DETAILED ACTION
In Applicant’s Response filed 8/13/25, Applicant has amended claims 1, 3, 5-8, 15, 17-19; and added new claims 21-25. Claims 4, 10-13 and 16 have been cancelled. Currently, claims 1-3, 5-9, 14-15 and 17-25 are pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/13/25 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/16/25 and 1/2/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-8, 14-15, and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al (US 9168180) in view of Kelvered et al (US 9327098) and further in view of Holm et al (US 9452087).
With respect to claim 1, Ha discloses a medical dressing (10; fig 1-2) comprising:
a conformable dressing body (backing layer 14; the backing material of the dressing is a conformable backing – col 13 lines 30-34) having a top major surface (surface of layer 14 that faces layer 27 in fig 2) and a bottom major surface (surface of layer 14 that faces layer 17 in fig 2) opposite the top major surface (as shown in fig 2), a first dressing area defined by a dressing perimeter (perimeter 15; fig 1; the peripheral region that is covered by carrier 27 is interpreted as being the first dressing area); a second dressing area defined by the area within the first dressing area (central region identified in annotated fig 2);
a pressure sensitive adhesive (adhesive 17) on at least a portion of the bottom major surface of the conformable dressing body (as shown in fig 2); and
a carrier (27) comprising: a central carrier portion (portion of carrier 27 located at the center of the dressing; identified in annotated fig 1) adjacent to the first dressing area (the central portions of the carrier 27 are positioned along the perimeter of the dressing at the center of the dressing and adjacent to the perimeter at the ends as shown in fig 1); a peripheral carrier portion (portion of carrier 27 located at the outer peripheral ends of the dressing; identified in annotated fig 1) adjacent to the perimeter of the conformable dressing body (as shown in fig 1); a central carrier tab extending into the second dressing area (tab 33; see annotated fig 1); and
a line of weakness between the central portion and the adjacent peripheral carrier portion (cut lines 31 separate the carrier 27 into the portions identified as the central and peripheral carrier portions; see annotated fig 1), the line of weakness is a partial thickness cut or a perforation (the area of weakness is a “cut” 31 that separates the carrier 27 into the portions identified as the central and peripheral carrier portions; see annotated fig 1),
wherein the carrier (27) is releasably secured to the top major surface of the conformable dressing body (attached to the top face of backing 14 – col 10 lines 35-36; fig 2; carrier remains attached to backing 14 when the liner 24 is removed but is configured to be removed from the backing 14 – col 10 lines 40-59), with the line of weakness on the top surface of the carrier (the cut lines 31 extend through the thickness of the carrier 27 and thus are present on the top surface of carrier 27; see also fig 1 which shows the cut lines 31 being present and extending through the top surface of carrier 27).
ANNOTATED FIG 1 of Ha et al (US 9168180)
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ANNOTATED FIG 2 of Ha et al (US 9168180)
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Ha does not, however, disclose that the dressing body further comprises a slot defined by a recess of the dressing perimeter at the second dressing area having a larger head portion and a narrower body portion.
Kelvered teaches a fixation device for retaining a skin penetrating medical device such as a cannula on the skin (abstract) wherein the device includes an adhesive coated component (landing zone component shown in fig 4) adapted to be adhesively attached to the skin around the point of penetration (abstract) and which comprises first (region along the outer perimeter edge) and second (central portion) areas which comprise a slot that is configured as a recess of the perimeter at the second area (dividing line 14 shown in fig 4) and wherein the slot has a larger head portion and a narrower body portion (opening 15 at the end of dividing line 14 is larger than the narrower portion of dividing line 14 that extends between the perimeter edge and the opening 15 as shown in fig 4). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the dressing of Ha so that the dressing body further comprises a slot defined by a recess of the dressing perimeter at the second dressing area having a larger head portion and a narrower body portion, as taught by Kelvered, in order to accommodate and secure a skin penetrating medical device such as a cannula on the skin.
Ha also discloses that the dressing may include additional tape strips for securing devices such as catheters (col 13 lines 12-17) but does not, however, explicitly disclose at least one fixation strip disposed on the top surface of the carrier, where the at least one fixation strip extends beyond the central carrier portion to secure to at least a portion of the peripheral carrier portion.
Holm, however, teaches a wound dressing assembly comprising a conformable dressing body (backing 26 formed from a conformable film – col 7 lines 40-46), a carrier (carrier 29), and at least one fixation strip (tape strip 30) disposed on the top surface of the carrier (as shown in fig 6), where the at least one fixation strip extends beyond the central carrier portion to secure to at least a portion of the peripheral carrier portion (as shown in fig 6, the tape strip 30 extends across not only the central portion of carrier 29 but outwardly therefrom with opposing ends being secured in the peripheral region; see also col 5 line 66 – col 6 line 31). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Ha in view of Kelvered so that the tape strip(s) (as taught by Ha) are disposed on the top surface of the carrier and extend beyond the central carrier portion to secure to at least a portion of the peripheral carrier portion, like the tape strip 30 in Holm, in order to provide fixation over a larger area of the dressing and, furthermore, because such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
With respect to claim 2, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the second dressing area (identified in annotated fig 2) is at least partially surrounded by the peripheral carrier portion and the central carrier portion (the second dressing area forms a ring around the center of the dressing and thus includes regions where it is surrounded on one side by the portions of carrier 27 that are at the center and on the peripheral ends; see 2nd annotated fig 1).
2nd ANNOTATED FIG 1 of Ha et al (US 9168180)
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With respect to claim 3, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that at the second dressing area (identified in annotated fig 2 and 2nd annotated fig 1), the conformable dressing body forms an outermost surface of the medical dressing (the surface of backing 14 is uncovered and exposed at the areas identified as the “second dressing area” and thus defines the outermost upper surface of the dressing; see figs 1-2 and annotated figs 1-2 and 2nd annotated fig 1).
With respect to claim 5, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body is a single or multilayer film (the backing is preferably a film material – col 13 lines 44-51; it is inherent that the film is at least a single layer of material).
With respect to claim 6, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 5) and Ha also discloses that the multilayer film of the conformable dressing body at the first dressing area comprises a moisture-vapor permeable film and at the second dressing area comprises a reinforcing layer and a moisture vapor permeable and water impermeable film (the backing layer 14 can be multiple films – col 12 lines 43-51; suitable backings are fluid impermeable but vapor permeable – see col 13 line 30 – col 14 line 3; the center of the dressing which is interpreted as being the second dressing area further includes a self-supporting substrate 12 over backing layer 14 which is more rigid than the backing layer and thus is interpreted as being a reinforcing layer; see col 15 lines 16-17 and figs 1-2).
With respect to claim 7, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the pressure sensitive adhesive (17) is on the entire bottom major surface of the conformable dressing body (adhesive layer 17 is “on all or a portion of the surface of the backing layer 14 that faces the wound during use” – col 8 lines 7-9; adhesive 17 may cover all or part of the interior surface 41 in a continuous and/or pattern coated fashion – col 1 lines 1-2; see fig 1-3).
With respect to claim 8, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the pressure sensitive adhesive (17) is in a discontinuous pattern on the bottom major surface of the conformable dressing body (adhesive 17 may cover all or part of the interior surface 41 in a continuous and/or pattern coated fashion – col 1 lines 1-2; see fig 1-3).
With respect to claim 14, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the peripheral carrier portion (identified in annotated fig 1) further comprises a peripheral carrier tab extending into the second dressing
area (tab 33; see annotated fig 1).
With respect to claim 15, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the peripheral carrier portion (identified in annotated fig 1) extends to the dressing perimeter (as shown in figures 1-2, the carrier 27 extends to perimeter 15).
With respect to claims 17 and 18, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses a method of applying the dressing comprising the steps of: placing the pressure sensitive adhesive of the conformable dressing body onto a surface (col 2 lines 1-3; col 15 line 55- col 16 line 64) and removing the central and peripheral carrier portions (col 10 lines 40-59).
With respect to claim 19, Ha in view of Kelvered and further in view of Holm discloses the method substantially as claimed (see rejection of claim 17) and Ha also discloses the step of pulling the central carrier tab to remove the central carrier portion (col 10 lines 52-59).
With respect to claim 20, Ha in view of Kelvered and further in view of Holm discloses the method substantially as claimed (see rejection of claim 17) and Ha also discloses the step of pulling the peripheral carrier tab to remove the peripheral carrier portion (col 10 lines 52-59).
With respect to claim 21, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body (14) is a high moisture vapor permeable film (col 9 lines 51-53; col 13 lines 48-51).
With respect to claim 22, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body has a moisture vapor transmission rate of at least 300 g/m²/24 hrs/37°C/100-10% RH (col 13 lines 53-58).
With respect to claim 23, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body has a moisture vapor transmission rate of at least 700 g/m²/24 hrs/37°C/100-10% RH (col 13 lines 53-58).
With respect to claim 24, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body has a moisture vapor transmission rate of at least 2000 g/m²/24 hrs/37°C/100-10% RH (col 13 lines 53-58).
With respect to claim 25, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses that the conformable dressing body (14) is transparent (the backing 14 is typically transparent allowing the wound and/or surrounding skin to be viewed through it – col 8 lines 2-4; col 13 lines 46-48).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ha et al (US 9168180) in view of Kelvered et al (US 9327098) and Holm et al (US 9452087) and further in view of Heinecke et al (US 6685682).
With respect to claim 9, Ha in view of Kelvered and further in view of Holm discloses the dressing substantially as claimed (see rejection of claim 1) and Ha also discloses the dressing further comprising an absorbent (an absorbent material can be used in conjunction with the dressing – col 16 line 66 – col 17 line 8). Ha does not, however, explicitly disclose that the absorbent is on the bottom major surface.
Heinecke, however, teaches a medical dressing (dressing 21; figs 2A-2B) comprising:
a dressing body (backing 24) having a top major surface (surface facing frame 22) and a bottom major surface (surface facing adhesive 26) opposite the top major surface (as shown in figures 2A-2B), and a dressing perimeter (outer peripheral edge of backing 24 shown in figures 2A-2B) defining a dressing area (area disposed interiorly of the perimeter is interpreted as being the dressing area), wherein the dressing area has a first dressing area (area of backing 24 that is covered by frame 22 around the perimeter) and a second dressing area (area of backing 24 located where window area 25 is provided as shown in fig 2A);
a pressure sensitive adhesive (adhesive 26; PSA – col 4 lines 35-45) on at least a portion of the bottom major surface of the dressing body (adhesive 26 is provided on at least a portion of the bottom surface of backing 24 – col 3 lines 31-33);
a carrier (frame 22) releasably secured to the top major surface of the dressing body (col 3 lines 34-36), wherein the carrier (22) comprises a peripheral carrier portion (configured as a frame that extends around the perimeter of backing 24 – col 8 lines 47-49; fig 2A);
wherein the peripheral carrier portion is adjacent to the perimeter of the dressing body (fig 2A; col 8 lines 47-49);
wherein the second dressing area is free of the carrier (area at window 25 is not covered by carrier frame 22 as shown in fig 2A).
Heinecke also teaches an absorbent on the bottom major surface (absorbent pad 29 attached to the bottom surface of backing 24 via adhesive 26 as shown in fig 2B). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an absorbent material like the absorbent pad 29 of Heinecke to the bottom surface of the device of Ha in view of Kelvered in order to permit removal of fluids and wound exudate from a wound site and/or for application of antimicrobial agents or drugs.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 8/13/25 have been fully considered as follows:
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 6-10 of the Response have been fully considered but are ineffective to overcome the rejections of record.
Specifically, the Office has noted Applicant’s arguments on page 7 that the Ha reference does not teach or suggest a conformable dressing body as claimed because nothing in Ha et al. teaches or suggests that the alleged backing of Ha et al. is conformable and because Ha et al. teaches a self-supporting substrate 12 that forms a part of the dressing area wherein a self-supporting substrate is not conformable. The Office is not persuaded by these arguments, however, because the Office has interpreted the backing layer 14 of Ha as being equivalent to the claimed dressing body and Ha explicitly discloses that the backing material of the dressing is a “conformable” backing (col 13 lines 30-34). For at least this reason, the Office is not persuaded by this argument.
The Office has also noted Applicant’s arguments on page 8 that it is “unclear that the first dressing area is defined by the dressing perimeter and that the second dressing area is defined by the area within the first dressing area because there is a clear gap between portions of the second dressing area 14 where a self-supporting substrate 12 is located”. The Office is not persuaded by this argument, however, because there are no limitations in the claims which require the dressing body to be a continuous structure or which prevent the structure from including an opening such as the cavity 25 in Ha. Additionally, the opening at the center of the backing layer 14 does not negate the fact that the layer still includes a first area at the perimeter and a second area located interiorly of the perimeter, adjacent to the central opening, as identified in the annotated figures provided in the claim rejections above. For at least this reason, the Office is not persuaded by this argument.
The Office has also noted Applicant’s arguments on pages 8-9 regarding the claimed carrier and fixation strip, but these arguments are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
The Office has also noted Applicant’s arguments on page 10 regarding claim 9 but for at least the same reasons as provided above with respect to claim 1, the Office is not persuaded by these arguments.
Therefore, for at least the reasons outlined above, the Office is not persuaded by Applicant’s arguments and, therefore, maintains that the prior art of record reads on the claims substantially as recited in the present application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786