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 Objections
Claims 1-2, 5-6, 10-11 and 15 are objected to because of the following informalities:
Claim 1 recites the limitation “said dressing” in line 2. This limitation should be amended to recite “said wound dressing” to maintain consistency in the claims.
Claim 1 recites the limitation “the dressing” in line 3. This limitation should be amended to recite “the wound dressing” to maintain consistency in the claims.
Claim 1 recites the limitation “capable of exerting different adhesion strength to the skin”. This limitation should be amended to recite “configured for exerting” to avoid positively reciting a human organism.
Claim 2 as written is grammatically incorrect and has multiple objectionable issues. The claim should be amended to recite “wherein the adhesive material of the first adhesive layer is configured to have a higher adhesion strength to the skin of the human being than an adhesion strength of the adhesive material of the second adhesive layer” or similar, for grammatical, clarity, and consistency purposes.
Claim 5 recites the limitation “with acrylate adhesive” in line 3. This limitation should be amended to recite “the acrylate adhesive materials” to maintain consistency in the claims.
Claim 5 recites the limitation “with silicone adhesive” in line 3. This limitation should be amended to recite “the silicone adhesive materials” to maintain consistency in the claims.
Claim 6 recites the limitation “of the skin contact side” in line 2. This limitation should be amended to recite “of the area of the skin contact side” to maintain consistency in the claims.
Claim 6 recites the limitation “of the skin contact side” in line 3. This limitation should be amended to recite “of the area of the skin contact side” to maintain consistency in the claims.
Claim 10 recites the limitation “a wound dressing with adhesive borders according to claim 7”. This limitation should be amended to recite “the wound dressing with the adhesive borders according to claim 7” as these limitations are presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “providing a backing layer”. This limitation should be amended to recite “providing the backing layer” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “the dressing” in line 5. This limitation should be amended to recite “the wound dressing” to maintain consistency in the claims.
Claim 10 recites the limitation “providing a first adhesive layer”. This limitation should be amended to recite “providing the first adhesive layer” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “a surface of the backing layer intended to face the skin”. This limitation should be amended to recite “the skin-facing surface of the backing layer” to maintain consistency in the claims.
Claim 10 recites the limitation “providing a wound pad”. This limitation should be amended to recite “providing the wound pad” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “providing an inner layer”. This limitation should be amended to recite “providing the inner layer” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “a portion of the wound pad”. This limitation should be amended to recite “the portion of the wound pad” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “providing a second adhesive layer”. This limitation should be amended to recite “providing the second adhesive layer” as this limitation is presented earlier in the claims from which claim 10 depends.
Claim 10 recites the limitation “characterized in that it further”. This limitation should be amended to recite “characterized in that the method of manufacturing the wound dressing” to remove the pronoun which may render the claim indefinite.
Claim 10 recites the limitation “providing said first adhesive layer and said second adhesive layer by means of different adhesive materials”. This limitation should be amended to recite “providing said first adhesive layer and said second adhesive layer as different adhesive materials” for grammatical purposes.
Claim 11 recites the limitation “the acrylate adhesive”. This limitation should be amended to recite “the acrylate adhesive material” to maintain consistency in the claims.
Claim 11 recites the limitation “the silicone adhesive”. This limitation should be amended to recite “the silicone adhesive material” to maintain consistency in the claims.
Claim 15 recites the limitation “a wound dressing with adhesive borders according to claim 1”. This limitation should be amended to recite “the wound dressing with the adhesive borders according to claim 1” as these limitations are presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “providing a backing layer”. This limitation should be amended to recite “providing the backing layer” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “the dressing” in line 4. This limitation should be amended to recite “the wound dressing” to maintain consistency in the claims.
Claim 15 recites the limitation “providing a first adhesive layer”. This limitation should be amended to recite “providing the first adhesive layer” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “a surface of the backing layer intended to face the skin”. This limitation should be amended to recite “the skin-facing surface of the backing layer” to maintain consistency in the claims.
Claim 15 recites the limitation “providing a wound pad”. This limitation should be amended to recite “providing the wound pad” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “providing an inner layer”. This limitation should be amended to recite “providing the inner layer” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “a portion of the wound pad”. This limitation should be amended to recite “the portion of the wound pad” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “providing a second adhesive layer”. This limitation should be amended to recite “providing the second adhesive layer” as this limitation is presented earlier in claim 1 from which claim 15 depends.
Claim 15 recites the limitation “characterized in that it further”. This limitation should be amended to recite “characterized in that the method of manufacturing the wound dressing” to remove the pronoun which may render the claim indefinite.
Claim 15 recites the limitation “providing said first adhesive layer and said second adhesive layer by means of different adhesive materials”. This limitation should be amended to recite “providing said first adhesive layer and said second adhesive layer as different adhesive materials” for grammatical purposes.
Appropriate correction is required.
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 1-15 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.
Claim 1 recites the limitation "the non-skin facing surface of the dressing" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a non-skin facing surface of the dressing”.
Claim 1 recites the limitation "the skin-facing surface of the dressing " in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin-facing surface of the dressing”.
Claim 1 recites the limitation "the skin-facing surface of the inner layer" in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin-facing surface of the inner layer”
Claim 1 recites the limitation "the skin" in line 13. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin”.
Claim 4 recites the limitation "the surface of the adhesive borders" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a surface of the adhesive borders”.
Claim 4 recites the limitation “two different areas, based respectively on acrylate and silicone adhesive materials”. This limitation renders the claim indefinite because it is unclear if Applicant is claiming the two different areas comprise acrylate and silicone adhesive materials, or that the adhesive areas are made based on (and thus, do not actively require) acrylate and silicone adhesive materials. For the purpose of examination, Examiner will interpret this limitation as the two different areas comprise acrylate and silicone adhesive materials.
Claim 5 recites the limitation "the area" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an area”.
Claim 5 recites the limitation "the skin contact side of the adhesive borders" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin contact side”.
Claim 7 recites the limitation "the perimetral area" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a perimeter of the area of the skin contact side of the adhesive borders”.
Claim 8 recites the limitation “wherein said wound pad is based on…”. This limitation renders the claim indefinite because it is unclear if Applicant is claiming the wound pad is made from the claimed materials or is made based on the claimed materials and therefore, the claimed materials are not required. For the purpose of examination, Examiner will interpret this limitation as “wherein said wound pad is made from”.
Claim 9 recites the limitation "the wound contact site" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a wound contact site”.
Claim 9 recites the limitation "said thin layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “said layer”
Claim 9 recites the limitation “wherein said thin layer may be selected from the group” This limitation renders the claim indefinite because it is unclear if the thin layer being formed from the group of claimed materials is formed from the claimed materials, or if the thin layer being formed from the claimed materials is merely a preference which is not required by the claim. For the purpose of examination, Examiner will interpret this limitation as “wherein said thin layer is selected from the group consisting of”.
Claim 9 recites the limitation “wherein said thin layer may also comprise”. This limitation renders the claim indefinite because it is unclear if the limitations which follow “may also comprise” are required by the claim, or merely preferred embodiments of the thin layer. For the purpose of examination, Examiner will interpret this limitation as being optional, preferred embodiments which are not positively required by the claim and thus, not required by the prior art to read on the claim.
Claim 10 recites the limitation "the steps" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a plurality of steps comprising”.
Claim 11 recites the limitation "the maximum coverage" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a maximum coverage”.
Claim 11 recites the limitation "the skin contact side of the acrylate adhesive" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin contact side”.
Claim 11 recites the limitation "the minimum coverage" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a minimum coverage”.
Claim 11 recites the limitation "the skin contact side of the silicone adhesive" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a skin contact side”.
Claim 11 recites “wherein the maximum coverage of the skin contact side of the acrylate adhesive is 50% and wherein the minimum coverage of the skin contact side of the silicone adhesive is 50%” which as a whole is indefinite because Applicant has not claimed what “the maximum/minimum coverage” is of (i.e. is it of the surface of the adhesive borders recited in claim 4, or a coverage of some other structure) thereby rendering the claim unclear as to the scope of the claim. For the purpose of examination, Examiner will interpret this limitation as “wherein the acrylate adhesive of the at least two different adhesive areas covers at most 50% of the skin contact side of the adhesive borders and wherein the silicone adhesive of the at least two different adhesive areas covers at least 50% of the skin contact side of the adhesive borders”.
Claim 12 recites the limitation "the perimetral area of the skin contact side" in line 2. There is insufficient antecedent basis for these limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “a perimeter area of a skin contact side of the adhesive borders”.
Claim 13 recites the limitation “wherein said wound pad is based on…”. This limitation renders the claim indefinite because it is unclear if Applicant is claiming the wound pad is made from the claimed materials or is made based on the claimed materials and therefore, the claimed materials are not required. For the purpose of examination, Examiner will interpret this limitation as “wherein said wound pad is made from”.
Claim 14 recites the limitation "the wound contact site" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a wound contact site”.
Claim 14 recites the limitation "said thin layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “said layer”
Claim 14 recites the limitation “wherein said thin layer may be selected from the group” This limitation renders the claim indefinite because it is unclear if the thin layer being formed from the group of claimed materials is formed from the claimed materials, or if the thin layer being formed from the claimed materials is merely a preference which is not required by the claim. For the purpose of examination, Examiner will interpret this limitation as “wherein said thin layer is selected from the group consisting of”.
Claim 14 recites the limitation “wherein said thin layer may also comprise”. This limitation renders the claim indefinite because it is unclear if the limitations which follow “may also comprise” are required by the claim, or merely preferred embodiments of the thin layer. For the purpose of examination, Examiner will interpret this limitation as being optional, preferred embodiments which are not positively required by the claim and thus, not required by the prior art to read on the claim.
Claim 15 recites the limitation "the steps" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a plurality of steps comprising”.
Claims 2, 3, and 6 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and thus, contain the same offending limitations.
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.
(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.
Claim(s) 1-4, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke et al. (US 2018/0353342 A1) (hereinafter Locke).
In regards to claim 1, Locke discloses a wound dressing (110; see [0030]; see figure 2) with adhesive borders (borders surrounding 205 as seen in figure 3), said dressing comprising:
a backing layer (125; see [0030]; see figure 2) located on the non-skin-facing surface of the dressing (see figure 2),
a first adhesive layer (255; see [0078]; see figure 2) located on the skin-facing surface of the backing layer (see figure 2 that 255 is formed on the lower, skin facing side of 125),
a wound pad (205; see [0057]; see figure 2) attached to the backing layer (see figure 2),
an inner layer (215; see [0057]; see figure 2) attached to the backing layer and surrounding at least a portion of the wound pad (see figure 3 that 215 is attached to 125 and surrounds 205), and
a second adhesive layer (soft silicone; see [0072]; 215 is intended to be tacky to hold the dressing in position (see [0094]) and thus, the soft silicone coating is considered to be tacky and an adhesive layer) located on the skin-facing surface of the inner layer (the soft silicone to seal with the user’s skin as intended is positioned on the skin-facing surface of 215), characterized in that the first adhesive layer and the second adhesive layer comprise different adhesive materials capable of exerting different adhesion strength to the skin of a human being (255 being an acrylic pressure sensitive adhesive (see [0078]), and the second layer being soft silicone, are different adhesive materials which exert different adhesion strengths to a user’s skin).
In regards to claim 2, Locke discloses the invention as discussed above.
Locke further discloses wherein the first adhesive layer (255) comprises an adhesive material which exerts adhesion strength to the skin of a human being higher with respect to the adhesive material of the second adhesive layer (soft silicone; 255 is formed from acrylic adhesives (see [0044]) which have greater adhesion than soft silicone adhesives).
In regards to claim 3, Locke discloses the invention as discussed above.
Locke further discloses wherein the first adhesive layer comprises an acrylate-based adhesive material (see [0044]) and the second adhesive layer comprises a silicone-based adhesive material (see [0072]).
In regards to claim 4, Locke discloses the invention as discussed above.
Locke further discloses wherein the surface of the adhesive borders of the wound dressing contains at least two different adhesive areas, based respectively on acrylate and silicone adhesive materials (see figure 3 that the borders of the dressing contain two adhesive areas formed by the soft silicone which forms an adhesive material coated on 215, and 255 exposed through 235 of 215).
In regards to claim 12, Locke discloses the invention as discussed above.
Locke further discloses wherein the perimetral area (225; see [0073]; see figure 2) of the skin contact side of the adhesive borders comprises acrylate adhesive (225 comprises 235 which expose the acrylate adhesive of 125; see [0096]; see figure 3).
In regards to claim 13, Locke discloses the invention as discussed above.
Locke further discloses wherein said wound pad (205) is based on polyurethane foam (reticulated polyurethane foam; see [0060]), non-woven cellulose, viscose, PP, PE (see [0062]), superabsorbent pad/material, or a combination of at least two of said materials.
In regards to claim 14, Locke discloses the invention as discussed above.
Locke further discloses wherein said materials that compose said wound pad (205) have a layer (210; see [0057]; see figure 2) at the wound contact site (see figure 2 that 210 is exposed through treatment aperture 230), wherein said thin layer may be selected from the group consisting of: a perforated synthetic film (see [0068]); a mesh made of synthetic fabrics or cotton or a combination thereof.
With respect to the limitations of wherein said thin layer may also comprise: a coating of silicone gel or medical gel; antimicrobial substances of metals, organic compounds with biguanide functional groups, (organo-)metal compounds or surfactants or, in combination, silicone dioxide ceramics. These limitations are optional requirements of the thin layer and thus, the prior art does not need to disclose these limitations to read on the claims.
In regards to claim 15, Locke discloses A method of manufacturing a wound dressing (11) with adhesive borders according to claim 1 (see discussion above),
wherein the method comprises the steps of:
providing a backing layer (125) intended for being located on the non-skin- facing surface of the dressing (110; see figure 2) when the wound dressing is in use,
providing a first adhesive layer (255) on a surface of the backing layer (see figure 2 that 255 is formed on the lower, skin-facing side of 125) intended to face the skin when the wound dressing (11) is in use,
providing a wound pad (205), attaching said wound pad to said first adhesive layer (205 is placed against and attached to 255; see figure 2),
providing an inner layer (215),
attaching said inner layer to said first adhesive layer so as to surround at least a portion of the wound pad (see [0095]; see figure 3),
providing a second adhesive layer (soft silicone) on the skin-facing surface of the inner layer (the soft silicone to seal with the user’s skin as intended is positioned on the skin-facing surface of 215) when the wound dressing is in use,
characterized in that it further comprises the steps of: providing said first adhesive layer (17) and said second adhesive layer (23) by means of different adhesive materials capable of exerting different adhesion strength to the skin of a human being (255 being an acrylic pressure sensitive adhesive (see [0078]), and the second layer being soft silicone, are different adhesive materials which exert different adhesion strengths to a user’s skin).
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.
Claim(s) 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke.
In regards to claim 5, Locke discloses the invention as discussed above.
Locke further discloses wherein the area of the skin contact side of the adhesive borders (area of 225; see figure 3) is covered by the acrylate adhesive (255) and the silicone adhesive (soft silicone; 255 is intended to be exposed through 235 (see [0083]) and thus, the area of 225 is covered by proportional areas of 255 and the soft silicone).
Locke does not explicitly disclose the area of the skin contact side of the adhesive borders is covered by a minimum of 5% with acrylate adhesive and a maximum of 95% with silicone adhesive.
However, Locke teaches that the diameter, pattern, and shape of 235 (and thus the area of soft silicone which is in contact with the user, and consequently the area of 255 in contact with the user) may be changed (see [0074-0076]), and 235 may be sized and changed in configuration to control the amount of 255 exposed through 235 to change the bond strength of 255 (see [0097-0098]) in the area of the skin contact side of the adhesive borders. Thus, the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive are considered to be a result effective variable in that changing the diameter, pattern, and shape of 235 changes the ability of the area of the skin contact side of the adhesive borders to properly bond with and adhere the wound dressing to the user (See [0098]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive in the area of the skin contact side of the adhesive borders of Locke as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the area of the skin contact side of the adhesive borders of Locke by changing the diameter, pattern, and/or shape of 235, thereby changing the minimum area of the acrylate adhesive to be 5% of the and the maximum area of the silicone adhesive to be 95% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ensuring the area of the skin contact side of the adhesive borders will properly bond with and adhere the wound dressing to the user (See [0098]).
In regards to claim 6, Locke discloses the invention as discussed above.
Locke does not explicitly disclose , wherein the maximum coverage of the skin contact side of the acrylate adhesive is 50% and wherein the minimum coverage of the skin contact side of the silicone adhesive is 50%.
However, as discussed above, Locke teaches that the diameter, pattern, and shape of 235 (and thus the area of soft silicone which is in contact with the user, and consequently the area of 255 in contact with the user) may be changed (see [0074-0076]), and 235 may be sized and changed in configuration to control the amount of 255 exposed through 235 to change the bond strength of 255 (see [0097-0098]) in the area of the skin contact side of the adhesive borders. Thus, the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive are considered to be a result effective variable in that changing the diameter, pattern, and shape of 235 changes the ability of the area of the skin contact side of the adhesive borders to properly bond with and adhere the wound dressing to the user (See [0098]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive in the area of the skin contact side of the adhesive borders of Locke as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the area of the skin contact side of the adhesive borders of Locke by changing the diameter, pattern, and/or shape of 235, thereby changing the maximum area of the acrylate adhesive to be 50% of the and the minimum area of the silicone adhesive to be 50% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ensuring the area of the skin contact side of the adhesive borders will properly bond with and adhere the wound dressing to the user (See [0098]).
In regards to claim 7, Locke discloses the invention as discussed above.
Locke further discloses wherein the perimetral area (225; see [0073]; see figure 2) of the skin contact side of the adhesive borders comprises acrylate adhesive (225 comprises 235 which expose the acrylate adhesive of 125; see [0096]; see figure 3).
In regards to claim 8, Locke discloses the invention as discussed above.
Locke further discloses wherein said wound pad (205) is based on polyurethane foam (reticulated polyurethane foam; see [0060]), non-woven cellulose, viscose, PP, PE (see [0062]), superabsorbent pad/material, or a combination of at least two of said materials.
In regards to claim 9, Locke discloses the invention as discussed above.
Locke further discloses wherein said materials that compose said wound pad (205) have a layer (210; see [0057]; see figure 2) at the wound contact site (see figure 2 that 210 is exposed through treatment aperture 230), wherein said thin layer may be selected from the group consisting of: a perforated synthetic film (see [0068]); a mesh made of synthetic fabrics or cotton or a combination thereof.
With respect to the limitations of wherein said thin layer may also comprise: a coating of silicone gel or medical gel; antimicrobial substances of metals, organic compounds with biguanide functional groups, (organo-)metal compounds or surfactants or, in combination, silicone dioxide ceramics. These limitations are optional requirements of the thin layer and thus, the prior art does not need to disclose these limitations to read on the claims.
In regards to claim 10, Locke discloses A method of manufacturing a wound dressing (11) with adhesive borders according to claim 7 (see discussion above),
wherein the method comprises the steps of:
providing a backing layer (125) intended for being located on the non-skin- facing surface of the dressing (110; see figure 2) when the wound dressing is in use,
providing a first adhesive layer (255) on a surface of the backing layer (see figure 2 that 255 is formed on the lower, skin-facing side of 125) intended to face the skin when the wound dressing (11) is in use,
providing a wound pad (205), attaching said wound pad to said first adhesive layer (205 is placed against and attached to 255; see figure 2),
providing an inner layer (215),
attaching said inner layer to said first adhesive layer so as to surround at least a portion of the wound pad (see [0095]; see figure 3),
providing a second adhesive layer (soft silicone) on the skin-facing surface of the inner layer (the soft silicone to seal with the user’s skin as intended is positioned on the skin-facing surface of 215) when the wound dressing is in use,
characterized in that it further comprises the steps of: providing said first adhesive layer (17) and said second adhesive layer (23) by means of different adhesive materials capable of exerting different adhesion strength to the skin of a human being (255 being an acrylic pressure sensitive adhesive (see [0078]), and the second layer being soft silicone, are different adhesive materials which exert different adhesion strengths to a user’s skin).
In regards to claim 11, Locke discloses the invention as discussed above.
Locke does not explicitly disclose , wherein the maximum coverage of the skin contact side of the acrylate adhesive is 50% and wherein the minimum coverage of the skin contact side of the silicone adhesive is 50%.
However, as discussed above, Locke teaches that the diameter, pattern, and shape of 235 (and thus the area of soft silicone which is in contact with the user, and consequently the area of 255 in contact with the user) may be changed (see [0074-0076]), and 235 may be sized and changed in configuration to control the amount of 255 exposed through 235 to change the bond strength of 255 (see [0097-0098]) in the area of the skin contact side of the adhesive borders. Thus, the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive are considered to be a result effective variable in that changing the diameter, pattern, and shape of 235 changes the ability of the area of the skin contact side of the adhesive borders to properly bond with and adhere the wound dressing to the user (See [0098]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the minimum area of the acrylate adhesive and the maximum area of the silicone adhesive in the area of the skin contact side of the adhesive borders of Locke as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the area of the skin contact side of the adhesive borders of Locke by changing the diameter, pattern, and/or shape of 235, thereby changing the maximum area of the acrylate adhesive to be 50% of the and the minimum area of the silicone adhesive to be 50% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ensuring the area of the skin contact side of the adhesive borders will properly bond with and adhere the wound dressing to the user (See [0098]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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