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 § 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 5, 7-8, and 13-16 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 5 recites the limitation "the concentration" 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 concentration”.
Claim 7 recites the limitation "the " 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 surface area”.
Claim 8 recites the limitation "the " 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 height”.
Claim 13 recites the limitation "the " 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 contact surface”.
Claim 14 recites the limitation “a dressing” in line 2. This limitation renders the claim indefinite because it is unclear if the dressing in line 2 is the same “medical dressing” recited in the preamble, or a new dressing. For the purpose of examination, Examiner will interpret this limitation as being the same dressing.
Claims 15-16 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 § 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.
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) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flach et al. (US 2017/0258956 A1) (hereinafter Flach) in view of Fabo et al. (WO 2007/117208 A1) (hereinafter Fabo).
In regards to claim 1, Flach discloses a medical dressing (20; see [0054]; see figure 2a) comprising a top layer (10; see [0053]; see figure 2a), an adhesive skin contact layer (3; see [col 54]; see figure 2b); said adhesive skin contact layer having a first side facing said top layer and a second side (see figure 2b that 3 has a side which faces 10 and a side which faces away from 10), wherein said second side of said adhesive skin contact layer is provided with a coating (9; see [0053]; see figure 2c) comprising a skin and/or wound beneficial agent configured to be released from said adhesive skin contact layer during use (see [0011]).
Flach does not disclose a release liner detachably attached to at least a portion of said adhesive skin contact layer; and
wherein said release liner has a first side facing said second side of said adhesive skin contact layer and an opposing, second side wherein said first side of said release liner comprises a plurality of protrusions.
However, Fabo teaches an analogous medical dressing (1; see [pg 4 ln 16]; see figure 1) comprising a top layer (2; see [pg 4 ln 17]; see figure 1), an adhesive skin contact layer (3; see [pg 4 ln 17]; figure 1); further comprising; a release liner (4; see [pg 4 ln 18]; see figure 1) detachably attached to at least a portion of said adhesive skin contact layer (see figure 1); and
wherein said release liner has a first side facing said second side of said adhesive skin contact layer and an opposing, second side (see figure 1 that 4 has a first side which faces 3 and a second side facing away from 3) wherein said first side of said release liner comprises a plurality of protrusions (6; see [pg 4 ln 25-28]; see figure 1) for the purpose of providing a layer which protects the adhesive of the dressing before the use of the dressing (See [pg 3 ln 5-10]).
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 medical dressing as disclosed by Flach and to have included the release liner comprising projections as taught by Fabo in order to have provided an improved medical dressing that would add the benefit of providing a layer which protects the adhesive of the dressing before the use of the dressing (See [pg 3 ln 5-10]).
In regards to claim 2, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said coating is a discontinuous coating (see [0014]).
In regards to claim 3, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said coating is soluble in an aqueous medium (see [0077] that the coating can be configured with more or less solubility in an aqueous solution).
In regards to claim 4, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said skin and/or wound beneficial agent is an antimicrobial agent (see [0020] that the coating may comprise an antimicrobial compound).
In regards to claim 5, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein the concentration of said skin and/or wound beneficial agent in said coating is from 1 to 1000 µg/cm2 (see [0085 that the concentration of the coating may be 1-150 µg/cm2).
In regards to claim 6, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein said plurality of protrusions are spaced apart from one another by non-protruding areas (see Fabo figure 1 that the plurality of 6 are spaced apart from one another as claimed), wherein said non-protruding areas form gaps between said first side of said release liner and said second side of said adhesive skin contact layer (see Fabo figure 1).
In regards to claim 7, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein said first side of said release liner is detachably attached to from 5 to 75 % of the surface area of said second side of said adhesive skin contact layer (see Fabo figure 1 that 6 of 4 is detachably attached to at least 5% or more of the surface area of the adhesive layer and thus, would be similarly engaged with the adhesive layer of Flach).
In regards to claim 8, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein the height of each of said protrusions is from 0.1 to 2.0 mm (See Fabo [pg 11 ln 9-11] that the height of the projections are the thickness of the adhesive layer; see Flach [0111] that the layer of silicone adhesive is .125mm; thus, the projections in the combination of Flach as now modified by Fabo have a height of .125mm).
In regards to claim 9, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein said medical dressing comprises an absorbent pad (2; see [0053]; see figure 2b; see [0017] that the substrate may be absorbent) arranged between said top layer and said adhesive skin contact layer (See figure 2b), and wherein said plurality of protrusions are arranged in an area on the first side of said release liner that underlies said absorbent pad (6 of Fabo underlies the entire dressing and thus, when positioned on the dressing of Flach would underlie the absorbent pad).
In regards to claim 10, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said adhesive skin contact layer comprises a silicone-based adhesive coating (see [0013]).
In regards to claim 11, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said adhesive skin contact layer comprises a polymeric film (11; see [0054]; see figure 2b; see [0061] that 11 is a polymer) provided with a silicone-based adhesive coating (see [0013] that the adhesive (i.e. 3) may be a silicone adhesive coating).
In regards to claim 12, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said silicone-based adhesive coating has a thickness of from 35 to 300 gsm (see [0079]).
In regards to claim 13, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein each of the plurality of protrusions has a substantially flat top surface; said top surface forming the contact surface for detachable attachment of said release liner to said adhesive skin contact layer (see Fabo figure 1).
In regards to claim 14, Flach discloses a process for manufacturing (see [abstract]) a medical dressing (20; see [0054]; see figure 2a) comprising:
a) providing a dressing (20) comprising a top layer (10; see [0053]; see figure 2a) and an adhesive skin contact layer (3; see [col 54]; see figure 2b); said adhesive skin contact layer having a first side facing said top layer and a second, opposing side (see figure 2b that 3 has a side which faces 10 and a side which faces away from 10),
b) applying a coating (9; see [0053]; see figure 2c) onto said second side of said adhesive skin contact layer, wherein said coating comprises a skin and/or wound beneficial agent configured to be released from said adhesive skin contact layer during use (see [0011]).
Flach does not disclose c) providing a release liner having a first side and an opposing second side , wherein at least a portion of said first side of said release liner comprises a plurality of protrusions;
d) applying said release liner onto said adhesive skin contact layer such that said plurality of protrusions become detachably attached to said second side of said adhesive skin contact layer.
However, Fabo teaches an analogous process for manufacturing a medical dressing (1; see [pg 4 ln 16]; see figure 1) comprising a top layer (2; see [pg 4 ln 17]; see figure 1), an adhesive skin contact layer (3; see [pg 4 ln 17]; figure 1); further comprising providing a release liner (4; see [pg 4 ln 18]; see figure 1) having a first side and an opposing second side (see figure 1 that 4 has a first side which faces 3 and a second side facing away from 3), wherein at least a portion of said first side of said release liner comprises a plurality of protrusions (6; see [pg 4 ln 25-28]; see figure 1);
d) applying said release liner onto said adhesive skin contact layer (see figure 1) such that said plurality of protrusions become detachably attached to said second side of said adhesive skin contact layer (see [pg 4 ln 25-30]) for the purpose of providing a layer which protects the adhesive of the dressing before the use of the dressing (See [pg 3 ln 5-10]).
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 process of manufacturing the medical dressing as disclosed by Flach and to have included the release liner comprising projections as taught by Fabo in order to have provided an improved medical dressing that would add the benefit of providing a layer which protects the adhesive of the dressing before the use of the dressing (See [pg 3 ln 5-10]).
In regards to claim 15, Flach as now modified by Fabo discloses the invention as discussed above.
Flach further discloses wherein said step b) of applying a coating is performed by spray coating (see [0102]).
In regards to claim 16, Flach as now modified by Fabo discloses the invention as discussed above.
Flach as now modified by Fabo further discloses wherein said plurality of protrusions are formed as an in-line step in said process (see Fabo [pg 11 ln 25-30] that the protection release layers are embossed (i.e. formed through embossing) which as per Applicant’s specification on page 7 is an “in-line step” in the process of manufacturing).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
