see 0022 and para. 0138). Flick teaches (Claim 8) wherein the at least one electrode (114) is an electrically conductive polymer foam (see para. 0042 – in a preferred embodiment of the medical device, the conductive layer may comprise a polymeric foam structure indicating that the polymeric foam is electrically conductive, see Fig. 13 and para. 0109 – conductive layer 114 is being interpreted as the least one electrode as it is electrically conductive).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one electrode taught by Papay to be in the form of an electrically conductive polymer foam as taught by Flick. The motivation for an electrically conductive polymer foam to form the at least one electrode is that foam electrodes can cover a larger surface area and allow for fluids to move within the channels of the foam while trapping or storing other substances (see para. 0042).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Papay in view of Hu et al. (U.S Patent Pub. No. 20100228205, “Hu”).
Regarding claim 9, Papay discloses the system of claim 1, as discussed above. However, Papay fails to disclose (Claim 9) further comprising an electroactive polymer disposed in the wound dressing that expands when an electrical stimulus is applied thereto.
Hu discloses a negative pressure therapy device with a skin patch layer attached to a suction device for wound healing. Hu teaches (Claim 9) further comprising an electroactive polymer disposed in the wound dressing that expands when an electrical stimulus is applied thereto (see para. 0179 – the wound dressing construction may have an integrated suction generating element in the form of an electroactive polymer that expand or contract upon application of voltage).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction system taught by Papay to be substituted with an electroactive polymer as taught by Hu such that a suction generating element can be directly integrated into the wound dressing construction to provide an additional production of reduced pressure to enhance wound healing that provides the patient freedom and mobility while using the device (see para. 0179, 0060, and 0002).
Claim(s) 12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Papay in view of Shokoueinejad Maragheh et al. (U.S Patent Pub. No. 20160015962 A1, “Shoko”)
Regarding claim 12, Papay discloses the system of claim 1, as discussed above. However, Papay fails to disclose (Claim 12) further comprising a sensor configured to sense a physiological parameter associated with the wound and generate a sensor signal based on the physiological parameter.
Shoko discloses a wound dressing comprising sensors and electrical stimulation to a targeted site on a patient. Shoko teaches (Claim 12) further comprising a sensor (30) configured to sense a physiological parameter associated with the wound and generator a sensor signal based on the physiological parameter (see Fig. 2 and para. 0026-0032 – patch 10 may accommodate one or more various medical sensors 30 that may be pH sensors, moisture sensors, or biosensors to monitor physiological parameters associated with the wound and send the information to the controller 28).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound healing system taught by Papay to have medical sensors as taught by Shoko to accelerate the wound healing process by providing adaptable and controlled electrical stimulation, monitor the healing process for signs of infection, and provide a system for relaying the information wirelessly to a central location for storage and interpretation by a physician and to enable the physician to control the operation (see para. 0007).
Regarding claim 14, modified Papay discloses the sensors of claim 12, as discussed above. In modified Papay, Shoko discloses (Claim 14) wherein the sensor (30) is a temperature, pH, blood oxygen saturation level, pressure, light, or impedance sensor (see Fig. 2 and para. 0026-0032 – patch 10 may accommodate one or more various medical sensors 30 that may be pH sensors, sensors capable of measuring temperature on the wound area, sensors capable of measuring ratio of oxygenated to deoxygenated wound area, sensors capable of measuring impedance of the tissue, etc).
Regarding claim 15, modified Papay discloses the sensors of claim 12, as discussed above. In modified Papay, Shoko discloses (Claim 15) wherein the sensor (30) is disposed in the wound dressing (10, see Fig. 2).
Regarding claim 16, Papay discloses the system of claim 1, as discussed above. However, Papay fails to disclose (Claim 16) further comprising an ultrasound emitter, a light emitter, a cold plasma emitter, or a shock wave emitter disposed in the wound dressing or in a component in communication with the wound dressing.
Shoko teaches (Claim 16) further comprising a light emitter (32) disposed in the wound dressing (10, see Fig. 2 and para. 0017-0018 – patch 10 may further comprise an LED array 32 as a light source).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound healing system taught by Papay to have a light source as taught by Shoko to accelerate the wound healing process by providing adaptable and controlled light exposure and electrical stimulation as phototherapy and electrical stimulation are effective methods of treating wounds and reducing pain (see para. 0003 and 0007).
Regarding claim 17, modified Papay discloses the light emitter of claim 16, as discussed above. However, modified Papay fails to disclose (Claim 17) further comprising a dormant sensor disposed in the wound dressing that is activated by the respective ultrasound emitter, light emitter, cold plasma emitter, or shock wave emitter.
Shoko teaches (Claim 17) further comprising a dormant sensor (30) disposed in the wound dressing (10) that is activated by the respective light emitter (32, see para. 0032 – one of the sensors 30 may be a passive sensor such as a photodiode sensor that monitor light emission of the LED array 32, examiner notes a passive sensor detects and measure energy only when naturally available and therefore a passive photodiode sensor would lie dormant until light emission became available from the LED array 32).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound healing system taught by Papay to have a dormant sensors in communication with the light emitter as taught by Shoko to provide a system for closed-loop feedback of light emission, temperature, or heat generated by the light emitter to allow for relaying the information wirelessly to a central location for storage and interpretation by a physician and to enable the physician to control the operation (see para. 0007).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable Papay in view of Shoko, as applied to claim 12 above, and further in view of Holladay.
Regarding claim 13, modified Papay discloses the system of claim 12, as discussed above. However, modified Papay fails to disclose (Claim 13) wherein the controller is in communication with the sensor and programmed to generate a drive signal to automatically control activation of the at least one electrode or parameters of the electrical field delivered by the at least one electrode to heal the subject's wound in response to the sensor signal.
Shoko teaches (Claim 13) wherein the controller (28) is in communication with the sensor (30) and programmed to generate a drive signal to automatically control activation to heal the subject’s wound in response to the sensor signal (see para. 0026 – controller 28 is in communication with sensors 30 to receive the sensed information, assess the state of the wound, and change the light dosages from the LEDS 32 to treat the infection).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound healing system taught by Papay to have medical sensors in communication with the controller as taught by Shoko to accelerate the wound healing process by providing adaptable and controlled electrical stimulation, monitor the healing process for signs of infection, and provide a system for relaying the information wirelessly to a central location for storage and interpretation by a physician and to enable the physician to control the operation (see para. 0007).
However, modified Papay fails to disclose automatically controlling activation of the at least one electrode or parameters of the electrical field delivered by the at least one electrode.
Holladay teaches (Claim 13) wherein the controller (24) is in communication with the sensor and programmed to generate a drive signal to automatically control activation of the at least one electrode (12,14) or parameters of the electrical field delivered by the at least one electrode to heal the subject’s wound in response to the sensor signal (see Fig. 1 and Col.12, lines 5-37 – device 10 may further comprise a current generating and control circuitry layer 24 which includes one or more batteries and electronic circuitry for controlling the delivered current from the batteries to the electrodes 12 and 14 as a function of time, layer 24 may further comprise a biosensor in communication with the control circuitry that monitors biosignals and provides feedback to the control circuitry to adjust the current accordingly).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors, electrodes, and controller taught by modified Papay to be in a closed feedback loop as taught by Holladay such that in addition to controlling phototherapy to the wound based on feedback from the sensors, the controller can adjust the electrical stimulation and thus the drug delivery of the patch based on feedback (see Col.12, lines 5-37).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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