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 .
Specification
The abstract of the disclosure is objected to because it exceeds 150 words in length. See MPEP 608.01 (b) for guidelines for preparation of an abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim(s) 38, 42, 48-49, 55, 62, 70-71, 75, 77-78, 81, 90-91, 97, 105, 111-112 and 114-115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 9566417) in view of Fabo (US 2010/0069850).
Regarding claim 38, Propp discloses a dressing (110) for use with a percutaneous medical device (C) (Fig.23, col. 10, lines 29-39) for insertion through skin of a patient at a skin-insertion site (I) (col. 1, lines 20-30; col. 10, lines 29-39), the dressing comprising: an upper layer (114, 112) (annotated Fig. 2A below),
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which (a) defines an insertion area (124) (col. 10, lines 29-39; Fig. 23; 124 is an area in which the catheter is inserted) having a non-adhesive skin-facing surface (122) configured to be positioned above the skin-insertion site (Fig. 2A; NOTE: surface 122 is above portion of opening 136 and insertion site I is generally in the opening 136), and (b) is configured to allow passage of the percutaneous medical device through the insertion area (Fig. 23; col. 10, lines 29-39); an adhesive area (120), which is disposed around at least a portion of a perimeter of the insertion area (col. 4, lines 24-44; NOTE: 122 is a perimeter of the insertion area as seen in Fig. 1 and it is also a non-adhesive skin facing surface and the adhesive area is disposed around it), and which has a skin-facing surface coated with an adhesive (col. 11, lines 9-26), wherein the insertion area is shaped so as to define an insertion chamber (132) (col. 6, lines 11-43, NOTE: it is a part of the insertion area and is a chamber in that it is an enclosed space i.e. it holds and delivers active agent and has sides that enclose it) between the non-adhesive skin-facing surface and the skin (annotated Fig. 2A) when the dressing is adhered to the skin by at least a portion of the adhesive area (annotated Fig 2A; capable of intended use; col. 11, lines 9-15); and one or more passages (col. 1, lines 13-17, lines 59-65; NOTE: catheter C has a passage within it).
Propp does not disclose a fillable insertion chamber; a flowable substance; one or more reservoirs, which are separate from the fillable insertion chamber, and contain the flowable substance; and one or more passages connecting the one or more reservoirs of the flowable substance and the insertion area so as to enable flow of the flowable substance from the one or more reservoirs to the insertion area upon application of pressure to the one or more reservoirs.
Fabo teaches an analogous dressing (Fig. 4) ([0014]; [0017]) for use with an analogous percutaneous medical device (9) ([0037]), the analogous dressing comprising an analogous upper layer (10) which defines an analogous insertion area (5), wherein the insertion area is shaped so as to define a fillable insertion chamber ([0035]; [0047]; NOTE: body 5 is made of a soft fluid-distributing material and a tube supplies the body 5 which is thus a fillable enclosed space); a flowable substance ([0047]; irrigation fluid); one or more reservoirs (12), which are separate from the fillable insertion chamber (Fig. 4), and contain the flowable substance ([0047]); and one or more analogous passages (8) (inside of tube is a passage) connecting the one or more reservoirs of the flowable substance and the insertion area so as to enable flow of the flowable substance from the one or more reservoirs to the insertion area ([0047]; the fluid trickles into the cellular body 5 thus has a low flow) upon application of pressure to the one or more reservoirs ([0047]; NOTE: the irrigation fluid is sucked out of the container thus there is an application of negative pressure to the container [reservoir]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the insertion chamber of the dressing for use with a percutaneous medical device of Propp is a fillable chamber and to provide to the dressing of Propp a flowable substance; and one or more reservoirs, which are separate from the fillable insertion chamber, and contain the flowable substance; and one or more passages connecting the one or more reservoirs of the flowable substance and the insertion area so as to enable flow of the flowable substance from the one or more reservoirs to the insertion area upon application of pressure to the one or more reservoirs, as taught by Fabo, in order to provide an improved dressing that facilitates irrigation of a wound (Fabo, [0046]) and facilitates wound healing (Fabo, [0002]).
Regarding claim 42, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Fabo further teaches wherein the flowable substance comprises a substance selected from the group consisting of: a gel, a cream, and a liquid ([0044]; NOTE: irrigation fluid is a liquid).
Regarding claim 48, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
The combination further discloses wherein the adhesive area entirely surrounds the perimeter of the insertion area except at one or more locations at which the one or more passages connect to the insertion area (see Propp annotated Fig. 2A below; Fig. 1, col. 2, lines 32-44, the perimeter 122 of the insertion area is an adhesive free portion and the rest of the layer includes an adhesive portion thus the adhesive entirely surrounds the perimeter and in the combination with Fabo the passage from the irrigation fluid would connect to the insertion area), and
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wherein the upper layer is configured to allow passage of the percutaneous medical device through the insertion area by puncturing of the upper layer (Propp, col. 4, line 45 to col. 5, line 47; Propp, Abstract; Capable of intended use; As to claim 48, the limitation, “wherein the upper layer is configured to allow passage of the percutaneous medical device through the insertion area by puncturing of the upper layer” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Propp is silent as to the process used to form the puncture of the upper layer, the apparatus disclosed is the same as claimed as there is an opening 136 which could have been formed in various ways including a puncture and it is in the upper layer and configured for the passage of the percutaneous medical device).
Regarding claim 49, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
The combination further discloses wherein the adhesive area is a first adhesive area (annotated Fig. 2A with regard to the rejection to claim 48), and wherein the dressing comprises a second adhesive area that is configured to adhere the one or more reservoirs to the skin (Propp discloses a second adhesive area; see annotated Fig. 2A below; col. 4, lines 37-44; NOTE: in the combination Fabo teaches that the reservoir is connected to the analogous percutaneous medical device [tube] and that the tube is connected to the dressing [see Fabo Fig. 23 and also col. 10, lines 29-39] and the dressing is connected to the user and in Propp the dressing is adhered to the user at a first adhesive area and a second adhesive area [Propp, col. 11, lines 9-26] thus it would follow in the combination the reservoir is indirectly adhered to the skin via its connection to the second adhesive area which is adhered to the skin).
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Regarding claim 55, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp further discloses wherein the insertion area of the upper layer is shaped so as to define a slit (138) (Fig. 1) having first and second edges (Fig. 1, there are edges in the slit 138), wherein an adhesive-area slit-closing portion (148) (col. 6, line 44 to line 64; NOTE: the liner 148 closes the slit and is in an adhesive area) of the adhesive area (annotated Fig. 2C below)
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is disposed alongside at least the first edge of the slit (col. 6, line 44-64; NOTE: the release liners facilitate easy opening of the slit and reclosure of the slit and thus are disposed alongside [by] the slit and the first edge of the slit and the second edge of the slit; alongside is defined as “at the side; close by” merriamwebster.com and as the release liner is close by the first edge of the slit it is alongside it), and is configured to be adhered to an upper surface of an upper-layer slit-closing portion (144) (col. 6, line 44-64; adhered is defined as “to stay attached, dictionary.com “, NOTE: as the liner 148 is releasably mounted on a portion of the film layer it follows stays attached to the surface and is thus adhered and it is thus indirectly adhered to an upper surface of an upper-layer slit closing portion 144) of the upper layer (112) alongside the second edge of the slit (col. 6, line 44 to line 64; NOTE: the liner 144 connects to the liner 148 which closes the slit and thus it is alongside [close by] the first edge of the slit and is in an adhesive area and is close by the second edge of the slit), and wherein the upper layer (112) is configured to allow passage of the percutaneous medical device through the insertion area via an opening (136) through the insertion area (124) (col. 5, lines 36-47; col. 4, line 44 to col. 5, line 35; lumen encircling antimicrobial member encircles large diameter catheter or multi-lumen catheter) defined at a junction of respective inner ends of the first and the second edges of the slit, respectively (annotated Fig. 1 below).
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Regarding claim 62, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Fabo further teaches wherein the flowable substance comprises one or more agents selected from the group of agents consisting of: an antimicrobial agent and an antiseptic agent ([0051]).
Regarding claim 70, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp further discloses wherein the percutaneous medical device is a percutaneous-insertion instrument (see claim 71 which states a percutaneous instrument is a catheter; Propp Abstract indicates that the percutaneous medical device is a catheter; Fig. 23), and wherein the upper layer is configured to allow passage of the percutaneous-insertion instrument through the insertion area (Propp, Abstract, col. 1, line 54 to col. 2, line 2; col. 10, lines 29-39).
Regarding claim 71, Propp in view of Fabo discloses the invention as described above with regard to claim 70.
Propp further discloses wherein the percutaneous- insertion instrument is a tube selected from the group of tubes consisting of: a catheter and a cannula (see description above with regard to claim 70), and wherein the upper layer is configured to allow passage of the tube through the insertion area (col. 5, lines 36-47; Abstract; hole 136 is in the upper layer [Fig. 1, Fig. 2A] and the catheter/tube is inserted through the hole; capable of intended use).
Regarding claim 75, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp further discloses wherein the adhesive area is disposed around at least 70% of the perimeter of the insertion area (Fig. 1,col. 2, lines 32-44, the perimeter 122 of the insertion area is an adhesive free portion and the rest of the layer includes an adhesive portion thus an adhesive area is disposed around at least 70% of the perimeter of the insertion area as the adhesive portion is disposed around all of the perimeter of the insertion area).
Regarding claim 77, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp further discloses wherein the adhesive area entirely surrounds the perimeter of the insertion area (see description above with regard to claim 75), and wherein the upper layer is configured to allow passage of the percutaneous medical device through the insertion area (capable of intended use; col. 5, lines 36-47; Abstract; hole 136 is in the upper layer [Fig. 1, Fig. 2A] and the catheter/tube is inserted through the hole) by puncturing of the upper layer (Propp, col. 4, line 45 to col. 5, line 5; Capable of intended use; As to claim 77, the limitation, “wherein the upper layer is configured to allow passage of the percutaneous medical device through the insertion area by puncturing of the upper layer” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Propp is silent as to the process used to form the puncture of the upper layer, the apparatus disclosed is the same as claimed as there is an opening 136 which could have been formed in various ways including a puncture and it is in the upper layer and configured for the passage of the percutaneous medical device).
Regarding claim 78, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp further teaches wherein the one or more passages are connected to the insertion area via one or more openings through the insertion area the upper layer (col. 5, lines 27-47; col. 10, lines 29-39, catheter with a passage is connected to the area I via the opening in member 124).
Regarding claim 81, Propp in view of Fabo discloses the dressing as described above with regard to claim 38.
Propp further discloses wherein the upper layer defines, in addition to the insertion area, a peripheral area (Fig. 1, Fig. 2A; area outside of 122 is the peripheral area), which surrounds at least 50% of the perimeter of the insertion area (col. 4, lines 32-63, the adhesive area 120 surrounds all of the non adhesive area 122 as there are two portions in the dressing, an adhesive portion and a non adhesive portion 122), and wherein the peripheral area defines the skin-facing surface coated with the adhesive (Fig. 23, col. 11, lines 15-26).
Regarding claim 90, Propp in view of Fabo discloses the dressing as described above with regard to claim 38.
Propp further discloses wherein, when the adhesive area is adhered to the skin (col. 11, lines 15-26), the one or more passages are open to the skin (col. 10, lines 29-39, Fig. 23) such that the skin partially defines the one or more passages (col. 1, lines 21-65, catheter punctures a patient’s skin and thus the skin is connected to the catheter/passage and the skin partially defines the passage).
Regarding claim 91, Propp in view of Fabo discloses the dressing as described above with regard to claim 38.
Propp further discloses a removable protective backing (144, 146, 148) (col. 6, line 44-64) that removably covers (col. 6, lines 44-64) (a) the non-adhesive skin-facing surface of the insertion area (Fig. 2C, liners 144 and 146 cover non-adhesive skin-facing surface 122), (b) the adhesive area (Fig. 2C, liners 144, 146 cover adhesive portion 120), and (c) at least a portion of the one or more passages, so as to seal the one or more passages (col. 10, lines 40- 65, the liner 148 is removed exposing a middle portion of the dressing including the non adhered portion of member 124 thus implying that it covers the opening 136 and the opening 136 is a part of the passage as it is connected to the catheter inserted it thus the opening/passage is sealed with the liner 148).
Regarding claim 97, Propp in view of Fabo discloses the dressing as described above with regard to claim 38.
Fabo further teaches wherein the dressing comprises first (12) and second reservoirs (13), which contain respective first and second portions of the flowable substance ([0047], the reservoir 12 contains irrigation fluid and the reservoir 13 contains fluid that is sucked out which includes the flowable substance/irrigation fluid).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide wherein the dressing of Propp in view of Fabo comprises first and second reservoirs which contain respective first and second portions of flowable substance as taught by Fabo, in order to provide an improved dressing that facilitates healing of a wound (Fabo, [0002]).
Regarding claim 105, Propp in view of Fabo discloses the dressing as described above with regard to claim 38.
The combination further discloses a kit comprising the dressing, the kit further comprising the percutaneous medical device (kit is defined “as a set or collection of tools, supplies, instructional matter, etc., for a specific purpose”, dictionary.com; NOTE: the dressing of the combination is a set of supplies for a specific purpose and thus is a kit; Propp discloses a catheter [percutaneous medical device] as a part of the collection of supplies for the dressing).
Regarding claim 111, Propp discloses a method comprising: applying a dressing (110) to skin of a patient (col. 11, lines 9-16; Fig. 23) by: positioning, above a skin-insertion site, a non-adhesive skin-facing surface (122) (see annotated Fig. 2A with regard to claim 38 showing 122 above 124 depending on orientation) of an insertion area (124) (col. 10, lines 29-39; Fig. 23; 124 is an area in which the catheter is inserted) of an upper layer (112, 114) of the dressing (annotated Fig. 2A with regard to the claim 38 rejection), and adhering at least a portion of a skin-facing surface of an adhesive area (120) of the dressing to the skin (col. 11, lines 9-16), such that the insertion area is shaped so as to define a insertion chamber (132) (col. 6, lines 11-43, NOTE: it is a part of the insertion area and is a chamber in that it is an enclosed space i.e. it holds and delivers active agent and has sides that enclose it) between the non-adhesive skin-facing surface and the skin (annotated Fig. 2A with regard to the rejection to claim 38), wherein the adhesive area is disposed around at least a portion of a perimeter of the insertion area (col. 4, lines 24-44; NOTE: 122 is a perimeter of the insertion area as seen in Fig. 1 and 122 is also a non-adhesive skin facing surface) and is coated with an adhesive (col. 11, lines 9-15); causing a percutaneous medical device to pass through the insertion area (Fig. 23; Propp, col. 4, line 45 to col. 5, line 5; Propp Abstract); before or after causing the percutaneous medical device to pass through the insertion area (Propp, col. 4, line 45 to col. 5, line 47; Propp Abstract), passing the percutaneous medical device through the skin at the skin-insertion site (col. 7, lined 45-49).
Propp does not disclose a fillable insertion chamber and after applying the dressing to the skin, applying pressure to one or more reservoirs of the dressing that are separate from the fillable insertion chamber, such that a flowable substance contained within the one or more reservoirs flows from the one or more reservoirs to the fillable insertion chamber via one or more passages connecting the one or more reservoirs and the insertion area.
Fabo teaches an analogous dressing (Fig. 4) ([0014]; [0017]) for use with an analogous percutaneous medical device (9) ([0037]), the analogous dressing comprising an analogous upper layer (10) which defines an analogous insertion area (5), wherein the insertion area is shaped so as to define a fillable insertion chamber ([0035]; [0047]; NOTE: body 5 is made of a soft fluid-distributing material and a tube supplies the body 5 which is thus a fillable enclosed space); a flowable substance ([0047]; irrigation fluid); one or more reservoirs (12), which are separate from the fillable insertion chamber (Fig. 4), and contain the flowable substance ([0047]); and one or more analogous passages (8) (inside of tube is a passage) connecting the one or more reservoirs of the flowable substance and the insertion area and after applying the dressing to the skin ([0045]; [0046]; Fig. 4), applying pressure to one or more reservoirs of the dressing that are separate from the fillable insertion chamber ([0047]; NOTE: the irrigation fluid is sucked out of the container thus there is an application of negative pressure to the container [reservoir]), such that a flowable substance (irrigation fluid) contained within the one or more reservoirs ([0047]) flows from the one or more reservoirs to the fillable insertion chamber (Fig. 4, see arrow showing fluid going from reservoir 12 to fillable insertion chamber 5’ seen in Fig. 5) via one or more passages (8) connecting the one or more reservoirs and the insertion area (Fig. 4, Fig. 5).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the insertion chamber of the dressing of Propp is a fillable insertion chamber and after applying the dressing to the skin, applying pressure to one or more reservoirs of the dressing that are separate from the fillable insertion chamber, such that a flowable substance contained within the one or more reservoirs flows from the one or more reservoirs to the fillable insertion chamber via one or more passages connecting the one or more reservoirs and the insertion area, as taught by Fabo, in order to provide an improved method that facilitates irrigation of a wound ([0046]).
Regarding claim 112, Propp discloses a dressing (110) for covering an area of skin of a patient (capable of intended use), the dressing comprising: an upper layer (114, 112) (annotated Fig. 2A above with regard to claim 38), which defines a central area (124) (Fig. 1, area 124 is in a central location of the dressing) having a non-adhesive skin-facing surface (122) configured to be positioned above the skin area(Fig. 2A; NOTE: surface 122 is above portion of opening 136 and insertion site I is generally in the opening 136); an adhesive area (12), which is disposed around at least a portion of a perimeter of the central area(col. 4, lines 24-44; NOTE: 122 is a perimeter of the insertion area as seen in Fig. 1 and it is also a non-adhesive skin facing surface), and which has a skin-facing surface coated with an adhesive (col. 11, lines 9-26), wherein the central area is shaped so as to define a chamber between the non-adhesive skin-facing surface and the skin (annotated Fig. 2A with regard to claim 38; col. 6, lines 11-43, NOTE: it is a part of the insertion area and is a chamber in that it is an enclosed space i.e. it holds and delivers active agent and has sides that enclose it) when the dressing is adhered to the skin by at least a portion of the adhesive area (annotated Fig 2A; capable of intended use; col. 11, lines 9-26).
Propp does not disclose a fillable chamber; a flowable substance; one or more reservoirs, which are separate from the fillable chamber, and contain the flowable substance; and one or more passages connecting the one or more reservoirs of the flowable substance and the central area so as to enable flow of the flowable substance from the one or more reservoirs to the central area upon application of pressure to the one or more reservoirs.
Fabo teaches an analogous dressing (Fig. 4) ([0014]; [0017]) for use with an analogous percutaneous medical device (9) ([0037]), the analogous dressing comprising an analogous upper layer (10) which defines an analogous central area (5) (Fig. 1 is in a central area of the dressing), wherein the insertion area is shaped so as to define a fillable insertion chamber ([0035]; [0047]; NOTE: body 5 is made of a soft fluid-distributing material and a tube supplies the body 5 which is thus a fillable enclosed space); a flowable substance ([0047]; irrigation fluid); one or more reservoirs (12), which are separate from the fillable insertion chamber (Fig. 4), and contain the flowable substance ([0047]); and one or more analogous passages (8) connecting the one or more reservoirs of the flowable substance and the central area so as to enable flow of the flowable substance from the one or more reservoirs to the central area ([0047]; the fluid trickles into the cellular body 5 thus has a low flow) upon application of pressure to the one or more reservoirs ([0047]; NOTE: the irrigation fluid is sucked out of the container thus there is an application of negative pressure to the container [reservoir]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the insertion chamber of the dressing for use with a percutaneous medical device of Propp is a fillable chamber and to provide to the dressing of Propp a flowable substance; and one or more reservoirs, which are separate from the fillable chamber, and contain the flowable substance; and one or more passages connecting the one or more reservoirs of the flowable substance and the central area so as to enable flow of the flowable substance from the one or more reservoirs to the insertion area upon application of pressure to the one or more reservoirs, as taught by Fabo, in order to provide an improved dressing that facilitates irrigation of a wound ([0046]).
Regarding claim 114, Propp in view of Fabo discloses the invention as described above with regard to claim 111.
Prop further discloses wherein the insertion area of the upper layer is shaped so as to define a slit (138) having first and second edges (Fig. 1, there are edges in the slit 138), and an adhesive-area slit-closing portion (148) (col. 6, line 44 to line 64; NOTE: the liner 148 closes the slit and is in an adhesive area) of the adhesive area (annotated Fig. 2C above with regard to claim 55) is disposed alongside at least the first edge of the slit (col. 6, line 44-64; NOTE: the release liners facilitate easy opening of the slit and reclosure of the slit and thus are disposed alongside [by] the slit and the first edge of the slit and the second edge of the slit; alongside is defined as “at the side; close by” merriamwebster.com and as the release liner is close by the first edge of the slit it is alongside it), wherein causing the percutaneous medical device to pass through the insertion area comprises causing the percutaneous medical device to pass through the insertion area via an opening (136) through the insertion area (124) (col. 5, lines 36-47; col. 4, line 44 to col. 5, line 35; lumen encircling antimicrobial member encircles large diameter catheter or multi-lumen catheter) defined at a junction of respective inner ends of the first and the second edges of the slit, respectively (annotated Fig. 1 above with regard to claim 55), and wherein applying the dressing comprises adhering the adhesive-area slit-closing portion of the adhesive area to an upper surface (114) of an upper-layer slit-closing portion (144) (col. 6, line 44-64; adhered is defined as “to stay attached”,dictionary.com “NOTE: as the liner 148 is releasably mounted on a portion of the film layer it follows stays attached to the surface and is thus adhered) of the upper layer alongside the second edge of the slit (col. 6, line 44 to line 64; NOTE: the liner 144 connects to the liner 148 which closes the slit and thus it is alongside the first edge of the slit and is in an adhesive area and is close by the second edge of the slit)55.
Regarding claim 115, Propp in view of Fabo discloses the invention as described above with regard to claim 114.
Prop further discloses wherein causing the percutaneous medical device to pass through the insertion area via the opening comprises, after passing the percutaneous medical device through the skin at the skin-insertion site, positioning the first and the second edges of the slit around a longitudinal portion of the percutaneous medical device such that the percutaneous medical device passes through the opening (col. 5, lines 25-35, lines 36-47, col. 10, line 29 to col. 11 , line 26; col. 10, lines 60-65, the slit flexes open and encircles and the closes back around and under a catheter lumen and the lumen is fully disposed in the opening 136).
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 9566417) in view of Fabo (US 2010/0069850) as applied to claim 38, and in further view of Detwiler (US 2023/0414491).
Regarding claim 64, Propp in view of Fabo discloses the invention as described above with regard to claim 38.
Propp in view of Fabo does not disclose wherein the flowable substance is a glue.
Detwiler teaches an analogous dressing and an analogous flowable substance wherein the flowable substance is a glue ([0059]; antimicrobial component includes a combination of a solution and a glue).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the flowable substance of the dressing of Propp in view of Fabo comprise a glue as taught by Detwiler in order to provide an improved dressing that provides supplemental antimicrobial components (Detwiler, [0059]).
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 9566417) in view of Fabo (US 2010/0069850) as applied to claim 70 above, and in further view of Burkholz (US 2018/0289921).
Regarding claim 73, Propp in view of Fabo discloses the invention as described above.
Propp further discloses wherein the upper layer is configured to allow passage of the selected instrument through the insertion area ((Propp, Abstract, col. 1, line 54 to col. 2, line 2; col. 10, lines 29-39).
Propp in view of Fabo does not disclose wherein the percutaneous-insertion instrument is selected from the group of instruments consisting of: a cable and a wire, and wherein the upper layer is configured to allow passage of the selected instrument through the insertion area.
Burkholz teaches an analogous dressing having an analogous insertion area (24) ([0022]), an analogous percutaneous-insertion (12) instrument selected from rom the group of instruments consisting of: a cable and a wire ([0018]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the percutaneous-insertion instrument of the dressing of Propp in view of Fabo is selected from the group of instruments consisting of: a cable and a wire, as taught by Burkholz, in order to provide an improved dressing that facilitates securement of alternative vascular devices (Burkholz, [0018]).
Allowable Subject Matter
Claims 56-58, 66, 68, 83 and 116-117 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/G.M./ Examiner, Art Unit 3786
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786