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 § 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, 18, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 5538500 A) in view of Keinan et al. (US 10507139 B2), hereinafter referred to as “Keinan”.
Regarding Claim 1, Peterson teaches a wound dressing system (dressing 10, see Figures 1-2) comprising:
a bandage (bandage wrap 12); and
a dressing (wound covering section 14) forming a patient-contacting face (section 14 is wound covering, see Col. 3 ln 23-26) that defines an interior wound-contacting portion (gauze mesh 26) and a peripheral adhesive portion (tape 28), the peripheral adhesive portion at least partially surrounding the interior wound-contacting portion (see Figure 1), with a removable outer cover overlying the peripheral adhesive portion (a sterile covering over the gauze mesh prior to use of the dressing; the covering is removed at the time of use to expose the gauze mesh, see Col. 5 ln 29-34).
However, Peterson does not explicitly disclose a outer cover comprising a dressing pad.
Keinan teaches a wound dressing system (400, see Figure 4) comprising an interior wound contacting portion having a dressing pad (absorbent layer 407) and a outer cover (wrapping 401) comprising a dressing pad (absorbent layer 406).
Peterson and Keinan are analogous art because both teach a wound dressing system for treating wounds.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the removable outer cover of Peterson and further include a dressing pad, as taught by Keinan. Keinan teaches the additional dressing pad may be used to treat a complex wound having an entry and an exit wound, such as, but not limited to, a bullet wound, an amputation, a large area wound or a multiple injuries wound (see Col. 7 ln 17-32).
Regarding Claim 3, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches in which the interior wound-contacting portion comprises a dressing pad (gauze mesh 26 makes up the interior wound-contacting portion, Figure 1).
Regarding Claim 18, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches in which the bandage comprises a dressing pad (an absorbent pad 24 which is affixed to the interior surface of the wound-covering section of bandage wrap 12, see Figure 1).
Regarding Claim 36, Peterson teaches a wound dressing system (dressing 10, see Figures 1-2), comprising:
a dressing (wound covering section 14) forming a patient-contacting face(section 14 is wound covering, see Col. 3 ln 23-26) that defines an interior wound-contacting portion (gauze mesh 26) and a peripheral adhesive portion (tape 28), the peripheral adhesive portion at least partially surrounding the interior wound-contacting portion (see Figure 1), with a removable outer cover overlying the peripheral adhesive portion (a sterile covering over the gauze mesh prior to use of the dressing; the covering is removed at the time of use to expose the gauze mesh, see Col. 5 ln 29-34).
However, Peterson does not explicitly disclose the removable outer cover having a dressing pad.
Keinan teaches a wound dressing system (400, see Figure 4) comprising an interior wound contacting portion having a dressing pad (absorbent layer 407) and a outer cover (wrapping 401) comprising a dressing pad (absorbent layer 406).
Peterson and Keinan are analogous art because both teach a wound dressing system for treating wounds.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the removable outer cover of Peterson and further include a dressing pad, as taught by Keinan. Keinan teaches the additional dressing pad may be used to treat a complex wound having an entry and an exit wound, such as, but not limited to, a bullet wound, an amputation, a large area wound or a multiple injuries wound (see Col. 7 ln 17-32).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 5538500 A) in view of Turngren et al. (US 5891078 A), hereinafter referred to as “Turngren”.
Regarding Claim 41, Peterson teaches a wound dressing system (dressing 10, see Figures 1-2) comprising:
a bandage (bandage wrap 12); and
a dressing (wound covering section 14) having:
an adhesive layer (tape 28);
a removable outer cover layer overlying the adhesive layer (a sterile covering over the gauze mesh prior to use of the dressing; the covering is removed at the time of use to expose the gauze mesh, see Col. 5 ln 29-34); and
a dressing pad layer overlying the removable outer cover layer (gauze 26, see Figure 2).
However, Peterson does not explicitly disclose in which the removable outer cover layer and the dressing pad layer are cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions.
Turngren teaches a sterile delivery system for delivering an adhesive strip or bandage (see Abstract; Figures 1-8) in which the removable outer cover layer (outer surrounding frame 16 and carrier member 18, see Figures 5-6) and the dressing pad layer (wound pad 20) are cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions (a first die 56 of known construction having a predetermined shape die cut/kiss cuts through the wound pad 20 and web roll 38 but short of the release backing; the planar outer surrounding frame and inner strip are thus defined, see Figure 6 and 9-10; see Col. 8 ln 1-11).
Peterson and Turngren are analogous art because both teach a wound dressing system comprising a bandage.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the removable outer cover layer and dressing pad layer to be cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions, as taught by Turngren. Turngren teaches to provide a sterile delivery device including an external packaging, whereby a sterile adhesive thin film, strip or bandage may be removed from the external package and applied with a single hand without any contaminating contact to the adhesive strip and to provide a method for manufacturing a continuous roll of interconnected bandages that may be separated individually, dispensed, and applied by the user using only one hand (see Col. 4 ln 16-21, ln 30-33).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson and Keinan as applied to claim 1 above, and further in view of Turngren (US 5891078 A).
Regarding Claim 5, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches in which the dressing is formed by: an adhesive layer defining the peripheral adhesive portion (tape 28 is an adhesive layer); a removable outer cover layer defining the removable outer cover (the covering is removed at the time of use to expose the gauze mesh, see Col. 5 ln 29-34); and a dressing pad layer overlying the removable outer cover layer (absorbent pad 24 overlying the covering, see Figure 2).
However, Modified Peterson does not explicitly disclose in which the removable outer cover layer and the dressing pad layer are cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions, with the interior portion of the dressing pad layer defining the interior wound-contacting portion, and the peripheral portion defining a peripheral wound-contacting portion.
Turngren teaches a sterile delivery system for delivering an adhesive strip or bandage (see Abstract; Figures 1-8) in which the removable outer cover layer (outer surrounding frame 16 and carrier member 18, see Figures 5-6) and the dressing pad layer (wound pad 20) are cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions (a first die 56 of known construction having a predetermined shape die cut/kiss cuts through the wound pad 20 and web roll 38 but short of the release backing; the planar outer surrounding frame and inner strip are thus defined, see Figure 6 and 9-10; see Col. 8 ln 1-11), with the interior portion of the dressing pad layer defining the interior wound-contacting portion (wound pad 20), and the peripheral portion defining a peripheral wound-contacting portion (flexible adhesive strip 14).
Peterson, Keinan, and Turngren are analogous art because all teach a wound dressing system comprising a bandage.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the removable outer cover layer and dressing pad layer to be cut along aligned interior paths to separate the removable outer cover layer and the dressing pad layer into interior and peripheral portions, as taught by Turngren. Turngren teaches to provide a sterile delivery device including an external packaging, whereby a sterile adhesive thin film, strip or bandage may be removed from the external package and applied with a single hand without any contaminating contact to the adhesive strip and to provide a method for manufacturing a continuous roll of interconnected bandages that may be separated individually, dispensed, and applied by the user using only one hand (see Col. 4 ln 16-21, ln 30-33).
Claims 6 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson and Keinan as applied to claims 1 and 36 above, and further in view of Purcell et al. (US 20050049537 A1), hereinafter referred to as “Purcell”.
Regarding Claim 6, Peterson and Keinan teach all of the limitations, as discussed above in claim 1. However, Modified Peterson does not explicitly disclose in which the peripheral adhesive portion comprises hydrogel.
Purcell teaches a wound dressing system (flexible wrap 10) in which the peripheral adhesive portion comprises hydrogel (adhesive layer 12 may be a hydrogel, see Paragraph [0037]).
Peterson, Keinan, and Purcell are analogous art because all teaches a dressing wrapped around an injured area on a body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the peripheral adhesive portion of Modified Peterson and further include in which the peripheral adhesive portion comprises hydrogel, as taught by Purcell. Purcell teaches some adhesives may be adapted to be detachably mounted directly to skin on the body (see Paragraph [0037]).
Regarding Claim 40, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches the interior wound-contacting portion comprises a non-adherent gauze dressing pad (non-adherent gauze mesh 26, see Figure 1; Col. 2 ln 53-55).
However, Peterson does not explicitly disclose wherein the peripheral adhesive portion comprising hydrogel.
Purcell teaches a wound dressing system (flexible wrap 10) in which the peripheral adhesive portion comprises hydrogel (adhesive layer 12 may be a hydrogel, see Paragraph [0037]).
Peterson, Keinan, and Purcell are analogous art because all teaches a dressing wrapped around an injured area on a body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the peripheral adhesive portion of Modified Peterson and further include in which the peripheral adhesive portion comprises hydrogel, as taught by Purcell. Purcell teaches some adhesives may be adapted to be detachably mounted directly to skin on the body (see Paragraph [0037]).
Claims 9 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson and Keinan as applied to claim 1 above, and further in view of Dozier et al. (US 7135606 B1), hereinafter referred to as “Dozier”.
Regarding Claim 9, Peterson and Keinan teach all of the limitations, as discussed above in claim 1. However, Modified Peterson does not explicitly disclose in which the removable outer cover comprises a tab.
Dozier teaches a wound dressing system (10, see Figure 1) comprising a removable outer cover (release sheet 20) in which the removable outer cover comprises a tab (engagement tab 21).
Peterson, Keinan, and Dozier are analogous art because all teach a wound dressing system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the removable outer cover of Modified Peterson and further include in which the removable outer cover comprises a tab, as taught by Dozier. Dozier teaches this allows for a simple and effective placement and deployment of the wound dressing of the invention, taking advantage of the unique support and enclosure frame and integral frangible release sheet (see Col. 3 ln 4-7).
Regarding Claim 27, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches the adhesive portion (tape 28). However, Modified Peterson does not explicitly disclose in which the adhesive tail portion has a removable outer tail portion cover, wherein the removable outer tail portion cover preferably comprises a tab.
Dozier teaches a wound dressing system (10, see Figure 1) comprising in which the adhesive portion (18) has a removable outer tail portion cover (specialized release sheet 20), wherein the removable outer tail portion cover preferably comprises a tab (engagement tab 21, see Figure 3).
Peterson, Keinan, and Dozier are analogous art because all teach a wound dressing system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the adhesive portion of Modified Peterson and further include an adhesive tail portion having a removable outer tail portion cover, wherein the removable outer tail portion cover preferably comprises a tab, as taught by Dozier. Dozier teaches this allows for a simple and effective placement and deployment of the wound dressing of the invention, taking advantage of the unique support and enclosure frame and integral frangible release sheet (see Col. 3 ln 4-7).
Claims 10, 12-13 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson and Keinan as applied to claim 1 above, and further in view of Buteux et al. (US 20170105877 A1), hereinafter referred to as “Buteux”.
Regarding Claim 10, Peterson and Keinan teach all of the limitations, as discussed above in claim 1. However, Modified Peterson does not explicitly disclose in which the interior wound-contacting portion has a stadium shape.
Buteux teaches a wound dressing system (300) in which the interior wound-contacting portion has a stadium shape (wherein the shape of the pad 340 may be adjusted to any suitable shape, see Paragraph [0155]; Figure 6).
Peterson, Keinan, and Buteux teaches a wound dressing having an interior wound contacting portion.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the interior wound-contacting portion of Modified Peterson and further include in which the interior wound-contacting portion has a stadium shape, as taught by Buteux. Buteux teaches the dressing may be adjusted to any suitable shape, size and proportions for different applications (see Paragraph [0155]).
Regarding Claim 12, Peterson and Keinan teach all of the limitations, as discussed above in claim 1. However, Modified Peterson does not explicitly disclose in which the bandage is sized to extend at least one revolution around a patient’s torso.
Buteux teaches a wound dressing system (100) in which a bandage (20) is sized to extend at least one revolution around a patient’s torso (the dressing may be sized to wrap around a human torso, see Paragraph [0010]).
Peterson, Keinan, and Buteux teaches a wound dressing having a bandage to treat wounds.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the bandage of Modified Peterson and further include in which the bandage is sized to extend at least one revolution around a patient’s torso, as taught by Buteux. Buteux teaches the application is designed to be used for treatment of a wide variety of wounds and be substituted for dressings for simple traumatic wounds and for more complex and larger wounds (see Paragraph [0003]).
Regarding Claim 13, Modified Peterson teaches all of the limitations, as discussed above in claim 12 and Buteux further teaches in which the bandage has a length of at least forty eight inches to sixty inches (the length of the bandage 20 can be 2000-2200 mm, see Paragraph [0073]; 2000-2200 mm is equal to 78-86 inches).
Regarding Claim 31, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Keinan further teaches in which the interior wound-contacting portion is sized to cover a bullet wound (wound-dressing apparatus 400 comprising absorbent layer 406 may be used to treat a complex wound having an entry and an exit wound, such as, but not limited to, a bullet wound, see Col. 7 ln 12-15).
However, Modified Peterson does not explicitly disclose in which the interior wound-contacting portion having a minimum lateral dimension of two inches or more.
Buteux teaches a wound dressing system (300, see Figure 3) having an interior wound-contacting portion (pad 340) with a minimum lateral dimension of two inches or more (the width of the pad 340 across the width of the bandage 320 may 150 mm, see Paragraph [0160]; 150 mm equal to 5.9 inches).
Peterson, Keinan, and Buteux teaches a wound dressing having a bandage to treat wounds.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the interior wound-contacting portion of Modified Peterson and further include in which the interior wound-contacting portion having a minimum lateral dimension of two inches or more, as taught by Buteux. Buteux teaches the application is designed to be used for treatment of a wide variety of wounds and be substituted for dressings for simple traumatic wounds and for more complex and larger wounds. (see Paragraph [0003]).
Claims 15, 19-20, 22, 24, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson and Keinan as applied to claim 1 above, and further in view of Owen (WO 2020163880 A2).
Regarding Claim 15, Peterson and Keinan teach all of the limitations, as discussed above in claim 1 and Peterson further teaches in which the bandage has a detachable connector that secures the bandage to the dressing (see Col. 4 ln 11-15 and 42-46). However, Modified Peterson does not explicitly disclose in which the detachable connector comprises a frangible portion of the bandage, such as a hook and loop connector.
Owen teaches an enhanced trauma bandage (100, see Abstract; Figure ) in which a detachable connector comprises a frangible portion of the bandage, such as a hook and loop connector (the absorbent pad is removably attached to the compression dressing by hook and loop fasteners, see Paragraph [0031]).
Peterson, Keinan, and Owen are analogous art because all teach dressing comprising a bandage for a wound.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the detachable connector of Modified Peterson and further include in which the detachable connector comprises a frangible portion of the bandage, such as a hook and loop connector, as taught by Owen. Owen teaches a wound dressing and wound dressing system whereby the wound may be rapidly and effectively dressed, easily using only one hand to self- apply if necessary and easily reconfigurable for effective application to a number of different types of wounds (see Paragraph [0002]).
Regarding Claim 19, Peterson and Keinan teach all of the limitations, as discussed above in claim 1. However, Modified Peterson does not explicitly teach in which the bandage is secured in an at least partially rolled configuration via a roll retention mechanism.
Owen teaches an enhanced trauma bandage (100, see Abstract; Figure 1) in which the bandage is secured in an at least partially rolled configuration (the compression dressing is rolled into a roll or folded into a pad of varying sizes and shapes, see Paragraph [0034]) via a roll retention mechanism (the bandage material 110 may be configured and manufactured to provide a desired degree of self-tack sufficient to allow the roll to maintain its integrity until deliberately unrolled, see Paragraph [0064]).
Peterson, Keinan, and Owen are analogous art because all teach dressing comprising a bandage for a wound.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the bandage of Modified Peterson and further include in which the bandage is secured in an at least partially rolled configuration via a roll retention mechanism, as taught by Owen. Owen teaches it would be highly advantageous to have wound dressings and wound dressing systems that provide for rapid and effective deployment for controlling bleeding that are not subject to the limitations of conventional wound dressings and wound dressing systems (see Paragraph [0007]).
Regarding Claim 20, Modified Peterson teaches all of the limitations as discussed above in claim 19 and Owen further teaches in which the roll retention mechanism comprises a plurality of stays spaced longitudinally along the bandage, wherein the plurality of stays are preferably hook and loop connectors (the self-adhering elastic bandage is constructed whereby premature deployment is suppressed using patches of hook and loop fasteners or other complementary fastening surfaces on the adjacent layers of the elastic bandage, see Paragraph [0031]).
Regarding Claim 22, Modified Peterson teaches all of the limitations as discussed above in claim 19 and Owen further teaches in which the roll retention mechanism comprises a thread ( tack stitching may also be used), wherein the thread preferably extends perpendicular relative to a roll axis of the bandage in the at least partially rolled configuration (plurality of discrete attachments 114 that may comprise adhesives and stitching for securely attaching the various materials to one another, see Paragraph [0075]; attachments 114 extend perpendicular to the roll axis, Figure 1A-B).
Regarding Claim 24, Modified Peterson teaches all of the limitations as discussed above in claim 22 and Owen further teaches in which the thread comprises adhesive (plurality of discrete attachments 114 that may comprise adhesives and stitching, see Paragraph [0075]).
Regarding Claim 29, Peterson and Keinan teach all of the limitations as discussed above in claim 1. However, Modified Peterson does not explicitly disclose an outer packaging enclosing the bandage and dressing portion, preferably vacuum packaging.
Owen teaches an enhanced trauma bandage (100, see Abstract; Figure 1) comprising an outer packaging enclosing the bandage and dressing portion, preferably vacuum packaging (the compression dressing is rolled into a roll or folded into a pad of varying sizes and shapes, and packaged in a sterile or non-sterile package. The bandage may be compressed and/or vacuum sealed, see Paragraph [0034]).
Peterson, Keinan, and Owen are analogous art because all teach dressing comprising a bandage for a wound.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the bandage of Modified Peterson and further include an outer packaging enclosing the bandage and dressing portion, preferably vacuum packaging, as taught by Owen. Owen teaches a vacuum packaged bandage is beneficial to minimize the overall size of the packaged device (see Paragraph [0034]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Namier (US 6573419 B2) teaches a wound dressing system (see Abstract; Figures 1-4) comprising: a bandage (12); and a dressing (10) forming a patient-contacting face (contacting surface of pad 14) that defines an interior wound-contacting portion (14) and a peripheral adhesive portion (24 ), the peripheral adhesive portion at least partially surrounding the interior wound-contacting portion (overlaying the pad 14, see Figure 3-4). However, Namier fails to teach a removable outer cover overlying the peripheral adhesive portion comprising a dressing pad.
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/E.R./ (9/23/2025)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781