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 .
Receipt is acknowledged of Amendments, Remarks and an IDS filed on 12/04/25. Claims 6 and 18-19 have been amended, no new claims have been added and no claims have been canceled. Accordingly, claims 1-20 remain pending and under examination on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 09/23/22. It is noted, however, that applicant has not filed a certified copy of the priority application as required by 37 CFR 1.55.
Information Disclosure Statement
The new IDS filed on 12/04/25 has been considered and signed.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
Claim 19 is 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.
Claim 19 is indefinite for reciting “or another adhesive”. This renders the claim indefinite because it is not clear what is encompassed by “other adhesive”. That is, the limitation of “other adhesive” fails as being a particular and distinct subject matter. This is in addition to the fact that the Specification does not provide support for ALL known adhesives encompassed by this recitation.
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.
(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.
Claims 1-5, 13, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by CN 211512310.
CN ‘310 teaches dressing for observing the wound condition, which comprises a protective film, a gel layer attached to the protective film on one side, a acryl glue layer attached to the gel layer on the other side, and a transparent film attached to the acryl glue layer on one side, wherein the protective film is a tearable part, the gel layer, the acryl glue layer and the transparent film are all made of transparent materials, the gel layer is provided with a first vent hole, the acryl glue layer is provided with a second vent hole, the transparent film comprises a left side film arranged on the left side, a right side film arranged on the right side, and adhesive films attached to the left side film and the right side film, an acryl glue layer exposed area is formed between the left side film and the right side film, the two sides of the adhesive film are provided with first adhesive strips, the right side of the left side film and the left side of the right side film are provided with second adhesive strips, the first adhesive strip and the second adhesive strip are matched with each other (See abstract).
Regarding claim 1, CN ‘310 discloses a medical dressing with the same function as the medical dressing recited in claim 1, i.e. capable of observing wound conditions. In the first embodiment depicted in Figure 1 and discussed in para [0018]-[0019], the medical dressing of CN ‘310 expressly includes: (1) a silicone gel layer 2 with one bottom surface facing the wound, which is configured to contact skin after removing the tearable protective film 1; (2) a hydrogel layer 4 attached to the upper surface of the silicone gel layer 2, and (1) the upper portion of the silicone gel layer 2 or the bottom portion of the acryl gel layer 6 is the support layer supporting hydrogel material, or (ii) the upper portion or the bottom portion of the hydrogel layer can be interpreted as support layer; (3) an acryl gel layer 6 (corresponding to the adhesive layer) attached to the upper surface of the hydrogel layer 4; (4) a transparent film (corresponding to the top film) with one wound facing surface attached to the acryl gel layer 6; and (5) the gel layer (including silicone gel layer 2 and the hydrogel layer 4), the acryl gel layer 6 and the transparent film are all made of transparent materials.
Regarding claim 2, CN ‘310 further discloses a protective film 1 attached to the wound-facing surface of silicone gel layer 2, and the hydrogel layer 4 is attached to another surface of silicone gel layer 2, such that the protective film 1 is opposite to the hydrogel layer 4, see Figure 1 and para [0018]- [0019].
Regarding claim 3, CN ‘310 further discloses that the protective film 1 is made of polyethylene material, see para [0021].
Regarding claim 4, para [0007] of CN ‘310 recites that the hydrogel layer can absorb wound fluids and thus it is disclosed that the hydrogel layer is able to swell and expand. Para [0018] of CN ‘310 recites that a first vent hole 3 is formed in the gel layer, and a second vent hole 5 is formed in the acryl gel layer 6. Para [0020] of CN ‘310 recites that the first vent hole 3 is communicated with the second vent hole 5, and the gel layer is communicated with the leakage area of the acrylic adhesive layer 6 through the first vent hole 3 and the second vent hole 5. As described above, (1) the upper portion of the silicone gel layer 2 or the bottom portion of the acryl gel layer 6 is the support layer, or (ii) the upper portion or the bottom portion of the hydrogel layer can be interpreted as support layer. Thus, the vent holes 3/5 are the recesses configured to receive hydrogel as it expands, and the surfaces of the support layers contacting hydrogel material are textured surfaces.
Regarding claim 5, the vent holes 3/5 recited in CN ‘310 are the pores of the support layers, and thus CN ‘310 discloses that the support layer is a porous material.
Regarding claim 13, CN ‘310 discloses that the hydrogel layer 4 is made of acrylamide hydrogel material, see para [0022].
Regarding claim 15, as discussed above, (i) the upper portion of the silicone gel layer 2 is the first support layer and then the bottom portion of the acryl gel layer 6 is the second support layer; or (2) the upper portion of the hydrogel layer is the first support layer and then the bottom portion of the hydrogel layer is the second support layer, and in both situations the second support layer is positioned opposite the first support layer.
Regarding claim 16, para [0018] of CN ‘310 recites that a first vent hole 3 (corresponding to the plurality of openings of claim 16) is formed in the gel layer. Para [0020] of CN ‘310 recites that the first vent hole 3 is communicated with the second vent hole 5, and the gel layer is communicated with the leakage area of the acrylic adhesive layer 6 through the first vent hole 3 and the second vent hole 5. Para [0025] of CN ‘310 recites that the hydrogel absorbs the wound surface seepage. Thus, CN ‘310 discloses that the hydrogel layer is in fluid communication with a wound under the silicone gel layer.
Regarding claim 18, para [0025] recites that acryl gel layer is biocompatible and is to bond the materials. Para [0018] recites that acryl gel layer is provided between the hydrogel layer 4 and the transparent film. Thus, CN ‘310 discloses that the adhesive layer is made of a biocompatible material and is used to bond the hydrogel layer and the transparent film.
Regarding claim 20, para [0018] of CN ‘310 recites that the transparent film comprises a left side film 7, right side film 11 and adhesive film 10, any of the films can be interpreted as the single layer top film, and Para [0021] of CN ‘310 further discloses that the transparent film is made of polyurethane material.
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Fig. 1.
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 1-13, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over CN 211512310 in combination with CN 113116634.
Teachings of CN ‘310 are delineated above and incorporated herein.
CN ‘310 lacks a specific disclosure on some features of the disclosed medical dressing including, support layer being a thin-film polymer, a woven or non-woven fabric, including an antibacterial agent and the silicone layer comprising a plurality of openings. These are well known in the art as taught by CN ‘634.
CN ‘634 teach a wound dressing combined with functional modules, which sequentially comprises a wound contact unit, an absorption unit and a backing unit from near to far from a wound; the wound contact element comprises at least one wound contact layer in direct contact with the wound; the absorption unit sequentially comprises a distribution layer for guiding wound fluid and an absorption core for absorbing the wound fluid according to the distance from the wound to the wound from near to far; the backing unit is made of breathable and waterproof materials. The wound dressing can select wound contacting unit, absorption unit and backing unit materials and combinations according to different types of wounds, different exudates and the condition of whether infected bleeding exists, and has better effects of seepage, infection resistance and wound moistening (See abstract).
Regarding claim 1, the medical dressing of ‘634 expressly includes: (1) a silicone gel layer 32, for example, see embodiment 3 depicted in Fig. 3 and discussed in para [0066]-[0069]; (2) a hydrogel layer (the combination of the polymer film layer 31, distribution layer 23 and absorption core 22 is corresponding to the hydrogel layer, wherein the polymer film layer 31 and distribution layer 23 are corresponding to the support layers and the absorption core 22 made of hydrogel, see Fig. 3 and para [0043], [0069]- [0070]); (3) an adhesive layer to adhere the absorption core 22 and backing unit 1, see para [0029]; and (4) backing unit 1 (corresponding to the top film), see Fig. 3 and para [0071].
Regarding claim 2, ‘634 discloses that the medical dressing further comprises a protective layer attached to a skin-facing surface of the silicone gel layer, opposite the hydrogel layer. For example, embodiment 3, Fig. 3, and para [0067] of ‘634 recites that the medical dressing includes a release film 4 which is opposite the hydrogel layer 22, wherein the release film 4 is corresponding to the protective layer.
Regarding claim 3, ‘634 discloses that the protective layer is made of silicone-coated release paper. For example, embodiment 3 and para [0068] of ‘634 recites that the release film 4 adopts glassine release paper. It is common knowledge of the skilled in the art that the glassine release paper is a kind of silicone-coated release paper.
Regarding claim 4, ‘634 discloses that the support layer includes a textured surface in contact with the hydrogel material including one or more recesses configured to receive hydrogel as it expands. For example, para [0027] recites that the material of the distribution layer 23 can be various woven, knitted, braided, or non-woven fabrics. It is common general knowledge of the skilled in the art that the woven, knitted, braided, or non-woven fabrics have a textured surface with recesses which can receive hydrogel as it expands.
Regarding claim 5, ‘634 discloses that the support layer is a porous material. As discussed above, according to Fig. 3 and para [0069]- [0070], the polymer film layer 31 and distribution layer 23 are corresponding to the support layer. Further, para [0027] recites that the material of the distribution layer 23 can be various woven, knitted, braided, or non-woven fabrics, preferably non-woven fabrics. And non-woven fabrics have the advantage of high porosity, i.e., non-woven fabrics are porous material.
Regarding claim 6, ‘634 discloses that the support layer is a thin-film polymer. As discussed above, according to Fig. 3 and para [0069]- [0070], the thin polymer film layer 31 and distribution layer 23 are corresponding to the support layer.
Regarding claim 7, ‘634 discloses that the support layer is a woven fabric. As discussed above, according to Fig. 3 and para [0069]- [0070], the polymer film layer 31 and distribution layer 23 are corresponding to the support layer. Further, para [0027] recites that the material of the distribution layer 23 can be woven fabrics.
Regarding claim 8, ‘634 discloses that the support layer is a nonwoven fabric. As discussed above, according to Fig. 3 and para [0069]- [0070], the polymer film layer 31 and distribution layer 23 are corresponding to the support layer. Further, para [0027] recites that the material of the distribution layer 23 can be non-woven fabrics.
Regarding claim 9, ‘634 discloses that hydrogel includes an antibacterial agent, see para [0043] and [0046]. Para [0043] recites that absorption core 22 is made of hydrogel, and para [0046] recites that the absorption core 22 also can be added with antibacterial component.
Regarding claim 10, ‘634 discloses that the antibacterial agent is provided as a surface coating on the hydrogel material, see para [0046]-[0047]. Para [0046] recites that the absorption core 22 also can be added with antibacterial component, antibacterial component is silver ion compound. And para [0047] recites that the silver-containing ion fibers can also be arranged as a layer structure near the distribution layer 23.
Regarding claim 11, ‘634 discloses that the antibacterial agent is mixed into the hydrogel material, see para [0046]. Para [0046] recites that the absorption core 22 also can be added with antibacterial component, antibacterial component is a silver ion compound. The silver ions in the absorption core 22 can be brought to the wound area through very few exudates, that is, the silver ions are mixed into the absorption core 22.
Regarding claim 12, ‘634 discloses that the antibacterial agent is nano silver, see para [0046].
Regarding claim 15, ‘634 discloses that the hydrogel layer includes a second support layer positioned opposite the support layer. As discussed above, according to Fig. 3 and para [0069]- [0070], the polymer film layer 31 and distribution layer 23 correspond to the support layers, wherein one is the support layer and the other is the second support layer.
Regarding claim 16, ‘634 discloses that the silicone gel layer includes a plurality of openings formed therethrough such that the hydrogel layer is in fluid communication with a wound under the silicone gel layer, see Fig. 3, para [0041] and [0069]. Para [0069] recites that the gel layer 32 is silicone gel and the gel layer 32 is provided with a cylindrical hole with an average diameter of 2.2 mm. Para [0041] recites that the advantage of the holes is that the exudates can be better absorbed by the absorbing layer.
Regarding claim 17, ‘634 discloses that the silicone gel layer includes a plurality of openings formed therethrough such that the hydrogel layer is in fluid communication with a wound under the silicone gel layer, see Fig. 3, para [0041] and [0069]. Para [0069] recites that the gel layer 32 is silicone gel and the gel layer 32 is provided with a cylindrical hole with an average diameter of 2.2 mm. it is noted that while claim 17 recites a first group of large openings and a second group of small openings, both large and small openings overlap in diameter as stated by the Specification (large is from 0.5 to 5 mm and small is from 0.1 to 2 mm).
Regarding claim 18, ‘634 discloses that the adhesive layer is made of a biocompatible material and is used to adhere the antibacterial hydrogel layer and the backing film, see Fig.3 and para [0048]. Para [0048] recites that the absorbing unit and backing unit 1 are connected by pressure-sensitive adhesive such as acrylic acid, and it is common general knowledge of the skilled in the art that the acrylic acid adhesive is biocompatible.
Regarding claim 19, ‘634 discloses that the adhesive layer is an acrylic acid adhesive, a pressure- sensitive adhesive, see para [0048]. Para [0048] recites that absorbing unit and backing unit 1are connected by pressure-sensitive adhesive, and the pressure-sensitive adhesive includes one of acrylic acid, acrylate copolymer, polyvinyl ether, and polyurethane.
Regarding claim 20, ‘634 discloses that the top film is a single layer of a polyurethane material, see Fig.3 and para [0071]. Fig.3 shows that the backing unit is a single film and para [0071] recites that the backing unit 1 in embodiment 3 is made of a polyurethane film material.
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Fig 3.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of CN ‘634 with that of CN ‘310 to arrive at the instant invention. It would have been obvious to do so because both references are directed to a transparent medical dressing comprising multiple layers of silicone, hydrogel, support and top film. The combination of references would advise one of ordinary skill in the art of the best material and features of the disclosed dressings. For example, while CN ‘310 discloses the layered dressing it lacks an express disclosure on the support layer being made of woven or non-woven fabric. CN ‘634, however, clearly teach this feature and one of ordinary skill in the art is more than motivated to incorporate this feature of CN ‘634 into the dressing of CN ‘310 with a reasonable expectation of success. Also, CN ‘310 is silent with regard to the dressing comprising an antibacterial agent. As CN ‘634 teaches, it is beneficial to the wound healing and treatment that an antibacterial agent such as silver ions be present to prevent infections at the site of wound as they are very common.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Additionally, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over CN 211512310 as applied to claims 1 and 13 above and further in combination with Andrews (US 20170189238).
Teachings of CN ‘310 are delineated and incorporated herein.
CN ‘310 teach a transparent medical dressing comprising a hydrogel layer and wherein the said hydrogel material is acrylamide. CN ‘310 lacks an express disclosure on the properties of the said acrylamide hydrogel, as stated in claim 14. This is known in the art as taught by Andrews.
Andrews teach a composition comprising: a layer of water-swellable hydrogel, wherein the hydrogel has embedded therein a reinforcement sheet of liquid-water-permeable material, wherein the layer of hydrogel has a wound-facing side and a non-wound-facing side (See abstract).
Andrews teach that suitable monomers for use in forming the hydrogel, include acrylamides such as 2-acrylamido-2-methylpropane sulphonic acid, hydroxyethyl acrylamide, etc, (See [0068]).
The said hydrogel in the dressing or composition preferably consists essentially of a cross-linked hydrophilic polymer of a hydrophilic monomer and optionally one or more comonomers, together with water and/or one or more additive (See [0063]).
It is further disclosed that the precursor solution preferably contains one or more monomers capable on polymerisation of forming a three-dimensional matrix of cross-linked polymer molecules (See [0065]).
The said hydrogel comprises a plasticised three-dimensional matrix of cross-linked polymer molecules, and has sufficient structural integrity to be self-supporting even at very high levels of internal water content, with sufficient flexibility to conform to the surface contours of mammalian skin or other surfaces with which it is in contact (See [0069]-[0070]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Andrews with that of CN ‘310 to arrive at the instant invention. It would have been obvious to do so because CN ‘310 teach a transparent medical dressing comprising a hydrogel layer made of acrylamide. Andrews also teach a wound dressing comprising a hydrogel layer and discloses the properties of the said hydrogel layer that provide benefits to the said dressing such as it being superabsorbent, flexible, long lasting with sufficient structural integrity. Thus, one of ordinary skill in the art is motivated to use a cross-linked, three-dimensional water-swellable hydrogel material such as acrylamide to ensure effective wound treatment.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Response to Arguments
Applicant's arguments filed 12/04/25 have been fully considered but they are not persuasive.
Applicant’s arguments regarding the anticipatory rejection of claims by CN ‘634 reference are persuasive. As such this rejection is withdrawn.
Regarding the rejection of claims as anticipated by CN ‘310, Applicant argues that “The Examiner relies on either the silicone layer or the adhesive layer as corresponding to the "support layer," however, claim 1 requires both a support layer and a silicone layer, such that the silicone layer cannot also be the claimed "support layer" (See Remarks, page 7).
The argument is not found persuasive. Claim 1 reads, in part, -wherein the hydrogel layer includes a support layer supporting hydrogen material-. CN ‘310 also teaches that -the bottom portion of the acryl gel layer 6 is the support layer supporting hydrogel material, or (ii) the upper portion or the bottom portion of the hydrogel layer can be interpreted as support layer. Thus, CN ‘310 teaches the same layers as claimed in claim 1.
Applicant makes similar argument regarding the rejection of claims as being obvious over the combination of references.
The argument is not found convincing because as clearly shown in the rejection and the above response, CN ‘310 teaches the same dressing and the same layers. It does not expressly disclose what the support layer is made of or the addition of antibacterial agent. These would have been obvious to incorporate into the dressing as taught by the prior art, CN ‘634.
Similarly, Applicant’s arguments regarding the rejection of claim 14 over CN ‘310 in view of Andrews is not persuasive because Andrews clearly teach the properties of acrylamide hydrogel, which one of ordinary skill in the art is more than capable of reciting in a claim drawn to an acrylamide hydrogel product.
Claims 1-20 remain rejected.
THIS ACTION IS MADE FINAL. 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 Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616