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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/20/2025 has been entered.
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.
Claims 1-4, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US9566417B1)(please see "US9566417B1_Description.pdf") in view of Vo et al. (US 20210177456 A1) in further view of Propp (US 20070073211 A1), hereinafter Propp-2.
Regarding Claim 1, Propp discloses a skin protection and intravenous catheter securement dressing assembly (integrated antimicrobial dressing 110, Fig 1-3), comprising: a dressing body (transparent film layer 112 + window 118, Fig 1and 2C) comprising a plastic film (transparent film layer 112, Fig 2C) with a transparent window (viewing portion window 118, Fig 1), a first surface (top side 114, Fig 2A), and a second surface (bottom side 116, Fig 2A) having a first adhesive layer (adhesive portion 120, Fig 2C), said plastic film (112) having a recessed portion (160, Annotated Fig 1) midway along one edge (161, Annotated Fig 1); two juxtaposed (Fig 2C) removable release liner strips (first release liner member 144, release liner second member 146, Fig 2C; [0046], [0063]) covering the first adhesive layer (Fig 2C; [0046]); a foam pad (antimicrobial member 124, Fig 1) with a second adhesive layer ([0043]: “The antimicrobial member bottom side 128 may include an adhesive thereon, and the antimicrobial member bottom side may include both an adhesive portion and an adhesive-free portion adjacent the slit 138 or slot 140”), a fixed end (portion 130, Fig 2C) thereof hingedly connected to the first adhesive layer (120) of the dressing body (112+118) (Fig 2B) ([0041]); a removable release liner tab (third member 148, Fig 2C) covering the second adhesive layer (Fig 2C shows the section covered under third member 148; [0063]); wherein, when in a use position, and the second adhesive layer adheres the foam pad directly to a patient's skin ([0043])
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However Propp is silent regarding a removable release liner frame covering a perimeter of the first surface; and an adhesive strip removably attached to the removable release liner frame; catheter hub or line is intravenous (IV); the foam pad is positioned under an intravenous (IV) catheter hub such that the entire IV catheter hub rests on the foam pad.
Vo teaches skin protection and intravenous catheter ([0025]) securement dressing assembly (window dressing 100, Fig 1) comprising a removable release liner frame (support structure 110, Fig 2) covering a perimeter of the first surface (primary layer 102, Fig 2) ([0034]: “support structure 110 to be adhered to the upper surface 104 of the primary layer 102”); and an adhesive strip (closure strips 112, Fig 2) removably attached to the removable release liner frame (110) ([0030])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp with a similar liner frame and strips and configured to be used with intravenous type catheters as taught by Vo for the to provide for increased support for the dressing and securement of the tubing against the patient's skin or placed underneath the tubing to further secure a side edge of the window dressing against the patient's skin ([0030]); and be used to secured intravenous catheter ([0025]).
Propp/Vo are silent wherein the foam pad is positioned under an intravenous catheter hub such that the entire IV catheter hub rests on the foam pad.
Propp-2 teaches a skin protection and intravenous catheter securement dressing assembly (cushioned securement device 10) comprising a foam pad (foam pad 12, Fig 1; [0010]) is positioned under an intravenous catheter hub (catheter hub 60, Fig 6) such that the entire IV catheter hub rests on the foam pad (Fig 6 shows the entire catheter hub 60 resting on the pad 12).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the size and shape of the foam pad of device of Propp/Vo similarly covering the entire surface of the hub as taught by Propp-2 for the purpose of providing cushioning to maximize patient comfort ([0021]).
Regarding Claim 2, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses wherein the fixed end (130) is positioned such that at least part of the foam pad (124) rests within an area visible through the transparent window (118) ([0040: “The adhesive-free portion 122 is disposed within the insertion site viewing portion 118.”; Fig 1 shows the foam pad 124 within a visible area through window 118.)
Regarding Claim 3, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses wherein the recessed portion (160, Annotated Fig 1) is configured to accommodate a portion of the IV line ([0062]-[0063]]; recess portion is structurally capable of accommodate a portion of an IV line; see also modification of Propp/Vo of claim 1)
Regarding Claim 4, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp configured to accommodate a portion of the catheter hub and/or the line between the foam pad and the transparent window ([0063]: “a 20 to 30 degree turn of the dressing 110 can be made at this point, in order to lay the catheter lumen on top of the antimicrobial member 124”; catheter lumen after 20–30-degree turn is located between the foam pad 124 and the window 138). Propp is silent regarding the catheter hub or line is intravenous (IV).
Vo teaches skin protection and intravenous catheter securement dressing assembly (window dressing 100, Fig 1) ([0025]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp/Vo/Propp-2 to be used with intravenous catheters as taught by Vo for the purpose of securing a venous catheter ([0025]).
Regarding Claim 7, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses wherein the dressing body has a substantially flattened capital letter "A" shape having a pair of stems (1000, Annotated Fig 3) joined by a crossbar (1001, Annotated Fig 3) and the recessed portion (160, Annotated Fig 1) is formed between the pair of stems (1000, Annotated Fig 3). Propp is silent regarding further comprising a counter formed above the crossbar, wherein the counter contains the transparent window
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Vo teaches skin protection and intravenous catheter ([0025]) securement dressing assembly (window dressing 100, Fig 1); the dressing body has a substantially flattened capital letter "A" shape having a pair of stems (2000, Annotated Fig 4) joined by a crossbar (2001, Annotated Fig 4) and the recessed portion (120, Annotated Fig 4) is formed between the pair of stems (2000, Annotated Fig 4) a counter (2002, Annotated Fig 4) formed above the crossbar (2001, Annotated Fig 4), wherein the counter (2002) contains the transparent window (118).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp/Vo/Propp-2 with similar shape of the dressing body having a counter containing the transparent window as taught by Vo for the purpose of having an increased viewing area which would make easier for the user to perform the procedure ([0027]).
Regarding Claim 8, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses wherein the foam (124) pad has a substantially rectangular shape with a rounded corner (Annotated Fig 5).
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Regarding Claim 9, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp is silent wherein the removable release liner frame has a substantially rectangular portion, a first corner of a substantially triangular portion extending from an elongated edge of the substantially rectangular portion, a first arm extending from a second corner of the substantially triangular portion, and a second arm extending from a third corner of the substantially triangular portion.
Vo teaches a skin protection and intravenous catheter ([0025]) securement dressing assembly (window dressing 100, Fig 1) comprising a removable release liner frame (support structure 110, Fig 2) covering a perimeter of the first surface (primary layer 102, Fig 2) ([0034]: “support structure 110 to be adhered to the upper surface 104 of the primary layer 102”); wherein the removable release liner frame (110) has a substantially rectangular portion (2003, Annotated Fig 6), a first corner (2004, Annotated Fig 6) of a substantially triangular portion (2005, Annotated Fig 6) extending from an elongated edge (2006, Annotated Fig 6) of the substantially rectangular portion (2003, Annotated Fig 6), a first arm (2007, Annotated Fig 6) extending from a second corner (2008, Annotated Fig 6) of the substantially triangular portion (2004, Annotated Fig 6), and a second arm (2009, Annotated Fig 6) extending from a third corner (2010, Annotated Fig 6) of the substantially triangular portion (2005, Annotated Fig 6).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp/Vo/Propp-2 with the shape teaching of the liner frame as taught by Vo for the purpose of providing support to the dressing and area for placement of adhesive strips for further securing the catheter ([0030]).
Regarding Claim 10, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 9. Propp is silent wherein the first arm has a substantially L-shaped configuration and the second arm is a mirror image of the first arm
Vo discloses wherein the first arm (2007, Annotated Fig 6) has a substantially L-shaped configuration and the second arm is a mirror image of the first arm (Annotated Fig 6)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp/Vo/Propp-2 with the shape teaching of the liner frame as taught by Vo for the purpose of providing support to the dressing and area for placement of adhesive strips for further securing the catheter ([0030]).
Regarding Claim 11, Propp/Vo/Propp-2 discloses the dressing assembly of claim 1. Propp is silent wherein the foam pad prevents direct contact between the IV catheter hub and the patient's skin.
Propp-2 teaches a skin protection and intravenous catheter securement dressing assembly (cushioned securement device 10) comprising a foam pad (foam pad 12, Fig 1; [0010]) is positioned under an intravenous catheter hub (catheter hub 60, Fig 6) such that the entire IV catheter hub rests on the foam pad (Fig 6 shows the entire catheter hub 60 resting on the pad 12); wherein the foam pad (12) prevents direct contact between the IV catheter hub (60) and the patient's skin (Fig 5).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the size and shape of the foam pad of device of Propp/Vo/Propp-2 similarly covering the entire surface of the hub and preventing direct contact with the skin as taught by Propp-2 for the purpose of providing cushioning to maximize patient comfort ([0021]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Propp (US9566417B1)(please see "US9566417B1_Description.pdf") in view of Vo et al. (US 20210177456 A1) in further view of Propp (US 20070073211 A1), hereinafter Propp-2, in view of Hanson et al. (US 20160193452 A1).
Regarding Claim 6, Propp/Vo/Propp-2 discloses the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses the plastic film (112) is operative to retain the catheter hub in the use position (Col 10 line 65 – Col 11, line 6; plastic film 112 of dressing 110, Fig 2 is disposed over the hub and retained to the skin through adhesive layer of the film); and the transparent window (118) is operative to provide visibility of the patient's skin for a visual assessment (Skin of user is visible through transparent window, Fig 1)
Propp is silent regarding the catheter hub or line is intravenous (IV); wherein the foam pad is operative to space the catheter hub from the patient's skin reducing pressure on the patient's skin; and the transparent window is operative to provide visibility of the IV catheter hub
Vo teaches skin protection and intravenous catheter securement dressing assembly (window dressing 100, Fig 1) ([0025])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Propp/Vo/Propp-2 to be used with intravenous catheters as taught by Vo for the purpose of securing a venous catheter ([0025]).
Propp/Vo are silent wherein the foam pad is operative to space the catheter hub from the patient's skin reducing pressure on the patient's skin; and the transparent window is operative to provide visibility of the IV catheter hub.
Propp-2 teaches a skin protection and intravenous catheter securement dressing assembly (cushioned securement device 10) comprising a foam pad (foam pad 12, Fig 1; [0010]) is positioned under an intravenous catheter hub (catheter hub 60, Fig 6) such that the entire IV catheter hub rests on the foam pad (Fig 6 shows the entire catheter hub 60 resting on the pad 12); the foam pad (12) is operative to space the catheter hub (60) from the patient's skin reducing pressure on the patient's skin (Fig 6)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the size and shape of the foam pad of device of Propp/Vo similarly covering the entire surface of the hub as taught by Propp-2 for the purpose of providing cushioning to maximize patient comfort ([0021]).
Propp/Vo/Propp-2 are silent wherein the transparent window is operative to provide visibility of the IV catheter hub.
Hanson teaches a skin protection and intravenous catheter securement dressing assembly (medical dressing 100, Fig 5) comprising a transparent window (transparent window 109, Fig 5) is operative to provide visibility of the IV catheter hub (catheter hub 64, Fig 5).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify transparent window of device of Propp/Vo/Propp-2 with similar window size structurally capable of providing visibility to the catheter hub as taught by Hanson for monitoring purposes while the medical dressing is coupled to the patient without having to remove the medical dressing ([0030]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Propp (US9566417B1) (please see "US9566417B1_Description.pdf") in view of Vo et al. (US 20210177456 A1) in further view of Propp (US 20070073211 A1), hereinafter Propp-2.
Regarding Claim 5, Propp/Vo/Propp-2 discloses a method for securing an intravenous catheter to a subject with a pressure relieving dressing the method comprising: providing the skin protection and intravenous catheter securement dressing assembly of claim 1. Propp discloses removing the removable release liner tab (148)([0063]); removing the two juxtaposed removable release liner strips sequentially (liners 144 and 146 are removed sequentially ([0063]); centering the line in the recessed portion (Annotated Fig 2 shows the line being centered in the recess portion of the dressing assembly); adhering the plastic film (112) over the catheter hub (Col 11, lines 2-6).
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Propp is silent regarding the catheter being an intravenous (IV) catheter; placing the foam pad on the patient's skin under an IV catheter hub; the entire IV catheter hub rests on top of the foam pad; removing the adhesive strip from the removable release liner frame; removing the removable release liner frame from the plastic film; and adhering the adhesive strip to the subject over the IV line.
Vo teaches a method for securing an intravenous catheter skin protection and intravenous catheter ([0025]) securement dressing assembly (window dressing 100, Fig 1) comprising a removable release liner frame (support structure 110, Fig 2) and an adhesive strip (closure strips 112, Fig 2) removably attached to the removable release liner frame (110) ([0030]); removing the adhesive strip (112) from the removable release liner frame (110) ([0030]); removing the removable release liner frame (110) from the plastic film (104) ([0036]); and adhering the adhesive strip (112)to the subject over the IV line ([0030]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Propp to use a similar IV catheter and liner frame and adhesive strips as taught Vo for the purpose of providing support to the dressing and secure the IV catheter line ([0030]).
Propp/Vo are silent regarding placing the foam pad on the patient's skin under the IV catheter hub; the entire IV catheter hub rests on top of the foam pad.
Propp-2 teaches a method for securing an intravenous catheter skin protection and intravenous catheter (catheter 56, Fig 6) comprising placing a foam pad (foam pad 12, Fig 1; [0010]) on the patient's skin under the IV catheter hub (catheter hub 60, Fig 6); the entire IV catheter hub (60) rests on top of the foam pad (Fig 6 shows the entire catheter hub 60 resting on top of the pad 12).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the size and shape of the foam pad of method of Propp/Vo similarly covering the entire surface of the hub as taught by Propp-2 for the purpose of providing cushioning to maximize patient comfort ([0021]).
Response to Arguments
Applicant’s arguments with respect to claims 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783