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 Arguments
Status of claims – Claims 3 and 7-11 are canceled. New claims 16-21 have been added. Claims 1, 2, 4-6, and 12-21 are pending.
Applicant’s arguments with respect to claims 1, 4-6, and 12-15 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1, 2, 4-6, and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Boyde US Patent Application Publication 2005/0107732 in view of Skiba US Patent Application Publication 2016/0058999 and further in view of Horng WO 2005/055924.
As to claim 1, Boyde teaches a wound management system 10 comprising;
an absorbent substrate 39 (Boyde Fig. 2; para. 0020); and
a cover substrate (flap) 14 shaped to fit over the absorbent substrate 39
Boyde teaches the present invention substantially as claimed. Boyde does not teach the absorbent substrate 39 comprises one of biocompatible zinc electrodes or biocompatible silver electrodes; and a silver gel solution or a zinc gel solution to be applied to the absorbent substrate. Skiba teaches a wound dressing having biocompatible electrodes on a surface, for example a fabric (Skiba para. 0030). Skiba teaches the surface can comprise a gauze or mesh for use in absorbent textiles, foams, foam-based materials, or cellulose-based materials, all of which form absorbent substrates (Skiba para. 0030).
Boyde/Skiba do not teach a silver gel solution or a zinc gel solution to be applied to the absorbent substrate. Horng WO 2005/055927 teaches a hydrogel useful as cavity-filling wound dressings, and conductive electrodes (Horng Abstract). Horng teaches applying a gel to a substrate (page 9, lines 26-27). Horng teaches the gels are flexible and transparent or translucent and may be used alone or with various additives (page 5, lines 13-15). One of the additives taught in Horng is silver sulfadiazine (page 8, line 26), and also teaches the gel may contain a bactericide such as silver or copper compounds (page 8, line 33 through page 9, line 2). Horng further teaches the gels are biocompatible, able to conform to a wound cavity, non-adhere to the wound, can absorb exudates, removable in one piece from the wound and hold its physical integrity when swollen with exudates and provide comparative ease in handling (page 9, lines 15-18). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the wound management system of Boyde/Skiba for the benefits taught in Horng.
As to claim 2, Boyde/Skiba/Horng teach the wound management system of claim 1, wherein the absorbent substrate comprises biocompatible zinc electrodes, then the application of the silver gel solution results in the generation of at least one of a low level electric field (LLEF) or low level electric current (LLEC). Skiba teaches a wound dressing having biocompatible electrodes on a surface, for example a fabric (Skiba para. 0030). Skiba teaches the surface can comprise a gauze or mesh for use in absorbent textiles, foams, foam-based materials, or cellulose-based materials, all of which form absorbent substrates (Skiba para. 0030). Skiba teaches at least one electrode is silver and at least one electrode is zinc (Skiba para. 0078). Skiba teaches embodiments of LLEF or LLMC comprises electrodes that include a conductive metal, i.e. silver and zinc (para. 0070). Skiba teaches a preferred material to use in combination with silver is zinc. Additionally, zinc has been well-described for its uses in prevention of infection in topical antibacterial agents. Skiba teaches zinc is a divalent cation with antibacterial properties of its own in addition to possessing the added benefit of being a cofactor to proteins of the metallorproteinase family of enzymes important to the phagocytic debridement and remodeling phases of wound healing. Skiba teaches as a cofactor, zinc promotes and accelerates the functional activity of these enzymes, resulting in better more efficient wound healing (para. 0079). Skiba teaches the zinc and silver in an alternating electrodes 6, 10 in a basic pattern (Skiba Fig. 1; para. 0096).
Skiba further teaches the wound system includes systems that can provide a low level electric field (LLEF) to a tissue or organism (thus a “LLEF system”) or, when brought into contact with an electrically conducting material, can provide a low level micro-current (LLMC) to a tissue or organism (thus a “LLMC system”) (Skiba para. 0028). Skiba teaches treating a wound can include covering the wound with a LLMC or LLEF system. Skiba teaches embodiments that can promote wound healing by directing cell migration during the wound healing process (Skiba para. 0126). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Boyde with biocompatible silver or zinc electrodes configured to generate a low level electric field for the benefits taught in Skiba.
As to claim 4, Boyde/Skiba/Horng teaches the wound management system of claim 16, wherein the at least one slit 26 forms comprises two substantially parallel slits 28a, 30a, 28c, 30c that are joined at their ends by a third slit 28b, 30b (Boyde Fig. 1; para. 0017).
As to claim 5, Boyde/Skiba/Horng teaches the wound management system of claim 4, wherein the third slit 28b, 30b joins the two substantially parallel slits 28a, 30a, 28c, 30c at about a 90 degree angle (Boyde Fig.1).
As to claim 6, Boyde/Skiba/Horng teaches the wound management system of claim 4, wherein the cover substrate 14 is clear – where Boyde teaches the flap is constructed of a transparent material that would allow a status check of the dressing (Boyde Fig. 1; para. 0019).
As to claim 12, Boyde/Skiba/Horng teaches a method of dressing a wound, comprising applying to the wound the management system of claim 1 (Boyde Fig. 2; para. 0014-0016).
As to claim 13, Boyde/Skiba/Horng teaches the present invention substantially as claimed. Boyde does not teach the method of claim 12, wherein the wound comprises a surgical incision. However, Boyde/Skiba/Horng teaches the frame 12 may embody any suitable shape (Boyde para. 0017), the absorbent dressing 39 may be reproduced in several different sizes and shapes to accommodate a wide range of dressing choices for a particular application (Boyde para. 0020), and the wound dressing retainer 10 can assume other non-explicitly described dimensions that may be better suited for a particular application of wound dressing retainer 10 (Boyde para. 0017). Since Boyde/Skiba/Horng teaches a wound dressing for covering and treating a wound bed on various parts of the body (Boyde para. 0006 0009), it would have been obvious to provide a wound dressing sized and shaped for a surgical incision. A modification or the disclosure of a specific size and shape does not patentably distinguish the claimed invention from the prior art. One having ordinary skill in the art before the invention was originally filed would be able to determine through routine experimentation the ideal size and shape of the wound dressing to be effective for a surgical incision.
As to claim 14, Boyde/Skiba/Horng does not teach the method of claim 13, wherein the surgical incision comprises a dental surgical incision. However, Boyde/Skiba/Horng does teach the wound dressing can be used in in any moisture prone bodily area (Boyde para. 0009), which includes the mouth. Based on the teachings of Boyde, it would have been obvious to one having ordinary skill in the art to use the wound dressing in a mouth for a dental surgical incision.
As to claim 15, Boyde/Skiba/Horng teach a method of dressing a wound, comprising applying to the wound the management system of claim 1 (Skiba para. 0012, 0016, 0126).
As to claim 16, Boyde/Skiba/Horng teaches the wound management system of claim 1, wherein the cover substrate 14 further comprising a perimeter comprising an adhesive - where Boyde teaches the sealing element 16 for the substrate 14 can alternatively comprise a reusable adhesive (Boyde para. 0019) or an adhesive tape (Boyde para. 0026). The substrate (cover substrate) further comprises at least one slit 26, 28c, 30c forming a flap 14 within the perimeter sufficient to allow access to the absorbent substrate (Boyde para. 0009, 0018).
As to claim 17, Boyde/Skiba/Horng teaches the method of claim 12, wherein the method further comprises:
(i)applying the silver gel solution to the absorbent substrate comprising biocompatible zinc electrodes; or
(ii) applying the zinc gel solution to the absorbent substrate comprising biocompatible silver electrodes – where Skiba teaches a wound dressing having biocompatible electrodes on a surface, for example a fabric (Skiba para. 0030). Skiba teaches the surface can comprise a gauze or mesh for use in absorbent textiles, foams, foam-based materials, or cellulose-based materials, all of which form absorbent substrates (Skiba para. 0030). Skiba teaches at least one electrode is silver and at least one electrode is zinc (Skiba para. 0078). Horng teaches applying a gel to a substrate (page 9, lines 26-27). Horng teaches the gel may comprise silver compounds as a bactericide (page 8, line 33 through page 9, line 2).
As to claim 18, Boyde/Skiba/Horng teaches the wound management system of claim 1, wherein LLEF is between 0.05 and 5 volts (Skiba para. 0081).
As to claim 19, Boyde/Skiba/Horng teaches the wound management system of claim 1, wherein the LLMC is between 1 and 200 micro-amperes (Skiba para. 0084).
As to claim 20, Boyde/Skiba/Horng teaches the wound management system of claim 1, wherein the cover substrate 14 comprises a pliable material – where Boyde teaches the frame 12 is desirably constructed of a soft or semi-rigid, but flexible and elastic material. Boyde also teaches the flap 14 (cover) is constructed of a bendable plastic material, such as thin vinyl sheet (Boyde Figs. 1 and 2; para. 0019).
As to claim 21, Boyde/Skiba/Horng do not specifically teach the absorbent substrate comprises a pliable material. However, Boyde teaches the dressing 39 may be reproduced in several different sizes and shapes to accommodate a wide range of dressing choices for a particular application (Boyde para. 0020). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide a pliable material for the absorbent substrate so the substrate can conform to the frame opening.
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 JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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