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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tunius (US 20130017246).
Regarding claim 1, Tunius discloses a multi-layer wound dressing assembly 10 (fig. 2), comprising: a carrier film 40 comprising a transparent material or a semi-transparent material (par. 0077, 0082, 0096-0100); and an adhesive layer 70 comprising a silicone-based material (par. 0055) and in contact with the carrier film (see fig. 2) and exhibiting a tackiness formulated and configured to decrease over a duration of time (par. 0077, 0099).
Regarding claim 2, Tunius discloses the tackiness of the adhesive layer decays over the duration of time (par. 0077, 0099).
Regarding claim 3, Tunius discloses the tackiness of the adhesive layer is reduced responsive to exposure to a solvent, moisture, heat, cooling, or ultraviolet light (par. 0077, 0099).
Regarding claim 4, Tunius discloses the adhesive layer defines one or more channels (one central channel defined by 70, see fig. 2).
Regarding claim 5, Tunius discloses the adhesive layer comprises one or more of: one or more materials configured to reduce scarring; one or more antibiotic materials; one or more antimicrobial materials; and one or more pain relief materials (par. 0083).
Regarding claim 9, Tunius discloses the carrier film is permeable (breathability properties that don’t block water transmission, par. 0076).
Regarding claim 10, Tunius discloses that the film is substantially impermeable (other than to water transmission, par. 0076).
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burton (US 6903243).
Regarding claim 14, Burton discloses a multi-layer wound dressing assembly (fig. 1B or C), comprising: a transparent (col. 4, ln. 1-12) carrier film 20; a transparent (col. 4, ln. 1-12) adhesive layer 22 on a side of the transparent carrier film (bottom side of 20 in fig. 1B and C); and one or more absorbent materials 24 on a side of the transparent adhesive layer opposite the transparent carrier film (see fig. 1B and C, adhesive layer 22 is between layer 20 and layer 24).
Regarding claim 20, Burton discloses a multi-layer wound dressing assembly (fig. 1B or C), comprising: one or more first absorbent materials 26; a first substantially transparent (col. 4, ln. 1-12) adhesive layer 30 overlying the one or more first absorbent materials (overlying the bottom side of 26, with intervening layer 28, in fig. 1B and C); a first substantially transparent (col. 4, ln. 1-12) carrier film 28 overlying the first substantially transparent adhesive layer (overlying the top side of 26 in fig. 1B and C); one or more second absorbent materials 24 overlying the first substantially transparent carrier firm (overlying the top side of 28, with intervening layer 26, in fig. 1B and C); a second substantially transparent (col. 4, ln. 1-12) adhesive layer 22 overlying the one or more second absorbent materials (overlying the top side of 24 in fig. 1B and C); and a second substantially transparent (col. 4, ln. 1-12) carrier film 20 overlying the second substantially transparent adhesive layer (overlying the top side of 22 in fig. 1B and C).
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.
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) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tunius in view of Johnston et al. (US 20020082540).
Regarding claims 6-8, Tunius discloses the assembly as claimed, except for an absorbent material on a side of the adhesive layer opposite the carrier film, contacting less than an entire surface of the side of the adhesive layer, with a horizontally central portion of the adhesive layer that is not in contact with the absorbent material. However, Johnston et al. teaches providing an absorbent material perimeter layer 34 between an adhesive layer 32 and the target site (Fig. 1a), the absorbent material shaped as a ring/perimeter so that the central portion of the adhesive layer 32 is free of the absorbent material (see fig. 1a). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide an absorbent material layer perimeter, as taught by Johnston et al., positioned as claimed beneath the adhesive layer 70 of Tunius, for the purpose of providing sufficient structure to enhance protection against lateral escape of fluid from beneath the dressing.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tunius in view of Utsugi (US 20040044299).
Regarding claim 11, Tunius discloses the assembly as claimed, except for one of the adhesive layer and carrier film comprise a material formulated and configured to exhibit a color change in response to exposure to an infection. However, Utsugi teaches providing either a backing layer or an adhesive layer with a chemical composition that changes color when bacteria grow in a wound (par. 0006-0010). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify one or more of the adhesive layer and the carrier film of Tunius to include a composition that changes color in response to infection, as taught by Utsugi, in order to provide sufficient structure to clearly indicate when a dressed wound has become infected in situations where frequent removal of the dressing for medical attention is not possible (par. 0003).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tunius in view of Burton.
Regarding claim 12, Tunius discloses the assembly as claimed, except for disclosing the adhesive layer comprises a transparent or semi-transparent material. However, Burton teaches a wound dressing comprising a variety of layers, including adhesive layers, which is transparent (col. 4, ln. 1-12). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a transparent adhesive layer in the Tunius assembly, as taught by Burton, for the purpose or providing an assembly that does not impede visualization of the wound site.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tunius in view of Doshi et al. (US 20160199230).
Regarding claim 13, Tunius discloses the system as claimed, except for the adhesive layer comprising a textured surface. However, Doshi et al. teaches providing an adhesive layer with a textured surface (par. 0171). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive layer of Tunius to include a textured surface, as taught by Doshi et al., for the purpose of enhancing bonding (par. 0171).
Claim(s) 14, 15, and 17-20 (claims 14 and 20 in the alternative to those rejections presented above) is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Johnston et al.
Regarding claims 14, in the alternative, and 15, Burton discloses a multi-layer wound dressing assembly (fig. 1B or C), comprising: a transparent (col. 4, ln. 1-12) carrier film 28; a transparent (col. 4, ln. 1-12) adhesive layer 30 on a side of the transparent carrier film, except for disclosing one or more absorbent materials on a side of the adhesive layer opposite the carrier film (claim 14) with a horizontally central portion of the adhesive layer being free of the one or more absorbent materials. However, Burton envisions modifying the layered structure disclosed in fig. 1B or C with additional layers (col. 4, ln. 43-50), and Johnston et al. teaches providing an absorbent material layer 34 between an adhesive layer 32 and the target site (Fig. 1a), the absorbent material shaped as a ring/perimeter so that the central portion of the adhesive layer 32 is free of the absorbent material (see fig. 1a). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide an absorbent material layer perimeter, as taught by Johnston et al., positioned as claimed beneath the adhesive layer 30 of Burton, for the purpose of providing sufficient structure to enhance protection against lateral escape of fluid from beneath the dressing.
Regarding claim 17, Burton discloses the transparent carrier film includes one or more perforations extending therethrough (col. 10, ln. 5-21).
Regarding claim 18, Burton discloses the entirety of the carrier film to include perforations (col. 10, ln. 5-21), which would include those sections bounded by the modified absorbent material as taught by Johnston et al. (see fig. 1a of Johnston et al.).
Regarding claim 19, Burton discloses one or more additional absorbent materials (24, 26) on a side of the transparent carrier film 28 opposite the transparent adhesive layer 30 (see fig. 1B or C); and an additional transparent (col. 4, ln. 1-12) adhesive layer 22 on a side of the one or more additional absorbent materials (24,26) opposite the transparent carrier film 28 (see fig. 1B or C).
Regarding claim 20, in the alternative, Burton discloses a multi-layer wound dressing assembly (fig. 1B or C) comprising: a first substantially transparent (col. 4, ln. 1-12) adhesive layer 30; a first substantially transparent (col. 4, ln. 1-12) carrier film 28 overlying the first substantially transparent adhesive layer; one or more second absorbent materials (24, 26) overlying the first substantially transparent carrier firm; a second substantially transparent (col. 4, ln. 1-12) adhesive layer 22 overlying the one or more second absorbent materials; and a second substantially transparent (col. 4, ln. 1-12) carrier film 20 overlying the second substantially transparent adhesive layer, except for one or more first absorbent materials, the first substantially transparent adhesive layer overlying the one or more first absorbent materials. However, Burton envisions modifying the layered structure disclosed in fig. 1B or C with additional layers (col. 4, ln. 43-50), and Johnston et al. teaches providing an absorbent material perimeter layer 34 between an adhesive layer 32 and the target site (Fig. 1a). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide an absorbent material layer perimeter, as taught by Johnston et al., positioned as claimed beneath the adhesive layer 30 of Burton, for the purpose of providing sufficient structure to enhance protection against lateral escape of fluid from beneath the dressing.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Doshi et al. and, in the alternative, over Burton in view of Johnston et al., and further in view of Doshi et al.
Regarding claim 16, Burton, or in the alternative Burton as modified by Johnston et al., discloses/teaches the claimed assembly except for a portion of the transparent adhesive layer in contact with the one or more absorbent materials is textured. However, Doshi et al. teaches providing an adhesive layer with a textured surface (par. 0171). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive layer of Burton, or in the alternative Burton in view of Johnston et al., to include a textured surface, as taught by Doshi et al., for the purpose of enhancing bonding (par. 0171).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783