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 .
Specification
The disclosure is objected to because of the following informalities: Specification paragraph 041 – the statement “The ‘drop’ indicates the addition of a conductive liquid to the device” appears to be intended for Fig. 18 instead of Fig. 19. Fig. 19 does not show or discuss a ‘drop’.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim requires an absorbent substrate and a cover substrate. In line 3, the limitation “said substrate further comprises at least one slit’, appears to be directed to the cover substrate; however, clarification of which substrate is needed. Appropriate correction is required.
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.
Claims 1, 4-6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyde US Patent Application Publication 2005/0107732.
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,
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 4, Boyd teaches the wound management system of claim 1, 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, 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, the cover substrate 14 is clear – where Boyd 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, Boyd teaches a method of dressing a wound, comprising applying to the wound the management system of claim 1 ((Fig. 2; para. 0014-0016).
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 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Boyde US Patent Application Publication 2005/0107732
As to claim 13, Boyde 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 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 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 does not teach the method of claim 13, wherein the surgical incision comprises a dental surgical incision. However, Boyde does teach the wound dressing can be used int 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.
Claims 2, 3, 7-11, and 15 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.
As to claim 2, Boyde teaches the present invention substantially as claimed. Boyde does not teach the absorbent substrate 39 comprises two or more biocompatible electrodes configured to generate 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 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 two or more biocompatible electrodes configured to generate a low level electric field for the benefits taught in Skiba.
As to claim 3, Boyde/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)
As to claim 7, Boyde teaches the present invention substantially as claimed. Boyde does not teach the wound management system further comprising a substrate comprises two or more biocompatible electrodes configured to generate 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 further teaches the wound system includes systems that can provide a low level electric filed (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 two or more biocompatible electrodes configured to generate a low level electric field for the benefits taught in Skiba.
As to claim 8, Boyde/Skiba teaches the wound management system of claim 7, wherein Boyde/Skiba teach 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. Skiba teaches the zinc and silver in an alternating electrodes 6, 10 in a basic pattern (Skiba Fig. 1; para. 0096).
As to claim 9, Boyd/Skiba teaches the wound management system of claim 1, 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 10, Boyd/Skiba teaches the third slit 28b joins the two substantially parallel slits 28a, 30a, 28c, 30c at about a 90 degree angle (Boyde Fig.1).
As to claim 11, Boyd/Skiba teaches the cover substrate 14 is clear – where Boyd teaches the flap constructed of a transparent material that would allow a status check of the dressing (Boyde Fig. 1; para. 0019).
As to claim 15, Boyde/Skiba teach a method of dressing a wound, comprising applying to the wound the management system of claim 7 (Skiba para. 0012, 0016, 0126).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Roberts USPN 6124520 and Roberts US Patent Application Publication 2002/0169405 are cited to show wound treatment systems with windows.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781