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
Claims 1-11, 13-19, & 21 are pending, of which Claims 1-3, 5, 10-11, 14, 16, & 19 are amended. Claims 12 & 20 have been canceled in the Amendment filed on 10/22/2025. All pending claims are examined on the merits.
Response to Arguments
The indication of allowable subject matter set forth in the previous action is withdrawn and a new ground of rejection is set forth below.
Claim Objections
Claims 4, 11, 14 & 21 are objected to because of the following informalities:
Re Claims 4 & 11, Examiner notes references to “said bandage” whereas the remaining claims have already been amended to read “said one or more bandages.” Examiner encourages better consistency in claim terms.
Re Claim 14, there is subject-verb disagreement because "a bandage portion" is singular but the verb "have" is plural. For examination, Examiner changes "have" to "having."
Re Claim 21, while "the use of sensors" implies that the system includes sensors, such a recitation is not a positive recitation of sensors and may be interpreted as functional language. For examination, Examiner interprets Claim 21 to read " further comprising a sensor configured to detect and warn of vascular collapse or perfusion deficits in an affected area."
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1-11, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,912,679 in view of Bacon et al. (US 2016/0213521). The patented claim 1 recites the same limitations as current claims 1 & 3 except inserting one or more layers containing electrode pads and connectors for microcurrent delivery. Bacon discloses a wound dressing have a layer (100) that comprises electrodes (140a-d and 142 a-d) for delivering electrical stimulation to the skin surrounding a wound. It would have been obvious to one skilled in the art at the time of filing to modify with Bacon for improving wound healing. The patented claims 2-11 recite the limitations found in current claims 2, 4-11, & 13 respectively.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 17/171,485 in view of Bacon et al. (US 2016/0213521). Said copending claim 19 recites all of the limitations in current claim 14 except one or more layers containing electrode pads and connectors for microcurrent delivery. Bacon discloses a wound dressing have a layer (100) that comprises electrodes (140a-d and 142 a-d) for delivering electrical stimulation to the skin surrounding a wound. It would have been obvious to one skilled in the art at the time of filing to modify with Bacon for improving wound healing.
This is a provisional nonstatutory double patenting rejection.
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.
Claims 5 & 19 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.
Specifically, each of Claim 5 and 19 recites “present in said bandage portion or said foam layer …” It is noted that Claim 5 depends from Claim 4, which depends from Claim 1, but neither Claim 1 nor 4 recites a foam layer, therefore “said foam layer” lacks antecedent basis Similarly, Claim 19 now depends from Claim 17, which depends from Claim 14, and neither Claim 14 nor 17 recites a foam layer, therefore “said foam layer” lacks antecedent basis.
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 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.
Claims 1-3, 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Aali et al. (US 2010/0256545, note this Aali is different from that cited in the Non-Final Rejection of 4/10/2025) in view of Bacon et al. (US 2016/0213521) and Moore (US 2016/0136404).
Re Claim 1, Aali discloses a method of treating a wound, the method comprising:
applying (implied in Fig. 1A) one or more bandages (dressing 10 or 110) to cover an affected area containing at least one wound.
Aali does not disclose inserting one or more layers containing electrode pads and connectors for microcurrent delivery. Bacon discloses a wound dressing having a skin-contacting layer (100, Fig. 5), wherein said layer carries electrodes (snap components 140a-d and 142a-d), which are used in allowing electric currents to flow to the wound ([0040]). It would have been obvious to one skilled in the art at the time of filing to modify with Bacon for the benefit of accelerating wound healing.
Aali also does not disclose one or more straps for securing said one or more bandages to the affected area, said one or more straps having at least one inlet port for receiving a fluid or gas to apply pressure to said one or more straps for use as a tourniquet. Moore discloses a bag (620) for covering around a wound and supplying antiseptic solution to the wound (see Abstract), wherein the bag comprises straps (closing means 630 & 632) for securing the bag around the wound (Figs. 6-7). Moore further discloses that the straps may be an inflatable cuff (inflated via 480 & 490, see Fig. 4) such that it may be a tourniquet ([0018]). It would have been obvious to one skilled in the art at the time of filing to modify Aali with the inflatable straps taught in Moore because this can ensure fluid within the bandage portion does not leak out and it is well known that tourniquet can reduce bleeding, which would also allow the wound to start the healing process.
Re Claim 2, Aali, Bacon and Moore combine to disclose claim 1, but Aali and Bacon do not explicitly disclose wherein a portion of said one or more bandages further comprises of an amount of transparent material. Moore further discloses that the bag for covering the wound can be translucent or even fully transparent ([0052]-[0053]). It would have been obvious to one skilled in the art to further glean from Moore because this allows a caretaker to more easily assess the wound healing progress.
Re Claim 3, Aali, Bacon and Moore combine to disclose claim 1, Aali further discloses inserting an absorbent foam layer (wicking strip 30, [0044]) between said one or more bandages and the skin surrounding said affected area, wherein said foam layer assists in removing moisture from said affected area ([0044]) and elevates the bandage material of the said one or more bandages to prevent said one or more bandages from contacting the wound or the affected area (see Fig. 1B).
Re Claim 14, Aali discloses a bandage system for use in the treatment of wounds, the system comprising:
a bandage portion () have one or more ports (Fig. 10 where a port is necessary to allow tube 114 to deliver fluid into the wound).
Aali does not teach one or more layers containing electrode pads and connectors for microcurrent delivery connected to the perimeter of said bandage portion. Bacon discloses a wound dressing having a skin-contacting layer (100, Fig. 5), wherein said layer carries electrodes (snap components 140a-d and 142a-d), which are used in allowing electric currents to flow to the wound ([0040]). It would have been obvious to one skilled in the art at the time of filing to modify with Bacon for the benefit of accelerating wound healing.
Aali also does not teach one or more straps for securing said bandage portion and said one or more layers to the affected area, said one or more straps having at least one inlet port for receiving a fluid or gas to apply pressure to said one or more straps for use as a tourniquet. Moore discloses a bag (620) for covering around a wound and supplying antiseptic solution to the wound (see Abstract), wherein the bag comprises straps (closing means 630 & 632) for securing the bag around the wound (Figs. 6-7). Moore further discloses that the straps may be an inflatable cuff (inflated via 480 & 490, see Fig. 4) such that it may be a tourniquet ([0018]). It would have been obvious to one skilled in the art at the time of filing to modify Aali with the inflatable straps taught in Moore because this can ensure fluid within the bandage portion does not leak out and it is well known that tourniquet can reduce bleeding, which would also allow the wound to start the healing process.
Re Claim 15, the limitation is taught by the combination of references as explained in Claim 2 supra.
Re Claim 16, Aali, Bacon and Moore combine to disclose claim 14. Aali also discloses a foam layer (support cushion 111), said foam layer having one or more inlets or ports (Fig. 10 showing a port allowing tube 114 to enter and deliver fluids to the wound) for supplying one or more treatment gasses, one or more medicaments ([0093]), a vacuum, a pressure, or combinations thereof.
Re Claim 17, Aali, Bacon and Moore combine to disclose claim 14. Aali also discloses one or more inlets (where tube 114 passes through support cushion 111, Fig. 10) or ports for supplying one or more treatment gasses, one or more medicaments ([0093]), a vacuum to a portion of the bandage portion, a pressure to a portion of the bandage portion, or combinations thereof.
Re Claim 18, Aali, Bacon and Moore combine to disclose claim 14, and Aali further discloses a dermal adhesive for adhering the system to the skin around a wound (e.g., [0017]).
Claims 4-9, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aali, Bacon and Moore as applied to claim 1 above, and further in view of Quisenberry et al. (US 2007/0282249).
Re Claim 4, Aali, Bacon and Moore combine to disclose claim 1, but none discloses providing a flow of one or more treatment gasses to said one or more bandages. Aali instead discloses delivery of fluids such as antibiotics or washing fluid into the dressing ([0093]) so as to improve wound healing. Quisenberry teaches a wound treatment method of providing a dressing (see e.g. Figs. 4 & 5) elevated above a wound surface by a frame (adhesive strips 119, [0037] "having a thickness on the order of 1/8 inch"), wherein the method further comprises flowing a treatment gas (see at least Abstract) into the space bounded by the wound and the dressing. It would have been obvious to one skilled in the art at the time of filing to modify Aali with the method of flowing a treatment gas to the bandage so as to further improve healing of a large wound (e.g. [0006] in Quisenberry).
Re Claim 5, after the modification as explained for claim 4, Quisenberry also teaches that wherein said treatment gas is supplied (oxygenation gas line 24, see Figs. 4 & 5) through the bandage to the affected area using one or more ports (at least Fig. 6) which are present in said bandage or said foam layer, said port forming a leak-proof bond (implied because the space between the wound the dressing is sealed) to said bandage or said foam layer to prevent the introduction of outside contamination, or leakage of fluids, gas, or otherwise from the affected area.
Re Claim 6, after the modification as explained for claim 4, Quisenberry also teaches that the one or more treatment gasses is any inert gas, oxygen (at least Title), ozone, air, nitrogen, a carrier gas, or a combination thereof.
Re Claim 7-9, after the modification as explained for claim 4, Quisenberry also teaches that wherein the temperature of the treatment gas is monitored and controlled (at least [0019]- [0020]), in that said treatment gas is heated to a temperature greater than 102 degrees Fahrenheit for a first period of time (at least end of [0019]) and is cooled to a temperature less than 94 degrees Fahrenheit for a second period of time (at least [0020]).
Claims 10-11 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aali and Bacon as applied to claim 3 above, and further in view of Pace (US 2003/0212357).
Re Claim 10, Aali, Bacon and Moore teach the method of claim 3 but does not teach providing a medicament, a steroid, an antibiotic, a pain treatment, a therapeutic agent, or combinations thereof using one or more ports which are present in said one or more bandages or said foam layer. Pace teaches that medicaments such as antibiotic can be supplied to the wound with or without oxygen ([0028]), thus implying that such a medicament is supplied through the same port that oxygen is supplied through.
Re Claims 11 & 19, Aali, Bacon & Moore teach the method of claim 3 or 17 but does not teach connecting an outlet tube by using one or more ports which are present in said one or more bandages, said ports forming a leak-proof bond to said one or more bandages or said foam layer to prevent the introduction of outside contamination, or leakage of fluids, gas, or otherwise from the affected area, to assist with fluid drainage from the wound area and absorbent material. Pace teaches a wound treatment method using negative pressure, wherein a drainage/suction tube (e.g. 54, Fig. 2) is connected to a dressing via a port (52 in Fig. 2) to assist fluid drainage from the wound area. It is implied that the port would be leak-proof since it is necessary to generate a suction in the sealed wound area (at least [0031]) and it is further disclosed that the wound area is being controlled to achieve a desired reduced pressure ([0011]) and thus a leak would make it difficult to obtain the desired reduced pressure. It would have been obvious to one skilled in the art at the time of filing to modify Aali with the suction/drainage tube and port of Pace to help improve healing of a large wound since it is well known that negative pressure can enhance healing in large wounds.
Claims 13 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Aali and Bacon as applied to claim 1 or 14 above, and further in view of Weston (US 2011/0060204).
Re Claims 13 & 21, Aali, Bacon and Moore teach the method of claim 1 or 14 but none teaches using sensors to detect and warn of vascular collapse or perfusion deficits in the affected area. Weston teaches a wound treatment method using negative pressure through a dressing to treat a large wound as well as providing sensor(s) to monitor the perfusion of red blood cells into or adjacent to the wound site ([0107]). It would have been obvious to one skilled in the art at the time of filing to modify Aali with Weston for the benefit of having a good gauge of how well the wound is healing.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
3 March 2026